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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005791-35 | EudraCT Number |
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The purpose of this study is to determine if an investigational treatment (teduglutide) is safe and effective in Japanese children (age 4 months through 15 years of age) with SBS who are dependent on parenteral support. This study will also evaluate how teduglutide moves through the body (pharmacokinetics) and how it affects the body (pharmacodynamics).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teduglutide | Experimental | Participants will receive teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teduglutide | Drug | 0.05 mg/kg/day SC injection once daily for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data | Absolute change from baseline in PS volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Here, milliliter per kilogram per day is abbreviated as mL/kg/day. | Baseline, EOT (up to Week 24) |
| Percent Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data | Percent change from baseline in PS volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | Baseline, EOT (up to Week 24) |
| Absolute Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data | Absolute change from baseline in PS caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Here, kilo-calories per kilogram per day was abbreviated as (kcal/kg/day). | Baseline, EOT (up to Week 24) |
| Percent Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data | Percent change from baseline in PS caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | Baseline, EOT (up to Week 24) |
| Absolute Change From Baseline in Plasma Citrulline at End of Treatment (EOT) | Absolute change from baseline in plasma citrulline at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. |
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Inclusion Criteria:
For infants 4 to <12 months corrected gestational age: Inability to significantly reduce PN/IV support, usually associated with minimal or no advance in enteral feeds (ie, 10% or less change in PN or advance in feeds) for at least 1 month prior to and during screening, as assessed by the investigator.
For children 1 to 15 years of age:
Inability to significantly reduce PN/IV support, usually associated with minimal or no advance in enteral feeds (ie, 10% or less change in PN or advance in feeds) for at least 3 months prior to and during screening, as assessed by the investigator.
Transient instability for events such as interruption of central access or treatment of sepsis is allowed if the PN/IV support returns to within 10% of baseline prior to the event.
- Sexually active female participants of childbearing potential must use medically acceptable methods of birth control during and for 4 weeks following the last dose of investigational product.
Exclusion Criteria:
For infants 4 to <12 months corrected gestational age at least 2 of any of the following parameters:
For children 1 to 15 years of age:
Total bilirubin >= 2x upper limit of normal (ULN)
Aspartate aminotransferase (AST) >= 7x ULN
Alanine aminotransferase (ALT) >= 7x ULN
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Shire | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyushu University Hospital | Fukuoka | Fukuoka | 812-8582 | Japan | ||
| Tsukuba University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37364133 | Derived | Chiba M, Masumoto K, Kaji T, Matsuura T, Morii M, Fagbemi A, Hill S, Pakarinen MP, Protheroe S, Urs A, Chen ST, Sakui S, Udagawa E, Wada M. Efficacy and Safety of Teduglutide in Infants and Children With Short Bowel Syndrome Dependent on Parenteral Support. J Pediatr Gastroenterol Nutr. 2023 Sep 1;77(3):339-346. doi: 10.1097/MPG.0000000000003867. Epub 2023 Jun 26. |
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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 10 Japanese study participants were enrolled into the study, including 8 children ages 1 through 15 years of age and 2 infants aged 4 months through < 12 months of corrected gestational age. All the participants received treatment and completed the study.
The study was conducted at 6 centers in Japan between 13 January 2017 (first participant first visit) and 21 January 2020 (last participant last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Children (Aged: 1 to 15 Years) | Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28. |
| FG001 | Infants (Corrected Gestational Age: 4 to < 12 Months) | Participants (Infants) from 4 through < 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Intention-to-treat (ITT) population consisted of all participants who were enrolled into the study and met all eligible criteria for the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Children (Aged: 1 to 15 Years) | Participants aged from 1 through 15 years received teduglutide 0.05 milligram per kilogram per day (mg/kg/day) subcutaneous (SC) injection once daily for 24 weeks and completed the study at Week 28. |
| BG001 | Infants (Corrected Gestational Age: 4 to < 12 Months) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Absolute Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data | Absolute change from baseline in PS volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Here, milliliter per kilogram per day is abbreviated as mL/kg/day. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for the study. | Posted | Mean | Standard Deviation | mL/kg/day | Baseline, EOT (up to Week 24) |
|
From start of study drug administration up to end of the study (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 | Total Children (Aged: 1 - 15 Years) | Participants aged from 1 through 15 years received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.0 | 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 | Jun 12, 2018 | Dec 7, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 13, 2019 | Dec 7, 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 |
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| Baseline, EOT (up to Week 24) |
| Percent Change From Baseline in Plasma Citrulline at End of Treatment (EOT) | Percent change from baseline in plasma citrulline at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | Baseline, EOT (up to Week 24) |
| Absolute Change From Baseline in Enteral Nutritional (EN) Volume at End of Treatment (EOT) Based on Dairy Data | Absolute change from baseline in EN volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | Baseline, EOT (up to Week 24) |
| Percent Change From Baseline in Enteral Nutritional (EN) Volume at End of Treatment (EOT) Based on Dairy Data | Percent change from baseline in EN volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | Baseline, EOT (up to Week 24) |
| Absolute Change From Baseline in Enteral Nutritional (EN) Caloric Intake at End of Treatment (EOT) Based on Dairy Data | Absolute change from baseline in EN caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | Baseline, EOT (up to Week 24) |
| Percent Change From Baseline in Enteral Nutritional (EN) Caloric Intake at End of Treatment (EOT) Based on Dairy Data | Percent change from baseline in EN caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | Baseline, EOT (up to Week 24) |
| Number of Participants Who Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at Week 24 | Number of participants who achieved at least 20% reduction in PS volume at Week 24 was reported. | Week 24 |
| Number of Participants Who Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at End of Treatment (EOT) | Number of participants who achieved at least 20% reduction in PS volume at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | EOT (up to Week 24) |
| Number of Participants Who Achieved 100 Percent (%) Reduction in Complete Weaning of Parenteral Support (PS) Volume at End of Treatment (EOT) | Number of participants who achieved at least 100% reduction in complete weaning of PS volume at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | EOT (up to Week 24) |
| Number of Participants Who Achieved Greater Than or Equal to (>=) 20 Percent (%) Reduction in Parenteral Support (PS) Volume at Week 28 | Number of participants who achieved >= 20% reduction in PS volume at Week 28 was reported. | Week 28 |
| Absolute Change From End of Treatment (EOT) in Parenteral Support (PS) Volume at End of Study (EOS) Based on Dairy Data | Absolute change from EOT (up to Week 24) in PS volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | EOT (up to Week 24), EOS (up to Week 28) |
| Percent Change From End of Treatment (EOT) in Parenteral Support (PS) Volume at End of Study (EOS) Based on Dairy Data | Percent change from EOT (up to Week 24) in PS volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | EOT (up to Week 24), EOS (up to Week 28) |
| Absolute Change From End of Treatment (EOT) in Parenteral Support (PS) Caloric Intake at End of Study (EOS) Based on Dairy Data | Absolute change from EOT (up to Week 24) in PS caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | EOT (up to Week 24), EOS (up to Week 28) |
| Percent Change From End of Treatment (EOT) in Parenteral Support (PS) Caloric Intake at End of Study (EOS) Based on Dairy Data | Percent change from EOT (up to Week 24) in PS caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | EOT (up to Week 24), EOS (up to Week 28) |
| Absolute Change From End of Treatment (EOT) in Plasma Citrulline at End of Study (EOS) | Absolute change from EOT (up to Week 24) in plasma citrulline at EOS (up to Week 28) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | EOT (up to Week 24), EOS (up to Week 28) |
| Percent Change From End of Treatment (EOT) in Plasma Citrulline at End of Study (EOS) | Percent change from EOT (up to Week 24) in plasma citrulline at EOS (up to Week 28) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | EOT (up to Week 24), EOS (up to Week 28) |
| Absolute Change From End of Treatment (EOT) in Enteral Nutritional (EN) Volume at End of Study (EOS) Based on Dairy Data | Absolute change from EOT (up to Week 24) in EN volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | EOT (up to Week 24), EOS (up to Week 28) |
| Percent Change From End of Treatment (EOT) in Enteral Nutritional (EN) Volume at End of Study (EOS) Based on Dairy Data | Percent change from EOT (up to Week 24) in EN volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | EOT (up to Week 24), EOS (up to Week 28) |
| Absolute Change From End of Treatment (EOT) in Enteral Nutritional (EN) Caloric Intake at End of Study (EOS) Based on Dairy Data | Absolute change from EOT (up to Week 24) in EN caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | EOT (up to Week 24), EOS (up to Week 28) |
| Percent Change From End of Treatment (EOT) in Enteral Nutritional (EN) Caloric Intake at End of Study (EOS) Based on Dairy Data | Percent change from EOT (up to Week 24) in EN caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | EOT (up to Week 24), EOS (up to Week 28) |
| Absolute Change From Baseline in Number of Hours Per Day of Parenteral Support (PS) Usage at End of Treatment (EOT) Based on Dairy Data | Absolute change from baseline in number of hours per day of PS Usage at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | Baseline, EOT (up to Week 24) |
| Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at End of Treatment (EOT) Based on Dairy Data | Absolute change from baseline in number of days per Week of PS usage at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | Baseline, EOT (up to Week 24) |
| 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 any AEs whose onset occurred, severity worsened, or intensity increased after receiving the investigational product. | From start of study drug administration up to EOS (up to Week 28) |
| Change From Baseline in Body Weight for Age Z-score at Week 28 | Body weight was measured using age Z-score. A Z-score was defined as the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in body weight for age Z-score at Week 28 was reported. | Baseline, Week 28 |
| Change From Baseline in Height for Age Z-score at Week 28 | Height was measured using age Z-score. A Z-score was defined as the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in height for age Z-score at Week 28 was reported. | Baseline, Week 28 |
| Change From Baseline in Head Circumference for Age Z-score at Week 28 | Head circumference was measured using age Z-score. A Z-score was defined as the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in head circumference for age Z-score at Week 28 was reported. | Baseline, Week 28 |
| Number of Participants With Clinically Significant Changes in Vital Signs Reported as Treatment Emergent Adverse Events (TEAEs) | Vital sign assessments included pulse rate, blood pressure, or body temperature. Number of participants with clinically significant changes in vital signs by the investigator were recorded as TEAEs. | From start of study drug administration up to EOS (up to Week 28) |
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as Treatment Emergent Adverse Events (TEAEs) | 12-lead ECG was performed. Any change in ECG assessments which were deemed to be clinically significant changes were recorded as TEAEs. | From start of study drug administration up to EOS (up to Week 28) |
| Number of Participants With Clinically Significant Laboratory Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs) | Clinical laboratory assessments included biochemistry, hematology, coagulation, urinalysis. The number of participants with clinically significant laboratory abnormalities were reported as TEAEs. | From start of study drug administration up to EOS (up to Week 28) |
| Change From Baseline in the Average Urine Output at Week 28 | Average urine output was recorded in measured volume at Week 28 was recorded. | Baseline, Week 28 |
| Change From Baseline in the Fecal Output at Week 28 | Change from baseline in the fecal output (Average number of stools per day) at Week 28 was recorded. | Baseline, Week 28 |
| Number of Participants With Positive Specific Antibodies to Teduglutide | Number of participants with positive specific antibodies to teduglutide were used to summarize the presence of antibodies. | From start of study drug administration up to EOS (up to Week 28) |
| Number of Participants With Clinically Significant Abnormal Findings in Gastrointestinal (GI) Specific Testing | GI specific testing included colonoscopy or sigmoidoscopy, abdominal ultrasound, fecal occult blood testing, upper GI series with small bowel follow-through (UGI/SBFT). EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Number of participants with clinically significant abnormal findings in gastrointestinal specific testing were reported. | Baseline, EOT (up to Week 24) |
| Area Under the Concentration-time Curve at Steady State (AUCtau,ss) of Teduglutide in Plasma | Since only 2 sparse pharmacokinetics (PK) samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study. | Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose |
| Maximum Plasma Concentration at Steady-state (Cmax,ss) of Teduglutide in Plasma | Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study. | Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose |
| Minimum Plasma Concentration at Steady-state (Cmin.ss) of Teduglutide in Plasma | Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study. | Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose |
| Time to Reach Maximum Observed Drug Concentration (Tmax) of Teduglutide in Plasma | Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study. | Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose |
| Terminal-Phase Half-life (t1/2) of Teduglutide in Plasma | Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study. | Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose |
| Apparent Clearance (CL/F) of Teduglutide | Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study. | Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose |
| Apparent Volume of Distribution (V[Lambda z]/F) of Teduglutide | Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study. | Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose |
| Tsukuba |
| Ibaraki |
| 305-8576 |
| Japan |
| Kagoshima University | Kagoshima | Kagoshima-ken | 890-8520 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Showa University | Shinagawa-ku | Tokyo-To | 142-8555 | Japan |
Participants (Infants) from 4 through < 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Infants (Corrected Gestational Age: 4 to < 12 Months) | Participants (Infants) from 4 through < 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28. |
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| Primary | Percent Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data | Percent change from baseline in PS volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for the study. | Posted | Mean | Standard Deviation | Percent Change | Baseline, EOT (up to Week 24) |
