Trial Outcomes & Findings for Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study (NCT NCT02949362)

NCT ID: NCT02949362

Last Updated: 2025-03-19

Results Overview

An 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. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, was an important medical event. Number of participants with AEs, related AEs, serious adverse events (SAEs) and related SAEs of retrospective observation period were reported.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 29 participants
• Primary outcome timeframe: From end of the core study (TED-C13-003 [NCT01952080]) up to the beginning of the prospective period (up to Week 168)
• Results posted on: 2025-03-19

Participant Flow

Participants who completed TED-C13-003 (NCT01952080) were enrolled in this study which was conducted at 11 sites in the United States and United Kingdom between 09 December 2016 (first participant first visit) and 14 July 2020 (last participant last visit).

A total of 29 participants were enrolled in this study, 29 participants consented to retrospective period. Of these, 24 enrolled into Retro TED/NTT (did not receive teduglutide) and 5 into Retro TED/TED (received teduglutide). Out of 29 participants of retrospective period, 24 enrolled into prospective period (ANY TED group), of these, 19 in TED/TED and 5 in TED/NTT.

Participant milestones

Measure	Retrospective TED/NTT Group Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.	Prospective TED/NTT Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in prospective period in the current study SHP633-303 up to 24 weeks.	Prospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in prospective period in the current study SHP633-303 up to 24 weeks.
Retrospective Period STARTED	24	5	0	0
Retrospective Period COMPLETED	20	4	0	0
Retrospective Period NOT COMPLETED	4	1	0	0
Prospective Period STARTED	0	0	5	19
Prospective Period COMPLETED	0	0	4	15
Prospective Period NOT COMPLETED	0	0	1	4

Reasons for withdrawal

Measure	Retrospective TED/NTT Group Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.	Prospective TED/NTT Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in prospective period in the current study SHP633-303 up to 24 weeks.	Prospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in prospective period in the current study SHP633-303 up to 24 weeks.
Retrospective Period Inform consent not signed by participant	4	1	0	0
Prospective Period Discontinued the study early but didn't complete an ET Visit.	0	0	1	0
Prospective Period Other	0	0	0	4

Baseline Characteristics

Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study

Baseline characteristics by cohort

Measure	Retrospective TED/NTT Group n=24 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group n=5 Participants Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.	Total n=29 Participants Total of all reporting groups
Age, Continuous	4.0 Years STANDARD_DEVIATION 2.88 • n=5 Participants	8.2 Years STANDARD_DEVIATION 5.50 • n=7 Participants	4.7 Years STANDARD_DEVIATION 3.71 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	0 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	5 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	9 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	15 Participants n=5 Participants	3 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Not allowed based on local regulations	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	20 Participants n=5 Participants	3 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: From end of the core study (TED-C13-003 [NCT01952080]) up to the beginning of the prospective period (up to Week 168)

Population: Retrospective participants (RETRO): all participants who consented to participation in this extension study and provided data for the retrospective period of the protocol.

An 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. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, was an important medical event. Number of participants with AEs, related AEs, serious adverse events (SAEs) and related SAEs of retrospective observation period were reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=24 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group n=5 Participants Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Number of Participants With Adverse Events (AEs) in Retrospective Observation Period Participants with AEs	23 Participants	4 Participants
Number of Participants With Adverse Events (AEs) in Retrospective Observation Period Participants with Related AEs	23 Participants	4 Participants
Number of Participants With Adverse Events (AEs) in Retrospective Observation Period Participants with SAEs	23 Participants	4 Participants
Number of Participants With Adverse Events (AEs) in Retrospective Observation Period Participants with Related SAE	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to the beginning of the prospective period (up to Week 168)

Population: RETRO participants: all participants who consented to participation in this extension study and provided data for the retrospective period of the protocol. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. Data were not planned to be collected and analyzed for the retrospective TED/TED group.

Height was measured using age Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age greater than or equal to [>=] 2 years old) and World Health Organization (age less than [<] 2 years old) Z-score calculation charts are 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 up to Week 168 of retrospective observation period was reported. Data for this outcome was not planned to be collected and analyzed in retrospective TED/TED group.

Outcome measures

Measure	Retrospective TED/NTT Group n=2 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Change From Baseline in Height for Age Z-score up to Week 168 of Retrospective Observation Period	0.128 Z-score Standard Deviation 0.0505	—

PRIMARY outcome

Timeframe: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to the beginning of the prospective period (up to Week 168)

Population: RETRO participants: all participants who consented to participation in this extension study and provided data for the retrospective period of the protocol. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. Data were not planned to be collected and analyzed for the retrospective TED/TED group.

Body weight was measured using age Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are 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 up to Week 168 was reported. Data for this outcome was not planned to be collected and analyzed in retrospective TED/TED group.

Outcome measures

Measure	Retrospective TED/NTT Group n=2 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Change From Baseline in Body Weight for Age Z-score up to Week 168 of Retrospective Observation Period	-0.181 Z-score Standard Deviation 0.0601	—

PRIMARY outcome

Timeframe: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to the beginning of the prospective period (up to Week 168)

Population: RETRO participants: all participants who consented to participation in this extension study and provided data for the retrospective period of the protocol. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. Data were not planned to be collected and analyzed for the retrospective TED/TED group.

BMI Z-score was calculated by using the retrospective height and weight data. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are 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 up to Week 168 of retrospective observation period was reported. Data for this outcome was not planned to be collected and analyzed in retrospective TED/TED group.

Outcome measures

Measure	Retrospective TED/NTT Group n=2 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Change From Baseline in Body Mass Index (BMI) for Age Z-score up to Week 168 of Retrospective Observation Period	-0.283 Z-score Standard Deviation 0.0646	—

PRIMARY outcome

Timeframe: From the beginning of the prospective study period to End of Study (EOS) (up to Week 144)

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria.

TEAEs are defined as AEs that started or worsened on or after the first dose of teduglutide treatment in the core study. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, was an important medical event. AESI was an TEAE or TESAE of scientific and medical concern specific to the sponsor's product or program and for which ongoing monitoring and immediate notification by the investigator to the sponsor. Number of participants With TEAEs, treatment -emergent serious adverse events (TESAEs) and adverse events of special interest (AESI) of Prospective study period were reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=5 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group n=19 Participants Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Prospective Study Period Participants with TEAEs	4 Participants	19 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Prospective Study Period Participants with TESAEs	3 Participants	17 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Prospective Study Period Participants with AESI	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 12

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. Data were not planned to be collected and analyzed for the prospective TED/NTT group.

Height was measured using age Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are 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 up to Cycle 6 Week 12 during the end of teduglutide treatment period in prospective study period was reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=3 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Change From Baseline in Height for Age Z-score up to Cycle 6 Week 12 During the End of Teduglutide Treatment Period of Prospective Study Period	0.05 Z-score Standard Deviation 1.068	—

PRIMARY outcome

Timeframe: Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 24

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. Data were not planned to be collected and analyzed for the prospective TED/NTT group.

Body weight was measured using age Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are 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 up to Cycle 6 Week 24 during the end of teduglutide treatment period of prospective study period was reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=1 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Change From Baseline in Body Weight for Age Z-score up to Cycle 6 Week 24 During the End of Teduglutide Treatment Period of Prospective Study Period	-0.66 Z-score Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	—

PRIMARY outcome

Timeframe: Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 12

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. Data were not planned to be collected and analyzed for the prospective TED/NTT group.

BMI Z-score was calculated by using the height and weight data. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age >= 2 years old) and World Health Organization (age < 2 years old) Z-score calculation charts are 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 up to Cycle 6 Week 12 during the end of teduglutide treatment period of prospective study period was reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=3 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Change From Baseline in BMI for Age Z-score up to Cycle 6 Week 12 During the End of Teduglutide Treatment Period of Prospective Study Period	-0.68 Z-score Standard Deviation 0.349	—

PRIMARY outcome

Timeframe: Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 12

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. Data were not planned to be collected and analyzed for the prospective TED/NTT group.

