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The objectives of this clinical study are to evaluate the safety, efficacy, and pharmacokinetics (PK) of teduglutide in Japanese participants with short bowel syndrome (SBS) who are dependent on parenteral nutrition/intravenous (PN/IV) over a 24-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teduglutide 0.05 mg | Experimental | Participants will receive teduglutide 0.05 milligram per kilogram (mg/kg) subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teduglutide | Drug | Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET) | Change from baseline in weekly PS volume at EOT/ET was reported. | Baseline, EOT/ET (up to Week 28) |
| Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET) | Percent change from baseline in weekly PS volume at EOT/ET was reported. | Baseline, EOT/ET (up to Week 28) |
| Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 20 | Percentage of participants who achieved at least 20% reduction from baseline in weekly PS volume at Week 20 was reported. | Baseline, Week 20 |
| Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 | Percentage of participants who achieved at least 20% reduction from baseline in weekly PS volume at Week 24 was reported. | Baseline, Week 24 |
| 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) | Percentage of participants who achieve at least 20% reduction from baseline in weekly PS at EOT/ET was reported. | Baseline, EOT/ET (up to Week 28) |
| Change From Baseline in Days Per Week of Parenteral Support (PS) at End of Treatment/Early Termination (EOT/ET) | Change from baseline in days per week of PS at EOT/ET was reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Shire | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hiroshima University Hospital | Hiroshima | Hiroshima | 734-8551 | Japan | ||
| Hyogo College of Medicine Hospital |
De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites, …).
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A total of 7 participants were enrolled and received the treatment. Out of them, 6 participants completed the study.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants in the intent-to-treat (ITT) population who received at least 1 dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET) | Change from baseline in weekly PS volume at EOT/ET was reported. | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. | Posted | Mean | Standard Deviation | Liter per week (L/Week) | Baseline, EOT/ET (up to Week 28) |
|
|
From start of study drug administration up to EOT/ET (up to Week 28)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device related infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 27, 2018 | Jul 2, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 13, 2019 | Jul 2, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C494910 | teduglutide |
| D013594 | Syringes |
| D009339 | Needles |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Syringe | Device | Teduglutide will be administered using syringe. Syringe is approved for use in Japan by Pharmaceuticals and Medical Devices Agency (PMDA). |
|
| Needle | Device | Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA. |
|
| Vial Adapter for Device | Device | Vial adapter for device is approved for use in Japan by PMDA. |
|
| Baseline, EOT/ET (up to Week 28) |
| Change From Baseline in Plasma Citrulline Levels at End of Treatment/Early Termination (EOT/ET) | Plasma citrulline levels were measured as a biomarker of enterocyte mass. Change from baseline in plasma citrulline levels up to EOT/ET was reported. | Baseline, EOT/ET (up to Week 28) |
| Number of Participants Who Were Completely Weaned Off Parenteral Support (PS) at Week 24/End of Treatment (EOT) | Number of participants who were completely weaned off PS at Week 24/EOT was reported. | Week 24/EOT |
| Area Under the Plasma Concentration-Time Curve From Zero to the Last Measurable Concentration (AUC0-t) of Teduglutide | AUC0-t of teduglutide was reported. | 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 |
| Maximum Plasma Concentration (Cmax) of Teduglutide | Cmax of teduglutide was reported. | 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 |
| Time to Maximum Plasma Concentration (Tmax) of Teduglutide | Tmax of teduglutide was reported. | 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 |
| Terminal-phase Half-life (T1/2) of Teduglutide | T1/2 of teduglutide was reported. | 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 |
| Apparent Clearance (CL/F) of Teduglutide | CL/F of teduglutide was reported. | 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 |
| Apparent Volume of Distribution (Vz/F) of Teduglutide | Vz/F of teduglutide was reported. | 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 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | From start of study drug administration up to EOT/ET (up to Week 28) |
| Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG) | 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. | From start of study drug administration up to EOT/ET (up to Week 28) |
| Change From Baseline in Blood Pressure at End of Treatment/Early Termination (EOT/ET) | Change from baseline in systolic and diastolic blood pressure at EOT/ET was reported. | Baseline, EOT/ET (up to Week 28) |
| Change From Baseline in Pulse Rate at End of Treatment/Early Termination (EOT/ET) | Change from baseline in pulse rate at EOT/ET was reported. | Baseline, EOT/ET (up to Week 28) |
| Change From Baseline in Body Temperature at End of Treatment/Early Termination (EOT/ET) | Change from baseline in body temperature at EOT/ET was reported. | Baseline, EOT/ET (up to Week 28) |
| Change From Baseline in Hemoglobin at End of Treatment/Early Termination (EOT/ET) | Change from baseline in hemoglobin at EOT/ET was reported. | Baseline, EOT/ET (up to Week 28) |
