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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005404-36 | EudraCT Number |
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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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The purpose of this clinical study is to evaluate the long-term safety and tolerability of teduglutide treatment in Japanese pediatric participants with short bowel syndrome (SBS) who completed Study SHP633-302 (NCT02980666).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teduglutide | 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-week intervals. If a participant deteriorates during a follow-up period, the participant may be evaluated immediately for additional teduglutide treatment (24-week interval) until teduglutide is commercially available for each participant, the participant's participation in this study is discontinued, or the study is discontinued. |
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| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 (IP) in the core study (SHP633-302 [NCT02980666]) or this extension study. Number of participants with TEAEs were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | From Baseline up to follow-up (up to 50 months) |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | Vital sign assessments included pulse rate, blood pressure (systolic and diastolic blood pressure) and body temperature. Number of participants with clinically significant abnormalities in vital signs which were deemed clinically significant by the investigator were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | From Baseline up to follow-up (up to 50 months) |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Clinical laboratory parameters included biochemistry, hematology and urinalysis. Number of participants with clinically significant abnormalities in laboratory parameters which were deemed clinically significant by the investigator were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | From Baseline up to follow-up (up to 50 months) |
| Percent Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment | Average total urine output was recorded over a 48-hour period of parental support (PS) stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The Average daily urine output milliliter per kilogram per day (mL/kg/day) was calculated as: (Total urine output over 48 hours / 2) / body weight (kilogram [kg]) where total urine output was calculated as the sum of the urine output in milliliter (mL) and the urine-only diaper weights in gram (g) (1g = 1mL) for the participant collected on the output diary form of electronic case report from (eCRF). Percent change from baseline in average total urine output at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Participants Diary Parenteral Support (PS) Volume at EOT of Each Cycle During Teduglutide Treatment | PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent reduction in weight-normalized diary PS values from baseline was calculated using the formula: % reduction in PS value at the visit = ([average daily value at the scheduled visit - average daily value at baseline of the core study (SHP633-302 [NCT02980666]) / average daily value at baseline of the core study (SHP633-302 [NCT02980666])) *100. Number of participants who achieved at least 20% reduction from baseline in participants diary PS volume at EOT of each cycle during teduglutide treatment were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).](streamdown:incomplete-link) |
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Inclusion Criteria:
Exclusion Criteria:
There are no exclusion criteria for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Shire | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akita University Hospital | Akita | Akita | 010-8543 | Japan | ||
| Kyushu 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. |
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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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 9 Japanese pediatric participants who completed Study SHP633-302 (NCT02980666) were enrolled into the extension study based on age of participants i.e., 7 children (aged 1 through 15 years of age) and 2 infants (aged 4 months through < 12 months of corrected gestational age).
The study was conducted at 6 centers in Japan from 23 August 2017 (first participant first visit) and 02 November 2021 (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 who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 milligram per kilogram (mg/kg) subcutaneous (SC) injection once daily for 24 weeks in each treatment cycle depending on the disease course. |
| FG001 | Infants (Corrected Gestational Age: 4 to < 12 Months) | Participants (Infants) from 4 through < 12 months of corrected gestational age who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]).