Average total urine output was calculated based on the daily data recorded in participants diaries over a 48-hour period of nutritional stability prior to each scheduled visit. Average total 48-Hour urine output up to Cycle 6 Week 12 during the end of teduglutide treatment period of prospective study period was reported. Here, mL/kg/day is abbreviated as milliliter per kilogram per day.

Outcome measures

Measure	Retrospective TED/NTT Group n=3 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Average Total 48-Hour Urine Output up to Cycle 6 Week 12 During the End of Teduglutide Treatment Period of Prospective Study Period	14.38 mL/kg/day Standard Deviation 12.712	—

PRIMARY outcome

Timeframe: Baseline (from the beginning of the prospective study period) up to Week 108

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. Data were not planned to be collected and analyzed for the prospective TED/TED group.

Average total urine output was calculated based on the daily data recorded in participants diaries over a 48-hour period of nutritional stability prior to each scheduled visit. Average total 48-Hour urine output up to Week 108 during the end of NTT period in prospective study period was reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=2 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Average Total 48-Hour Urine Output up to Week 108 During the End of Non-Teduglutide Treatment (NTT) Period of Prospective Study Period	22.86 mL/kg/day Standard Deviation 9.956	—

PRIMARY outcome

Timeframe: Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 24

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. Data for this outcome was not planned to be collected and analyzed in prospective TED/NTT group.

Average number of stools per day was calculated based on the daily data recorded in participants diaries over a 48-hour period of nutritional stability prior to each scheduled visit. Average number of stools per day up to cycle 6 week 24 during the end of teduglutide treatment period in prospective study period was reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=1 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Average Number of Stools Per Day up to Cycle 6 Week 24 During the End of Teduglutide Treatment Period of Prospective Study Period	5.50 Stools per day Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	—

PRIMARY outcome

Timeframe: Baseline (from the beginning of the prospective study period) up to Week 120

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. Data were not planned to be collected and analyzed for the prospective TED/TED group.

Average number of stools per day was calculated based on the daily data recorded in participants diaries over a 48-hour period of nutritional stability prior to each scheduled visit. Average number of stools per day up to Week 120 during the end of NTT period in prospective study period was reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=2 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Average Number of Stools Per Day up to Week 120 During the End of NTT Period of Prospective Study Period	3.75 Stools per day Standard Deviation 3.182	—

PRIMARY outcome

Timeframe: From the beginning of the prospective study period, EOS (up to Week 156)

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. Data for this outcome was not planned to be collected and analyzed in prospective TED/NTT group.

Number of participants with positive specific antibodies to teduglutide were used to summarize the presence of antibodies.

Outcome measures

Measure	Retrospective TED/NTT Group n=7 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Number of Participants With Positive Specific Antibodies at EOS During the End of Teduglutide Treatment Period of Prospective Study Period	1 Participants	—

SECONDARY outcome

Timeframe: At Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156

Population: RETRO participants: all participants who consented to participation in this extension study and provided data for the retrospective period of the protocol. Here, number analyzed signifies participants who were evaluable for this outcome at specific time point.

Number of participants achieved at least 20% reduction in PS volume at 12 weeks interval up to Week 156 in retrospective observation period was reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=24 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group n=5 Participants Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Number of Participants Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period At Week 12	12 Participants	2 Participants
Number of Participants Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period At Week 24	9 Participants	2 Participants
Number of Participants Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period At Week 36	9 Participants	4 Participants
Number of Participants Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period At Week 48	9 Participants	4 Participants
Number of Participants Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period At Week 60	9 Participants	4 Participants
Number of Participants Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period At Week 72	6 Participants	2 Participants
Number of Participants Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period At Week 84	7 Participants	2 Participants
Number of Participants Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period At Week 96	10 Participants	5 Participants
Number of Participants Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period At Week 108	9 Participants	5 Participants
Number of Participants Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period At Week 120	10 Participants	4 Participants
Number of Participants Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period At Week 132	7 Participants	4 Participants
Number of Participants Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period At Week 144	3 Participants	1 Participants
Number of Participants Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period At Week 156	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156

Population: RETRO participants: all participants who consented to participation in this extension study and provided data for the retrospective period of the protocol. Here, number analyzed signifies participants who were evaluable for this outcome at specific time point.

Change from baseline in PS volume at 12 weeks interval up to Week 156 in retrospective observation period was reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=24 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group n=5 Participants Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 12	-14.45 mL/kg/day Standard Deviation 17.770	-12.84 mL/kg/day Standard Deviation 17.694
Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 24	-9.27 mL/kg/day Standard Deviation 21.642	-13.49 mL/kg/day Standard Deviation 14.530
Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 36	-10.65 mL/kg/day Standard Deviation 20.877	-17.91 mL/kg/day Standard Deviation 17.069
Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 48	-12.24 mL/kg/day Standard Deviation 29.646	-26.12 mL/kg/day Standard Deviation 8.044
Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 60	-13.85 mL/kg/day Standard Deviation 30.219	-21.35 mL/kg/day Standard Deviation 12.285
Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 72	-13.65 mL/kg/day Standard Deviation 30.577	-11.41 mL/kg/day Standard Deviation 22.030
Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 84	-8.74 mL/kg/day Standard Deviation 36.078	-15.65 mL/kg/day Standard Deviation 19.603
Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 96	-12.87 mL/kg/day Standard Deviation 37.996	-27.34 mL/kg/day Standard Deviation 16.531
Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 108	-10.35 mL/kg/day Standard Deviation 29.370	-31.83 mL/kg/day Standard Deviation 14.872
Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 120	-12.21 mL/kg/day Standard Deviation 27.480	-30.48 mL/kg/day Standard Deviation 19.043
Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 132	-19.20 mL/kg/day Standard Deviation 26.171	-37.70 mL/kg/day Standard Deviation 12.296
Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 144	-16.79 mL/kg/day Standard Deviation 29.620	-34.32 mL/kg/day Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.
Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 156	-7.46 mL/kg/day Standard Deviation 1.931	-34.43 mL/kg/day Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.

SECONDARY outcome

Timeframe: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156

Population: RETRO participants: all participants who consented to participation in this extension study and provided data for the retrospective period of the protocol. Here, number analyzed signifies participants who were evaluable for this outcome at specific time point.

Percent change from baseline in PS volume at 12 weeks interval up to Week 156 of retrospective observation period was reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=24 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group n=5 Participants Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Percent Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 24	-10.72 Percent change Standard Deviation 33.081	-32.10 Percent change Standard Deviation 31.645
Percent Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 36	-13.21 Percent change Standard Deviation 34.172	-43.09 Percent change Standard Deviation 42.753
Percent Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 48	-14.04 Percent change Standard Deviation 39.390	-65.18 Percent change Standard Deviation 31.650
Percent Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 60	-16.15 Percent change Standard Deviation 39.491	-53.61 Percent change Standard Deviation 37.141
Percent Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 72	-14.19 Percent change Standard Deviation 40.558	-14.11 Percent change Standard Deviation 58.452
Percent Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 84	-8.67 Percent change Standard Deviation 47.108	-30.25 Percent change Standard Deviation 39.598
Percent Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 96	-12.04 Percent change Standard Deviation 51.631	-61.19 Percent change Standard Deviation 29.335
Percent Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 108	-10.62 Percent change Standard Deviation 48.820	-73.43 Percent change Standard Deviation 29.298
Percent Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 120	-12.89 Percent change Standard Deviation 49.366	-69.61 Percent change Standard Deviation 39.194
Percent Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 132	-20.24 Percent change Standard Deviation 47.431	-85.92 Percent change Standard Deviation 17.457
Percent Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 144	-7.70 Percent change Standard Deviation 44.170	-65.20 Percent change Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.
Percent Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 156	-17.21 Percent change Standard Deviation 3.164	-65.42 Percent change Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.
Percent Change From Baseline in PS Volume at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 12	-24.50 Percent change Standard Deviation 27.853	-24.88 Percent change Standard Deviation 35.649

SECONDARY outcome

Timeframe: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156

Population: RETRO participants: all participants who consented to participation in this extension study and provided data for the retrospective period of the protocol. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome and number analyzed signifies participants who were evaluable at specific time point.

Change from baseline in PS caloric intake at 12 weeks interval up to Week 156 of retrospective observation period was reported. Here, kilo-calories per kilogram per day was abbreviated as (kcal/kg/day).

Outcome measures

Measure	Retrospective TED/NTT Group n=23 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group n=5 Participants Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 12	-10.15 kcal/kg/day Standard Deviation 13.026	-2.64 kcal/kg/day Standard Deviation 18.739
Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 24	-3.96 kcal/kg/day Standard Deviation 16.970	-7.25 kcal/kg/day Standard Deviation 11.916
Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 36	-8.38 kcal/kg/day Standard Deviation 17.148	-6.42 kcal/kg/day Standard Deviation 24.547
Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 48	-9.84 kcal/kg/day Standard Deviation 22.144	-18.11 kcal/kg/day Standard Deviation 7.896
Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 60	-10.55 kcal/kg/day Standard Deviation 23.136	-10.53 kcal/kg/day Standard Deviation 18.538
Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 72	-12.64 kcal/kg/day Standard Deviation 23.642	-0.05 kcal/kg/day Standard Deviation 23.552
Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 84	-9.70 kcal/kg/day Standard Deviation 24.860	-5.24 kcal/kg/day Standard Deviation 23.064
Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 96	-10.08 kcal/kg/day Standard Deviation 23.998	-15.09 kcal/kg/day Standard Deviation 18.604
Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 108	-7.20 kcal/kg/day Standard Deviation 22.875	-19.05 kcal/kg/day Standard Deviation 18.229
Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 120	-7.98 kcal/kg/day Standard Deviation 21.425	-17.18 kcal/kg/day Standard Deviation 23.169
Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 132	-12.93 kcal/kg/day Standard Deviation 18.744	-27.59 kcal/kg/day Standard Deviation 5.114
Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 144	-11.97 kcal/kg/day Standard Deviation 17.977	-25.53 kcal/kg/day Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.
Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 156	-6.55 kcal/kg/day Standard Deviation 4.708	-25.67 kcal/kg/day Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.

SECONDARY outcome

Timeframe: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156

Population: RETRO participants: all participants who consented to participation in this extension study and provided data for the retrospective period of the protocol. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome and number analyzed signifies participants who were evaluable at specific time point.

Percent change from baseline in PS caloric intake at 12 weeks interval up to Week 156 of retrospective observation period was reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=23 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group n=5 Participants Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Percent Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 24	-10.12 Percent change Standard Deviation 42.431	-21.29 Percent change Standard Deviation 37.759
Percent Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 36	-18.29 Percent change Standard Deviation 41.070	-3.38 Percent change Standard Deviation 118.167
Percent Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 48	-21.03 Percent change Standard Deviation 43.924	-59.31 Percent change Standard Deviation 38.042
Percent Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 60	-20.63 Percent change Standard Deviation 44.903	-25.65 Percent change Standard Deviation 83.470
Percent Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 72	-25.48 Percent change Standard Deviation 45.035	23.26 Percent change Standard Deviation 99.380
Percent Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 84	-20.42 Percent change Standard Deviation 45.287	4.41 Percent change Standard Deviation 102.162
Percent Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 96	-21.12 Percent change Standard Deviation 46.005	-36.49 Percent change Standard Deviation 72.357
Percent Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 108	-16.41 Percent change Standard Deviation 46.034	-50.24 Percent change Standard Deviation 70.513
Percent Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 120	-18.79 Percent change Standard Deviation 45.774	-38.58 Percent change Standard Deviation 97.750
Percent Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 132	-29.37 Percent change Standard Deviation 40.170	-82.01 Percent change Standard Deviation 21.165
Percent Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 144	-25.25 Percent change Standard Deviation 33.618	-60.36 Percent change Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.
Percent Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 156	-15.66 Percent change Standard Deviation 7.700	-60.69 Percent change Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.
Percent Change From Baseline in PS Caloric Intake at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 12	-24.91 Percent change Standard Deviation 29.001	7.64 Percent change Standard Deviation 82.061

SECONDARY outcome

Timeframe: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to Week 156

Population: Data for this outcome measure was not analyzed and collected because changes from baseline for prescribed hours per day were not collected at baseline in the core study.

Data for this outcome measure was not analyzed and collected because changes from baseline for prescribed hours per day were not collected at baseline in the core study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to Week 156

Population: Data for this outcome measure was not analyzed and collected because changes from baseline for prescribed hours per day were not collected at baseline in the core study.

Data for this outcome measure was not analyzed and collected because changes from baseline for prescribed hours per day were not collected at baseline in the core study. Hence, percent change was not assessed in this study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156

Population: RETRO participants: all participants who consented to participation in this extension study and provided data for the retrospective period of the protocol. Here, number analyzed signifies participants who were evaluable for this outcome at specific time point.

Change from baseline in number of days per Week of PS usage at 12 weeks interval up to Week 156 in retrospective observation period was reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=24 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group n=5 Participants Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 12	-0.38 Days per week Standard Deviation 1.469	-1.20 Days per week Standard Deviation 2.683
Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 24	-0.29 Days per week Standard Deviation 1.429	-1.00 Days per week Standard Deviation 2.000
Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 36	-0.43 Days per week Standard Deviation 1.562	-2.60 Days per week Standard Deviation 2.793
Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 60	-0.61 Days per week Standard Deviation 2.017	-3.00 Days per week Standard Deviation 3.536
Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 72	-0.64 Days per week Standard Deviation 2.060	-1.40 Days per week Standard Deviation 2.966
Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 84	-0.64 Days per week Standard Deviation 2.060	-1.40 Days per week Standard Deviation 2.966
Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 96	-1.17 Days per week Standard Deviation 2.665	-2.00 Days per week Standard Deviation 3.536
Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 108	-0.88 Days per week Standard Deviation 2.365	-3.80 Days per week Standard Deviation 3.701
Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 120	-0.95 Days per week Standard Deviation 2.459	-3.80 Days per week Standard Deviation 3.701
Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 132	-1.00 Days per week Standard Deviation 2.542	-5.25 Days per week Standard Deviation 2.062
Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 144	0.00 Days per week Standard Deviation 0.000	-3.00 Days per week Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.
Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 156	0.00 Days per week Standard Deviation 0.000	-3.00 Days per week Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.
Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Change at Week 48	-0.61 Days per week Standard Deviation 2.017	-4.50 Days per week Standard Deviation 2.082

SECONDARY outcome

Timeframe: Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156

Population: RETRO participants: all participants who consented to participation in this extension study and provided data for the retrospective period of the protocol. Here, number analyzed signifies participants who were evaluable for this outcome at specific time point.