| Change From Baseline in Hematocrit at End of Treatment/Early Termination (EOT/ET) | Change from baseline in hematocrit at EOT/ET was reported. | Baseline, EOT/ET (up to Week 28) |
| Change From Baseline in Serum Blood Urea Nitrogen (BUN) at End of Treatment/Early Termination (EOT/ET) | Change from baseline in serum blood urea nitrogen at EOT/ET was reported. | Baseline, EOT/ET (up to Week 28) |
| Change From Baseline in Creatinine at End of Treatment/Early Termination (EOT/ET) | Change from baseline in creatinine at EOT/ET was reported. | Baseline, EOT/ET (up to Week 28) |
| Change From Baseline in Urine Sodium at End of Treatment/Early Termination (EOT/ET) | Change from baseline in urine sodium at EOT/ET was reported. | Baseline, EOT/ET (up to Week 28) |
| Number of Participants Who Reported Positive Specific Antibodies to Teduglutide at End of Treatment/Early Termination (EOT/ET) | Number of participants who reported positive specific antibodies to teduglutide at EOT/ET was reported. | EOT/ET (up to Week 28) |
| Change From Baseline in 48-Hour Urine Output at End of Treatment/Early Termination (EOT/ET) | Change from baseline in 48-hour urine output at EOT/ET was reported. | Baseline, EOT/ET (up to Week 28) |
| Change From Baseline in Body Weight at End of Treatment/Early Termination (EOT/ET) | Change from baseline in body weight at EOT/ET was reported. | Baseline, EOT/ET (up to Week 28) |
| Change From Baseline in Body Mass Index (BMI) at End of Treatment/Early Termination (EOT/ET) | Change from baseline in BMI at EOT/ET was reported. | Baseline, EOT/ET (up to Week 28) |
| Number of Participants With Abnormal Clinically Significant Changes in Gastrointestinal (GI) Specific Tests at Week 24/ET (Early Termination) | 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. | Week 24/ET |
| Hyōgo |
| 663-8501 |
| Japan |
| Tohoku University Hospital | Miyagi-Ken | 980-8574 | Japan |
| Osaka University Hospital | Osaka | 565-0871 | Japan |
| Yokohama Municipal Citizen's Hospital | Yokohama | 240-8555 | Japan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET) | Percent change from baseline in weekly PS volume at EOT/ET was reported. | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. | Posted | Mean | Standard Deviation | Percent change | Baseline, EOT/ET (up to Week 28) |
|
|
|
| Primary | Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 20 | Percentage of participants who achieved at least 20% reduction from baseline in weekly PS volume at Week 20 was reported. | 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. | Posted | Number | Percentage of participants | Baseline, Week 20 |
|
|
|
| Primary | Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 | Percentage of participants who achieved at least 20% reduction from baseline in weekly PS volume at Week 24 was reported. | 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. | Posted | Number | Percentage of participants | Baseline, Week 24 |
|
|
|
| Primary | 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) | Percentage of participants who achieve at least 20% reduction from baseline in weekly PS at EOT/ET was reported. | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. | Posted | Number | Percentage of participants | Baseline, EOT/ET (up to Week 28) |
|
|
|
| Primary | Change From Baseline in Days Per Week of Parenteral Support (PS) at End of Treatment/Early Termination (EOT/ET) | Change from baseline in days per week of PS at EOT/ET was reported. | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. | Posted | Mean | Standard Deviation | Days per Week | Baseline, EOT/ET (up to Week 28) |
|
|
|
| Primary | Change From Baseline in Plasma Citrulline Levels at End of Treatment/Early Termination (EOT/ET) | Plasma citrulline levels were measured as a biomarker of enterocyte mass. Change from baseline in plasma citrulline levels up to EOT/ET was reported. | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. | Posted | Mean | Standard Deviation | Micromoles (mcmol) | Baseline, EOT/ET (up to Week 28) |
|
|
|
| Primary | Number of Participants Who Were Completely Weaned Off Parenteral Support (PS) at Week 24/End of Treatment (EOT) | Number of participants who were completely weaned off PS at Week 24/EOT was reported. | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. | Posted | Count of Participants | Participants | Week 24/EOT |
|
|
|
| Primary | Area Under the Plasma Concentration-Time Curve From Zero to the Last Measurable Concentration (AUC0-t) of Teduglutide | AUC0-t of teduglutide was reported. | 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. | Posted | Mean | Standard Deviation | Hour*nanogram per milliliter (h*ng/mL) | 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 |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) of Teduglutide | Cmax of teduglutide was reported. | PK population included all participants who received at least 1 dose of teduglutide and had at least 1 evaluable post-dose pharmacokinetic concentration value. | Posted | Mean | Standard Deviation | Nanograms per milliliter (ng/mL) | 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 |
|
|
|
| Primary | Time to Maximum Plasma Concentration (Tmax) of Teduglutide | Tmax of teduglutide was reported. | PK population included all participants who received at least 1 dose of teduglutide and had at least 1 evaluable post-dose pharmacokinetic concentration value. | Posted | Median | Full Range | Hour | 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 |
|
|
|
| Primary | Terminal-phase Half-life (T1/2) of Teduglutide | T1/2 of teduglutide was reported. | 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. | Posted | Median | Full Range | Hour | 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 |
|
|
|
| Primary | Apparent Clearance (CL/F) of Teduglutide | CL/F of teduglutide was reported. | 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. | Posted | Mean | Standard Deviation | Milliliter per hour (mL/h) | 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 |