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Children (Aged: 1 to 15 Years) | Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course. |
| BG001 |
| 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 | 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 (IP) in the core study (SHP633-302 [NCT02980666]) or this extension study. Number of participants with TEAEs were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). | Posted | Count of Participants | Participants | No | From Baseline up to follow-up (up to 50 months) |
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From Baseline up to follow-up (up to 50 months)
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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 to 15 Years) | Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colonic haematoma | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@takeda.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 | Nov 6, 2020 | Apr 4, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 25, 2019 | Apr 4, 2022 | 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 of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
| Percent Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment | Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average number of stools per day. The average number of stools per day was calculated as (sum of the daily data in a 48-hour period/2). Percent change from baseline in average number of stools per day at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
| Percent Change From Baseline in Average Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment | Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average stool/mixed stool diaper weight (gram per kilogram per day [g/kg/day]). The body weight was used to calculate the daily stool/mixed stool diaper weight (g/kg/day). Percent change from baseline in average stool/mixed stool diaper weight at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
| Percent Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment | Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The body weight was used to calculate the average total ostomy output per day (mL/kg/day) using a formula analogous to that used to calculate the average daily urine output. Percent change from baseline in average total ostomy output at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
| Percent Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment | Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized the average typical stool form score using Bristol Stool Form Scale. The average typical stool form score was calculated as (sum of the daily data in a 48-hour period / 2). Typical Stool Form based on Bristol Stool Form Scale: 1 - Separate hard lumps, hard to pass, 2 - Sausage-shaped, but lumpy, 3 - Like a sausage but with cracks on the surface, 4- Like a sausage or snake, smooth and soft, 5- Soft blobs with clear-cut edges, 6- Fluffy pieces with ragged edges, a mushy stool, 7- Watery, no solid pieces. Entirely liquid. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). A negative change from baseline indicates improvement. | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
| Number of Participants With Anti-drug Antibodies (ADAs) (Including Neutralizing Antibodies) at EOT of Last Cycle During Teduglutide Treatment | Number of participants with ADAs (including NAbs) to teduglutide were used to summarize the presence of antibodies. The participants who tested positive only for ADAs (including NAbs) were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
| Number of Participants With Clinically Significant Changes 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). Number of participants with clinically significant changes findings in gastrointestinal specific testing were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
| Change From Baseline in Body Weight For Age Z-Score at EOT of Last Cycle During Teduglutide Treatment | Body weight was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
| Change From Baseline in Height For Age Z-Score at EOT of Cycle 1 During Teduglutide Treatment | Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of cycle 1 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 1 (up to 24 Weeks) |
| Change From Baseline in Height For Age Z-Score at EOT of Cycle 2 During Teduglutide Treatment | Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 2 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 2 (up to 48 weeks) |
| Change From Baseline in Height For Age Z-Score at EOT of Cycle 3 During Teduglutide Treatment | Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 3 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 3 (up to 72 weeks) |
| Change From Baseline in Height For Age Z-Score at EOT of Cycle 4 During Teduglutide Treatment | Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 4 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 4 (up to 96 weeks) |
| Change From Baseline in Height For Age Z-Score at EOT of Cycle 5 During Teduglutide Treatment | Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 5 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 5 (up to 120 weeks) |
| Change From Baseline in Height For Age Z-Score at EOT of Cycle 6 During Teduglutide Treatment | Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 6 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 6 (up to 144 weeks) |
| Change From Baseline in Height For Age Z-Score at EOT of Cycle 7 During Teduglutide Treatment | Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 7 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 7 (up to 168 weeks) |
| Change From Baseline in Height For Age Z-Score at EOT of Cycle 8 During Teduglutide Treatment | Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 8 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 8 (up to 192 weeks) |
| Change From Baseline in Height For Age Z-Score at EOT of Cycle 9 During Teduglutide Treatment | Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 9 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 9 (up to 196 weeks) |
| Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 1 During Teduglutide Treatment | Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 1 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 1 (up to 24 weeks) |
| Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 2 During Teduglutide Treatment | Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 2 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 2 (up to 48 weeks) |
| Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 3 During Teduglutide Treatment | Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 3 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 3 (up to 72 weeks) |
| Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 4 During Teduglutide Treatment | Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 4 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 4 (up to 76 weeks) |
