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=99 Participants
|
59.9 Years
STANDARD_DEVIATION 6.1 • n=107 Participants
|
58.0 Years
STANDARD_DEVIATION 8.5 • n=206 Participants
|
59 Years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
50 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Multiple System Atropy Subtype
MSA - P
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
|
Multiple System Atropy Subtype
MSA - C
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
|
Diagnostic Category
Possible MSA
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Diagnostic Category
Probable MSA
|
18 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
45 Participants
n=7 Participants
|
|
Genotype
TSPO - High Affinity Binding
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
|
Genotype
TSPO - Mixed affinity binding
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Genotype
TSPO- Low Affinity Binding
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre randomization) and Week 12Population: 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 12Population: 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
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
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
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 visitPopulation: 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
|
|---|---|---|---|
|
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.
|
|
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.
|
|
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60