|
|
|
| Primary | Apparent Volume of Distribution (Vz/F) of Teduglutide | Vz/F of teduglutide was reported. | 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. | Posted | Mean | Standard Deviation | Milliliter (mL) | 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 |
|
|
|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | Safety population included all participants in the ITT population who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From start of study drug administration up to EOT/ET (up to Week 28) |
|
|
|
| Primary | Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG) | 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. | Safety population included all participants in the ITT population who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From start of study drug administration up to EOT/ET (up to Week 28) |
|
|
|
| Primary | Change From Baseline in Blood Pressure at End of Treatment/Early Termination (EOT/ET) | Change from baseline in systolic and diastolic blood pressure at EOT/ET was reported. | Safety population included all participants in the ITT population who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Millimetre of mercury (mmHg) | Baseline, EOT/ET (up to Week 28) |
|
|
|
| Primary | Change From Baseline in Pulse Rate at End of Treatment/Early Termination (EOT/ET) | Change from baseline in pulse rate at EOT/ET was reported. | Safety population included all participants in the ITT population who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Beats per minute (beats/min) | Baseline, EOT/ET (up to Week 28) |
|
|
|
| Primary | Change From Baseline in Body Temperature at End of Treatment/Early Termination (EOT/ET) | Change from baseline in body temperature at EOT/ET was reported. | Safety population included all participants in the ITT population who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Degree Celsius | Baseline, EOT/ET (up to Week 28) |
|
|
|
| Primary | Change From Baseline in Hemoglobin at End of Treatment/Early Termination (EOT/ET) | Change from baseline in hemoglobin at EOT/ET was reported. | Safety population included all participants in the ITT population who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Gram per liter (g/L) | Baseline, EOT/ET (up to Week 28) |
|
|
|
| Primary | Change From Baseline in Hematocrit at End of Treatment/Early Termination (EOT/ET) | Change from baseline in hematocrit at EOT/ET was reported. | Safety population included all participants in the ITT population who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Volume per volume (v/v) | Baseline, EOT/ET (up to Week 28) |
|
|
|
| Primary | Change From Baseline in Serum Blood Urea Nitrogen (BUN) at End of Treatment/Early Termination (EOT/ET) | Change from baseline in serum blood urea nitrogen at EOT/ET was reported. | Safety population included all participants in the ITT population who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | mmol/L | Baseline, EOT/ET (up to Week 28) |
|
|
|
| Primary | Change From Baseline in Creatinine at End of Treatment/Early Termination (EOT/ET) | Change from baseline in creatinine at EOT/ET was reported. | Safety population included all participants in the ITT population who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Micromoles per liter (mcmol/L) | Baseline, EOT/ET (up to Week 28) |
|
|
|
| Primary | Change From Baseline in Urine Sodium at End of Treatment/Early Termination (EOT/ET) | Change from baseline in urine sodium at EOT/ET was reported. | Safety population included all participants in the ITT population who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | millimoles per liter (mmol/L) | Baseline, EOT/ET (up to Week 28) |
|
|
|
| Primary | Number of Participants Who Reported Positive Specific Antibodies to Teduglutide at End of Treatment/Early Termination (EOT/ET) | Number of participants who reported positive specific antibodies to teduglutide at EOT/ET was reported. | Safety population included all participants in the ITT population who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | EOT/ET (up to Week 28) |
|
|
|
| Primary | Change From Baseline in 48-Hour Urine Output at End of Treatment/Early Termination (EOT/ET) | Change from baseline in 48-hour urine output at EOT/ET was reported. | Safety population included all participants in the ITT population who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Milliliter per day (mL/day) | Baseline, EOT/ET (up to Week 28) |
|
|
|
| Primary | Change From Baseline in Body Weight at End of Treatment/Early Termination (EOT/ET) | Change from baseline in body weight at EOT/ET was reported. | Safety population included all participants in the ITT population who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | kilogram (kg) | Baseline, EOT/ET (up to Week 28) |
|
|
|
| Primary | Change From Baseline in Body Mass Index (BMI) at End of Treatment/Early Termination (EOT/ET) | Change from baseline in BMI at EOT/ET was reported. | Safety population included all participants in the ITT population who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Kilograms per square meter (kg/m^2) | Baseline, EOT/ET (up to Week 28) |
|
|
|
| Primary | Number of Participants With Abnormal Clinically Significant Changes in Gastrointestinal (GI) Specific Tests at Week 24/ET (Early Termination) | 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. | Safety population included all participants in the ITT population who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Week 24/ET |
|
|
|
| 0 |
| 7 |
| 3 |
| 7 |
| 7 |
| 7 |
| Medical device site infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Polycythaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Muscle contusion | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Hypozincaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
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.
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |