Trial Outcomes & Findings for Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition (NCT NCT02682381)
NCT ID: NCT02682381
Last Updated: 2021-06-09
Results Overview
Reduction in weight-normalized PN/IV volume was performed using both participant diary and investigator prescribed data. Number of participants who achieved at least a 20% reduction in weight-normalized PN/IV volume between the baseline and week 24/EOT visit were reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
59 participants
Primary outcome timeframe
Baseline through Week 24
Results posted on
2021-06-09
Participant Flow
Study was conducted at 27 study centers in the United States, Belgium, Canada, the United Kingdom, Finland, Germany and Italy between 03 June 2016 (first participant first visit) and 18 August 2017 (last participant last visit).
Overall, 59 participants were enrolled; 50 in the teduglutide treatment arm (24 participants in the 0.025 milligram per kilogram per day (mg/kg/day) dose group and 26 participants in the 0.05 mg/kg/day dose group)and 9 in the standard of care arm.
Participant milestones
| Measure |
0.025 mg/kg/Day Teduglutide
Participants received 0.025 milligram per kilogram per day (mg/kg/day) of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
Participants received standard medical therapy.
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
9
|
|
Overall Study
COMPLETED
|
24
|
26
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition
Baseline characteristics by cohort
| Measure |
0.025 mg/kg/Day Teduglutide
n=24 Participants
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=26 Participants
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=9 Participants
Participants received standard medical therapy.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
6.6 Years
STANDARD_DEVIATION 3.61 • n=5 Participants
|
6.2 Years
STANDARD_DEVIATION 3.67 • n=7 Participants
|
5.7 Years
STANDARD_DEVIATION 4.72 • n=5 Participants
|
6.3 Years
STANDARD_DEVIATION 3.76 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race Customized · White
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race Customized · Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race Customized · Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race Customized · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race Customized · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race Customized · Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race Customized · Not allowed based on local regulations
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 24Population: ITT population included all enrolled participants.
Reduction in weight-normalized PN/IV volume was performed using both participant diary and investigator prescribed data. Number of participants who achieved at least a 20% reduction in weight-normalized PN/IV volume between the baseline and week 24/EOT visit were reported.
Outcome measures
| Measure |
0.025 mg/kg/Day Teduglutide
n=24 Participants
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=26 Participants
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=9 Participants
Participants received standard medical therapy.
|
|---|---|---|---|
|
Number of Participants Who Achieved at Least a 20 Percent (%) Reduction in Weight-Normalized Average Daily Parenteral Nutrition Intravenous (PN/IV) Volume at Week 24
Participant Diary
|
13 Participants
|
18 Participants
|
1 Participants
|
|
Number of Participants Who Achieved at Least a 20 Percent (%) Reduction in Weight-Normalized Average Daily Parenteral Nutrition Intravenous (PN/IV) Volume at Week 24
Investigator Prescribed
|
13 Participants
|
18 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment up to 28 weeksPopulation: Safety analysis population included all participants who received at least 1 dose of teduglutide and had undergone at least 1 post-baseline safety assessment in teduglutide treatment group or participants who had undergone at least 1 post-baseline safety assessment in standard of care treatment group.
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs that started or worsened on or after the date of first dose for treatment groups and those that started or worsened on or after the baseline visit for standard of care group.
Outcome measures
| Measure |
0.025 mg/kg/Day Teduglutide
n=24 Participants
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=26 Participants
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=9 Participants
Participants received standard medical therapy.
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
24 Participants
|
25 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: ITT population included all enrolled participants.
A participant was considered to have achieved independence from PN/IV support (completely weaned off PN/IV) if the investigator prescribed no PN/IV at EOT and there was no use of PN/IV recorded in the participant diary during the week prior to EOT.
Outcome measures
| Measure |
0.025 mg/kg/Day Teduglutide
n=24 Participants
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=26 Participants
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=9 Participants
Participants received standard medical therapy.
|
|---|---|---|---|
|
Number of Participants Who Were Completely Weaned Off Parenteral Nutrition Intravenous (PN/IV) Support at Week 24
|
2 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT population included all enrolled participants.
