Trial Outcomes & Findings for A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome (NCT NCT01952080)

NCT ID: NCT01952080

Last Updated: 2021-06-09

Results Overview

Percent change in PN/IV from the Baseline Visit to Week 12 Visit.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

42 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2021-06-09

Participant Flow

Participant milestones

Participant milestones
Measure	Standard of Care SOC- no teduglutide therapy	Teduglutide 0.0125 mg/kg/Day Cohort 1 - Teduglutide 0.0125 mg/kg/day	Teduglutide 0.025 mg/kg/Day Cohort 2 - Teduglutide 0.025 mg/kg/day	Teduglutide 0.05 mg/kg/Day Cohort 3 - Teduglutide 0.05 mg/kg/day
Overall Study STARTED	5	8	14	15
Overall Study Treated	5	8	14	15
Overall Study COMPLETED	5	7	14	14
Overall Study NOT COMPLETED	0	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard of Care SOC- no teduglutide therapy	Teduglutide 0.0125 mg/kg/Day Cohort 1 - Teduglutide 0.0125 mg/kg/day	Teduglutide 0.025 mg/kg/Day Cohort 2 - Teduglutide 0.025 mg/kg/day	Teduglutide 0.05 mg/kg/Day Cohort 3 - Teduglutide 0.05 mg/kg/day
Overall Study Withdrawal by Subject	0	0	0	1
Overall Study Protocol Non-compliance	0	1	0	0

Baseline Characteristics

A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care n=5 Participants SOC- no teduglutide therapy	Teduglutide 0.0125 mg/kg/Day n=8 Participants Cohort 1 - Teduglutide 0.0125 mg/kg/day	Teduglutide 0.025 mg/kg/Day n=14 Participants Cohort 2 - Teduglutide 0.025 mg/kg/day	Teduglutide 0.05 mg/kg/Day n=15 Participants Cohort 3 - Teduglutide 0.05 mg/kg/day	Total n=42 Participants Total of all reporting groups
Age, Continuous	2.2 years STANDARD_DEVIATION 0.45 • n=5 Participants	5.1 years STANDARD_DEVIATION 4.55 • n=7 Participants	4.6 years STANDARD_DEVIATION 3.43 • n=5 Participants	4.5 years STANDARD_DEVIATION 3.16 • n=4 Participants	4.7 years STANDARD_DEVIATION 3.5 • n=21 Participants
Age, Customized 1 to 3 years	5 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	22 Participants n=21 Participants
Age, Customized 4 to 12 years	0 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	17 Participants n=21 Participants
Age, Customized 13 to 17 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	14 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants	8 Participants n=4 Participants	28 Participants n=21 Participants
Region of Enrollment United States	5 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants	12 Participants n=4 Participants	39 Participants n=21 Participants
Region of Enrollment United Kingdom	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Percent change in PN/IV volume from baseline to Week 12 based on prescribed data - Intent-to-Treat Population (ITT), defined as all participants who were enrolled in the study.

Percent change in PN/IV from the Baseline Visit to Week 12 Visit.

Outcome measures

Outcome measures
Measure	Standard of Care n=5 Participants SOC- no teduglutide therapy	Teduglutide 0.0125 mg/kg/Day n=7 Participants Cohort 1 - Teduglutide 0.0125 mg/kg/day	Teduglutide 0.025 mg/kg/Day n=13 Participants Cohort 2 - Teduglutide 0.025 mg/kg/day	Teduglutide 0.05 mg/kg/Day n=14 Participants Cohort 3 - Teduglutide 0.05 mg/kg/day
Percent Change in Parenteral Support [Parenteral Nutrition (PN)/Intravenous (IV)] Volume at Week 12	7.38 percent change Standard Deviation 12.756	-9.95 percent change Standard Deviation 21.625	-37.34 percent change Standard Deviation 26.422	-39.11 percent change Standard Deviation 40.792

PRIMARY outcome

Timeframe: Baseline, End of Treatment

Population: Percent change in PN/IV volume from baseline to End of Treatment based on prescribed data - Intent-to-Treat Population

Percent change in PN/IV from the Baseline Visit to End of Treatment Visit.

