Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Cotadutide Given by Subcutaneous Injection in Adult Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis (NCT NCT05364931)

NCT ID: NCT05364931

Last Updated: 2025-09-03

Results Overview

To assess safety and tolerability of Cotadutide. Occurrence of AEs and serious AEs, including AEs leading to dose reduction, and AEs of special interest.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.

Results posted on

2025-09-03

Participant Flow

Participant milestones

Participant milestones
Measure	Cotadutide 300 ug Cotadutide 300 ug QD	Cotadutide 600 ug Cotadutide 600 ug QD	Placebo 600 ug Placebo 600 ug QD	Placebo 300 ug Placebo 300 ug QD
Overall Study STARTED	17	18	9	10
Overall Study COMPLETED	14	14	5	8
Overall Study NOT COMPLETED	3	4	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Cotadutide 300 ug Cotadutide 300 ug QD	Cotadutide 600 ug Cotadutide 600 ug QD	Placebo 600 ug Placebo 600 ug QD	Placebo 300 ug Placebo 300 ug QD
Overall Study Adverse Event	0	2	1	0
Overall Study Lost to Follow-up	1	0	0	0
Overall Study Withdrawal by Subject	1	1	3	2
Overall Study study terminated by sponsor (reason as collected in database, study was not terminated)	0	1	0	0
Overall Study Discontinued	1	0	0	0

Baseline Characteristics

The full analysis set population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cotadutide 300 ug n=17 Participants Cotadutide 300 ug QD	Cotadutide 600 ug n=18 Participants Cotadutide 600 ug QD	Placebo 600 ug n=9 Participants Placebo 600 ug QD	Placebo 300 ug n=10 Participants Placebo 300 ug QD	Total n=54 Participants Total of all reporting groups
Age, Continuous Mean(standard Deviation)	54.4 Years STANDARD_DEVIATION 12.4 • n=5 Participants	53 Years STANDARD_DEVIATION 12.6 • n=7 Participants	56.4 Years STANDARD_DEVIATION 9.4 • n=5 Participants	56.9 Years STANDARD_DEVIATION 11.6 • n=4 Participants	54.7 Years STANDARD_DEVIATION 11.7 • n=21 Participants
Age, Customized >= 65 years	4 Participants n=5 Participants • The full analysis set population	4 Participants n=7 Participants • The full analysis set population	2 Participants n=5 Participants • The full analysis set population	3 Participants n=4 Participants • The full analysis set population	13 Participants n=21 Participants • The full analysis set population
Age, Customized >=50 - <65 years	7 Participants n=5 Participants • The full analysis set population	7 Participants n=7 Participants • The full analysis set population	5 Participants n=5 Participants • The full analysis set population	4 Participants n=4 Participants • The full analysis set population	23 Participants n=21 Participants • The full analysis set population
Age, Customized < 50 years	6 Participants n=5 Participants • The full analysis set population	7 Participants n=7 Participants • The full analysis set population	2 Participants n=5 Participants • The full analysis set population	3 Participants n=4 Participants • The full analysis set population	18 Participants n=21 Participants • The full analysis set population
Sex: Female, Male Female	11 Participants n=5 Participants • The full analysis set population	10 Participants n=7 Participants • The full analysis set population	6 Participants n=5 Participants • The full analysis set population	4 Participants n=4 Participants • The full analysis set population	31 Participants n=21 Participants • The full analysis set population
Sex: Female, Male Male	6 Participants n=5 Participants • The full analysis set population	8 Participants n=7 Participants • The full analysis set population	3 Participants n=5 Participants • The full analysis set population	6 Participants n=4 Participants • The full analysis set population	23 Participants n=21 Participants • The full analysis set population
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants • The full analysis set population	0 Participants n=7 Participants • The full analysis set population	1 Participants n=5 Participants • The full analysis set population	1 Participants n=4 Participants • The full analysis set population	2 Participants n=21 Participants • The full analysis set population
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants • The full analysis set population	9 Participants n=7 Participants • The full analysis set population	2 Participants n=5 Participants • The full analysis set population	2 Participants n=4 Participants • The full analysis set population	18 Participants n=21 Participants • The full analysis set population
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants • The full analysis set population	1 Participants n=7 Participants • The full analysis set population	0 Participants n=5 Participants • The full analysis set population	0 Participants n=4 Participants • The full analysis set population	1 Participants n=21 Participants • The full analysis set population
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants • The full analysis set population	0 Participants n=7 Participants • The full analysis set population	0 Participants n=5 Participants • The full analysis set population	0 Participants n=4 Participants • The full analysis set population	0 Participants n=21 Participants • The full analysis set population
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • The full analysis set population	0 Participants n=7 Participants • The full analysis set population	0 Participants n=5 Participants • The full analysis set population	0 Participants n=4 Participants • The full analysis set population	0 Participants n=21 Participants • The full analysis set population
Race/Ethnicity, Customized Not Reported	1 Participants n=5 Participants • The full analysis set population	0 Participants n=7 Participants • The full analysis set population	0 Participants n=5 Participants • The full analysis set population	0 Participants n=4 Participants • The full analysis set population	1 Participants n=21 Participants • The full analysis set population
Race/Ethnicity, Customized Other	0 Participants n=5 Participants • The full analysis set population	0 Participants n=7 Participants • The full analysis set population	0 Participants n=5 Participants • The full analysis set population	0 Participants n=4 Participants • The full analysis set population	0 Participants n=21 Participants • The full analysis set population
Race/Ethnicity, Customized White	11 Participants n=5 Participants • The full analysis set population	8 Participants n=7 Participants • The full analysis set population	6 Participants n=5 Participants • The full analysis set population	7 Participants n=4 Participants • The full analysis set population	32 Participants n=21 Participants • The full analysis set population

