Trial Outcomes & Findings for AZD3241 PET MSA Trial, Phase 2, Randomized,12 Week Safety and Tolerability Trial With PET in MSA Patients (NCT NCT02388295)

NCT ID: NCT02388295

Last Updated: 2017-09-25

Results Overview

Striatum Brain region: Change from baseline in microglia activation via PET By \[11C\]PBR28 binding to translocator protein

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 59 participants
• Primary outcome timeframe: Baseline (pre randomization) and Week 12
• Results posted on: 2017-09-25

Participant Flow

124 subjects were screened, 22 of these were rescreened. A total of 61 subjects were assigned a treatment allocation through randomization. Two of ineligible subjects were never dispensed investigational product. One ineligible randomized subject was discontinued prior to dosing and refused to supply further data.

Protocol was administratively changed to allow reduction of sample size from 64 in this study population. A total of 59 completed screening and were randomized, but only 58 completed randomization and were dosed with study medication.

Participant milestones

Measure	Placebo Placebo to match AZD3241 dosed twice daily	AZD3241 300 mg AZD3241 300 mg dosed twice daily	AZD3241 600 mg AZD3241 600 mg dosed twice daily
Dose Escalation Week 1 STARTED	19	19	20
Dose Escalation Week 1 COMPLETED	17	16	18
Dose Escalation Week 1 NOT COMPLETED	2	3	2
Dose Escalation Week 2 STARTED	17	16	18
Dose Escalation Week 2 COMPLETED	16	14	17
Dose Escalation Week 2 NOT COMPLETED	1	2	1
Treatment Weeks 3 to 12 STARTED	16	14	17
Treatment Weeks 3 to 12 COMPLETED	15	13	17
Treatment Weeks 3 to 12 NOT COMPLETED	1	1	0

Reasons for withdrawal

Measure	Placebo Placebo to match AZD3241 dosed twice daily	AZD3241 300 mg AZD3241 300 mg dosed twice daily	AZD3241 600 mg AZD3241 600 mg dosed twice daily
Dose Escalation Week 1 Adverse Event	1	2	1
Dose Escalation Week 1 Determined not eligible	1	1	1
Dose Escalation Week 2 Protocol Violation	0	1	0
Dose Escalation Week 2 Determined not eligible	1	1	1
Treatment Weeks 3 to 12 Adverse Event	1	1	0

Baseline Characteristics

AZD3241 PET MSA Trial, Phase 2, Randomized,12 Week Safety and Tolerability Trial With PET in MSA Patients

Baseline characteristics by cohort

Measure	Placebo n=19 Participants Placebo to match AZD3241 dosed twice daily	AZD3241 300 mg n=19 Participants AZD3241 300 mg dosed twice daily	AZD3241 600 mg n=20 Participants AZD3241 600 mg dosed twice daily	Total n=58 Participants Total of all reporting groups
Age, Continuous	59.3 Years STANDARD_DEVIATION 7.9 • n=93 Participants	59.9 Years STANDARD_DEVIATION 6.1 • n=4 Participants	58.0 Years STANDARD_DEVIATION 8.5 • n=27 Participants	59 Years STANDARD_DEVIATION 7.5 • n=483 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	5 Participants n=4 Participants	5 Participants n=27 Participants	17 Participants n=483 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	14 Participants n=4 Participants	15 Participants n=27 Participants	41 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=93 Participants	16 Participants n=4 Participants	18 Participants n=27 Participants	50 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	3 Participants n=4 Participants	2 Participants n=27 Participants	7 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	3 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) White	16 Participants n=93 Participants	15 Participants n=4 Participants	16 Participants n=27 Participants	47 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	3 Participants n=4 Participants	2 Participants n=27 Participants	7 Participants n=483 Participants
Multiple System Atropy Subtype MSA - P	7 Participants n=93 Participants	10 Participants n=4 Participants	7 Participants n=27 Participants	24 Participants n=483 Participants
Multiple System Atropy Subtype MSA - C	12 Participants n=93 Participants	9 Participants n=4 Participants	13 Participants n=27 Participants	34 Participants n=483 Participants
Diagnostic Category Possible MSA	1 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants	13 Participants n=483 Participants
Diagnostic Category Probable MSA	18 Participants n=93 Participants	15 Participants n=4 Participants	12 Participants n=27 Participants	45 Participants n=483 Participants
Genotype TSPO - High Affinity Binding	12 Participants n=93 Participants	10 Participants n=4 Participants	16 Participants n=27 Participants	38 Participants n=483 Participants
Genotype TSPO - Mixed affinity binding	7 Participants n=93 Participants	9 Participants n=4 Participants	4 Participants n=27 Participants	20 Participants n=483 Participants
Genotype TSPO- Low Affinity Binding	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline (pre randomization) and Week 12