| Change From Baseline in Body Mass Index (BMI) for Age Z-score at EOT of Cycle 1 During Teduglutide Treatment | BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 1 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 1 (up to 24 weeks) |
| Change From Baseline in BMI for Age Z-score at EOT of Cycle 2 During Teduglutide Treatment | BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 2 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 2 (up to 48 weeks) |
| Change From Baseline in BMI for Age Z-score at EOT of Cycle 3 During Teduglutide Treatment | BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 3 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 3 (up to 72 weeks) |
| Change From Baseline in BMI for Age Z-score at EOT of Cycle 4 During Teduglutide Treatment | BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 4 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 4 (up to 96 weeks) |
| Change From Baseline in BMI for Age Z-score at EOT of Cycle 5 During Teduglutide Treatment | BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 5 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 5 (up to 120 weeks) |
| Change From Baseline in BMI for Age Z-score at EOT of Cycle 6 During Teduglutide Treatment | BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 6 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 6 (up to 144 weeks) |
| Change From Baseline in BMI for Age Z-score at EOT of Cycle 7 During Teduglutide Treatment | BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 7 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 7 (up to 168 weeks) |
| Change From Baseline in BMI for Age Z-score at EOT of Cycle 8 During Teduglutide Treatment | BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 8 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 8 (up to 192 weeks) |
| Change From Baseline in BMI for Age Z-score at EOT of Cycle 9 During Teduglutide Treatment | BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 9 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of Cycle 9 (up to 196 weeks) |
| Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
| Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment | PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent reduction in weight-normalized prescribed PS values from baseline was calculated using the formula: % reduction in PS value at the visit =([average daily value at the scheduled visit - average daily value at baseline of the core study (SHP633-302 [NCT02980666]) / average daily value at baseline of the core study (SHP633-302 [NCT02980666])) *100. Number of participants who achieved at least 20% reduction from baseline in Investigator prescribed PS volume at EOT of each cycle during teduglutide treatment were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).](streamdown:incomplete-link) | Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
| Change From Baseline in Participant Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment | PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Change from baseline in participants diary PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
| Percent Change From Baseline in Participant Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment | PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent change from baseline in participants diary PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
| Change From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment | PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Change from baseline in investigator prescribed PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
| Percent Change From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment | PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent change from baseline in investigator prescribed PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
| Number of Participants Who Achieved Enteral Autonomy PS Volume at EOT of Each Cycle During Teduglutide Treatment | Enteral autonomy (completely weaned off PS) was defined as the first visit where there is no use of PS for the 7 days prior to the visit and there is no prescribed PS at that visit, and the participants remains off PS for the remainder of the treatment period of that cycle. Number of participants who achieved enteral autonomy off PS volume at EOT of each cycle during teduglutide treatment were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
| Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment | Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7. Change from baseline in days per week of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
| Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment | Change from baseline in days per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7. Change from baseline in days Per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
| Fukuoka |
| Fukuoka |
| 812-8582 |
| Japan |
| Tsukuba University Hospital | Tsukuba | Ibaraki | 305-8576 | Japan |
| Kagoshima University Hospital | Kagoshima | Kagoshima-ken | 890-8520 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Showa University Hospital | Shinagawa-ku | Tokyo-To | 142-8666 | Japan |
| Infants (Corrected Gestational Age: 4 to < 12 Months) |
Participants (Infants) from 4 through < 12 months of corrected gestational age who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course. |
| 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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Participants aged from 1 through 15 years who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course. |
| OG001 | Infants (Corrected Gestational Age: 4 to < 12 Months) | Participants (Infants) from 4 through < 12 months of corrected gestational age who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course. |
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| Primary | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Vital sign assessments included pulse rate, blood pressure (systolic and diastolic blood pressure) and body temperature. Number of participants with clinically significant abnormalities in vital signs which were deemed clinically significant by the investigator were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). | Posted | Count of Participants | Participants | No | From Baseline up to follow-up (up to 50 months) |
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| Primary | Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Clinical laboratory parameters included biochemistry, hematology and urinalysis. Number of participants with clinically significant abnormalities in laboratory parameters which were deemed clinically significant by the investigator were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). | Posted | Count of Participants | Participants | No | From Baseline up to follow-up (up to 50 months) |