PRIMARY outcome

Timeframe: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.

Population: Although there are two placebo arms for blinding purposes, the safety, immunogenicity, and efficacy analyses in the (abbreviated) CSR pooled the two placebo arms and analyzed them as a single group as prespecified in the SAP.

To assess safety and tolerability of Cotadutide. Occurrence of AEs and serious AEs, including AEs leading to dose reduction, and AEs of special interest.

Outcome measures

Outcome measures
Measure	Cotadutide 300 ug n=17 Participants Cotadutide 300 ug QD	Cotadutide 600 ug n=18 Participants Cotadutide 300 ug QD	Placebo n=19 Participants Placebo 300 ug or 600 ug QD
Number of Participants With Adverse Events (AEs).	16 Participants	16 Participants	13 Participants

PRIMARY outcome

Timeframe: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.

Population: Although there are two placebo arms for blinding purposes, the safety and efficacy analyses in the (abbreviated) CSR pooled the two placebo arms and analyzed them as a single group as prespecified in the SAP.

To assess safety and tolerability of Cotadutide.

Outcome measures

Outcome measures
Measure	Cotadutide 300 ug n=17 Participants Cotadutide 300 ug QD	Cotadutide 600 ug n=18 Participants Cotadutide 300 ug QD	Placebo n=19 Participants Placebo 300 ug or 600 ug QD
Number of Participants With Abnormal Vital Signs.	13 Participants	14 Participants	17 Participants

PRIMARY outcome

Timeframe: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.

Population: Although there are two placebo arms for blinding purposes, the safety and efficacy analyses in the (abbreviated) CSR pooled the two placebo arms and analyzed them as a single group as prespecified in the SAP.

To assess safety and tolerability of Cotadutide.

Outcome measures

Outcome measures
Measure	Cotadutide 300 ug n=17 Participants Cotadutide 300 ug QD	Cotadutide 600 ug n=18 Participants Cotadutide 300 ug QD	Placebo n=19 Participants Placebo 300 ug or 600 ug QD
Number of Participants With Abnormal Laboratory Assessments	16 Participants	17 Participants	19 Participants

PRIMARY outcome

Timeframe: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.

Population: Although there are two placebo arms for blinding purposes, the safety and efficacy analyses in the (abbreviated) CSR pooled the two placebo arms and analyzed them as a single group as prespecified in the SAP.

To assess safety and tolerability of Cotadutide.

Outcome measures

Outcome measures
Measure	Cotadutide 300 ug n=17 Participants Cotadutide 300 ug QD	Cotadutide 600 ug n=18 Participants Cotadutide 300 ug QD	Placebo n=19 Participants Placebo 300 ug or 600 ug QD
Number of Participants With Treatment Emergent Abnormality in 12-lead Electrocardiogram (ECG).	4 Participants	2 Participants	6 Participants

PRIMARY outcome

Timeframe: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.

Population: Although there are two placebo arms for blinding purposes, the safety and efficacy analyses in the (abbreviated) CSR pooled the two placebo arms and analyzed them as a single group as prespecified in the SAP.