Outcome measures

Outcome measures
Measure	Standard of Care n=5 Participants SOC- no teduglutide therapy	Teduglutide 0.0125 mg/kg/Day n=8 Participants Cohort 1 - Teduglutide 0.0125 mg/kg/day	Teduglutide 0.025 mg/kg/Day n=14 Participants Cohort 2 - Teduglutide 0.025 mg/kg/day	Teduglutide 0.05 mg/kg/Day n=15 Participants Cohort 3 - Teduglutide 0.05 mg/kg/day
Percent Change in Parenteral Support (PN/IV) Volume at End of Treatment	7.38 percent change Standard Deviation 12.756	-8.60 percent change Standard Deviation 20.380	-35.61 percent change Standard Deviation 26.198	-36.50 percent change Standard Deviation 40.585

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: Percent change in PN/IV volume from baseline to Week 16 based on prescribed data - Intent-to-Treat Population

Percent change in PN/IV from the Baseline Visit to Week 16 Visit.

Outcome measures

Outcome measures
Measure	Standard of Care n=5 Participants SOC- no teduglutide therapy	Teduglutide 0.0125 mg/kg/Day n=7 Participants Cohort 1 - Teduglutide 0.0125 mg/kg/day	Teduglutide 0.025 mg/kg/Day n=14 Participants Cohort 2 - Teduglutide 0.025 mg/kg/day	Teduglutide 0.05 mg/kg/Day n=14 Participants Cohort 3 - Teduglutide 0.05 mg/kg/day
Percent Change in Parenteral Support (PN/IV) Volume at Week 16	3.92 percent change Standard Deviation 16.616	-11.25 percent change Standard Deviation 21.196	-33.85 percent change Standard Deviation 27.017	-31.80 percent change Standard Deviation 39.264

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Absolute change in PN/IV volume from baseline to Week 12 based on prescribed data - Intent-to-Treat Population

Absolute change in PN/IV from the Baseline Visit to Week 12 Visit.

Outcome measures

Outcome measures
Measure	Standard of Care n=5 Participants SOC- no teduglutide therapy	Teduglutide 0.0125 mg/kg/Day n=7 Participants Cohort 1 - Teduglutide 0.0125 mg/kg/day	Teduglutide 0.025 mg/kg/Day n=13 Participants Cohort 2 - Teduglutide 0.025 mg/kg/day	Teduglutide 0.05 mg/kg/Day n=14 Participants Cohort 3 - Teduglutide 0.05 mg/kg/day
Absolute Change in Parenteral Support (PN/IV) Volume at Week 12	0.43 Liters/week Standard Deviation 0.746	-0.50 Liters/week Standard Deviation 0.910	-2.78 Liters/week Standard Deviation 1.985	-2.57 Liters/week Standard Deviation 3.564

PRIMARY outcome

Timeframe: Baseline, End of Treatment

Population: Absolute change in PN/IV volume from baseline to End of Treatment based on prescribed data - Intent-to-Treat Population

Absolute change in PN/IV from the Baseline Visit to End of Treatment Visit.

Outcome measures

Outcome measures
Measure	Standard of Care n=5 Participants SOC- no teduglutide therapy	Teduglutide 0.0125 mg/kg/Day n=8 Participants Cohort 1 - Teduglutide 0.0125 mg/kg/day	Teduglutide 0.025 mg/kg/Day n=14 Participants Cohort 2 - Teduglutide 0.025 mg/kg/day	Teduglutide 0.05 mg/kg/Day n=15 Participants Cohort 3 - Teduglutide 0.05 mg/kg/day
Absolute Change in Parenteral Support (PN/IV) Volume at End of Treatment	0.43 Liters/week Standard Deviation 0.746	-0.43 Liters/week Standard Deviation 0.864	-2.73 Liters/week Standard Deviation 1.916	-2.4 Liters/week Standard Deviation 3.498

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: Absolute change in PN/IV volume from baseline to Week 16 based on prescribed data - Intent-to-Treat Population

Absolute change in PN/IV from the Baseline Visit to Week 16 Visit.

