Trial Outcomes & Findings for CoA-Z in Pantothenate Kinase-associated Neurodegeneration (PKAN) (NCT NCT04182763)
NCT ID: NCT04182763
Last Updated: 2025-10-29
Results Overview
Safety will be measured using the number of treatment-emergent adverse events (both AE and SAE) by treatment arm. Counts are adjusted for number of prescription medications at baseline as a measure of baseline disease severity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
77 participants
Primary outcome timeframe
6 months following first dose in double-blind phase
Results posted on
2025-10-29
Participant Flow
Participant milestones
| Measure |
CoA-Z Group 1
Double blind CoA-Z 20mg/m\^2 (Dose 1) Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z Group 2
Double blind CoA-Z 15mg/m\^2 (Dose 2) Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z Group 3
Double blind CoA-Z 5mg/m\^2 (Dose 3) Open label CoA-Z 15mg/m\^2
|
Placebo Group
Double blind CoA-Z Placebo Open label CoA-Z 15mg/m\^2
|
Open-label arm
Open-label Arm CoA-Z 15mg/m\^2
|
|---|---|---|---|---|---|
|
Double-Blind Period, initial 6 months
STARTED
|
15
|
17
|
17
|
16
|
0
|
|
Double-Blind Period, initial 6 months
COMPLETED
|
15
|
16
|
17
|
15
|
0
|
|
Double-Blind Period, initial 6 months
NOT COMPLETED
|
0
|
1
|
0
|
1
|
0
|
|
Open-Label Period, subsequent 18 months
STARTED
|
15
|
16
|
17
|
15
|
12
|
|
Open-Label Period, subsequent 18 months
COMPLETED
|
8
|
9
|
11
|
13
|
10
|
|
Open-Label Period, subsequent 18 months
NOT COMPLETED
|
7
|
7
|
6
|
2
|
2
|
Reasons for withdrawal
| Measure |
CoA-Z Group 1
Double blind CoA-Z 20mg/m\^2 (Dose 1) Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z Group 2
Double blind CoA-Z 15mg/m\^2 (Dose 2) Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z Group 3
Double blind CoA-Z 5mg/m\^2 (Dose 3) Open label CoA-Z 15mg/m\^2
|
Placebo Group
Double blind CoA-Z Placebo Open label CoA-Z 15mg/m\^2
|
Open-label arm
Open-label Arm CoA-Z 15mg/m\^2
|
|---|---|---|---|---|---|
|
Double-Blind Period, initial 6 months
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
|
Double-Blind Period, initial 6 months
Death
|
0
|
1
|
0
|
0
|
0
|
|
Open-Label Period, subsequent 18 months
Death
|
3
|
2
|
2
|
0
|
1
|
|
Open-Label Period, subsequent 18 months
Withdrawal by Subject
|
2
|
1
|
2
|
0
|
1
|
|
Open-Label Period, subsequent 18 months
Participation ended early due to shortage of study product (COVID 19 supply chain issue)
|
2
|
4
|
2
|
2
|
0
|
Baseline Characteristics
CoA-Z in Pantothenate Kinase-associated Neurodegeneration (PKAN)
Baseline characteristics by cohort
| Measure |
CoA-Z dose 1
n=15 Participants
Double blind CoA-Z 20mg/m\^2 (Dose 1) Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z dose 2
n=17 Participants
Double blind CoA-Z 15mg/m\^2 (Dose 2) Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z dose 3
n=17 Participants
Double blind CoA-Z 5mg/m\^2 (Dose 3) Open label CoA-Z 15mg/m\^2
|
Placebo
n=16 Participants
Double blind CoA-Z Placebo Open label CoA-Z 15mg/m\^2
|
Open Label
n=12 Participants
Open-label Arm CoA-Z 15mg/m\^2
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
33 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
49 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
59 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
61 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Unknown or not reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Type of pantothenate kinase-associated neurodegeneration (PKAN)
Classic PKAN
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
38 Participants
n=8 Participants
|
|
Type of pantothenate kinase-associated neurodegeneration (PKAN)
Atypical PKAN
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
39 Participants
n=8 Participants
|
|
Mean number of baseline medications
|
7.7 medications
STANDARD_DEVIATION 6.1 • n=5 Participants
|
6.2 medications
STANDARD_DEVIATION 5.4 • n=7 Participants
|
5.1 medications
STANDARD_DEVIATION 4.0 • n=5 Participants
|
5.6 medications
STANDARD_DEVIATION 4.5 • n=4 Participants
|
2.7 medications
STANDARD_DEVIATION 3.2 • n=21 Participants
|
6.1 medications
STANDARD_DEVIATION 5.0 • n=8 Participants
|
PRIMARY outcome
Timeframe: 6 months following first dose in double-blind phasePopulation: All randomized participants.
