Short Bowel Syndrome
Conditions
Brief summary
The purpose of this clinical study is to evaluate the long-term safety and efficacy of teduglutide in Japanese participants with PN/IV (parenteral nutrition/intravenous)-dependent SBS (short bowel syndrome) who completed SHP633-306 or who were in the extension phase of the TED-C14-004 (NCT02340819) study.
Interventions
DRUGTeduglutide
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.
DEVICESyringe
Teduglutide will be administered using syringe. Syringe is approved for use in Japan by PMDA.
DEVICENeedle
Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.
DEVICEVial Adapter for Device
Vial adapter for device is approved for use in Japan by PMDA.
Sponsors
Takeda
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants who meet all of the following criteria will be enrolled in this study: 1. Ability to voluntarily provide written, signed, and informed consent to participate in the study. 2. Completion of the SHP633-306 study or participation in TED-C14-004 (NCT02340819) Stage 3 or Stage 4. 3. Females of childbearing potential must agree to comply with the contraceptive requirements of the protocol. 4. An understanding, ability, and willingness to fully comply with study procedures and restrictions.
Exclusion criteria
There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)\*7. Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. |
| Change From Baseline in Weekly PS Volume | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)\*7. Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. |
| Percent Change From Baseline in Weekly PS Volume | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)\*7. Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. |
| Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS) | From the first dose of study drug (in current study) up to EOS (up to approximately 42 months) | — |
| Change From Baseline in Days Per Week of PS | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. |
| Change From Baseline in Plasma Citrulline Levels | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | Plasma citrulline was measured as an assessment of enterocyte mass. Plasma samples were analyzed using a validated high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From the first dose of study drug (in current study) up to EOS (up to approximately 42 months) | — |
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. |
| Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Values | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. |
| Number of Participants Who Reported Positive Specific Antibodies to Teduglutide at EOS | From the first dose of study drug (in current study) up to EOS (up to approximately 42 months) | — |
| Change From Baseline in 48-Hour Urine Output | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. |
| Number of Participants With Clinically Significant Change From Baseline in Body Weight Measurements | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. |
| Number of Participants With Clinically Significant Change From Baseline in BMI | Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study) | Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study. |
| Number of Participants With Clinically Significant Colonoscopy/Sigmoidoscopy Results | From the first dose of study drug (in current study) up to EOS (up to approximately 42 months) | — |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 5 investigative sites in Japan from 09 July 2018 to 13 January 2022.
Pre-assignment details
Participants with a historical diagnosis with short bowel syndrome, who completed 24 weeks of treatment in core studies SHP633-306 (NCT03663582) or TED-C14-004 (NCT02340819) were enrolled and received teduglutide in this current study (SHP633-307). Total study duration were approximately 13 months for SHP633-306 (NCT03663582) and approximately 47 months for TED-C14-004 (NCT02340819).
Participants by arm
| Arm | Count |
|---|---|
| SHP633-306: Teduglutide 0.05 mg/kg Participants who completed SHP633-306 (NCT03663582) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 30.3 months in this study. | 4 |
| TED-C14-004: Teduglutide 0.05 mg/kg Participants who were in extension phase of TED-C14-004 (NCT02340819) were enrolled and received teduglutide 0.05 mg/kg, subcutaneous injection, once daily for up to approximately 40.2 months in this study. | 7 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Death | 1 | 0 |
Baseline characteristics
| Characteristic | TED-C14-004: Teduglutide 0.05 mg/kg | SHP633-306: Teduglutide 0.05 mg/kg | Total |
|---|---|---|---|
| Age, Continuous | 42.4 years STANDARD_DEVIATION 7.21 | 40.8 years STANDARD_DEVIATION 12.28 | 41.8 years STANDARD_DEVIATION 8.78 |
| Body Mass Index (BMI) | 19.80 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.153 | 18.96 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.441 | 19.49 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.114 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 4 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 167.77 centimeter (cm) STANDARD_DEVIATION 6.735 | 161.10 centimeter (cm) STANDARD_DEVIATION 6.168 | 165.35 centimeter (cm) STANDARD_DEVIATION 7.068 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 4 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 7 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 7 Participants |