Percent change from baseline in number of days per Week of PS usage at 12 weeks interval up to Week 156 in retrospective observation period was reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=24 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group n=5 Participants Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Percent Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 12	-6.25 Percent change Standard Deviation 22.421	-14.86 Percent change Standard Deviation 41.913
Percent Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 24	-4.17 Percent change Standard Deviation 20.412	-14.29 Percent change Standard Deviation 28.571
Percent Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 36	-6.21 Percent change Standard Deviation 22.309	-34.86 Percent change Standard Deviation 44.648
Percent Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 48	-8.70 Percent change Standard Deviation 28.810	-64.29 Percent change Standard Deviation 29.738
Percent Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 60	-8.70 Percent change Standard Deviation 28.810	-40.57 Percent change Standard Deviation 54.638
Percent Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 72	-9.09 Percent change Standard Deviation 29.424	-17.71 Percent change Standard Deviation 45.821
Percent Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 84	-9.09 Percent change Standard Deviation 29.424	-17.71 Percent change Standard Deviation 45.821
Percent Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 96	-16.67 Percent change Standard Deviation 38.069	-26.29 Percent change Standard Deviation 53.886
Percent Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 108	-12.50 Percent change Standard Deviation 33.783	-52.00 Percent change Standard Deviation 57.407
Percent Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 120	-13.64 Percent change Standard Deviation 35.125	-52.00 Percent change Standard Deviation 57.407
Percent Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 132	-14.29 Percent change Standard Deviation 36.314	-75.00 Percent change Standard Deviation 29.451
Percent Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 144	0.00 Percent change Standard Deviation 0.000	-42.86 Percent change Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.
Percent Change From Baseline in Number of Days Per Week of PS Usage at 12 Weeks Interval up to Week 156 of Retrospective Observation Period Percent change at Week 156	0.00 Percent change Standard Deviation 0.000	-42.86 Percent change Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.

SECONDARY outcome

Timeframe: At EOT of each Cycles 1 to 6 (up to Week 140) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 20 weeks)

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Here, number analyzed signifies participants who were evaluable for this outcome at specific time point. Data were not planned to be collected and analyzed for the prospective TED/NTT group.

Number of participants who achieved at least 20, 50 and 75% reduction in PS volume at EOT of each cycle during the end of teduglutide treatment period in prospective study period was reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=19 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Number of Participants Who Achieved At Least 20, 50 and 75% Reduction in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 1: EOT at >= 20%	13 Participants	—
Number of Participants Who Achieved At Least 20, 50 and 75% Reduction in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 2: EOT at >= 20%	12 Participants	—
Number of Participants Who Achieved At Least 20, 50 and 75% Reduction in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 3: EOT at >= 20%	10 Participants	—
Number of Participants Who Achieved At Least 20, 50 and 75% Reduction in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 4: EOT at >= 20%	9 Participants	—
Number of Participants Who Achieved At Least 20, 50 and 75% Reduction in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 5: EOT at >= 20%	7 Participants	—
Number of Participants Who Achieved At Least 20, 50 and 75% Reduction in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 6: EOT at >= 20%	5 Participants	—
Number of Participants Who Achieved At Least 20, 50 and 75% Reduction in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 1: EOT at >= 50%	5 Participants	—
Number of Participants Who Achieved At Least 20, 50 and 75% Reduction in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 2: EOT at >= 50%	10 Participants	—
Number of Participants Who Achieved At Least 20, 50 and 75% Reduction in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 3: EOT at >= 50%	9 Participants	—
Number of Participants Who Achieved At Least 20, 50 and 75% Reduction in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 4: EOT at >= 50%	9 Participants	—
Number of Participants Who Achieved At Least 20, 50 and 75% Reduction in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 5: EOT at >= 50%	5 Participants	—
Number of Participants Who Achieved At Least 20, 50 and 75% Reduction in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 1: EOT at >= 75%	2 Participants	—
Number of Participants Who Achieved At Least 20, 50 and 75% Reduction in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 2: EOT at >= 75%	4 Participants	—
Number of Participants Who Achieved At Least 20, 50 and 75% Reduction in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 3: EOT at >= 75%	6 Participants	—
Number of Participants Who Achieved At Least 20, 50 and 75% Reduction in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 4: EOT at >= 75%	5 Participants	—
Number of Participants Who Achieved At Least 20, 50 and 75% Reduction in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 5: EOT at >= 75%	4 Participants	—
Number of Participants Who Achieved At Least 20, 50 and 75% Reduction in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 6: EOT at >= 75%	3 Participants	—
Number of Participants Who Achieved At Least 20, 50 and 75% Reduction in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 6: EOT at >= 50%	4 Participants	—

SECONDARY outcome

Timeframe: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specific time point. Data were not planned to be collected and analyzed for the prospective TED/NTT group.

Change from baseline in PS volume at EOT of each cycle during the end of teduglutide treatment period in prospective study period was reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=18 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Change From Baseline in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 1: EOT	-25.18 mL/kg/day Standard Deviation 19.915	—
Change From Baseline in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 2: EOT	-28.59 mL/kg/day Standard Deviation 29.856	—
Change From Baseline in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 3: EOT	-40.05 mL/kg/day Standard Deviation 29.711	—
Change From Baseline in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 4: EOT	-40.10 mL/kg/day Standard Deviation 30.359	—
Change From Baseline in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 5: EOT	-40.49 mL/kg/day Standard Deviation 24.259	—
Change From Baseline in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 6: EOT	-47.57 mL/kg/day Standard Deviation 26.243	—

SECONDARY outcome

Timeframe: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specific time point. Data were not planned to be collected and analyzed for the prospective TED/NTT group.

Percent change from baseline in PS volume at EOT of each cycle during the end of teduglutide treatment period in prospective study period.

Outcome measures

Measure	Retrospective TED/NTT Group n=18 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Percent Change From Baseline in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change: Cycle 1: EOT	-38.02 Percent change Standard Deviation 28.611	—
Percent Change From Baseline in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change: Cycle 2: EOT	-45.58 Percent change Standard Deviation 48.150	—
Percent Change From Baseline in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change: Cycle 3: EOT	-62.16 Percent change Standard Deviation 41.805	—
Percent Change From Baseline in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change: Cycle 4: EOT	-62.92 Percent change Standard Deviation 38.466	—
Percent Change From Baseline in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change: Cycle 5: EOT	-73.49 Percent change Standard Deviation 34.593	—
Percent Change From Baseline in PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change: Cycle 6: EOT	-78.75 Percent change Standard Deviation 33.949	—

SECONDARY outcome

Timeframe: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Here, number analyzed signifies participants who were evaluable for this outcome at specific time point. Data were not planned to be collected and analyzed for the prospective TED/NTT group.

Change from baseline in PS caloric intake at EOT of each cycle during the end of teduglutide treatment period in prospective study period was reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=19 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Change From Baseline in PS Caloric Intake at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 1: EOT	-17.66 kcal/kg/day Standard Deviation 17.649	—
Change From Baseline in PS Caloric Intake at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 2: EOT	-19.95 kcal/kg/day Standard Deviation 23.402	—
Change From Baseline in PS Caloric Intake at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 3: EOT	-27.66 kcal/kg/day Standard Deviation 19.668	—
Change From Baseline in PS Caloric Intake at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 5: EOT	-26.98 kcal/kg/day Standard Deviation 27.465	—
Change From Baseline in PS Caloric Intake at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 6: EOT	-27.53 kcal/kg/day Standard Deviation 32.486	—
Change From Baseline in PS Caloric Intake at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 4: EOT	-24.05 kcal/kg/day Standard Deviation 22.746	—

SECONDARY outcome

Timeframe: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Here, number analyzed signifies participants who were evaluable for this outcome at specific time point. Data were not planned to be collected and analyzed for the prospective TED/NTT group.

Percent change from baseline in PS caloric intake at EOT of each cycle during the end of teduglutide treatment period in prospective study period was reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=19 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Percent Change From Baseline in PS Caloric Intake at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change at Cycle 1: EOT	-33.50 Percent change Standard Deviation 40.439	—
Percent Change From Baseline in PS Caloric Intake at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change at Cycle 2: EOT	-42.06 Percent change Standard Deviation 44.077	—
Percent Change From Baseline in PS Caloric Intake at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change at Cycle 3: EOT	-62.47 Percent change Standard Deviation 37.677	—
Percent Change From Baseline in PS Caloric Intake at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change at Cycle 4: EOT	-49.51 Percent change Standard Deviation 54.041	—
Percent Change From Baseline in PS Caloric Intake at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change at Cycle 5: EOT	-54.08 Percent change Standard Deviation 64.002	—
Percent Change From Baseline in PS Caloric Intake at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change at Cycle 6: EOT	-59.00 Percent change Standard Deviation 57.267	—

SECONDARY outcome

Timeframe: At EOT of each Cycles 1 to 6 (up to Week 144) (length of each Cycle 1 to 6 = 24 weeks)

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Here, number analyzed signifies participants who were evaluable for this outcome at specific time point. Data were not planned to be collected and analyzed for the prospective TED/NTT group.

Number of participants who achieved at least 100% reduction in complete weaning of PS volume at EOT of each cycle during the end of teduglutide treatment period in prospective study period was reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=19 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 1: EOT	1 Participants	—
Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 2: EOT	3 Participants	—
Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 3: EOT	6 Participants	—
Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 4: EOT	5 Participants	—
Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 5: EOT	4 Participants	—
Number of Participants Who Achieved 100% Reduction in Complete Weaning of PS Volume at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Cycle 6: EOT	3 Participants	—

SECONDARY outcome

Timeframe: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specific time point. Data were not planned to be collected and analyzed for the prospective TED/NTT group.

Change from baseline in number of hours per day of PS usage at EOT of each cycle during the end of teduglutide treatment period in prospective study period was reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=18 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Change From Baseline in Number of Hours Per Day of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 1: EOT	-3.40 Hours per day Standard Deviation 3.752	—
Change From Baseline in Number of Hours Per Day of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 2: EOT	-4.80 Hours per day Standard Deviation 5.360	—
Change From Baseline in Number of Hours Per Day of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 3: EOT	-6.69 Hours per day Standard Deviation 4.247	—
Change From Baseline in Number of Hours Per Day of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 4: EOT	-6.48 Hours per day Standard Deviation 4.881	—
Change From Baseline in Number of Hours Per Day of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 5: EOT	-6.71 Hours per day Standard Deviation 6.175	—
Change From Baseline in Number of Hours Per Day of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 6: EOT	-8.08 Hours per day Standard Deviation 6.075	—

SECONDARY outcome

Timeframe: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specific time point. Data were not planned to be collected and analyzed for the prospective TED/NTT group.

Percent change from baseline in number of hours per day of PS usage at EOT of each cycle during the end of teduglutide treatment period in prospective study period was reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=18 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Percent Change From Baseline in Number of Hours Per Day of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change at Cycle 1: EOT	-26.32 Percent change Standard Deviation 29.732	—
Percent Change From Baseline in Number of Hours Per Day of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change at Cycle 2: EOT	-40.47 Percent change Standard Deviation 40.476	—
Percent Change From Baseline in Number of Hours Per Day of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change at Cycle 3: EOT	-57.61 Percent change Standard Deviation 36.973	—
Percent Change From Baseline in Number of Hours Per Day of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change at Cycle 4: EOT	-55.87 Percent change Standard Deviation 42.693	—
Percent Change From Baseline in Number of Hours Per Day of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change at Cycle 5: EOT	-58.85 Percent change Standard Deviation 52.717	—
Percent Change From Baseline in Number of Hours Per Day of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change at Cycle 6: EOT	-66.39 Percent change Standard Deviation 46.042	—

SECONDARY outcome

Timeframe: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specific time point. Data were not planned to be collected and analyzed for the prospective TED/NTT group.

Change from baseline in number of days per week of PS usage at EOT of each cycle during the end of teduglutide treatment period in prospective study period was reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=18 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Change From Baseline in Number of Days Per Week of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 1: EOT	-0.60 Days per week Standard Deviation 1.892	—
Change From Baseline in Number of Days Per Week of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 2: EOT	-1.93 Days per week Standard Deviation 2.840	—
Change From Baseline in Number of Days Per Week of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 3: EOT	-3.03 Days per week Standard Deviation 3.257	—
Change From Baseline in Number of Days Per Week of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 4: EOT	-2.99 Days per week Standard Deviation 3.610	—
Change From Baseline in Number of Days Per Week of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 5: EOT	-3.83 Days per week Standard Deviation 3.969	—
Change From Baseline in Number of Days Per Week of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Change at Cycle 6: EOT	-4.37 Days per week Standard Deviation 3.618	—

SECONDARY outcome

Timeframe: Baseline (from the beginning of the prospective study period), EOT of each Cycles 1 to 6 (up to Week 136) (length of each Cycle 1 to 5 = 24 weeks, length of Cycle 6 = 16 weeks)

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specific time point. Data were not planned to be collected and analyzed for the prospective TED/NTT group.

Percent change from baseline in number of days per week of PS usage at EOT of each cycle during the end of teduglutide treatment period in prospective study period was reported.

Outcome measures

Measure	Retrospective TED/NTT Group n=18 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Percent Change From Baseline in Number of Days Per Week of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change at Cycle 1: EOT	-9.01 Percent change Standard Deviation 27.472	—
Percent Change From Baseline in Number of Days Per Week of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change at Cycle 2: EOT	-29.24 Percent change Standard Deviation 40.525	—
Percent Change From Baseline in Number of Days Per Week of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change at Cycle 3: EOT	-44.51 Percent change Standard Deviation 47.929	—
Percent Change From Baseline in Number of Days Per Week of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change at Cycle 4: EOT	-42.38 Percent change Standard Deviation 51.929	—
Percent Change From Baseline in Number of Days Per Week of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change at Cycle 5: EOT	-54.29 Percent change Standard Deviation 57.404	—
Percent Change From Baseline in Number of Days Per Week of PS Usage at EOT of Each Cycle During the End of Teduglutide Treatment Period of Prospective Study Period Percent change at Cycle 6: EOT	-62.86 Percent change Standard Deviation 51.110	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (from the beginning of the prospective study period), Week 12 and 24 of Cycles 1 to 6

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specific time point. Data were not planned to be collected and analyzed for the prospective TED/NTT group.

PedsQL GCS was used for quality of life assessment. It encompasses 4 dimensions of functioning (physical, emotional, social, school). Age groups are: Toddler (2-4 years), Young child (5-7 years), Child (8-12 years), and Teens (13-18 years). Depending on the participants age, the questionnaire may be completed by either the participant or the parent/caregiver as appropriate. For the Toddler group, the PedsQL GCS consisted of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consisted of 23 items, with a 3-point Likert scale (0, 2, 4) for the young child, and a 5-point Likert scale for the child and teens groups. Scores are transformed on a scale from 0 to 100 where 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.