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| Primary | Percent Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment | Average total urine output was recorded over a 48-hour period of parental support (PS) stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The Average daily urine output milliliter per kilogram per day (mL/kg/day) was calculated as: (Total urine output over 48 hours / 2) / body weight (kilogram [kg]) where total urine output was calculated as the sum of the urine output in milliliter (mL) and the urine-only diaper weights in gram (g) (1g = 1mL) for the participant collected on the output diary form of electronic case report from (eCRF). Percent change from baseline in average total urine output at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent change | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
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| Primary | Percent Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment | Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average number of stools per day. The average number of stools per day was calculated as (sum of the daily data in a 48-hour period/2). Percent change from baseline in average number of stools per day at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent change | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
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| Primary | Percent Change From Baseline in Average Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment | Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average stool/mixed stool diaper weight (gram per kilogram per day [g/kg/day]). The body weight was used to calculate the daily stool/mixed stool diaper weight (g/kg/day). Percent change from baseline in average stool/mixed stool diaper weight at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent change | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
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| Primary | Percent Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment | Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The body weight was used to calculate the average total ostomy output per day (mL/kg/day) using a formula analogous to that used to calculate the average daily urine output. Percent change from baseline in average total ostomy output at EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here, "0" in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group. | Posted | Mean | Standard Deviation | Percent change | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
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| Primary | Percent Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment | Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized the average typical stool form score using Bristol Stool Form Scale. The average typical stool form score was calculated as (sum of the daily data in a 48-hour period / 2). Typical Stool Form based on Bristol Stool Form Scale: 1 - Separate hard lumps, hard to pass, 2 - Sausage-shaped, but lumpy, 3 - Like a sausage but with cracks on the surface, 4- Like a sausage or snake, smooth and soft, 5- Soft blobs with clear-cut edges, 6- Fluffy pieces with ragged edges, a mushy stool, 7- Watery, no solid pieces. Entirely liquid. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). A negative change from baseline indicates improvement. | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent change | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
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| Primary | Number of Participants With Anti-drug Antibodies (ADAs) (Including Neutralizing Antibodies) at EOT of Last Cycle During Teduglutide Treatment | Number of participants with ADAs (including NAbs) to teduglutide were used to summarize the presence of antibodies. The participants who tested positive only for ADAs (including NAbs) were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "overall number of participants analyzed" refer to the participants evaluable for this outcome measure and "number analyzed" refer to participants evaluable for this outcome at given categories. "0" in number analyzed signifies that no participant was evaluable for specified category for the specified group. | Posted | Count of Participants | Participants | No | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
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| Primary | Number of Participants With Clinically Significant Changes 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). Number of participants with clinically significant changes findings in gastrointestinal specific testing were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | No | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
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| Primary | Change From Baseline in Body Weight For Age Z-Score at EOT of Last Cycle During Teduglutide Treatment | Body weight was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of last cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of last cycle (up to Month 45) (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
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| Primary | Change From Baseline in Height For Age Z-Score at EOT of Cycle 1 During Teduglutide Treatment | Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of cycle 1 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of Cycle 1 (up to 24 Weeks) |
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| Primary | Change From Baseline in Height For Age Z-Score at EOT of Cycle 2 During Teduglutide Treatment | Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 2 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of Cycle 2 (up to 48 weeks) |
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| Primary | Change From Baseline in Height For Age Z-Score at EOT of Cycle 3 During Teduglutide Treatment | Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 3 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of Cycle 3 (up to 72 weeks) |
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| Primary | Change From Baseline in Height For Age Z-Score at EOT of Cycle 4 During Teduglutide Treatment | Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 4 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Z-Score | Baseline, EOT of Cycle 4 (up to 96 weeks) |
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| Primary | Change From Baseline in Height For Age Z-Score at EOT of Cycle 5 During Teduglutide Treatment | Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 5 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here,"0" in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of Cycle 5 (up to 120 weeks) |