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| Primary | Absolute Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data | Absolute change from baseline in PS caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Here, kilo-calories per kilogram per day was abbreviated as (kcal/kg/day). | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for the study. | Posted | Mean | Standard Deviation | kcal/kg/day | Baseline, EOT (up to Week 24) |
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| Primary | Percent Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data | Percent change from baseline in PS caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. | Posted | Mean | Standard Deviation | Percent change | Baseline, EOT (up to Week 24) |
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| Primary | Absolute Change From Baseline in Plasma Citrulline at End of Treatment (EOT) | Absolute change from baseline in plasma citrulline at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Data for this outcome measure was not planned to be collected and analyzed for infants. | Posted | Mean | Standard Deviation | Micromoles per liter (mcmol/L) | Baseline, EOT (up to Week 24) |
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| Primary | Percent Change From Baseline in Plasma Citrulline at End of Treatment (EOT) | Percent change from baseline in plasma citrulline at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Data for this outcome measure was not planned to be collected and analyzed for infants. | Posted | Mean | Standard Deviation | Percent change | Baseline, EOT (up to Week 24) |
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| Primary | Absolute Change From Baseline in Enteral Nutritional (EN) Volume at End of Treatment (EOT) Based on Dairy Data | Absolute change from baseline in EN volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. | Posted | Mean | Standard Deviation | mL/kg/day | Baseline, EOT (up to Week 24) |
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| Primary | Percent Change From Baseline in Enteral Nutritional (EN) Volume at End of Treatment (EOT) Based on Dairy Data | Percent change from baseline in EN volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent change | Baseline, EOT (up to Week 24) |
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| Primary | Absolute Change From Baseline in Enteral Nutritional (EN) Caloric Intake at End of Treatment (EOT) Based on Dairy Data | Absolute change from baseline in EN caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. | Posted | Mean | Standard Deviation | kcal/kg/day | Baseline, EOT (up to Week 24) |
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| Primary | Percent Change From Baseline in Enteral Nutritional (EN) Caloric Intake at End of Treatment (EOT) Based on Dairy Data | Percent change from baseline in EN caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent change | Baseline, EOT (up to Week 24) |
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| Primary | Number of Participants Who Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at Week 24 | Number of participants who achieved at least 20% reduction in PS volume at Week 24 was reported. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Week 24 |
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| Primary | Number of Participants Who Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at End of Treatment (EOT) | Number of participants who achieved at least 20% reduction in PS volume at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. | Posted | Count of Participants | Participants | EOT (up to Week 24) |
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| Primary | Number of Participants Who Achieved 100 Percent (%) Reduction in Complete Weaning of Parenteral Support (PS) Volume at End of Treatment (EOT) | Number of participants who achieved at least 100% reduction in complete weaning of PS volume at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. | Posted | Count of Participants | Participants | EOT (up to Week 24) |
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| Primary | Number of Participants Who Achieved Greater Than or Equal to (>=) 20 Percent (%) Reduction in Parenteral Support (PS) Volume at Week 28 | Number of participants who achieved >= 20% reduction in PS volume at Week 28 was reported. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. | Posted | Count of Participants | Participants | Week 28 |
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| Primary | Absolute Change From End of Treatment (EOT) in Parenteral Support (PS) Volume at End of Study (EOS) Based on Dairy Data | Absolute change from EOT (up to Week 24) in PS volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. | Posted | Mean | Standard Deviation | mL/kg/day | EOT (up to Week 24), EOS (up to Week 28) |
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| Primary | Percent Change From End of Treatment (EOT) in Parenteral Support (PS) Volume at End of Study (EOS) Based on Dairy Data | Percent change from EOT (up to Week 24) in PS volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent change | EOT (up to Week 24), EOS (up to Week 28) |
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| Primary | Absolute Change From End of Treatment (EOT) in Parenteral Support (PS) Caloric Intake at End of Study (EOS) Based on Dairy Data | Absolute change from EOT (up to Week 24) in PS caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. | Posted | Mean | Standard Deviation | kcal/kg/day | EOT (up to Week 24), EOS (up to Week 28) |
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| Primary | Percent Change From End of Treatment (EOT) in Parenteral Support (PS) Caloric Intake at End of Study (EOS) Based on Dairy Data | Percent change from EOT (up to Week 24) in PS caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent change | EOT (up to Week 24), EOS (up to Week 28) |
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| Primary | Absolute Change From End of Treatment (EOT) in Plasma Citrulline at End of Study (EOS) | Absolute change from EOT (up to Week 24) in plasma citrulline at EOS (up to Week 28) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Data for this outcome measure was not planned to be collected and analyzed for infants. | Posted | Mean | Standard Deviation | Micromoles (mcM) | EOT (up to Week 24), EOS (up to Week 28) |