Outcome measures

Measure	Retrospective TED/NTT Group n=15 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period School Functioning: Change at Cycle 5 Week 12	15.00 Score on a scale Standard Deviation 11.180	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Physical Functioning: Change at Cycle 1 Week 12	-0.39 Score on a scale Standard Deviation 24.326	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Physical Functioning: Change at Cycle 1 Week 24	-0.83 Score on a scale Standard Deviation 10.726	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Physical Functioning: Change at Cycle 2 Week 12	2.34 Score on a scale Standard Deviation 15.717	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Physical Functioning: Change at Cycle 2 Week 24	2.40 Score on a scale Standard Deviation 16.296	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Physical Functioning: Change at Cycle 3 Week 12	-0.57 Score on a scale Standard Deviation 16.167	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Physical Functioning: Change at Cycle 3 Week 24	-1.74 Score on a scale Standard Deviation 25.963	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Physical Functioning: Change at Cycle 4 Week 12	-1.74 Score on a scale Standard Deviation 22.378	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Physical Functioning: Change at Cycle 4 Week 24	1.79 Score on a scale Standard Deviation 19.998	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Physical Functioning: Change at Cycle 5 Week 12	-7.50 Score on a scale Standard Deviation 19.961	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Physical Functioning: Change at Cycle 5 Week 24	-2.34 Score on a scale Standard Deviation 14.292	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Physical Functioning: Change at Cycle 6 Week 12	-6.25 Score on a scale Standard Deviation 22.244	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Physical Functioning: Change at Cycle 6 Week 24	3.13 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Emotional Functioning: Change at Cycle 1 Week 12	4.17 Score on a scale Standard Deviation 18.843	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Emotional Functioning: Change at Cycle 1 Week 24	-4.67 Score on a scale Standard Deviation 24.511	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Emotional Functioning: Change at Cycle 2 Week 12	-3.33 Score on a scale Standard Deviation 28.591	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Emotional Functioning: Change at Cycle 2 Week 24	-0.38 Score on a scale Standard Deviation 21.454	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Emotional Functioning: Change at Cycle 3 Week 12	7.05 Score on a scale Standard Deviation 29.661	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Emotional Functioning: Change at Cycle 3 Week 24	-8.33 Score on a scale Standard Deviation 36.120	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Emotional Functioning: Change at Cycle 4 Week 12	2.78 Score on a scale Standard Deviation 33.481	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Emotional Functioning: Change at Cycle 4 Week 24	-0.71 Score on a scale Standard Deviation 35.786	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Emotional Functioning: Change at Cycle 5 Week 12	-11.00 Score on a scale Standard Deviation 40.566	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Emotional Functioning: Cycle 5 Week 24	-17.50 Score on a scale Standard Deviation 37.804	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Emotional Functioning: Change at Cycle 6 Week 12	-5.63 Score on a scale Standard Deviation 56.065	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Emotional Functioning: Change at Cycle 6 Week 24	17.50 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Social Functioning: Change at Cycle 1 Week 12	-15.00 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Social Functioning: Change at Cycle 1 Week 24	-10.00 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Social Functioning: Change at Cycle 2 Week 12	-5.00 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Social Functioning: Change at Cycle 2 Week 24	0.00 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Social Functioning: Change at Cycle 3 Week 12	10.00 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Social Functioning: Change at Cycle 3 Week 24	0.00 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Social Functioning: Change at Cycle 4 Week 12	10.00 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Social Functioning: Change at Cycle 4 Week 24	10.00 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Social Functioning: Change at Cycle 5 Week 12	10.00 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Social Functioning: Change at Cycle 5 Week 24	10.00 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Social Functioning: Change at Cycle 6 Week 12	10.00 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period School Functioning: Change at Cycle 1 Week 12	5.67 Score on a scale Standard Deviation 19.445	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period School Functioning: Change at Cycle 1 Week 24	2.00 Score on a scale Standard Deviation 20.160	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period School Functioning: Change at Cycle 2 Week 12	-5.00 Score on a scale Standard Deviation 24.027	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period School Functioning: Change at Cycle 3 Week 24	-3.33 Score on a scale Standard Deviation 22.500	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period School Functioning: Change at Cycle 4 Week 12	0.00 Score on a scale Standard Deviation 15.000	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period School Functioning: Change at Cycle 4 Week 24	13.57 Score on a scale Standard Deviation 8.018	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period School Functioning: Change at Cycle 5 Week 24	18.75 Score on a scale Standard Deviation 8.539	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period School Functioning: Change at Cycle 6 Week 12	13.75 Score on a scale Standard Deviation 4.787	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period School Functioning: Change at Cycle 6 Week 24	20.00 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period School Functioning: Change at Cycle 2 Week 24	8.75 Score on a scale Standard Deviation 16.394	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period School Functioning: Change at Cycle 3 Week 12	3.64 Score on a scale Standard Deviation 23.355	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (from the beginning of the prospective study period), End of Last NTT period (up to Week 120)

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Data was not collected and analyzed at this time point, for this respective arms.

PedsQL GCS was used for quality of life assessment. It encompasses 4 dimensions of functioning (physical, emotional, social, school). Age groups are: Toddler (2-4 years), Young child (5-7 years), Child (8-12 years), and Teens (13-18 years). Depending on the participants age, the questionnaire may be completed by either the participant or the parent/caregiver as appropriate. For the Toddler group, the PedsQL GCS consisted of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consisted of 23 items, with a 3-point Likert scale (0, 2, 4) for the young child, and a 5-point Likert scale for the child and teens groups. Scores are transformed on a scale from 0 to 100 where 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (from the beginning of the prospective study period), Week 12 and 24 of Cycles 1 to 6

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Here, number analyzed signifies participants who were evaluable for this outcome at specific time point. Data were not planned to be collected and analyzed for the prospective TED/NTT group.

PedsQL Family Impact Module was composed of 36 items comprising Physical Functioning (6 items), Emotional Functioning (5 items), Social Functioning (4 items), Cognitive Functioning (5 items), Communication (3 items), Worry (5 items), Daily Activities (3 items) and Family Relationships (5 items). Total score was calculated as the sum of all the items over the number of items answered on all the scales. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.

Outcome measures

Measure	Retrospective TED/NTT Group n=19 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Family Impact Module Total Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Change at Cycle 1 Week 12	1.39 Score on a scale Standard Deviation 15.742	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Family Impact Module Total Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Change at Cycle 1 Week 24	1.56 Score on a scale Standard Deviation 13.372	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Family Impact Module Total Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Change at Cycle 2 Week 12	0.10 Score on a scale Standard Deviation 13.622	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Family Impact Module Total Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Change at Cycle 2 Week 24	1.90 Score on a scale Standard Deviation 11.664	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Family Impact Module Total Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Change at Cycle 3 Week 12	2.72 Score on a scale Standard Deviation 15.051	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Family Impact Module Total Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Change at Cycle 3 Week 24	3.90 Score on a scale Standard Deviation 16.018	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Family Impact Module Total Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Change at Cycle 4 Week 12	2.14 Score on a scale Standard Deviation 20.762	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Family Impact Module Total Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Change at Cycle 4 Week 24	4.66 Score on a scale Standard Deviation 23.546	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Family Impact Module Total Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Change at Cycle 5 Week 12	0.11 Score on a scale Standard Deviation 14.105	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Family Impact Module Total Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Change at Cycle 5 Week 24	2.23 Score on a scale Standard Deviation 16.099	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Family Impact Module Total Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Change at Cycle 6 Week 12	5.13 Score on a scale Standard Deviation 18.084	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Family Impact Module Total Score at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Change at Cycle 6 Week 24	-17.86 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (from the beginning of to the end the prospective study period), End of Last NTT period (up to Week 120)

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Data was not collected and analyzed at this time point, for this respective arms.

PedsQL Family Impact Module was composed of 36 items comprising Physical Functioning (6 items), Emotional Functioning (5 items), Social Functioning (4 items), Cognitive Functioning (5 items), Communication (3 items), Worry (5 items), Daily Activities (3 items) and Family Relationships (5 items). Total score was calculated as the sum of all the items over the number of items answered on all the scales. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (from the beginning of the prospective study period), Week 12 and 24 of Cycles 1 to 6

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. 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 at specific time point at specific time point. Data for this outcome was not planned to be collected and analyzed in prospective TED/NTT group.

PedsQL GI symptoms module was composed of 58 items, comprised of 10 different symptom scales that assess gastrointestinal symptom-related quality of life: food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea. Only the scales of food and drink limits (6 items) and diarrhea (7 items) was used in this study. Subscale score was calculated as the sum of the items over the number of items answered in the scale. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.

