Trial Outcomes & Findings for Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458) (NCT NCT00172185)

Last Updated: 2021-06-02

Results Overview

For those subjects who received teduglutide (0.05 or 0.10 mg dose) in Study 004 and the same in Study 005, Parenteral Nutrition (PN) Use at Week 28 was compared to the Baseline Visit of Study 004 to calculate the 20% reduction in PN Use. For those subjects who received placebo in Study 004 and either teduglutide 0.05 or 0.10 mg dose in Study 005, PN Use at Week 28 was compared to the use of PN at Week 24 of Study 004 to calculate the 20% reduction in PN Use.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

65 participants

Primary outcome timeframe

28 weeks

Results posted on

2021-06-02

Participant Flow

10Jan2005 - First Subject Enrolled 24Jan2008 - Last Subject Completed

This was a 28-week study of the safety and efficacy of teduglutide in subjects with parenteral nutrition-dependent short bowel syndrome who completed protocol CL0600-004

Participant milestones

Participant milestones
Measure	Placebo/0.05 Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005	Placebo/0.10 Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005	0.05/0.05 Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005	0.10/0.10 Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
Overall Study STARTED	6	7	25	27
Overall Study COMPLETED	6	5	20	23
Overall Study NOT COMPLETED	0	2	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo/0.10 Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005	0.05/0.05 Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005	0.10/0.10 Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
Overall Study Adverse Event	1	3	4
Overall Study Physician Decision	0	1	0
Overall Study SPONSOR Decision	1	0	0
Overall Study Withdrawal by Subject	0	1	0

Baseline Characteristics

Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo/0.05 n=6 Participants Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005	Placebo/0.10 n=7 Participants Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005	0.05/0.05 n=25 Participants Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005	0.10/0.10 n=27 Participants Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005	Total n=65 Participants Total of all reporting groups
Age, Continuous	42.2 years STANDARD_DEVIATION 14.06 • n=99 Participants	56.6 years STANDARD_DEVIATION 9.74 • n=107 Participants	46.7 years STANDARD_DEVIATION 13.48 • n=206 Participants	49.4 years STANDARD_DEVIATION 14.04 • n=7 Participants	48.5 years STANDARD_DEVIATION 13.61 • n=31 Participants
Sex: Female, Male Female	4 Participants n=99 Participants	4 Participants n=107 Participants	10 Participants n=206 Participants	14 Participants n=7 Participants	32 Participants n=31 Participants
Sex: Female, Male Male	2 Participants n=99 Participants	3 Participants n=107 Participants	15 Participants n=206 Participants	13 Participants n=7 Participants	33 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	0 Participants n=107 Participants	3 Participants n=206 Participants	2 Participants n=7 Participants	6 Participants n=31 Participants
Race (NIH/OMB) White	5 Participants n=99 Participants	7 Participants n=107 Participants	22 Participants n=206 Participants	25 Participants n=7 Participants	59 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants

PRIMARY outcome

Timeframe: 28 weeks

Population: Number of participants for analysis was determined based on completing all of the prerequisite visits in Study 005. Subjects who dropped out of the study were considered failures.

Outcome measures

Outcome measures
Measure	Placebo/0.05 n=6 Participants Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005	Placebo/0.10 n=7 Participants Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005	0.05/0.05 n=25 Participants Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005	0.10/0.10 n=27 Participants Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
Number of Subjects Achieving a 20% Reduction at Week 28	5 Participants	3 Participants	17 Participants	14 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Response Status is Yes or No

Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use (Responder Status is Yes or No)

Outcome measures

Outcome measures
Measure	Placebo/0.05 n=6 Participants Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005	Placebo/0.10 n=7 Participants Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005	0.05/0.05 n=25 Participants Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005	0.10/0.10 n=27 Participants Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use Response Status: No	2 participants	5 participants	8 participants	17 participants
Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use Response Status: Yes	4 participants	2 participants	17 participants	10 participants

Adverse Events

Placebo/0.05

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo/0.10

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

0.05/0.05

Serious events: 13 serious events

Other events: 22 other events

Deaths: 0 deaths

0.10/0.10

Serious events: 9 serious events

Other events: 26 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

Restriction type: LTE60

Serious adverse events
Measure	Placebo/0.05 n=6 participants at risk Received placebo in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005	Placebo/0.10 n=7 participants at risk Received placebo in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005	0.05/0.05 n=25 participants at risk Received teduglutide 0.05 mg/kg/d in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005	0.10/0.10 n=27 participants at risk Received teduglutide 0.10 mg/kg/d in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
Blood and lymphatic system disorders Anemia	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	3.7% 1/27 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Eye disorders Amaurosis fugax	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	3.7% 1/27 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Gastrointestinal disorders Colonic stenosis	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	4.0% 1/25 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Gastrointestinal disorders Gastric ulcer	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.3% 1/7 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Gastrointestinal disorders GI haemorrhage	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.3% 1/7 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Gastrointestinal disorders Haemorrhoids	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	4.0% 1/25 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Gastrointestinal disorders Ileus	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	4.0% 1/25 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	4.0% 1/25 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.3% 1/7 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	— 0/0 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
General disorders Catheter related complication	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.3% 1/7 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	4.0% 1/25 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Hepatobiliary disorders Cholecystitis	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.3% 1/7 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	4.0% 1/25 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	3.7% 1/27 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Infections and infestations Bronchitis	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.3% 1/7 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Infections and infestations Catheter bacteremia	16.7% 1/6 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.3% 1/7 • Number of events 3 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	3.7% 1/27 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Infections and infestations Catheter sepsis	16.7% 1/6 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	16.0% 4/25 • Number of events 7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	7.4% 2/27 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Infections and infestations Catheter site infection	16.7% 1/6 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Infections and infestations Clostridium colitis	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	4.0% 1/25 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Infections and infestations Fungaemia	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	3.7% 1/27 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Infections and infestations Pneumonia	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	4.0% 1/25 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Infections and infestations Pyelonephritis	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	3.7% 1/27 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Infections and infestations Subdiaphragmatic abscess	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.3% 1/7 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Infections and infestations Urinary tract infection	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	4.0% 1/25 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Injury, poisoning and procedural complications Device failure	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	3.7% 1/27 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Injury, poisoning and procedural complications Medical device complication	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	4.0% 1/25 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	4.0% 1/25 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Nervous system disorders Cerebrovascular accident	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	3.7% 1/27 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Renal and urinary disorders Renal colic	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	4.0% 1/25 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Renal and urinary disorders Ureteric obstruction	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	3.7% 1/27 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.3% 1/7 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.