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| Primary | Percent Change From End of Treatment (EOT) in Plasma Citrulline at End of Study (EOS) | Percent change from EOT (up to Week 24) in plasma citrulline at EOS (up to Week 28) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Data for this outcome measure was not planned to be collected and analyzed for infants. | Posted | Mean | Standard Deviation | Percent change | EOT (up to Week 24), EOS (up to Week 28) |
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| Primary | Absolute Change From End of Treatment (EOT) in Enteral Nutritional (EN) Volume at End of Study (EOS) Based on Dairy Data | Absolute change from EOT (up to Week 24) in EN volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. | Posted | Mean | Standard Deviation | mL/kg/day | EOT (up to Week 24), EOS (up to Week 28) |
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| Primary | Percent Change From End of Treatment (EOT) in Enteral Nutritional (EN) Volume at End of Study (EOS) Based on Dairy Data | Percent change from EOT (up to Week 24) in EN volume at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent change | EOT (up to Week 24), EOS (up to Week 28) |
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| Primary | Absolute Change From End of Treatment (EOT) in Enteral Nutritional (EN) Caloric Intake at End of Study (EOS) Based on Dairy Data | Absolute change from EOT (up to Week 24) in EN caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. | Posted | Mean | Standard Deviation | kcal/kg/day | EOT (up to Week 24), EOS (up to Week 28) |
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| Primary | Percent Change From End of Treatment (EOT) in Enteral Nutritional (EN) Caloric Intake at End of Study (EOS) Based on Dairy Data | Percent change from EOT (up to Week 24) in EN caloric intake at EOS (up to Week 28) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent change | EOT (up to Week 24), EOS (up to Week 28) |
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| Primary | Absolute Change From Baseline in Number of Hours Per Day of Parenteral Support (PS) Usage at End of Treatment (EOT) Based on Dairy Data | Absolute change from baseline in number of hours per day of PS Usage at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. | Posted | Mean | Standard Deviation | Hours per day (hours/day) | Baseline, EOT (up to Week 24) |
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| Primary | Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at End of Treatment (EOT) Based on Dairy Data | Absolute change from baseline in number of days per Week of PS usage at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. | Posted | Mean | Standard Deviation | Days per week | Baseline, EOT (up to Week 24) |
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| 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 any AEs whose onset occurred, severity worsened, or intensity increased after receiving the investigational product. | Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up. | Posted | Count of Participants | Participants | From start of study drug administration up to EOS (up to Week 28) |
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| Primary | Change From Baseline in Body Weight for Age Z-score at Week 28 | Body weight was measured using age Z-score. A Z-score was defined as the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in body weight for age Z-score at Week 28 was reported. | Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up. | Posted | Mean | Standard Deviation | Z-score | Baseline, Week 28 |
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| Primary | Change From Baseline in Height for Age Z-score at Week 28 | Height was measured using age Z-score. A Z-score was defined as the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in height for age Z-score at Week 28 was reported. | Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up. | Posted | Mean | Standard Deviation | Z-score | Baseline, Week 28 |
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| Primary | Change From Baseline in Head Circumference for Age Z-score at Week 28 | Head circumference was measured using age Z-score. A Z-score was defined as the deviation of the value for an individual from the mean value of the reference population divided by the standard deviation for the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in head circumference for age Z-score at Week 28 was reported. | Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up. Data for this outcome measure was not planned to be collected and analyzed for Total Children (Aged: 1 to 15 Years). | Posted | Mean | Standard Deviation | Z-score | Baseline, Week 28 |
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| Primary | Number of Participants With Clinically Significant Changes in Vital Signs Reported as Treatment Emergent Adverse Events (TEAEs) | Vital sign assessments included pulse rate, blood pressure, or body temperature. Number of participants with clinically significant changes in vital signs by the investigator were recorded as TEAEs. | Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up. | Posted | Count of Participants | Participants | From start of study drug administration up to EOS (up to Week 28) |
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| Primary | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as Treatment Emergent Adverse Events (TEAEs) | 12-lead ECG was performed. Any change in ECG assessments which were deemed to be clinically significant changes were recorded as TEAEs. | Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up. | Posted | Count of Participants | Participants | From start of study drug administration up to EOS (up to Week 28) |
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| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs) | Clinical laboratory assessments included biochemistry, hematology, coagulation, urinalysis. The number of participants with clinically significant laboratory abnormalities were reported as TEAEs. | Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up. | Posted | Count of Participants | Participants | From start of study drug administration up to EOS (up to Week 28) |