Outcome measures

Measure	Retrospective TED/NTT Group n=19 Participants Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Food and Drink Limits: Change at Cycle 1 Week 12	-2.08 Score on a scale Standard Deviation 30.460	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Food and Drink Limits: Change at Cycle 1 Week 24	-7.06 Score on a scale Standard Deviation 27.524	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Food and Drink Limits: Change at Cycle 2 Week 12	-0.83 Score on a scale Standard Deviation 29.723	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Food and Drink Limits: Change at Cycle 2 Week 24	9.31 Score on a scale Standard Deviation 26.292	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Food and Drink Limits: Change at Cycle 3 Week 12	1.19 Score on a scale Standard Deviation 35.784	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Food and Drink Limits: Change at Cycle 3 Week 24	-0.08 Score on a scale Standard Deviation 29.511	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Food and Drink Limits: Change at Cycle 4 Week 12	-4.63 Score on a scale Standard Deviation 33.750	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Food and Drink Limits: Change at Cycle 4 Week 24	1.04 Score on a scale Standard Deviation 35.895	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Food and Drink Limits: Change at Cycle 5 Week 12	1.19 Score on a scale Standard Deviation 21.343	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Food and Drink Limits: Change at Cycle 5 Week 24	-17.36 Score on a scale Standard Deviation 44.986	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Food and Drink Limits: Change at Cycle 6 Week 12	-1.39 Score on a scale Standard Deviation 30.142	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Food and Drink Limits: Change at Cycle 6 Week 24	-45.83 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Diarrhea: Change at Cycle 1 Week 12	7.79 Score on a scale Standard Deviation 23.137	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Diarrhea: Change at Cycle 1 Week 24	9.33 Score on a scale Standard Deviation 23.279	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Diarrhea: Change at Cycle 2 Week 12	5.48 Score on a scale Standard Deviation 15.144	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Diarrhea: Change at Cycle 2 Week 24	6.72 Score on a scale Standard Deviation 19.880	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Diarrhea: Change at Cycle 3 Week 12	13.27 Score on a scale Standard Deviation 22.124	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Diarrhea: Change at Cycle 3 Week 24	5.19 Score on a scale Standard Deviation 21.569	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Diarrhea: Change at Cycle 4 Week 12	9.13 Score on a scale Standard Deviation 18.653	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Diarrhea: Change at Cycle 4 Week 24	12.95 Score on a scale Standard Deviation 26.448	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Diarrhea: Change at Cycle 5 Week 12	10.71 Score on a scale Standard Deviation 23.237	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Diarrhea: Change at Cycle 5 Week 24	8.33 Score on a scale Standard Deviation 30.612	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Diarrhea: Change at Cycle 6 Week 12	5.95 Score on a scale Standard Deviation 22.961	—
Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module at Week 12 and 24 of Each Treatment Cycle During the Teduglutide Treatment Periods of Prospective Study Period Diarrhea: Change at Cycle 6 Week 24	-7.14 Score on a scale Standard Deviation NA Standard deviation could not be calculated because single participant was analyzed.	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (from the beginning of the prospective study period), End of Last NTT period (up to Week 120)

Population: Safety population included all enrolled participants who provided informed consent for the prospective portion and met all the inclusion criteria. Data was not collected and analyzed at this time point, for this respective arms.

PedsQL GI symptoms module was composed of 58 items, comprised of 10 different symptom scales that assess gastrointestinal symptom-related quality of life: food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea. Only the scales of food and drink limits (6 items) and diarrhea (7 items) was used in this study. Subscale score was calculated as the sum of the items over the number of items answered in the scale. Scores are transformed on a scale from 0 to 100 were 0=100, 1=75, 2=50, 3=25, and 4=0. Higher scores indicate improved quality of life.

Outcome measures

Outcome data not reported

Adverse Events

Retrospective TED/NTT Group

Serious events: 23 serious events

Other events: 1 other events

Deaths: 0 deaths

Retrospective TED/TED Group

Serious events: 4 serious events

Other events: 1 other events

Deaths: 0 deaths

Prospective TED/NTT Group

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Prospective TED/TED Group

Serious events: 17 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Retrospective TED/NTT Group n=24 participants at risk Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group n=5 participants at risk Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.	Prospective TED/NTT Group n=5 participants at risk Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in prospective period in the current study SHP633-303 up to 24 weeks.	Prospective TED/TED Group n=19 participants at risk Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in prospective period in the current study SHP633-303 up to 24 weeks.
Blood and lymphatic system disorders Anaemia	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Blood and lymphatic system disorders Haemorrhagic anaemia	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Cardiac disorders Tachycardia	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Congenital, familial and genetic disorders Congenital megacolon	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Abdominal adhesions	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Diarrhoea	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Duodenal ulcer	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Enteritis	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Functional gastrointestinal disorder	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 6 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Gastrointestinal hypomotility	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Ileus	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Ileus paralytic	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Intestinal obstruction	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Pancreatitis	8.3% 2/24 • Number of events 4 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Rectal haemorrhage	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Short-bowel syndrome	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Small intestinal obstruction	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Small intestinal stenosis	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Vomiting	8.3% 2/24 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
General disorders Complication associated with device	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
General disorders Face oedema	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
General disorders Hyperpyrexia	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
General disorders Oedema peripheral	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
General disorders Pyrexia	58.3% 14/24 • Number of events 31 • From start of screening up to end of the study (up to 168 weeks)	60.0% 3/5 • Number of events 6 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	36.8% 7/19 • Number of events 12 • From start of screening up to end of the study (up to 168 weeks)
General disorders Systemic inflammatory response syndrome	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Hepatobiliary disorders Hepatic failure	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Hepatobiliary disorders Jaundice	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Adenovirus infection	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Bacteraemia	8.3% 2/24 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Bacterial infection	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Bronchiolitis	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Cellulitis	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Cystitis	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Device related infection	70.8% 17/24 • Number of events 33 • From start of screening up to end of the study (up to 168 weeks)	40.0% 2/5 • Number of events 6 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	47.4% 9/19 • Number of events 13 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Device related sepsis	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Enterococcal infection	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Fungal infection	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Gastroenteritis	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Gastroenteritis viral	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 3 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Influenza	20.8% 5/24 • Number of events 5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	21.1% 4/19 • Number of events 4 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Metapneumovirus infection	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Micrococcus infection	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Osteomyelitis	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Parainfluenzae virus infection	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Respiratory syncytial virus bronchiolitis	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Respiratory syncytial virus infection	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Rhinovirus infection	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Rotavirus infection	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Sepsis	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Staphylococcal bacteraemia	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Staphylococcal sepsis	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Upper respiratory tract infection	4.2% 1/24 • Number of events 3 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Urinary tract infection	8.3% 2/24 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Urosepsis	8.3% 2/24 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Viral infection	4.2% 1/24 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Viral pharyngitis	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Viral upper respiratory tract infection	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Injury, poisoning and procedural complications Anastomotic ulcer	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Injury, poisoning and procedural complications Foot fracture	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Investigations Influenza A virus test positive	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Investigations Staphylococcus test positive	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Investigations Weight decreased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Metabolism and nutrition disorders Dehydration	8.3% 2/24 • Number of events 3 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Metabolism and nutrition disorders Electrolyte imbalance	8.3% 2/24 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 4 • From start of screening up to end of the study (up to 168 weeks)
Metabolism and nutrition disorders Feeding intolerance	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Metabolism and nutrition disorders Metabolic acidosis	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Metabolism and nutrition disorders Weight gain poor	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Product Issues Device breakage	25.0% 6/24 • Number of events 8 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Product Issues Device dislocation	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Product Issues Device failure	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Product Issues Device malfunction	20.8% 5/24 • Number of events 5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Product Issues Device occlusion	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Respiratory, thoracic and mediastinal disorders Asthma	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Respiratory, thoracic and mediastinal disorders Tachypnoea	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Skin and subcutaneous tissue disorders Skin irritation	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Surgical and medical procedures Catheter management	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Surgical and medical procedures Central venous catheterisation	8.3% 2/24 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Vascular disorders Superior vena cava occlusion	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Vascular disorders Superior vena cava syndrome	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)