Safety will be measured using the number of treatment-emergent adverse events (both AE and SAE) by treatment arm. Counts are adjusted for number of prescription medications at baseline as a measure of baseline disease severity.
Outcome measures
| Measure |
CoA-Z dose 1
n=15 Participants
Double blind CoA-Z 20mg/m\^2 (Dose 1) Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z dose 2
n=17 Participants
Double blind CoA-Z 15mg/m\^2 (Dose 2) Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z dose 3
n=17 Participants
Double blind CoA-Z 5mg/m\^2 (Dose 3) Open label CoA-Z 15mg/m\^2
|
Placebo
n=16 Participants
Double blind CoA-Z Placebo Open label CoA-Z 15mg/m\^2
|
|---|---|---|---|---|
|
Number of Treatment-emergent Adverse Events Assessed Using CTCAE v4.0
|
1.15 Events per person
Interval 0.78 to 1.52
|
1.38 Events per person
Interval 0.93 to 1.83
|
1.14 Events per person
Interval 0.5 to 1.77
|
0.86 Events per person
Interval 0.55 to 1.16
|
PRIMARY outcome
Timeframe: 6-month randomized, double-blind, placebo-controlled phaseSafety will be assessed by measuring the number of treatment-emergent clinically significant laboratory abnormalities on Complete Blood Count. Clinical significance will be determined by Medical Safety Monitor and Clinical Investigators.
Outcome measures
| Measure |
CoA-Z dose 1
n=15 Participants
Double blind CoA-Z 20mg/m\^2 (Dose 1) Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z dose 2
n=17 Participants
Double blind CoA-Z 15mg/m\^2 (Dose 2) Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z dose 3
n=17 Participants
Double blind CoA-Z 5mg/m\^2 (Dose 3) Open label CoA-Z 15mg/m\^2
|
Placebo
n=16 Participants
Double blind CoA-Z Placebo Open label CoA-Z 15mg/m\^2
|
|---|---|---|---|---|
|
Number of Treatment-emergent Clinically Significant Laboratory Abnormalities on Complete Blood Count.
|
0 Abnormal CBC event
|
1 Abnormal CBC event
|
0 Abnormal CBC event
|
0 Abnormal CBC event
|
PRIMARY outcome
Timeframe: 6-month randomized, double-blind, placebo-controlled phaseSafety will be assessed by measuring the number of treatment-emergent clinically significant laboratory abnormalities on Comprehensive Metabolic Profile by collection month. Clinical significance will be determined by Medical Safety Monitor and Clinical Investigators.