Other adverse events
Measure	Placebo/0.05 n=6 participants at risk Received placebo in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005	Placebo/0.10 n=7 participants at risk Received placebo in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005	0.05/0.05 n=25 participants at risk Received teduglutide 0.05 mg/kg/d in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005	0.10/0.10 n=27 participants at risk Received teduglutide 0.10 mg/kg/d in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
Cardiac disorders Cardiac disorders	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	8.0% 2/25 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	3.7% 1/27 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Gastrointestinal disorders Abdominal discomfort	16.7% 1/6 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	4.0% 1/25 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	3.7% 1/27 • Number of events 3 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Gastrointestinal disorders Abdominal distension	16.7% 1/6 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.3% 1/7 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	3.7% 1/27 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	28.6% 2/7 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	16.0% 4/25 • Number of events 6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	11.1% 3/27 • Number of events 7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Gastrointestinal disorders Diarrhea	33.3% 2/6 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	4.0% 1/25 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	3.7% 1/27 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Gastrointestinal disorders Flatulence	16.7% 1/6 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.3% 1/7 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	3.7% 1/27 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Gastrointestinal disorders Nausea	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	8.0% 2/25 • Number of events 3 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	22.2% 6/27 • Number of events 7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Gastrointestinal disorders Vomiting	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	8.0% 2/25 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	18.5% 5/27 • Number of events 8 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
General disorders Asthenia	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	4.0% 1/25 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	7.4% 2/27 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
General disorders Injection site bruising	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.3% 1/7 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	7.4% 2/27 • Number of events 3 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
General disorders Injection site erythema	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	28.6% 2/7 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	3.7% 1/27 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
General disorders Edema peripheral	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.3% 1/7 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	7.4% 2/27 • Number of events 3 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
General disorders Pyrexia	33.3% 2/6 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.3% 1/7 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Infections and infestations Catheter bacteremia	16.7% 1/6 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.3% 1/7 • Number of events 3 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	3.7% 1/27 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Infections and infestations Catheter sepsis	16.7% 1/6 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	16.0% 4/25 • Number of events 15 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	7.4% 2/27 • Number of events 5 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Infections and infestations Nasopharyngitis	16.7% 1/6 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	12.0% 3/25 • Number of events 4 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.8% 4/27 • Number of events 5 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Infections and infestations Sinusitis	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	8.0% 2/25 • Number of events 3 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	3.7% 1/27 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Infections and infestations Urinary tract infection	16.7% 1/6 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	16.0% 4/25 • Number of events 9 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	7.4% 2/27 • Number of events 3 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Injury, poisoning and procedural complications Contusion	33.3% 2/6 • Number of events 3 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	4.0% 1/25 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	7.4% 2/27 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Injury, poisoning and procedural complications Intestinal stoma complication	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.3% 1/7 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	8.0% 2/25 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	3.7% 1/27 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	4.0% 1/25 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	7.4% 2/27 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.3% 1/7 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	8.0% 2/25 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Musculoskeletal and connective tissue disorders Back pain	16.7% 1/6 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.3% 1/7 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	4.0% 1/25 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Nervous system disorders Dizziness	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.3% 1/7 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	7.4% 2/27 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Nervous system disorders Headache	33.3% 2/6 • Number of events 4 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.3% 1/7 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	8.0% 2/25 • Number of events 3 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	22.2% 6/27 • Number of events 6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Psychiatric disorders Psychiatric disorders	16.7% 1/6 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	14.3% 1/7 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	4.0% 1/25 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Renal and urinary disorders Renal and urinary disorders	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	28.6% 2/7 • Number of events 5 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	8.0% 2/25 • Number of events 2 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	11.1% 3/27 • Number of events 3 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Reproductive system and breast disorders Reproductive system and breast Disorders	50.0% 3/6 • Number of events 4 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	16.7% 1/6 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/25 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	7.4% 2/27 • Number of events 3 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorder	16.7% 1/6 • Number of events 1 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	8.0% 2/25 • Number of events 4 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	22.2% 6/27 • Number of events 10 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.
Surgical and medical procedures Tooth extraction	0.00% 0/6 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/7 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	12.0% 3/25 • Number of events 3 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.	0.00% 0/27 • 28 weeks Treatment-emergent AEs were newly emergent events and/or increased in severity and/or relationship to drug relative to Baseline. AEs prior to Baseline and continued after Randomization were counted only if there was an increase in severity of the event and/or an increase in drug relationship.