Change in PN/IV volume was reported based on the participant diary and the investigator prescribed data.
Outcome measures
| Measure |
0.025 mg/kg/Day Teduglutide
n=24 Participants
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=26 Participants
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=9 Participants
Participants received standard medical therapy.
|
|---|---|---|---|
|
Change From Baseline in Parenteral Nutrition Intravenous (PN/IV) Volume at Week 24
Participant Diary
|
-16.16 Milliliters per kilogram per day
Standard Deviation 10.52
|
-23.30 Milliliters per kilogram per day
Standard Deviation 17.50
|
-6.03 Milliliters per kilogram per day
Standard Deviation 4.55
|
|
Change From Baseline in Parenteral Nutrition Intravenous (PN/IV) Volume at Week 24
Investigator Prescribed
|
-11.28 Milliliters per kilogram per day
Standard Deviation 15.51
|
-22.13 Milliliters per kilogram per day
Standard Deviation 17.92
|
-5.84 Milliliters per kilogram per day
Standard Deviation 9.80
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT population included all enrolled participants.
Change in PN/IV caloric intake was reported based on the participant diary and the investigator prescribed data.
Outcome measures
| Measure |
0.025 mg/kg/Day Teduglutide
n=24 Participants
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=26 Participants
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=9 Participants
Participants received standard medical therapy.
|
|---|---|---|---|
|
Change From Baseline in Parenteral Nutrition Intravenous (PN/IV) Caloric Intake at Week 24
Participant Diary
|
-14.92 Kilocalories per kilogram per day
Standard Deviation 8.29
|
-18.99 Kilocalories per kilogram per day
Standard Deviation 14.28
|
-0.46 Kilocalories per kilogram per day
Standard Deviation 4.95
|
|
Change From Baseline in Parenteral Nutrition Intravenous (PN/IV) Caloric Intake at Week 24
Investigator Prescribed
|
-11.76 Kilocalories per kilogram per day
Standard Deviation 10.46
|
-18.51 Kilocalories per kilogram per day
Standard Deviation 13.22
|
-0.27 Kilocalories per kilogram per day
Standard Deviation 2.73
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT population with number of participants evaluable for this outcome measure.
Plasma citrulline level was reported.
Outcome measures
| Measure |
0.025 mg/kg/Day Teduglutide
n=21 Participants
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=24 Participants
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=8 Participants
Participants received standard medical therapy.
|
|---|---|---|---|
|
Change From Baseline in Plasma Citrulline Levels at Week 24
|
7.7 Micromoles per liter
Standard Deviation 8.50
|
12.0 Micromoles per liter
Standard Deviation 12.00
|
0.1 Micromoles per liter
Standard Deviation 7.79
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT population included all enrolled participants.
Enteral nutrition was defined as specialized formula taken orally or by tube feeding, and excluded table foods and other fluids. Change in enteral nutrition volume was reported.
Outcome measures
| Measure |
0.025 mg/kg/Day Teduglutide
n=24 Participants
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=26 Participants
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=9 Participants
Participants received standard medical therapy.
|
|---|---|---|---|
|
Change From Baseline in Enteral Nutrition Volume at Week 24
Participant Diary
|
7.69 Milliliter per kilogram per day
Standard Deviation 13.46
|
10.96 Milliliter per kilogram per day
Standard Deviation 16.59
|
0.74 Milliliter per kilogram per day
Standard Deviation 5.91
|
|
Change From Baseline in Enteral Nutrition Volume at Week 24
Investigator Prescribed
|
7.67 Milliliter per kilogram per day
Standard Deviation 17.77
|
8.17 Milliliter per kilogram per day
Standard Deviation 17.87
|
0.33 Milliliter per kilogram per day
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT population included all enrolled participants.
Enteral nutrition was defined as specialized formula taken orally or by tube feeding, and excluded table foods and other fluids. Change in enteral nutrition caloric intake was reported.