Outcome measures
| Measure |
CoA-Z dose 1
n=15 Participants
Double blind CoA-Z 20mg/m\^2 (Dose 1) Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z dose 2
n=17 Participants
Double blind CoA-Z 15mg/m\^2 (Dose 2) Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z dose 3
n=17 Participants
Double blind CoA-Z 5mg/m\^2 (Dose 3) Open label CoA-Z 15mg/m\^2
|
Placebo
n=16 Participants
Double blind CoA-Z Placebo Open label CoA-Z 15mg/m\^2
|
|---|---|---|---|---|
|
Number of Treatment-emergent Clinically Significant Laboratory Abnormalities on Comprehensive Metabolic Profile.
|
1 Abnormal CMP event
|
1 Abnormal CMP event
|
0 Abnormal CMP event
|
0 Abnormal CMP event
|
PRIMARY outcome
Timeframe: 6 month randomized, double-blind, placebo-controlled periodPopulation: All participants who completed Screening, Informed Consent, and enrolled in the study.
Tolerability will be assessed by measuring the number of participants retained in each arm over the course of the study.
Outcome measures
| Measure |
CoA-Z dose 1
n=15 Participants
Double blind CoA-Z 20mg/m\^2 (Dose 1) Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z dose 2
n=17 Participants
Double blind CoA-Z 15mg/m\^2 (Dose 2) Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z dose 3
n=17 Participants
Double blind CoA-Z 5mg/m\^2 (Dose 3) Open label CoA-Z 15mg/m\^2
|
Placebo
n=16 Participants
Double blind CoA-Z Placebo Open label CoA-Z 15mg/m\^2
|
|---|---|---|---|---|
|
Number of Participants Retained in Each Arm.
|
15 Participants
|
16 Participants
|
17 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: 6-month randomized, double-blind, placebo-controlled phasePopulation: Population of all subjects who returned partial or complete dosing diaries.
Tolerability will be assessed by adherence to the study product regimen arm at each follow-up time point.
Outcome measures
| Measure |
CoA-Z dose 1
n=13 Participants
Double blind CoA-Z 20mg/m\^2 (Dose 1) Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z dose 2
n=15 Participants
Double blind CoA-Z 15mg/m\^2 (Dose 2) Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z dose 3
n=16 Participants
Double blind CoA-Z 5mg/m\^2 (Dose 3) Open label CoA-Z 15mg/m\^2
|
Placebo
n=13 Participants
Double blind CoA-Z Placebo Open label CoA-Z 15mg/m\^2
|
|---|---|---|---|---|
|
Mean Percent of Study Product Consumed.
|
98.98 percent of doses taken
Standard Deviation .014
|
99.25 percent of doses taken
Standard Deviation .009
|
98.66 percent of doses taken
Standard Deviation .022
|
96.94 percent of doses taken
Standard Deviation .048
|
SECONDARY outcome
Timeframe: Up to 6 months after first dosePopulation: All randomized participants
Average relative CoASY gene expression, measured as the ratio to baseline of 1 / (2\^\[COASY Ct - 18s Ct\]), where Ct = cycle time and 18s is a housekeeping gene. Values \>1 reflect higher expression.