Outcome measures

Outcome measures
Measure	Standard of Care n=5 Participants SOC- no teduglutide therapy	Teduglutide 0.0125 mg/kg/Day n=7 Participants Cohort 1 - Teduglutide 0.0125 mg/kg/day	Teduglutide 0.025 mg/kg/Day n=14 Participants Cohort 2 - Teduglutide 0.025 mg/kg/day	Teduglutide 0.05 mg/kg/Day n=14 Participants Cohort 3 - Teduglutide 0.05 mg/kg/day
Absolute Change in Parenteral Support (PN/IV) Volume at Week 16	0.17 Liters/week Standard Deviation 1.027	-0.56 Liters/week Standard Deviation 0.885	-2.56 Liters/week Standard Deviation 1.917	-1.99 Liters/week Standard Deviation 3.092

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 12

Population: Percent change of EN volume from baseline to Week 12 based on subject diary data - Intent-to-Treat Population

Percent change in enteral support requirements at Week 12 (liters/week)

Outcome measures

Outcome measures
Measure	Standard of Care n=3 Participants SOC- no teduglutide therapy	Teduglutide 0.0125 mg/kg/Day n=4 Participants Cohort 1 - Teduglutide 0.0125 mg/kg/day	Teduglutide 0.025 mg/kg/Day n=12 Participants Cohort 2 - Teduglutide 0.025 mg/kg/day	Teduglutide 0.05 mg/kg/Day n=8 Participants Cohort 3 - Teduglutide 0.05 mg/kg/day
Percent Change in Enteral Support (EN) Volume From Baseline at Week 12	16.82 percent change Standard Deviation 14.921	23.50 percent change Standard Deviation 22.060	50.93 percent change Standard Deviation 61.416	57.96 percent change Standard Deviation 44.953

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 16

Population: Percent change of EN volume from baseline to Week 16 based on subject diary data - Intent-to-Treat Population

Percent change in enteral support requirements at Week 16 (liters/week)

Outcome measures

Outcome measures
Measure	Standard of Care n=4 Participants SOC- no teduglutide therapy	Teduglutide 0.0125 mg/kg/Day n=1 Participants Cohort 1 - Teduglutide 0.0125 mg/kg/day	Teduglutide 0.025 mg/kg/Day n=11 Participants Cohort 2 - Teduglutide 0.025 mg/kg/day	Teduglutide 0.05 mg/kg/Day n=9 Participants Cohort 3 - Teduglutide 0.05 mg/kg/day
Percent Change in Enteral Support (EN) Volume From Baseline at Week 16	52.06 percent change Standard Deviation 66.194	60.30 percent change	43.98 percent change Standard Deviation 78.599	58.93 percent change Standard Deviation 63.927

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 12

Population: Absolute change of EN volume from baseline to Week 12 based on subject diary data - Intent-to-Treat Population

Absolute change in enteral support requirements at Week 12 (liters/week)

Outcome measures

Outcome measures
Measure	Standard of Care n=4 Participants SOC- no teduglutide therapy	Teduglutide 0.0125 mg/kg/Day n=7 Participants Cohort 1 - Teduglutide 0.0125 mg/kg/day	Teduglutide 0.025 mg/kg/Day n=12 Participants Cohort 2 - Teduglutide 0.025 mg/kg/day	Teduglutide 0.05 mg/kg/Day n=12 Participants Cohort 3 - Teduglutide 0.05 mg/kg/day
Absolute Change in Enteral Support (EN) Volume From Baseline at Week 12	0.69 Liters/week Standard Deviation 0.715	2.67 Liters/week Standard Deviation 4.412	2.64 Liters/week Standard Deviation 3.220	0.97 Liters/week Standard Deviation 1.127