Outcome measures
| Measure |
0.025 mg/kg/Day Teduglutide
n=24 Participants
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=26 Participants
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=9 Participants
Participants received standard medical therapy.
|
|---|---|---|---|
|
Change From Baseline in Enteral Nutrition Caloric Intake at Week 24
Participant Diary
|
8.43 Kilocalorie per kilogram per day
Standard Deviation 14.39
|
12.98 Kilocalorie per kilogram per day
Standard Deviation 18.93
|
4.22 Kilocalorie per kilogram per day
Standard Deviation 13.75
|
|
Change From Baseline in Enteral Nutrition Caloric Intake at Week 24
Investigator Prescribed
|
7.29 Kilocalorie per kilogram per day
Standard Deviation 15.88
|
11.47 Kilocalorie per kilogram per day
Standard Deviation 21.13
|
6.66 Kilocalorie per kilogram per day
Standard Deviation 14.77
|
SECONDARY outcome
Timeframe: Week 24, Week 28Population: ITT population included all enrolled participants.
Change in PN/IV volume was reported.
Outcome measures
| Measure |
0.025 mg/kg/Day Teduglutide
n=24 Participants
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=26 Participants
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=9 Participants
Participants received standard medical therapy.
|
|---|---|---|---|
|
Change From Week 24 in Parenteral Nutrition Intravenous (PN/IV) Volume at Week 28
Participant Diary
|
2.63 Milliliter per kilogram per day
Standard Deviation 7.80
|
1.52 Milliliter per kilogram per day
Standard Deviation 12.68
|
-2.99 Milliliter per kilogram per day
Standard Deviation 4.94
|
|
Change From Week 24 in Parenteral Nutrition Intravenous (PN/IV) Volume at Week 28
Investigator Prescribed
|
2.13 Milliliter per kilogram per day
Standard Deviation 6.95
|
-0.35 Milliliter per kilogram per day
Standard Deviation 5.96
|
-0.91 Milliliter per kilogram per day
Standard Deviation 2.18
|
SECONDARY outcome
Timeframe: Week 24, Week 28Population: ITT population included all enrolled participants.
Change in PN/IV caloric intake was reported.
Outcome measures
| Measure |
0.025 mg/kg/Day Teduglutide
n=24 Participants
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=26 Participants
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=9 Participants
Participants received standard medical therapy.
|
|---|---|---|---|
|
Change From Week 24 in Parenteral Nutrition Intravenous (PN/IV) Caloric Intake at Week 28
Participant Diary
|
0.88 Kilocalorie per kilogram per day
Standard Deviation 2.94
|
-0.91 Kilocalorie per kilogram per day
Standard Deviation 7.14
|
-4.21 Kilocalorie per kilogram per day
Standard Deviation 10.30
|
|
Change From Week 24 in Parenteral Nutrition Intravenous (PN/IV) Caloric Intake at Week 28
Investigator Prescribed
|
0.55 Kilocalorie per kilogram per day
Standard Deviation 3.42
|
0.08 Kilocalorie per kilogram per day
Standard Deviation 6.13
|
-4.34 Kilocalorie per kilogram per day
Standard Deviation 11.22
|
SECONDARY outcome
Timeframe: Week 24, Week 28Population: ITT population with number of participants evaluable for this outcome measure.
Change in plasma citrulline level was reported.
Outcome measures
| Measure |
0.025 mg/kg/Day Teduglutide
n=24 Participants
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=25 Participants
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=9 Participants
Participants received standard medical therapy.
|
|---|---|---|---|
|
Change From Week 24 in Plasma Citrulline Levels at Week 28
|
-6.0 Micromoles per liter
Standard Deviation 9.26
|
-9.5 Micromoles per liter
Standard Deviation 10.33
|
1.8 Micromoles per liter
Standard Deviation 6.48
|
SECONDARY outcome
Timeframe: Week 24, Week 28Population: ITT population included all enrolled participants.
Enteral nutrition was defined as specialized formula taken orally or by tube feeding, and excluded table foods and other fluids. Change in enteral nutrition volume was reported.