Outcome measures
| Measure |
CoA-Z dose 1
n=15 Participants
Double blind CoA-Z 20mg/m\^2 (Dose 1) Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z dose 2
n=17 Participants
Double blind CoA-Z 15mg/m\^2 (Dose 2) Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z dose 3
n=17 Participants
Double blind CoA-Z 5mg/m\^2 (Dose 3) Open label CoA-Z 15mg/m\^2
|
Placebo
n=16 Participants
Double blind CoA-Z Placebo Open label CoA-Z 15mg/m\^2
|
|---|---|---|---|---|
|
CoASY mRNA Expression
6 months after first dose
|
1.07 Ratio to baseline
Interval 0.87 to 1.28
|
0.97 Ratio to baseline
Interval 0.77 to 1.16
|
1.02 Ratio to baseline
Interval 0.77 to 1.27
|
0.96 Ratio to baseline
Interval 0.83 to 1.09
|
|
CoASY mRNA Expression
1 month +3 days after first dose
|
1.31 Ratio to baseline
Interval 1.05 to 1.57
|
1.13 Ratio to baseline
Interval 0.97 to 1.3
|
1.04 Ratio to baseline
Interval 0.86 to 1.22
|
1.07 Ratio to baseline
Interval 0.98 to 1.16
|
Adverse Events
CoA-Z dose 1 -- double-blind period
Serious events: 8 serious events
Other events: 10 other events
Deaths: 0 deaths
CoA-Z dose 2 -- double-blind period
Serious events: 7 serious events
Other events: 15 other events
Deaths: 1 deaths
CoA-Z dose 3 -- double-blind period
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo -- double-blind period
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
CoA-Z dose 1 -- open-label period
Serious events: 7 serious events
Other events: 9 other events
Deaths: 3 deaths
CoA-Z dose 2 -- open-label period
Serious events: 7 serious events
Other events: 10 other events
Deaths: 2 deaths
CoA-Z dose 3 -- open-label period
Serious events: 7 serious events
Other events: 10 other events
Deaths: 2 deaths
Placebo -- open-label period
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Open-label period only
Serious events: 3 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
CoA-Z dose 1 -- double-blind period
n=15 participants at risk
Double blind CoA-Z 20mg/m\^2 (Dose 1)
|
CoA-Z dose 2 -- double-blind period
n=17 participants at risk
Double blind CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z dose 3 -- double-blind period
n=17 participants at risk
Double blind CoA-Z 5mg/m\^2 (Dose 3)
|
Placebo -- double-blind period
n=16 participants at risk
Double blind CoA-Z Placebo
|
CoA-Z dose 1 -- open-label period
n=15 participants at risk
Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z dose 2 -- open-label period
n=16 participants at risk
Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z dose 3 -- open-label period
n=17 participants at risk
Open label CoA-Z 15mg/m\^2 (Dose 2)
|
Placebo -- open-label period
n=16 participants at risk
Open label CoA-Z 15mg/m\^2 (Dose 2)
|
Open-label period only
n=12 participants at risk
Open label CoA-Z 15mg/m\^2 (Dose 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bone fracture
|
6.7%
1/15 • Number of events 2 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
General disorders
Excessive sleep
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Gastrointestinal disorders
G-tube placement/surgery
|
13.3%
2/15 • Number of events 2 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
13.3%
2/15 • Number of events 2 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Hip dislocation
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
General disorders
Hospitalization
|
13.3%
2/15 • Number of events 6 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 2 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
17.6%
3/17 • Number of events 3 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
33.3%
5/15 • Number of events 20 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
37.5%
6/16 • Number of events 12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
35.3%
6/17 • Number of events 10 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
12.5%
2/16 • Number of events 6 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
16.7%
2/12 • Number of events 3 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Gastrointestinal disorders
Mouth injury
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Orthopedic surgery
|
6.7%
1/15 • Number of events 3 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
12.5%
2/16 • Number of events 2 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infection
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Gastrointestinal disorders
Appendix rupture
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Blood and lymphatic system disorders
Septic shock
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Gastrointestinal disorders
Surgery for excessive salivation
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Cardiac disorders
Cardiopulmonary arrest
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
8.3%
1/12 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Nervous system disorders
Hypoxic encephalopathy
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
8.3%
1/12 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Nervous system disorders
Deep brain stimulator placement
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
Other adverse events
| Measure |
CoA-Z dose 1 -- double-blind period
n=15 participants at risk
Double blind CoA-Z 20mg/m\^2 (Dose 1)
|
CoA-Z dose 2 -- double-blind period
n=17 participants at risk
Double blind CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z dose 3 -- double-blind period
n=17 participants at risk
Double blind CoA-Z 5mg/m\^2 (Dose 3)
|
Placebo -- double-blind period
n=16 participants at risk
Double blind CoA-Z Placebo
|
CoA-Z dose 1 -- open-label period
n=15 participants at risk
Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z dose 2 -- open-label period
n=16 participants at risk
Open label CoA-Z 15mg/m\^2 (Dose 2)
|
CoA-Z dose 3 -- open-label period
n=17 participants at risk
Open label CoA-Z 15mg/m\^2 (Dose 2)
|
Placebo -- open-label period
n=16 participants at risk
Open label CoA-Z 15mg/m\^2 (Dose 2)
|
Open-label period only
n=12 participants at risk
Open label CoA-Z 15mg/m\^2 (Dose 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Cauliflower ear
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Skin and subcutaneous tissue disorders
Boil
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Cardiac disorders
Chest pain
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Ear and labyrinth disorders
Ear infection
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Ear and labyrinth disorders
Ear tube placement
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Investigations
Elevated AST