To assess the immunogenicity of Cotadutide

Outcome measures

Outcome measures
Measure	Cotadutide 300 ug n=17 Participants Cotadutide 300 ug QD	Cotadutide 600 ug n=18 Participants Cotadutide 300 ug QD	Placebo n=19 Participants Placebo 300 ug or 600 ug QD
Number of Treatment-induced Anti-Drug Antibody (ADA) Participants	7 Participants	11 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose on Day 1 until the follow-up period, 28 days post last dose (from randomization up to approximately 52 weeks).

To assess the immunogenicity of cotadutide. Titers represent a dilution and are therefore unitless. Summary statistics are based on the maximum observed titer for each ADA positive subject within the time frame.

Outcome measures

Outcome measures
Measure	Cotadutide 300 ug n=17 Participants Cotadutide 300 ug QD	Cotadutide 600 ug n=18 Participants Cotadutide 300 ug QD	Placebo Placebo 300 ug or 600 ug QD
Titer of Treatment-induced Anti-Drug Antibody (ADA)	240 titer Interval 15.0 to 7680.0	60 titer Interval 15.0 to 240.0	—

Adverse Events

Cotadutide 300 ug

Serious events: 1 serious events

Other events: 16 other events

Deaths: 1 deaths

Cotadutide 600 ug

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo 600 ug

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo 300 ug

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cotadutide 300 ug n=17 participants at risk Description (Arm-group)	Cotadutide 600 ug n=18 participants at risk Description (Arm-group)	Placebo 600 ug n=9 participants at risk Description (Arm-group)	Placebo 300 ug n=10 participants at risk Description (Arm-group)
Cardiac disorders Atrioventricular block complete	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
General disorders Pacemaker generated arrhythmia	5.9% 1/17 • Number of events 2 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Cardiac disorders Atrioventricular block second degree	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.