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 16

Population: Absolute change of EN volume from baseline to Week 16 based on subject diary data - Intent-to-Treat Population

Absolute change in enteral support requirements at Week 16 (liters/week)

Outcome measures

Outcome measures
Measure	Standard of Care n=5 Participants SOC- no teduglutide therapy	Teduglutide 0.0125 mg/kg/Day n=3 Participants Cohort 1 - Teduglutide 0.0125 mg/kg/day	Teduglutide 0.025 mg/kg/Day n=11 Participants Cohort 2 - Teduglutide 0.025 mg/kg/day	Teduglutide 0.05 mg/kg/Day n=13 Participants Cohort 3 - Teduglutide 0.05 mg/kg/day
Absolute Change in Enteral Support (EN) Volume From Baseline at Week 16	0.84 Liters/week Standard Deviation 0.624	4.56 Liters/week Standard Deviation 5.384	2.47 Liters/week Standard Deviation 3.403	0.91 Liters/week Standard Deviation 0.968

Adverse Events

Standard of Care

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Teduglutide 0.0125 mg/kg/Day

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Teduglutide 0.025 mg/kg/Day

Serious events: 6 serious events

Other events: 14 other events

Deaths: 0 deaths

Teduglutide 0.05 mg/kg/Day

Serious events: 8 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Standard of Care n=5 participants at risk SOC- no teduglutide therapy	Teduglutide 0.0125 mg/kg/Day n=8 participants at risk Cohort 1 - Teduglutide 0.0125 mg/kg/day	Teduglutide 0.025 mg/kg/Day n=14 participants at risk Cohort 2 - Teduglutide 0.025 mg/kg/day	Teduglutide 0.05 mg/kg/Day n=15 participants at risk Cohort 3 - Teduglutide 0.05 mg/kg/day
Blood and lymphatic system disorders Pancytopenia	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Gastrointestinal disorders Abdominal Distension	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Gastrointestinal disorders Frequent Bowel Movement	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Gastrointestinal disorders Haematochezia	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
General disorders Pyrexia	40.0% 2/5 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	20.0% 3/15 • Number of events 3 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
General disorders Catheter related complication	20.0% 1/5 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	14.3% 2/14 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
General disorders Fatigue	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
General disorders Irritability	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Immune system disorders Anaphylactic reaction	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Infections and infestations Central line infection	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	21.4% 3/14 • Number of events 5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	6.7% 1/15 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Infections and infestations Parainfluenzae virus infection	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Infections and infestations Adenovirus infection	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	12.5% 1/8 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Infections and infestations Catheter related infection	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	12.5% 1/8 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Infections and infestations Catheter sepsis	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Infections and infestations Influenza	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	12.5% 1/8 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Infections and infestations Rhinovirus infection	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Infections and infestations Fungaemia	20.0% 1/5 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Infections and infestations Gastroenteritis viral	20.0% 1/5 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Infections and infestations Viral infection	20.0% 1/5 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Investigations Blood creatinine increased	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Metabolism and nutrition disorders Dehydration	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Nervous system disorders Depressed level of consciousness	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Nervous system disorders Grand mal convulsion	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Skin and subcutaneous tissue disorders Rash	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Vascular disorders Hypovolemic shock	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.