Outcome measures
| Measure |
0.025 mg/kg/Day Teduglutide
n=24 Participants
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=26 Participants
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=9 Participants
Participants received standard medical therapy.
|
|---|---|---|---|
|
Change From Week 24 in Enteral Nutrition Volume at Week 28
Participant Diary
|
-0.68 Milliliter per kilogram per day
Standard Deviation 3.86
|
1.38 Milliliter per kilogram per day
Standard Deviation 8.41
|
-0.75 Milliliter per kilogram per day
Standard Deviation 6.78
|
|
Change From Week 24 in Enteral Nutrition Volume at Week 28
Investigator Prescribed
|
1.67 Milliliter per kilogram per day
Standard Deviation 5.73
|
0.68 Milliliter per kilogram per day
Standard Deviation 6.65
|
0.39 Milliliter per kilogram per day
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: Week 24, Week 28Population: ITT population included all enrolled participants.
Enteral nutrition was defined as specialized formula taken orally or by tube feeding, and excluded table foods and other fluids. Change in enteral nutrition caloric intake was reported.
Outcome measures
| Measure |
0.025 mg/kg/Day Teduglutide
n=24 Participants
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=26 Participants
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=9 Participants
Participants received standard medical therapy.
|
|---|---|---|---|
|
Change From Week 24 in Enteral Nutrition Caloric Intake at Week 28
Participant Diary
|
-1.07 Kilocalorie per kilogram per day
Standard Deviation 4.36
|
-0.14 Kilocalorie per kilogram per day
Standard Deviation 7.73
|
-0.42 Kilocalorie per kilogram per day
Standard Deviation 6.13
|
|
Change From Week 24 in Enteral Nutrition Caloric Intake at Week 28
Investigator Prescribed
|
1.28 Kilocalorie per kilogram per day
Standard Deviation 4.30
|
-0.11 Kilocalorie per kilogram per day
Standard Deviation 3.77
|
0.45 Kilocalorie per kilogram per day
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: Safety analysis population included all participants who received at least 1 dose of teduglutide and had undergone at least 1 post-baseline safety assessment in teduglutide treatment group or participants who had undergone at least 1 post-baseline safety assessment in standard of care treatment group.
Body weight z-score is a measure of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.
Outcome measures
| Measure |
0.025 mg/kg/Day Teduglutide
n=24 Participants
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=26 Participants
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=9 Participants
Participants received standard medical therapy.
|
|---|---|---|---|
|
Change From Baseline in Body Weight Z-score at Week 28
|
-0.12 Z-score
Standard Deviation 0.41
|
-0.18 Z-score
Standard Deviation 0.59
|
-0.05 Z-score
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: Safety analysis population with number of participants evaluable for this outcome measure.
Body height z-score is a measure of relative height adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.
Outcome measures
| Measure |
0.025 mg/kg/Day Teduglutide
n=24 Participants
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=25 Participants
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=9 Participants
Participants received standard medical therapy.
|
|---|---|---|---|
|
Change From Baseline in Body Height Z-score at Week 28
|
0 Z-score
Standard Deviation 0.29
|
0.05 Z-score
Standard Deviation 0.45
|
0.16 Z-score
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: Safety analysis population with number of participants evaluable for this outcome measure.
Head circumference z-score is a measure of relative head circumference adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. Head circumference was collected only for participants of less than or equal to (\<=) 36 months of age at the time of measurement.
Outcome measures
| Measure |
0.025 mg/kg/Day Teduglutide
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=1 Participants
Participants received standard medical therapy.
|
|---|---|---|---|
|
Change From Baseline in Head Circumference Z-score at Week 28
|
—
|
—
|
-0.014 Z-score
Standard Deviation NA
"NA" signifies that the standard deviation was not calculated due to less number of participants.
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: Safety analysis population with number of participants evaluable for this outcome measure.
BMI z-score is a measure of relative BMI adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.