Other adverse events

Measure	Retrospective TED/NTT Group n=24 participants at risk Participants received teduglutide 0.05 milligrams per kilogram (mg/kg) subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in retrospective period in the current study SHP633-303.	Retrospective TED/TED Group n=5 participants at risk Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in retrospective period in the current study SHP633-303.	Prospective TED/NTT Group n=5 participants at risk Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and did not receive teduglutide in prospective period in the current study SHP633-303 up to 24 weeks.	Prospective TED/TED Group n=19 participants at risk Participants who received teduglutide 0.05 mg/kg subcutaneous injection once daily in TED-C13-003 (NCT01952080) and also received teduglutide in prospective period in the current study SHP633-303 up to 24 weeks.
Gastrointestinal disorders Dyspepsia	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 3 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Faecal volume increased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 3 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Faeces discoloured	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Blood and lymphatic system disorders Anaemia	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)	15.8% 3/19 • Number of events 7 • From start of screening up to end of the study (up to 168 weeks)
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Ear and labyrinth disorders Ear pain	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Ear and labyrinth disorders Middle ear effusion	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Endocrine disorders Adrenal insufficiency	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Eye disorders Visual impairment	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Abdominal discomfort	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Abdominal distension	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	15.8% 3/19 • Number of events 3 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Abdominal pain	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	40.0% 2/5 • Number of events 4 • From start of screening up to end of the study (up to 168 weeks)	36.8% 7/19 • Number of events 22 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 7 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Constipation	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Diarrhoea	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	26.3% 5/19 • Number of events 10 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Flatulence	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Frequent bowel movements	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 3 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Gastritis	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Gastroenteritis eosinophilic	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Haematochezia	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 3 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Lip swelling	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Nausea	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	15.8% 3/19 • Number of events 7 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Oral mucosal erythema	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Perianal erythema	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Post-tussive vomiting	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Proctalgia	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 3 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Proctitis	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Rectal discharge	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 8 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Toothache	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Gastrointestinal disorders Vomiting	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	40.0% 2/5 • Number of events 3 • From start of screening up to end of the study (up to 168 weeks)	52.6% 10/19 • Number of events 55 • From start of screening up to end of the study (up to 168 weeks)
General disorders Administration site extravasation	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
General disorders Catheter site inflammation	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
General disorders Fatigue	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 3 • From start of screening up to end of the study (up to 168 weeks)
General disorders Generalised oedema	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
General disorders Ill-defined disorder	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
General disorders Injection site induration	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
General disorders Injection site pain	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
General disorders Injection site reaction	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
General disorders Injection site swelling	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
General disorders Medical device site irritation	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
General disorders Pyrexia	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
General disorders Secretion discharge	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Immune system disorders Food allergy	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 4 • From start of screening up to end of the study (up to 168 weeks)
Immune system disorders Hypersensitivity	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Immune system disorders Seasonal allergy	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Bronchiolitis	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Cellulitis	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Croup infectious	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Device related infection	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Ear infection	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Escherichia urinary tract infection	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Furuncle	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Gastroenteritis	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	15.8% 3/19 • Number of events 5 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Gastroenteritis viral	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	15.8% 3/19 • Number of events 3 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Impetigo	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Influenza	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 3 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Lyme disease	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Nasopharyngitis	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	15.8% 3/19 • Number of events 7 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Otitis media	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 4 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Pharyngitis streptococcal	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 3 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Respiratory tract infection	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 4 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Rhinovirus infection	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Upper respiratory tract infection	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	60.0% 3/5 • Number of events 5 • From start of screening up to end of the study (up to 168 weeks)	36.8% 7/19 • Number of events 18 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Urinary tract infection	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	15.8% 3/19 • Number of events 3 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Viral infection	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	15.8% 3/19 • Number of events 5 • From start of screening up to end of the study (up to 168 weeks)
Infections and infestations Viral upper respiratory tract infection	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	40.0% 2/5 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 3 • From start of screening up to end of the study (up to 168 weeks)
Injury, poisoning and procedural complications Medication error	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Injury, poisoning and procedural complications Procedural pain	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Investigations Alanine aminotransferase increased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Investigations Bacterial test positive	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	15.8% 3/19 • Number of events 3 • From start of screening up to end of the study (up to 168 weeks)
Investigations Blood albumin decreased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Investigations Blood creatine increased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Investigations Blood creatinine increased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Investigations Blood iron decreased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Investigations Blood sodium decreased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Investigations Blood urine present	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Investigations Body temperature increased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Investigations C-reactive protein increased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	26.3% 5/19 • Number of events 6 • From start of screening up to end of the study (up to 168 weeks)
Investigations Gamma-glutamyltransferase increased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Investigations Gastrointestinal stoma output increased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Investigations Haematocrit decreased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Investigations Haemoglobin decreased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Investigations Heart rate increased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Investigations Hepatic enzyme increased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Investigations Lipase increased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Investigations Lymph node palpable	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Investigations Occult blood positive	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Investigations Platelet count increased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Investigations Serum ferritin decreased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Investigations Streptococcus test positive	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Investigations Vitamin A decreased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Investigations Weight decreased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Investigations White blood cells urine positive	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Investigations pH urine increased	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Metabolism and nutrition disorders Acidosis	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Metabolism and nutrition disorders Dehydration	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Nervous system disorders Dizziness	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	15.8% 3/19 • Number of events 4 • From start of screening up to end of the study (up to 168 weeks)
Nervous system disorders Dysarthria	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Nervous system disorders Headache	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	26.3% 5/19 • Number of events 16 • From start of screening up to end of the study (up to 168 weeks)
Nervous system disorders Lethargy	4.2% 1/24 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	15.8% 3/19 • Number of events 6 • From start of screening up to end of the study (up to 168 weeks)
Nervous system disorders Migraine	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Nervous system disorders Seizure	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Nervous system disorders Syncope	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Product Issues Device dislocation	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Product Issues Device leakage	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Product Issues Device occlusion	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	15.8% 3/19 • Number of events 4 • From start of screening up to end of the study (up to 168 weeks)
Psychiatric disorders Aggression	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Psychiatric disorders Attention deficit/hyperactivity disorder	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Psychiatric disorders Depression	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Psychiatric disorders Sleep disorder	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Renal and urinary disorders Haematuria	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	31.6% 6/19 • Number of events 8 • From start of screening up to end of the study (up to 168 weeks)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 10 • From start of screening up to end of the study (up to 168 weeks)
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	15.8% 3/19 • Number of events 3 • From start of screening up to end of the study (up to 168 weeks)
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Skin and subcutaneous tissue disorders Acne	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Skin and subcutaneous tissue disorders Eczema	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Skin and subcutaneous tissue disorders Erythema	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Skin and subcutaneous tissue disorders Nodular rash	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Skin and subcutaneous tissue disorders Rash	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	21.1% 4/19 • Number of events 4 • From start of screening up to end of the study (up to 168 weeks)
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	20.0% 1/5 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/19 • From start of screening up to end of the study (up to 168 weeks)
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	10.5% 2/19 • Number of events 2 • From start of screening up to end of the study (up to 168 weeks)
Vascular disorders Flushing	0.00% 0/24 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	0.00% 0/5 • From start of screening up to end of the study (up to 168 weeks)	5.3% 1/19 • Number of events 1 • From start of screening up to end of the study (up to 168 weeks)

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: ClinicalTransparency@shire.com

Results disclosure agreements

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

Restriction type: OTHER