| Weight | 56.01 kilogram (kg) STANDARD_DEVIATION 10.958 | 49.29 kilogram (kg) STANDARD_DEVIATION 10.01 | 53.57 kilogram (kg) STANDARD_DEVIATION 10.66 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 4 | 0 / 7 | 1 / 11 |
| other Total, other adverse events | 4 / 4 | 7 / 7 | 11 / 11 |
| serious Total, serious adverse events | 3 / 4 | 4 / 7 | 7 / 11 |
Outcome results
Primary
Change From Baseline in 48-Hour Urine Output
Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Population: The safety population included all enrolled participants in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHP633-306: Teduglutide 0.05 mg/kg | Change From Baseline in 48-Hour Urine Output | 428.8 Milliliter per day (mL/day) | Standard Deviation 286.57 |
| TED-C14-004: Teduglutide 0.05 mg/kg | Change From Baseline in 48-Hour Urine Output | 308.6 Milliliter per day (mL/day) | Standard Deviation 589.36 |
| Total Participants | Change From Baseline in 48-Hour Urine Output | 352.3 Milliliter per day (mL/day) | Standard Deviation 486.54 |
Primary
Change From Baseline in Days Per Week of PS
Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Population: The safety population included all enrolled participants in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHP633-306: Teduglutide 0.05 mg/kg | Change From Baseline in Days Per Week of PS | -2.3 days per week | Standard Deviation 3.3 |
| TED-C14-004: Teduglutide 0.05 mg/kg | Change From Baseline in Days Per Week of PS | -2.0 days per week | Standard Deviation 3.42 |
Primary
Change From Baseline in Plasma Citrulline Levels
Plasma citrulline was measured as an assessment of enterocyte mass. Plasma samples were analyzed using a validated high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Population: The safety population included all enrolled participants in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHP633-306: Teduglutide 0.05 mg/kg | Change From Baseline in Plasma Citrulline Levels | 12.96 micromoles per liter | Standard Deviation 5.568 |
| TED-C14-004: Teduglutide 0.05 mg/kg | Change From Baseline in Plasma Citrulline Levels | 19.15 micromoles per liter | Standard Deviation 18.851 |
Primary
Change From Baseline in Weekly PS Volume
The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)\*7. Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Population: The safety population included all enrolled participants in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHP633-306: Teduglutide 0.05 mg/kg | Change From Baseline in Weekly PS Volume | -7.45 liter per week (L/Week) | Standard Deviation 7.908 |
| TED-C14-004: Teduglutide 0.05 mg/kg | Change From Baseline in Weekly PS Volume | -8.67 liter per week (L/Week) | Standard Deviation 7.45 |
Primary
Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume
The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)\*7. Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Population: The safety population included all enrolled participants in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SHP633-306: Teduglutide 0.05 mg/kg | Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume | 3 Participants |
| TED-C14-004: Teduglutide 0.05 mg/kg | Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume | 5 Participants |
Primary
Number of Participants Who Reported Positive Specific Antibodies to Teduglutide at EOS
Time frame: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)
Population: The safety population included all enrolled participants in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SHP633-306: Teduglutide 0.05 mg/kg | Number of Participants Who Reported Positive Specific Antibodies to Teduglutide at EOS | 3 Participants |
| TED-C14-004: Teduglutide 0.05 mg/kg | Number of Participants Who Reported Positive Specific Antibodies to Teduglutide at EOS | 4 Participants |
| Total Participants | Number of Participants Who Reported Positive Specific Antibodies to Teduglutide at EOS | 7 Participants |
Primary
Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS)
Time frame: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)
Population: The safety population included all enrolled participants in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SHP633-306: Teduglutide 0.05 mg/kg | Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS) | 1 Participants |
| TED-C14-004: Teduglutide 0.05 mg/kg | Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS) | 2 Participants |
Primary
Number of Participants With Clinically Significant Change From Baseline in BMI
Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Population: The safety population included all enrolled participants in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SHP633-306: Teduglutide 0.05 mg/kg | Number of Participants With Clinically Significant Change From Baseline in BMI | 0 Participants |
| TED-C14-004: Teduglutide 0.05 mg/kg | Number of Participants With Clinically Significant Change From Baseline in BMI | 0 Participants |