Outcome measures
| Measure |
0.025 mg/kg/Day Teduglutide
n=24 Participants
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=25 Participants
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=9 Participants
Participants received standard medical therapy.
|
|---|---|---|---|
|
Change From Baseline in Body Mass Index (BMI) Z-score at Week 28
|
-0.13 Z-score
Standard Deviation 0.57
|
-0.22 Z-score
Standard Deviation 0.70
|
-0.25 Z-score
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: Baseline, Week 28Population: Safety analysis population with number of participants evaluable for this outcome measure.
Stool consistency was assessed by typical stool form based on Bristol Stool Form Scale: 1 - Separate hard lumps, hard to pass, 2 - Sausage-shaped, but lumpy, 3 - Like a sausage but with cracks on the surface, 4 - Like a sausage or snake, smooth and soft, 5 - Soft blobs with clear-cut edges, 6 - Fluffy pieces with ragged edges, a mushy stool, 7 - Watery, no solid pieces, entirely liquid.
Outcome measures
| Measure |
0.025 mg/kg/Day Teduglutide
n=8 Participants
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=16 Participants
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=2 Participants
Participants received standard medical therapy.
|
|---|---|---|---|
|
Change From Baseline in Participants' Stool Consistency at Week 28
|
-1.3 Score on a scale
Standard Deviation 1.77
|
-1.4 Score on a scale
Standard Deviation 1.38
|
-3.3 Score on a scale
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT population included all enrolled participants.
The mean duration of the PN/IV infusions in hours, on the days when PN/IV was administered was reported.
Outcome measures
| Measure |
0.025 mg/kg/Day Teduglutide
n=24 Participants
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=26 Participants
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=9 Participants
Participants received standard medical therapy.
|
|---|---|---|---|
|
Change From Baseline in Hours Per Day of Parenteral Nutrition Intravenous (PN/IV) Support at Week 24
Participant Diary
|
-2.47 Hours per day (hour/day)
Standard Deviation 2.73
|
-3.03 Hours per day (hour/day)
Standard Deviation 3.84
|
-0.21 Hours per day (hour/day)
Standard Deviation 0.69
|
|
Change From Baseline in Hours Per Day of Parenteral Nutrition Intravenous (PN/IV) Support at Week 24
Investigator Prescribed
|
-1.48 Hours per day (hour/day)
Standard Deviation 3.59
|
-1.79 Hours per day (hour/day)
Standard Deviation 3.52
|
0.11 Hours per day (hour/day)
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT population included all enrolled participants.
The number of days per week of PN/IV infusions were reported.
Outcome measures
| Measure |
0.025 mg/kg/Day Teduglutide
n=24 Participants
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=26 Participants
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=9 Participants
Participants received standard medical therapy.
|
|---|---|---|---|
|
Change From Baseline in Days Per Week of Parenteral Nutrition Intravenous (PN/IV) Support at Week 24
Participant Diary
|
-0.88 Days per week (Days/week)
Standard Deviation 1.78
|
-1.34 Days per week (Days/week)
Standard Deviation 2.24
|
0 Days per week (Days/week)
Standard Deviation 0
|
|
Change From Baseline in Days Per Week of Parenteral Nutrition Intravenous (PN/IV) Support at Week 24
Investigator Prescribed
|
-0.79 Days per week (Days/week)
Standard Deviation 1.62
|
-1.42 Days per week (Days/week)
Standard Deviation 2.32
|
0 Days per week (Days/week)
Standard Deviation 0
|
Adverse Events
0.025 mg/kg/Day Teduglutide
Serious events: 15 serious events
Other events: 24 other events
Deaths: 0 deaths
0.05 mg/kg/Day Teduglutide
Serious events: 20 serious events
Other events: 23 other events
Deaths: 0 deaths
Standard of Care
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.025 mg/kg/Day Teduglutide
n=24 participants at risk
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=26 participants at risk
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=9 participants at risk
Participants received standard medical therapy.