Other adverse events
Measure	Standard of Care n=5 participants at risk SOC- no teduglutide therapy	Teduglutide 0.0125 mg/kg/Day n=8 participants at risk Cohort 1 - Teduglutide 0.0125 mg/kg/day	Teduglutide 0.025 mg/kg/Day n=14 participants at risk Cohort 2 - Teduglutide 0.025 mg/kg/day	Teduglutide 0.05 mg/kg/Day n=15 participants at risk Cohort 3 - Teduglutide 0.05 mg/kg/day
Blood and lymphatic system disorders Neutropenia	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	14.3% 2/14 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	14.3% 2/14 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Cardiac disorders Tachycardia	20.0% 1/5 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Eye disorders Eyes sunken	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	13.3% 2/15 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Gastrointestinal disorders Vomiting	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	35.7% 5/14 • Number of events 8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	46.7% 7/15 • Number of events 29 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Gastrointestinal disorders Abdominal pain	20.0% 1/5 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	12.5% 1/8 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	26.7% 4/15 • Number of events 15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Gastrointestinal disorders Nausea	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	12.5% 1/8 • Number of events 3 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	14.3% 2/14 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	13.3% 2/15 • Number of events 8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Gastrointestinal disorders Diarrhoea	20.0% 1/5 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	20.0% 3/15 • Number of events 6 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Gastrointestinal disorders Faecal volume increased	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	12.5% 1/8 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	13.3% 2/15 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Gastrointestinal disorders Abdominal distension	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	12.5% 1/8 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	6.7% 1/15 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Gastrointestinal disorders Flatulence	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	25.0% 2/8 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Gastrointestinal disorders Haematochezia	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	25.0% 2/8 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Gastrointestinal disorders Constipation	20.0% 1/5 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	13.3% 2/15 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Gastrointestinal disorders Painful defaecation	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	13.3% 2/15 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Gastrointestinal disorders Retching	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	14.3% 2/14 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
General disorders Catheter related complication	20.0% 1/5 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	37.5% 3/8 • Number of events 4 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	28.6% 4/14 • Number of events 4 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	13.3% 2/15 • Number of events 3 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
General disorders Pyrexia	40.0% 2/5 • Number of events 3 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	14.3% 2/14 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	46.7% 7/15 • Number of events 8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
General disorders Fatigue	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	26.7% 4/15 • Number of events 11 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
General disorders Injection site haemorrhage	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	20.0% 3/15 • Number of events 4 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Immune system disorders Drug hypersensitivity	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	14.3% 2/14 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Infections and infestations Upper respiratory tract infection	40.0% 2/5 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	25.0% 2/8 • Number of events 3 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	28.6% 4/14 • Number of events 6 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	26.7% 4/15 • Number of events 4 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Infections and infestations Central line infection	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	21.4% 3/14 • Number of events 5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	6.7% 1/15 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Infections and infestations Gastroenteritis viral	20.0% 1/5 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	12.5% 1/8 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	13.3% 2/15 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Infections and infestations Nasopharyngitis	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	25.0% 2/8 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Infections and infestations Influenza	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	12.5% 1/8 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Infections and infestations Overgrowth bacterial	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	25.0% 2/8 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Infections and infestations Parainfluenzae virus infection	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Infections and infestations Rhinovirus infection	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	14.3% 2/14 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	— 0/0 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	100.0% 1/1 • Number of events 5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Injury, poisoning and procedural complications Feeding tube complication	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	14.3% 2/14 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/15 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Injury, poisoning and procedural complications Incision site erythema	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Investigations Blood bicarbonate decreased	40.0% 2/5 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	12.5% 1/8 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	20.0% 3/15 • Number of events 4 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Investigations Weight decreased	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	12.5% 1/8 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Investigations Alanine aminotransferase increased	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Investigations Aspartate aminotransferase increased	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Investigations Bacteria urine	20.0% 1/5 • Number of events 1 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	13.3% 2/15 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Investigations Blood urine present	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	13.3% 2/15 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Investigations Protein urine present	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	13.3% 2/15 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Investigations Red blood cells urine positive	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	13.3% 2/15 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.
Investigations White blood cells urine positive	0.00% 0/5 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/8 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	0.00% 0/14 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.	13.3% 2/15 • Number of events 2 • Adverse event data were collected from the first patient consent signed through last subject last visit for a duration of 421 days. This section reports "treatment-emergent" adverse events. Serious adverse events may be included in the 5% NSAE section.