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| Primary | Change From Baseline in the Average Urine Output at Week 28 | Average urine output was recorded in measured volume at Week 28 was recorded. | Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mL/kg/day | Baseline, Week 28 |
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| Primary | Change From Baseline in the Fecal Output at Week 28 | Change from baseline in the fecal output (Average number of stools per day) at Week 28 was recorded. | Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Average number of stools per day | Baseline, Week 28 |
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| Primary | Number of Participants With Positive Specific Antibodies to Teduglutide | Number of participants with positive specific antibodies to teduglutide were used to summarize the presence of antibodies. | Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up. | Posted | Count of Participants | Participants | From start of study drug administration up to EOS (up to Week 28) |
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| Primary | Number of Participants With Clinically Significant Abnormal Findings in Gastrointestinal (GI) Specific Testing | GI specific testing included colonoscopy or sigmoidoscopy, abdominal ultrasound, fecal occult blood testing, upper GI series with small bowel follow-through (UGI/SBFT). EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Number of participants with clinically significant abnormal findings in gastrointestinal specific testing were reported. | Safety population consisted of all participants in the ITT population who received at least 1 administration of investigational product with any safety follow-up. Data for this outcome was not planned to be collected and analyzed for infants. | Posted | Count of Participants | Participants | Baseline, EOT (up to Week 24) |
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| Primary | Area Under the Concentration-time Curve at Steady State (AUCtau,ss) of Teduglutide in Plasma | Since only 2 sparse pharmacokinetics (PK) samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study. | Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study. | Posted | Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose |
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| Primary | Maximum Plasma Concentration at Steady-state (Cmax,ss) of Teduglutide in Plasma | Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study. | Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study. | Posted | Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose |
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| Primary | Minimum Plasma Concentration at Steady-state (Cmin.ss) of Teduglutide in Plasma | Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study. | Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study. | Posted | Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose |
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| Primary | Time to Reach Maximum Observed Drug Concentration (Tmax) of Teduglutide in Plasma | Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study. | Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study. | Posted | Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose |
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| Primary | Terminal-Phase Half-life (t1/2) of Teduglutide in Plasma | Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study. | Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study. | Posted | Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose |
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| Primary | Apparent Clearance (CL/F) of Teduglutide | Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study. | Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study. | Posted | Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose |
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| Primary | Apparent Volume of Distribution (V[Lambda z]/F) of Teduglutide | Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study. | Since only 2 sparse PK samples were collected during the study, PK parameters were not estimated and analyzed using this study samples. Therefore, no PK parameters were reported in this study. | Posted | Baseline: Pre-dose, 1, 6 hours post-dose; Week 4: Pre-dose, 2, 4 hours post-dose |
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| 0 |
| 8 |
| 6 |
| 8 |
| 8 |
| 8 |
| EG001 | Infants (Corrected Gestational Age: 4 to < 12 Months) | Participants (Infants) from 4 through < 12 months of corrected gestational age received teduglutide 0.05 mg/kg/day SC injection once daily for 24 weeks and completed the study at Week 28. | 0 | 2 | 2 | 2 | 1 | 2 |
| Enterocolitis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Adenovirus infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Medical device site infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Device damage | Product Issues | MedDRA 20.0 | Non-systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Proctalgia | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Catheter site granuloma | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Injection site haematoma | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Injection site induration | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Injection site rash | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Food allergy | Immune system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Gingivitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Medical device site infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Frostbite | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
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| Gastrostomy tube site complication | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
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| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
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| Amylase increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Hyperlipasaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Hyperzincaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Device damage | Product Issues | MedDRA 20.0 | Non-systematic Assessment |
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| Balanoposthitis | Reproductive system and breast disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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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 |