Trial Outcomes & Findings for A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021 (NCT NCT01560403)

Last Updated: 2021-06-10

Results Overview

As the primary intent of this study was to collect additional safety data, this outcomes measure will provide a summary of the treatment emergent adverse events. Based on the start date of each subject in this study and the study end date, not all subjects reached 12 months.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

14 participants

Primary outcome timeframe

12 months

Results posted on

2021-06-10

Participant Flow

This was a 1-year, open-label, multi-center study in subjects who completed Study CL0600-021 (NCT00930644) at any US site.

Participant milestones

Participant milestones
Measure	TED/TED This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600-021 (NCT00930644)	NT/PBO,TED This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly
Overall Study STARTED	5	9
Overall Study COMPLETED	5	8
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	TED/TED This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600-021 (NCT00930644)	NT/PBO,TED This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TED/TED n=5 Participants This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600 021 (NCT00930644)	NT/PBO,TED n=9 Participants This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly	Total n=14 Participants Total of all reporting groups
Age, Customized < 45 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Customized 45 - < 65 years	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Age, Customized >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Safety Population

Outcome measures

Outcome measures
Measure	NT,PBO/TED n=9 Participants This group represents those subjects who either participated in Study CL0600-020 (NCT00798967) and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension study CL0600-021 (NCT00930644) directly.	TED/TED n=5 Participants This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600 021 (NCT00930644).
Summary of Treatment-emergent Adverse Events	4 participants	5 participants

Adverse Events

NT/PBO,TED

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

TED/TED

Serious events: 5 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	NT/PBO,TED n=9 participants at risk This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly	TED/TED n=5 participants at risk This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600-021 (NCT00930644)
Cardiac disorders Atrial fibrillation	0.00% 0/9 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Cardiac disorders Atrial tachycardia	0.00% 0/9 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Cardiac disorders Cardiac failure acute	0.00% 0/9 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Cardiac disorders Cardiac failure congestive	0.00% 0/9 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Cardiac disorders Cardiomyopathy	0.00% 0/9 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/9 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Infections and infestations Central line infection	0.00% 0/9 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Infections and infestations Pneumonia	0.00% 0/9 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 2 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Infections and infestations Urinary tract infection	0.00% 0/9 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Injury, poisoning and procedural complications In-stent arterial restenosis	0.00% 0/9 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/9 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Metabolism and nutrition disorders Lactic acidosis	11.1% 1/9 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	0.00% 0/5 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/9 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.

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

Measure	NT/PBO,TED n=9 participants at risk This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly	TED/TED n=5 participants at risk This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600-021 (NCT00930644)
General disorders Asthenic conditions	22.2% 2/9 • Number of events 2 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Gastrointestinal disorders Diarrhoea	11.1% 1/9 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	40.0% 2/5 • Number of events 3 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Gastrointestinal disorders Abdominal pain	22.2% 2/9 • Number of events 2 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	0.00% 0/5 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Psychiatric disorders Anxiety symptoms	11.1% 1/9 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasms gastrointestinal	22.2% 2/9 • Number of events 2 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	0.00% 0/5 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Infections and infestations Catheter sepsis	0.00% 0/9 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	40.0% 2/5 • Number of events 2 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Injury, poisoning and procedural complications Catheter site related reaction	11.1% 1/9 • Number of events 2 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Psychiatric disorders Cognition and attention disorders and disturbances	22.2% 2/9 • Number of events 3 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	0.00% 0/5 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/9 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	40.0% 2/5 • Number of events 2 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Metabolism and nutrition disorders Fluid overload	11.1% 1/9 • Number of events 2 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 2 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Investigations Hepatic enzyme increased	11.1% 1/9 • Number of events 3 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Immune system disorders Hypersensitivity	22.2% 2/9 • Number of events 2 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	0.00% 0/5 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Vascular disorders Hypertension	11.1% 1/9 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Infections and infestations Lower respiratory tract infection	11.1% 1/9 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 2 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	11.1% 1/9 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Immune system disorders Seasonal allergy	11.1% 1/9 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Infections and infestations Upper respiratory tract infection	11.1% 1/9 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	20.0% 1/5 • Number of events 1 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Infections and infestations Viral infection	22.2% 2/9 • Number of events 2 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	0.00% 0/5 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.
Investigations Weight decreased	0.00% 0/9 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.	40.0% 2/5 • Number of events 3 • 1 year, 2 months Date of Study Initiation (first subject, first visit) 21 May 2012 Date of Study Completion (last subject, last visit) 23 July 2013. Due to the different start dates of each subject in this study, not all subjects completed the 12 month visits by the study completion date as the study was terminated on this date by the sponsor.