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| Primary | Change From Baseline in Height For Age Z-Score at EOT of Cycle 6 During Teduglutide Treatment | Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 6 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here,"0" in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of Cycle 6 (up to 144 weeks) |
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| Primary | Change From Baseline in Height For Age Z-Score at EOT of Cycle 7 During Teduglutide Treatment | Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 7 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here,"0" in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of Cycle 7 (up to 168 weeks) |
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| Primary | Change From Baseline in Height For Age Z-Score at EOT of Cycle 8 During Teduglutide Treatment | Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 8 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here,"0" in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of Cycle 8 (up to 192 weeks) |
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| Primary | Change From Baseline in Height For Age Z-Score at EOT of Cycle 9 During Teduglutide Treatment | Height was measured using Age Z-Score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 9 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here,"0" in Overall number of participants analyzed signifies that no participant was evaluable at specified time point for the specified group. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of Cycle 9 (up to 196 weeks) |
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| Primary | Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 1 During Teduglutide Treatment | Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 1 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here, head circumference was collected only for participants with less than (<) 12 months of age. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of Cycle 1 (up to 24 weeks) |
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| Primary | Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 2 During Teduglutide Treatment | Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 2 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here, head circumference was collected only for participants with < 12 months of age. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of Cycle 2 (up to 48 weeks) |
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| Primary | Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 3 During Teduglutide Treatment | Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 3 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here, head circumference was collected only for participants with < 12 months of age. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of Cycle 3 (up to 72 weeks) |
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| Primary | Change From Baseline in Head Circumference for Age Z-score at EOT of Cycle 4 During Teduglutide Treatment | Head circumference was measured using Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 EOT of Cycle 4 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here, head circumference was collected only for participants with < 12 months of age. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of Cycle 4 (up to 76 weeks) |
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| Primary | Change From Baseline in Body Mass Index (BMI) for Age Z-score at EOT of Cycle 1 During Teduglutide Treatment | BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 1 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants greater than or equal to (>=) 2 years of age. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of Cycle 1 (up to 24 weeks) |
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| Primary | Change From Baseline in BMI for Age Z-score at EOT of Cycle 2 During Teduglutide Treatment | BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 2 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants >= 2 years of age. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of Cycle 2 (up to 48 weeks) |
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| Primary | Change From Baseline in BMI for Age Z-score at EOT of Cycle 3 During Teduglutide Treatment | BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 3 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants >= 2 years of age. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of Cycle 3 (up to 72 weeks) |
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| Primary | Change From Baseline in BMI for Age Z-score at EOT of Cycle 4 During Teduglutide Treatment | BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 4 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants >= 2 years of age. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of Cycle 4 (up to 96 weeks) |
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| Primary | Change From Baseline in BMI for Age Z-score at EOT of Cycle 5 During Teduglutide Treatment | BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 5 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants >= 2 years of age. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of Cycle 5 (up to 120 weeks) |
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| Primary | Change From Baseline in BMI for Age Z-score at EOT of Cycle 6 During Teduglutide Treatment | BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 6 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants >= 2 years of age. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of Cycle 6 (up to 144 weeks) |
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| Primary | Change From Baseline in BMI for Age Z-score at EOT of Cycle 7 During Teduglutide Treatment | BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 7 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants >= 2 years of age. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of Cycle 7 (up to 168 weeks) |
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| Primary | Change From Baseline in BMI for Age Z-score at EOT of Cycle 8 During Teduglutide Treatment | BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 8 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants >= 2 years of age. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of Cycle 8 (up to 192 weeks) |
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| Primary | Change From Baseline in BMI for Age Z-score at EOT of Cycle 9 During Teduglutide Treatment | BMI Z-score was calculated by using the height and weight Age Z-score. A Z-score was 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. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts were used for calculation. 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 BMI for Age Z-score at EOT of Cycle 9 during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Here, BMI was calculated only for participants >= 2 years of age. | Posted | Mean | Standard Deviation | Z-score | Baseline, EOT of Cycle 9 (up to 196 weeks) |