Population: PET analysis population (Paired baseline and week 12 PET scans)

Striatum Brain region: Change from baseline in microglia activation via PET By [11C]PBR28 binding to translocator protein

Outcome measures

Measure	Placebo n=14 Participants Placebo to match AZD3241 dosed twice daily	AZD3241 300 mg n=13 Participants AZD3241 300 mg dosed twice daily	AZD3241 600 mg n=16 Participants AZD3241 600 mg dosed twice daily
Striatum Brain Region: Change From Baseline in Microglia Activation Via Positron Emission Tomography(PET)	-0.23 ml/cc Standard Deviation 0.61	0.12 ml/cc Standard Deviation 0.83	-0.35 ml/cc Standard Deviation 1.25

SECONDARY outcome

Timeframe: Baseline (Day -1) and week 12

Population: efficacy population, restricted to subjects with paired samples analyzed within 6 months of collection

Myeloperoxidase (MPO) inhibition in plasma (change from baseline), on samples collected and analyzed, specific activity (activity/protein)

Outcome measures

Measure	Placebo n=13 Participants Placebo to match AZD3241 dosed twice daily	AZD3241 300 mg n=8 Participants AZD3241 300 mg dosed twice daily	AZD3241 600 mg n=15 Participants AZD3241 600 mg dosed twice daily
Myeloperoxidase (MPO) Inhibition in Plasma (Change From Baseline), Specific Activity 1 hour post dose (WEEK 12	0.12 ratio Interval -0.3 to 0.54	-0.10 ratio Interval -0.58 to 0.39	0.10 ratio Interval -0.27 to 0.48
Myeloperoxidase (MPO) Inhibition in Plasma (Change From Baseline), Specific Activity Pre dose (week 12)	0.12 ratio Interval -0.1 to 0.5	-0.12 ratio Interval -0.22 to -0.03	-0.12 ratio Interval -0.18 to -0.05
Myeloperoxidase (MPO) Inhibition in Plasma (Change From Baseline), Specific Activity 2 to 6 hours post dose (week 12)	0.04 ratio Interval -0.04 to 0.13	-0.15 ratio Interval -0.25 to -0.08	-0.18 ratio Interval -0.26 to -0.11

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to final treatment visit

Population: Efficacy population: with baseline (Day -1) and post baseline assessment

Exploratory efficacy: Unified Multiple System Atropy Rating Scale, change from baseline (total Score, Part 1 + Part 2) : Score range 0 to 104, positive value indicates worsening symptoms

Outcome measures

Measure	Placebo n=17 Participants Placebo to match AZD3241 dosed twice daily	AZD3241 300 mg n=17 Participants AZD3241 300 mg dosed twice daily	AZD3241 600 mg n=18 Participants AZD3241 600 mg dosed twice daily
Exploratory Efficacy: Unified Multiple System Atropy Rating Scale, Change From Baseline (Total Score, Part 1 + Part 2)	4.7 Score change from baseline Interval 2.5 to 6.8	3.6 Score change from baseline Interval 1.4 to 5.7	2.6 Score change from baseline Interval 0.5 to 4.7

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

AZD3241 300 mg

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

AZD3241 600 mg

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=19 participants at risk Placebo to match AZD3241 dosed twice daily	AZD3241 300 mg n=19 participants at risk AZD3241 300 mg dosed twice daily	AZD3241 600 mg n=20 participants at risk AZD3241 600 mg dosed twice daily
Injury, poisoning and procedural complications Hip fracture	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Nervous system disorders Multipla System Atrophy	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Respiratory, thoracic and mediastinal disorders Choking	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.