| Total Participants | Number of Participants With Clinically Significant Change From Baseline in BMI | 0 Participants |
Primary
Number of Participants With Clinically Significant Change From Baseline in Body Weight Measurements
Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Population: The safety population included all enrolled participants in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SHP633-306: Teduglutide 0.05 mg/kg | Number of Participants With Clinically Significant Change From Baseline in Body Weight Measurements | 0 Participants |
| TED-C14-004: Teduglutide 0.05 mg/kg | Number of Participants With Clinically Significant Change From Baseline in Body Weight Measurements | 0 Participants |
| Total Participants | Number of Participants With Clinically Significant Change From Baseline in Body Weight Measurements | 0 Participants |
Primary
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values
Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Population: The safety population included all enrolled participants in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SHP633-306: Teduglutide 0.05 mg/kg | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values | 0 Participants |
| TED-C14-004: Teduglutide 0.05 mg/kg | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values | 0 Participants |
| Total Participants | Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values | 0 Participants |
Primary
Number of Participants With Clinically Significant Change From Baseline in Laboratory Values
Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Population: The safety population included all enrolled participants in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SHP633-306: Teduglutide 0.05 mg/kg | Number of Participants With Clinically Significant Change From Baseline in Laboratory Values | 0 Participants |
| TED-C14-004: Teduglutide 0.05 mg/kg | Number of Participants With Clinically Significant Change From Baseline in Laboratory Values | 0 Participants |
| Total Participants | Number of Participants With Clinically Significant Change From Baseline in Laboratory Values | 0 Participants |
Primary
Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements
Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Population: The safety population included all enrolled participants in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SHP633-306: Teduglutide 0.05 mg/kg | Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements | 0 Participants |
| TED-C14-004: Teduglutide 0.05 mg/kg | Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements | 0 Participants |
| Total Participants | Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements | 0 Participants |
Primary
Number of Participants With Clinically Significant Colonoscopy/Sigmoidoscopy Results
Time frame: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)
Population: The safety population included all enrolled participants in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SHP633-306: Teduglutide 0.05 mg/kg | Number of Participants With Clinically Significant Colonoscopy/Sigmoidoscopy Results | 0 Participants |
| TED-C14-004: Teduglutide 0.05 mg/kg | Number of Participants With Clinically Significant Colonoscopy/Sigmoidoscopy Results | 0 Participants |
| Total Participants | Number of Participants With Clinically Significant Colonoscopy/Sigmoidoscopy Results | 0 Participants |
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)
Population: The safety population included all enrolled participants in the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SHP633-306: Teduglutide 0.05 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TEAE | 4 Participants |
| SHP633-306: Teduglutide 0.05 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TESAE | 3 Participants |
| TED-C14-004: Teduglutide 0.05 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TEAE | 7 Participants |
| TED-C14-004: Teduglutide 0.05 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TESAE | 4 Participants |
| Total Participants | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TEAE | 11 Participants |
| Total Participants | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | TESAE | 7 Participants |
Primary
Percent Change From Baseline in Weekly PS Volume
The weekly volume was calculated as (sum of daily volumes in the diary/number of days with values)\*7. Baseline data refer to the baseline of core studies (SHP633-306 \[NCT03663582\] or TED-C14-004 \[NCT02340819\]), however the time frame represents the duration for which participants were assessed in current study. The only data presented from the Core Studies in this report are the comparison of the Extension Study data with the Baseline data of the Core Study.
Time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)
Population: The safety population included all enrolled participants in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SHP633-306: Teduglutide 0.05 mg/kg | Percent Change From Baseline in Weekly PS Volume | -49.55 percent change | Standard Deviation 41.411 |
| TED-C14-004: Teduglutide 0.05 mg/kg | Percent Change From Baseline in Weekly PS Volume | -52.52 percent change | Standard Deviation 39.828 |