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| Secondary | Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Participants Diary Parenteral Support (PS) Volume at EOT of Each Cycle During Teduglutide Treatment | PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent reduction in weight-normalized diary PS values from baseline was calculated using the formula: % reduction in PS value at the visit = ([average daily value at the scheduled visit - average daily value at baseline of the core study (SHP633-302 [NCT02980666]) / average daily value at baseline of the core study (SHP633-302 [NCT02980666])) *100. Number of participants who achieved at least 20% reduction from baseline in participants diary PS volume at EOT of each cycle during teduglutide treatment were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).](streamdown:incomplete-link) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and "number analyzed" signifies to participants evaluable for this outcome at given timepoints. | Posted | Count of Participants | Participants | No | Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
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| Secondary | Number of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment | PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent reduction in weight-normalized prescribed PS values from baseline was calculated using the formula: % reduction in PS value at the visit =([average daily value at the scheduled visit - average daily value at baseline of the core study (SHP633-302 [NCT02980666]) / average daily value at baseline of the core study (SHP633-302 [NCT02980666])) *100. Number of participants who achieved at least 20% reduction from baseline in Investigator prescribed PS volume at EOT of each cycle during teduglutide treatment were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]).](streamdown:incomplete-link) | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and "number analyzed" signifies to participants evaluable for this outcome at given timepoints. | Posted | Count of Participants | Participants | No | Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
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| Secondary | Change From Baseline in Participant Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment | PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Change from baseline in participants diary PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and "number analyzed" signifies to participants evaluable for this outcome at given timepoints. | Posted | Mean | Standard Deviation | mL/kg/day | Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
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| Secondary | Percent Change From Baseline in Participant Diary PS Volume at EOT of Each Cycle During Teduglutide Treatment | PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent change from baseline in participants diary PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and "number analyzed" signifies to participants evaluable for this outcome at given timepoints. | Posted | Mean | Standard Deviation | Percent change | Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
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| Secondary | Change From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment | PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Change from baseline in investigator prescribed PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and "number analyzed" signifies to participants evaluable for this outcome at given timepoints. | Posted | Mean | Standard Deviation | mL/kg/day | Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
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| Secondary | Percent Change From Baseline in Investigator Prescribed PS Volume at EOT of Each Cycle During Teduglutide Treatment | PS (parenteral nutrition or intravenous fluids) was considered for managing nutritional support in terms of volume during the treatment period. Percent change from baseline in investigator prescribed PS volume at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and "number analyzed" signifies to participants evaluable for this outcome at given timepoints. | Posted | Mean | Standard Deviation | Percent change | Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
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| Secondary | Number of Participants Who Achieved Enteral Autonomy PS Volume at EOT of Each Cycle During Teduglutide Treatment | Enteral autonomy (completely weaned off PS) was defined as the first visit where there is no use of PS for the 7 days prior to the visit and there is no prescribed PS at that visit, and the participants remains off PS for the remainder of the treatment period of that cycle. Number of participants who achieved enteral autonomy off PS volume at EOT of each cycle during teduglutide treatment were reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and "number analyzed" signifies to participants evaluable for this outcome at given timepoints. | Posted | Count of Participants | Participants | No | Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
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| Secondary | Change From Baseline in Days Per Week of Diary PS Usage at EOT of Each Cycle During Teduglutide Treatment | Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7. Change from baseline in days per week of diary PS usage at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and "number analyzed" signifies to participants evaluable for this outcome at given timepoints. | Posted | Mean | Standard Deviation | Days/week | Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
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| Secondary | Change From Baseline in Days Per Week of Prescribed PS Usage at EOT of Each Cycle During Teduglutide Treatment | Change from baseline in days per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Days per week of diary PS was calculated as: Days per week of actual PS = (number of days with non-zero values for PS volume within the 7 days prior to the visit / number of days for which any PS intake data was recorded within the 7 days prior to the visit) * 7. Change from baseline in days Per week of prescribed PS usage at EOT of each cycle during teduglutide treatment was reported. Baseline refers to the baseline value of the core study (SHP633-302 [NCT02980666]). | The safety population included all enrolled participants in the study and who received at least one dose of teduglutide (in study SHP633-302 [NCT02980666] or SHP633-305 [NCT03268811]). Here, overall number of participants analyzed signifies to the participants evaluable for this outcome measure and "number analyzed" signifies to participants evaluable for this outcome at given timepoints. | Posted | Mean | Standard Deviation | Days/week | Baseline, EOT of each cycle 1, 2, 3, 4, 5, 6, 7, 8 and 9 (Each Cycle 1 to 8 = 24 weeks, and Cycle 9 = 4 weeks) |