Other adverse events

Measure	Placebo n=19 participants at risk Placebo to match AZD3241 dosed twice daily	AZD3241 300 mg n=19 participants at risk AZD3241 300 mg dosed twice daily	AZD3241 600 mg n=20 participants at risk AZD3241 600 mg dosed twice daily
Psychiatric disorders Panic attack	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Psychiatric disorders Suicidal ideation	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Cardiac disorders atrial fibrilation	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Ear and labyrinth disorders Tinnitus	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Ear and labyrinth disorders Vertigo	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Eye disorders Diplopia	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	10.5% 2/19 • Number of events 2 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Gastrointestinal disorders Constipation	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Gastrointestinal disorders Diarrhoea	10.5% 2/19 • Number of events 2 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 2 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Gastrointestinal disorders Dysphagia	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Gastrointestinal disorders Salivary hypersecretion	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Gastrointestinal disorders Toothache	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Gastrointestinal disorders Nausea	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 2 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
General disorders Adverse drug reaction	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
General disorders Discomfort	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
General disorders Fatigue	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	15.8% 3/19 • Number of events 3 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	15.0% 3/20 • Number of events 4 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
General disorders Feeling jittery	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
General disorders Gait disturbance	10.5% 2/19 • Number of events 4 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
General disorders Influenza like illness	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
General disorders Pain	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
General disorders Pyrexia	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Infections and infestations Lower respiratory tract infection	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 4 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Infections and infestations Nasopharyngitis	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Infections and infestations Rhinitis	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Infections and infestations Urinary tract infection	15.8% 3/19 • Number of events 3 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	26.3% 5/19 • Number of events 5 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	15.0% 3/20 • Number of events 3 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Injury, poisoning and procedural complications Administration related reaction	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Injury, poisoning and procedural complications Fall	5.3% 1/19 • Number of events 12 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	20.0% 4/20 • Number of events 6 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Injury, poisoning and procedural complications Procedural pain	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Investigations Lymphocyte count decreased	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Investigations Weight decreased	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Investigations Weight increased	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Metabolism and nutrition disorders Decreased appetite	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Musculoskeletal and connective tissue disorders Back pain	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Musculoskeletal and connective tissue disorders Joint swelling	5.3% 1/19 • Number of events 3 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Musculoskeletal and connective tissue disorders Muscle fatigue	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	10.0% 2/20 • Number of events 2 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 2 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	10.0% 2/20 • Number of events 2 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Nervous system disorders Balance disorder	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Nervous system disorders Clumsiness	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Psychiatric disorders Depressed mood	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Psychiatric disorders Depression	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Psychiatric disorders Depressive symptom	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Nervous system disorders Dizziness	10.5% 2/19 • Number of events 2 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	10.5% 2/19 • Number of events 2 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	10.0% 2/20 • Number of events 4 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Nervous system disorders Dysarthria	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Nervous system disorders Headache	21.1% 4/19 • Number of events 5 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	15.8% 3/19 • Number of events 6 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	10.0% 2/20 • Number of events 4 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Nervous system disorders Hypokinesia	5.3% 1/19 • Number of events 2 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Nervous system disorders Lethargy	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Nervous system disorders Migraine with aura	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Nervous system disorders Presyncope	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 2 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	10.0% 2/20 • Number of events 3 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Nervous system disorders Radicular pain	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Nervous system disorders Restless leg syndrome	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Nervous system disorders Somnolence	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Nervous system disorders Syncope	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 4 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Psychiatric disorders Abnormal dreams	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Psychiatric disorders Confusional state	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Psychiatric disorders Disorientation	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Respiratory, thoracic and mediastinal disorders Cough	10.5% 2/19 • Number of events 2 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Respiratory, thoracic and mediastinal disorders Sleep apnoe syndrome	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.3% 1/19 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/20 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 2 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Skin and subcutaneous tissue disorders Skin necrosis	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 1 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.
Social circumstances Alcohol use	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	0.00% 0/19 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.	5.0% 1/20 • Number of events 2 • 12 weeks of randomized treation plus a follow up period up to 14 days after last dose Adverse events starting during screening period Before randomization or starting greater that 14 days after the last dose of study medication are not included in these tabulations.

Additional Information

Jamie Mullen MD

AstraZeneca Pharmaceuticals LP

Email: Clinicaltrialtransparency@astrazeneca.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60