|
|---|---|---|---|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Gastrointestinal disorders
Faecaloma
|
4.2%
1/24 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Gastrointestinal disorders
Ileus
|
4.2%
1/24 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
1/24 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
General disorders
Pyrexia
|
16.7%
4/24 • Number of events 6 • From start of study treatment up to 28 weeks
|
26.9%
7/26 • Number of events 8 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 3 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
11.5%
3/26 • Number of events 3 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Device related infection
|
4.2%
1/24 • Number of events 2 • From start of study treatment up to 28 weeks
|
11.5%
3/26 • Number of events 3 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Device related sepsis
|
4.2%
1/24 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Fungaemia
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Influenza
|
8.3%
2/24 • Number of events 2 • From start of study treatment up to 28 weeks
|
7.7%
2/26 • Number of events 2 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Orchitis
|
4.2%
1/24 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Otitis media
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Parainfluenzae virus infection
|
4.2%
1/24 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Roseola
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
2/24 • Number of events 2 • From start of study treatment up to 28 weeks
|
7.7%
2/26 • Number of events 2 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Urinary tract infection
|
4.2%
1/24 • Number of events 2 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Viral infection
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
7.7%
2/26 • Number of events 2 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Investigations
Blood urea increased
|
4.2%
1/24 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Investigations
Transaminases increased
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Hepatobiliary disorders
Cholestasis
|
4.2%
1/24 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
4/24 • Number of events 4 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.2%
1/24 • Number of events 1 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
4.2%
1/24 • Number of events 1 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Product Issues
Device breakage
|
8.3%
2/24 • Number of events 3 • From start of study treatment up to 28 weeks
|
7.7%
2/26 • Number of events 2 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Product Issues
Device dislocation
|
4.2%
1/24 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Product Issues
Device issue
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Product Issues
Device occlusion
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypocapnia
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
Other adverse events
| Measure |
0.025 mg/kg/Day Teduglutide
n=24 participants at risk
Participants received 0.025 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
0.05 mg/kg/Day Teduglutide
n=26 participants at risk
Participants received 0.05 mg/kg/day of teduglutide subcutaneously for 24 weeks along with standard medical therapy.
|
Standard of Care
n=9 participants at risk
Participants received standard medical therapy.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.2%
1/24 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
2/24 • Number of events 2 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
4.2%
1/24 • Number of events 1 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
7.7%
2/26 • Number of events 2 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
4/24 • Number of events 5 • From start of study treatment up to 28 weeks
|
23.1%
6/26 • Number of events 7 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Gastrointestinal disorders
Abdominal pain lower
|
8.3%
2/24 • Number of events 2 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
3/24 • Number of events 8 • From start of study treatment up to 28 weeks
|
11.5%
3/26 • Number of events 3 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
8/24 • Number of events 9 • From start of study treatment up to 28 weeks
|
7.7%
2/26 • Number of events 3 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Gastrointestinal disorders
Nausea
|
12.5%
3/24 • Number of events 3 • From start of study treatment up to 28 weeks
|
11.5%
3/26 • Number of events 3 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Gastrointestinal disorders
Perianal erythema
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 2 • From start of study treatment up to 28 weeks
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 2 • From start of study treatment up to 28 weeks
|
|
Gastrointestinal disorders
Vomiting
|
41.7%
10/24 • Number of events 23 • From start of study treatment up to 28 weeks
|
30.8%
8/26 • Number of events 17 • From start of study treatment up to 28 weeks
|
55.6%
5/9 • Number of events 7 • From start of study treatment up to 28 weeks
|
|
General disorders
Catheter site erythema
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
22.2%
2/9 • Number of events 2 • From start of study treatment up to 28 weeks
|
|
General disorders
Catheter site related reaction
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
General disorders
Injection site bruising
|
12.5%
3/24 • Number of events 4 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
General disorders
Medical device site pain
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
7.7%
2/26 • Number of events 2 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
General disorders
Pain
|
8.3%
2/24 • Number of events 2 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
General disorders
Pyrexia
|
20.8%
5/24 • Number of events 6 • From start of study treatment up to 28 weeks
|
23.1%
6/26 • Number of events 9 • From start of study treatment up to 28 weeks