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| 0 |
| 7 |
| 7 |
| 7 |
| 7 |
| 7 |
| EG001 | Infants (Corrected Gestational Age: 4 to < 12 Months) | Participants (Infants) from 4 through < 12 months of corrected gestational age who participated in the core study (SHP633-302 [NCT02980666]) were enrolled into this extension study and received teduglutide 0.05 mg/kg SC injection once daily for 24 weeks in each treatment cycle depending on the disease course. | 0 | 2 | 2 | 2 | 2 | 2 |
| 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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| Ileus | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Vomiting | 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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| Arthritis bacterial | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Beta haemolytic streptococcal 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 adenovirus | 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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| Streptococcal 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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| Viral pharyngitis | 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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| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Device breakage | Product Issues | MedDRA 20.0 | Non-systematic Assessment |
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| Device damage | Product Issues | MedDRA 20.0 | Non-systematic Assessment |
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| Device occlusion | Product Issues | MedDRA 20.0 | Non-systematic Assessment |
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| Central venous catheter removal | Surgical and medical procedures | MedDRA 20.0 | Non-systematic Assessment |
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| Conjunctivitis allergic | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Eye discharge | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Strabismus | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal 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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| Cheilitis | 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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| Gastric disorder | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Lip dry | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Rectal prolapse | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Stomatitis | Gastrointestinal 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 reaction | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Adenoviral conjunctivitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Epididymitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Infected bite | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Medical device site infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Auricular haematoma | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Epiphyseal injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Gastrostomy tube site complication | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Heat stroke | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Injury corneal | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Ligament injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hypozincaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Device damage | Product Issues | MedDRA 20.0 | Non-systematic Assessment |
|
| Head banging | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Skin induration | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.0 | 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 |
| Urinalysis. |
|
| Positive NAbs at EOT of the Last Cycle |
|
|
| At least 20% Reduction: At EOT of Cycle 2 |
|
|
| At least 20% Reduction: At EOT of Cycle 3 |
|
|
| At least 20% Reduction: At EOT of Cycle 4 |
|
|
| At least 20% Reduction: At EOT of Cycle 5 |
|
|
| At least 20% Reduction: At EOT of Cycle 6 |
|
|
| At least 20% Reduction: At EOT of Cycle 7 |
|
|
| At least 20% Reduction: At EOT of Cycle 8 |
|
|
| At least 20% Reduction: At EOT of Cycle 9 |
|
|
| At least 20% Reduction: At EOT of Cycle 2 |
|
|
| At least 20% Reduction: At EOT of Cycle 3 |
|
|
| At least 20% Reduction: At EOT of Cycle 4 |
|
|
| At least 20% Reduction: At EOT of Cycle 5 |
|
|
| At least 20% Reduction: At EOT of Cycle 6 |
|
|
| At least 20% Reduction: At EOT of Cycle 7 |
|
|
| At least 20% Reduction: At EOT of Cycle 8 |
|
|
| At least 20% Reduction: At EOT of Cycle 9 |
|
|
| Change at EOT of Cycle 2 |
|
|
| Change at EOT of Cycle 3 |
|
|
| Change at EOT of Cycle 4 |
|
|
| Change at EOT of Cycle 5 |
|
|
| Change at EOT of Cycle 6 |
|
|
| Change at EOT of Cycle 7 |
|
|
| Change at EOT of Cycle 8 |
|
|
| Change at EOT of Cycle 9 |
|
|
| Percent change at EOT of Cycle 2 |
|
|
| Percent change at EOT of Cycle 3 |
|
|
| Percent change at EOT of Cycle 4 |
|
|
| Percent change at EOT of Cycle 5 |
|
|
| Percent change at EOT of Cycle 6 |
|
|
| Percent change at EOT of Cycle 7 |
|
|
| Percent change at EOT of Cycle 8 |
|
|
| Percent change at EOT of Cycle 9 |
|
|
| Change at EOT of Cycle 2 |
|
|
| Change at EOT of Cycle 3 |
|
|
| Change at EOT of Cycle 4 |
|
|
| Change at EOT of Cycle 5 |
|
|
| Change at EOT of Cycle 6 |
|
|
| Change at EOT of Cycle 7 |
|
|
| Change at EOT of Cycle 8 |
|
|
| Change at EOT of Cycle 9 |
|
|
| Percent change at EOT of Cycle 2 |
|
|
| Percent change at EOT of Cycle 3 |
|
|
| Percent change at EOT of Cycle 4 |
|
|
| Percent change at EOT of Cycle 5 |
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|
| Percent change at EOT of Cycle 6 |
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|
| Percent change at EOT of Cycle 7 |
|
|
| Percent change at EOT of Cycle 8 |
|
|
| Percent change at EOT of Cycle 9 |
|
|
| At EOT of Cycle 2 |
|
|
| At EOT of Cycle 3 |
|
|
| At EOT of Cycle 4 |
|
|
| At EOT of Cycle 5 |
|
|
| At EOT of Cycle 6 |
|
|
| At EOT of Cycle 7 |
|
|
| At EOT of Cycle 8 |
|
|
| At EOT of Cycle 9 |
|
|
| Change at EOT of Cycle 2 |
|
|
| Change at EOT of Cycle 3 |
|
|
| Change at EOT of Cycle 4 |
|
|
| Change at EOT of Cycle 5 |
|
|
| Change at EOT of Cycle 6 |
|
|
| Change at EOT of Cycle 7 |
|
|
| Change at EOT of Cycle 8 |
|
|
| Change at EOT of Cycle 9 |
|
|
| Change at EOT of Cycle 2 |
|
|
| Change at EOT of Cycle 3 |
|
|
| Change at EOT of Cycle 4 |
|
|
| Change at EOT of Cycle 5 |
|
|
| Change at EOT of Cycle 6 |
|
|
| Change at EOT of Cycle 7 |
|
|
| Change at EOT of Cycle 8 |
|
|
| Change at EOT of Cycle 9 |
|
|