Other adverse events

Other adverse events
Measure	Cotadutide 300 ug n=17 participants at risk Description (Arm-group)	Cotadutide 600 ug n=18 participants at risk Description (Arm-group)	Placebo 600 ug n=9 participants at risk Description (Arm-group)	Placebo 300 ug n=10 participants at risk Description (Arm-group)
Gastrointestinal disorders Abdominal distension	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Gastrointestinal disorders Abdominal pain upper	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Gastrointestinal disorders Constipation	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	11.1% 1/9 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	10.0% 1/10 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.
Gastrointestinal disorders Diarrhoea	17.6% 3/17 • Number of events 3 • From first dose on Day 1 up to approximately 52 weeks.	16.7% 3/18 • Number of events 7 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	10.0% 1/10 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.
Gastrointestinal disorders Dry mouth	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Gastrointestinal disorders Dyspepsia	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Gastrointestinal disorders Flatulence	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Gastrointestinal disorders Food poisoning	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	11.1% 2/18 • Number of events 2 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Gastrointestinal disorders Nausea	29.4% 5/17 • Number of events 7 • From first dose on Day 1 up to approximately 52 weeks.	50.0% 9/18 • Number of events 14 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	10.0% 1/10 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.
Blood and lymphatic system disorders Anaemia	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Gastrointestinal disorders Toothache	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Gastrointestinal disorders Umbilical hernia	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Gastrointestinal disorders Vomiting	29.4% 5/17 • Number of events 7 • From first dose on Day 1 up to approximately 52 weeks.	33.3% 6/18 • Number of events 8 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
General disorders Early satiety	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
General disorders Exercise tolerance decreased	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
General disorders Face oedema	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
General disorders Injection site bruising	5.9% 1/17 • Number of events 2 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
General disorders Injection site haemorrhage	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	10.0% 1/10 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.
General disorders Injection site pain	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
General disorders Injection site pruritus	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	22.2% 2/9 • Number of events 2 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
General disorders Injection site reaction	11.8% 2/17 • Number of events 2 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	20.0% 2/10 • Number of events 3 • From first dose on Day 1 up to approximately 52 weeks.
General disorders Pyrexia	11.8% 2/17 • Number of events 2 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	10.0% 1/10 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.
Hepatobiliary disorders Gallbladder polyp	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	10.0% 1/10 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.
Immune system disorders Hypersensitivity	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Infections and infestations Covid-19	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	27.8% 5/18 • Number of events 5 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Infections and infestations Folliculitis	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Infections and infestations Gingivitis	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Infections and infestations Helicobacter gastritis	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Infections and infestations Influenza	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	11.1% 2/18 • Number of events 2 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Infections and infestations Nasopharyngitis	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	22.2% 4/18 • Number of events 4 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Infections and infestations Otitis media	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Infections and infestations Pharyngitis	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Infections and infestations Pneumonia	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Infections and infestations Upper respiratory tract infection	11.8% 2/17 • Number of events 2 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Infections and infestations Urinary tract infection	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Injury, poisoning and procedural complications Contusion	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	11.1% 1/9 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Injury, poisoning and procedural complications Epicondylitis	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Injury, poisoning and procedural complications Fall	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	10.0% 1/10 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.
Cardiac disorders Palpitations	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Injury, poisoning and procedural complications Head injury	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Injury, poisoning and procedural complications Immunisation reaction	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Injury, poisoning and procedural complications Joint injury	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	10.0% 1/10 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.
Injury, poisoning and procedural complications Ligament sprain	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	11.1% 1/9 • Number of events 2 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Investigations Alanine aminotransferase increased	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Investigations Amylase increased	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Investigations Aspartate aminotransferase increased	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	11.1% 2/18 • Number of events 3 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Investigations Blood cholesterol increased	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	10.0% 1/10 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.
Cardiac disorders Sinus tachycardia	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Investigations Blood pressure increased	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Investigations Gamma-glutamyltransferase increased	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Investigations Glycosylated haemoglobin increased	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	11.1% 1/9 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	10.0% 1/10 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.
Investigations Lipase increased	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	11.1% 1/9 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Investigations Weight decreased	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	11.1% 2/18 • Number of events 2 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Metabolism and nutrition disorders Decreased appetite	17.6% 3/17 • Number of events 3 • From first dose on Day 1 up to approximately 52 weeks.	22.2% 4/18 • Number of events 4 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Metabolism and nutrition disorders Folate deficiency	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Metabolism and nutrition disorders Hyperamylasaemia	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 3 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Metabolism and nutrition disorders Increased appetite	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	10.0% 1/10 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.
Ear and labyrinth disorders Excessive cerumen production	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Metabolism and nutrition disorders Iron deficiency	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Metabolism and nutrition disorders Type 2 diabetes mellitus	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Metabolism and nutrition disorders Vitamin b12 deficiency	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Metabolism and nutrition disorders Vitamin d deficiency	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Musculoskeletal and connective tissue disorders Flank pain	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	10.0% 1/10 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Musculoskeletal and connective tissue disorders Osteopenia	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	11.1% 1/9 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Ear and labyrinth disorders Vertigo	5.9% 1/17 • Number of events 2 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Nervous system disorders Dizziness	17.6% 3/17 • Number of events 3 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Nervous system disorders Headache	5.9% 1/17 • Number of events 2 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	20.0% 2/10 • Number of events 2 • From first dose on Day 1 up to approximately 52 weeks.
Nervous system disorders Lethargy	11.8% 2/17 • Number of events 2 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Nervous system disorders Somnolence	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Psychiatric disorders Anxiety	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	10.0% 1/10 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.
Psychiatric disorders Depression	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Psychiatric disorders Insomnia	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Renal and urinary disorders Nephrolithiasis	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	10.0% 1/10 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.
Reproductive system and breast disorders Testicular pain	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	10.0% 1/10 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	10.0% 1/10 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.
Gastrointestinal disorders Abdominal discomfort	11.8% 2/17 • Number of events 2 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	11.1% 1/9 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Respiratory, thoracic and mediastinal disorders Obstructive sleep apnoea syndrome	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	10.0% 1/10 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	10.0% 1/10 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.
Respiratory, thoracic and mediastinal disorders Productive cough	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	10.0% 1/10 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	11.1% 2/18 • Number of events 2 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Skin and subcutaneous tissue disorders Onychoclasis	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	22.2% 2/9 • Number of events 2 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Skin and subcutaneous tissue disorders Rash	5.9% 1/17 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	10.0% 1/10 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/18 • From first dose on Day 1 up to approximately 52 weeks.	11.1% 1/9 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.
Vascular disorders Hypotension	0.00% 0/17 • From first dose on Day 1 up to approximately 52 weeks.	5.6% 1/18 • Number of events 1 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/9 • From first dose on Day 1 up to approximately 52 weeks.	0.00% 0/10 • From first dose on Day 1 up to approximately 52 weeks.

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place