|
33.3%
3/9 • Number of events 4 • From start of study treatment up to 28 weeks
|
|
Immune system disorders
Seasonal allergy
|
4.2%
1/24 • Number of events 1 • From start of study treatment up to 28 weeks
|
7.7%
2/26 • Number of events 2 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Cellulitis
|
8.3%
2/24 • Number of events 3 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Conjunctivitis
|
12.5%
3/24 • Number of events 3 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Device related infection
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
7.7%
2/26 • Number of events 2 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Ear infection
|
4.2%
1/24 • Number of events 1 • From start of study treatment up to 28 weeks
|
11.5%
3/26 • Number of events 3 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
12.5%
3/24 • Number of events 3 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Gastrointestinal bacterial overgrowth
|
8.3%
2/24 • Number of events 6 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
4/24 • Number of events 4 • From start of study treatment up to 28 weeks
|
23.1%
6/26 • Number of events 9 • From start of study treatment up to 28 weeks
|
22.2%
2/9 • Number of events 2 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Otitis media
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
7.7%
2/26 • Number of events 2 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
7.7%
2/26 • Number of events 3 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 2 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Rhinitis
|
4.2%
1/24 • Number of events 1 • From start of study treatment up to 28 weeks
|
19.2%
5/26 • Number of events 6 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
20.8%
5/24 • Number of events 7 • From start of study treatment up to 28 weeks
|
23.1%
6/26 • Number of events 8 • From start of study treatment up to 28 weeks
|
44.4%
4/9 • Number of events 5 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Urinary tract infection
|
8.3%
2/24 • Number of events 4 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Viral infection
|
12.5%
3/24 • Number of events 4 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 2 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Injury, poisoning and procedural complications
Anaesthetic complication neurological
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Injury, poisoning and procedural complications
Stoma site erythema
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
7.7%
2/26 • Number of events 3 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Investigations
Alanine aminotransferase increased
|
29.2%
7/24 • Number of events 7 • From start of study treatment up to 28 weeks
|
7.7%
2/26 • Number of events 2 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
20.8%
5/24 • Number of events 5 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Investigations
Blood bicarbonate decreased
|
16.7%
4/24 • Number of events 5 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Investigations
Blood triglycerides increased
|
8.3%
2/24 • Number of events 2 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Investigations
Gamma-Glutamyltransferase increased
|
8.3%
2/24 • Number of events 2 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Investigations
Lymph node palpable
|
8.3%
2/24 • Number of events 2 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Investigations
Transaminases increased
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Hepatobiliary disorders
Drug-Induced liver injury
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Metabolism and nutrition disorders
Acidosis
|
8.3%
2/24 • Number of events 2 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
20.8%
5/24 • Number of events 9 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
8.3%
2/24 • Number of events 4 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 2 • From start of study treatment up to 28 weeks
|
|
Nervous system disorders
Headache
|
12.5%
3/24 • Number of events 4 • From start of study treatment up to 28 weeks
|
19.2%
5/26 • Number of events 7 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 3 • From start of study treatment up to 28 weeks
|
|
Product Issues
Device breakage
|
8.3%
2/24 • Number of events 2 • From start of study treatment up to 28 weeks
|
7.7%
2/26 • Number of events 2 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Product Issues
Device occlusion
|
12.5%
3/24 • Number of events 3 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
2/24 • Number of events 2 • From start of study treatment up to 28 weeks
|
38.5%
10/26 • Number of events 11 • From start of study treatment up to 28 weeks
|
33.3%
3/9 • Number of events 4 • From start of study treatment up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.2%
1/24 • Number of events 1 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 2 • From start of study treatment up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.5%
3/24 • Number of events 3 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
8.3%
2/24 • Number of events 20 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
0.00%
0/9 • From start of study treatment up to 28 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.2%
1/24 • Number of events 1 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 1 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.2%
1/24 • Number of events 1 • From start of study treatment up to 28 weeks
|
3.8%
1/26 • Number of events 4 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
|
Skin and subcutaneous tissue disorders
Red man syndrome
|
0.00%
0/24 • From start of study treatment up to 28 weeks
|
0.00%
0/26 • From start of study treatment up to 28 weeks
|
11.1%
1/9 • Number of events 1 • From start of study treatment up to 28 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonmentor 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