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Investigations
Elevated LFT
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Investigations
Elevated CK
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
General disorders
Fever
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
12.5%
2/16 • Number of events 3 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Gastrointestinal disorders
G-tube surgery (outpatient)
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
12.5%
2/16 • Number of events 2 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
12.5%
2/16 • Number of events 2 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Skin and subcutaneous tissue disorders
Head laceration
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Investigations
Low platelet count
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Infections and infestations
MSSA blood infection
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Gastrointestinal disorders
Mouth sores
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Infections and infestations
Nail infection
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Infections and infestations
Respiratory infection
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
11.8%
2/17 • Number of events 3 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Infections and infestations
Rhinovirus
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Skin and subcutaneous tissue disorders
Scratch
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Sinuplasty
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Infections and infestations
Skin infection
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Infections and infestations
Swimmer's ear
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Renal and urinary disorders
Urinary incontinence
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Renal and urinary disorders
Urinary tract infection
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
13.3%
2/15 • Number of events 2 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
11.8%
2/17 • Number of events 2 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
12.5%
2/16 • Number of events 2 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Skin and subcutaneous tissue disorders
Whitlow finger
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Infections and infestations
Wound infection
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Vascular disorders
Hypoxemia
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Infections and infestations
Coronavirus
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
17.6%
3/17 • Number of events 3 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
13.3%
2/15 • Number of events 2 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Gastrointestinal disorders
Foreign body
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Cardiac disorders
Aortic dilatation
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Gastrointestinal disorders
Barretts esophagus
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Eye disorders
Farsighted
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Infections and infestations
Foot infection
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Blood and lymphatic system disorders
Deep vein thrombosis
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Gastrointestinal disorders
Salivation, excessive
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.7%
1/15 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Nervous system disorders
ADHD
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
8.3%
1/12 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Skin and subcutaneous tissue disorders
Pressure sore
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Sinus infection
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Nervous system disorders
Seizure
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Social circumstances
Overdose
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Infections and infestations
Dental abscess
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Reproductive system and breast disorders
Bacterial vaginosis
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Skin and subcutaneous tissue disorders
Acne vulgaris
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Surgical and medical procedures
Baclofen pump
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Injury, poisoning and procedural complications
Tooth damage
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 2 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
8.3%
1/12 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Surgical and medical procedures
Hematoma drain
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Infections and infestations
c. diff infection
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Gastrointestinal disorders
GERD
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
5.9%
1/17 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Dislocation
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
8.3%
1/12 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Infections and infestations
Influenza
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
8.3%
1/12 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Bone fracture
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Bone fragment removal
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Eye disorders
Vision loss
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Nervous system disorders
Dysautonomia
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Anosmia
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Eye disorders
Hyperopia
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Pes planus
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Eye disorders
Sty
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Gastrointestinal disorders
Sialorrhea
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
|
Blood and lymphatic system disorders
Hyponatremia
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/15 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/16 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/17 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
6.2%
1/16 • Number of events 1 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
0.00%
0/12 • The 24-month study period for each participant
We included all treatment-emergent adverse events
|
Additional Information
Allison Gregory, MS CGC, Project Manager
Oregon Health & Science University
Phone: 503-494-4344
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place