Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of PF-06939926 for the Treatment of Duchenne Muscular Dystrophy (NCT NCT04281485)
NCT ID: NCT04281485
Last Updated: 2026-01-02
Results Overview
The NSAA was a 17-item test that graded performance of various functional skills using the following scale: 0 (unable to achieve independently), 1 (modified method but achieves goal independent of physical assistance from another), and 2 ("normal"- no obvious modification of activity). Total score was calculated as the sum of all 17 individual item responses and ranged from 0 (worst) to 34 (fully independent function) with higher scores indicating better function. Baseline NSAA total score is defined as the last non-missing NSAA total score collected prior to Year 1 drug administration.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
114 participants
Primary outcome timeframe
Baseline, Week 52
Results posted on
2026-01-02
Participant Flow
A total of 114 participants were enrolled and received at least one dose of study treatment. Results are reported based on primary completion date of Week 52.
Primary Completion Date (PCD) defined as the time point when at least 90 randomized participants received investigational product and completed the one-year follow-up/week 52 visit.
Participant milestones
| Measure |
Cohort 1
Participants were randomized to receive a single dose of fordadistrogene Movaparvovec 2\*10\^14 (2E14) vector genomes per kilogram body weight (vg/kg) on Day 1 (Year 1 Day 1) and a single dose of matching placebo on Day 390 (Year 2 Day 1).
|
Cohort 2
Participants were randomized to receive a single dose of matching placebo on Day 1 (Year 1 Day 1) and a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 390 (Year 2 Day 1).
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
35
|
|
Overall Study
Received Treatment Year 1 Day 1
|
79
|
35
|
|
Overall Study
Received Treatment Year 2 Day 1
|
42
|
18
|
|
Overall Study
COMPLETED
|
69
|
28
|
|
Overall Study
NOT COMPLETED
|
10
|
7
|
Reasons for withdrawal
| Measure |
Cohort 1
Participants were randomized to receive a single dose of fordadistrogene Movaparvovec 2\*10\^14 (2E14) vector genomes per kilogram body weight (vg/kg) on Day 1 (Year 1 Day 1) and a single dose of matching placebo on Day 390 (Year 2 Day 1).
|
Cohort 2
Participants were randomized to receive a single dose of matching placebo on Day 1 (Year 1 Day 1) and a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 390 (Year 2 Day 1).
|
|---|---|---|
|
Overall Study
No Longer Met Eligibility Criteria
|
0
|
2
|
|
Overall Study
Ongoing (Safety data collection)
|
10
|
5
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of PF-06939926 for the Treatment of Duchenne Muscular Dystrophy
Baseline characteristics by cohort
| Measure |
Cohort 1
n=79 Participants
Participants were randomized to receive a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 1 (Year 1 Day 1) and a single dose of matching placebo on Day 390 (Year 2 Day 1).
|
Cohort 2
n=35 Participants
Participants were randomized to receive a single dose of matching placebo on Day 1 (Year 1 Day 1) and a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 390 (Year 2 Day 1).
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.4 Years
STANDARD_DEVIATION 1.3 • n=228 Participants
|
6.6 Years
STANDARD_DEVIATION 1.2 • n=115 Participants
|
6.4 Years
STANDARD_DEVIATION 1.2 • n=343 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=228 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=343 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=228 Participants
|
35 Participants
n=115 Participants
|
114 Participants
n=343 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=228 Participants
|
4 Participants
n=115 Participants
|
19 Participants
n=343 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=228 Participants
|
30 Participants
n=115 Participants
|
93 Participants
n=343 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=228 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=343 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=228 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=343 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=228 Participants
|
9 Participants
n=115 Participants
|
33 Participants
n=343 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=228 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=343 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=228 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=343 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=228 Participants
|
24 Participants
n=115 Participants
|
73 Participants
n=343 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=228 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=343 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=228 Participants
|
2 Participants
n=115 Participants
|
8 Participants
n=343 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: Full analysis set (FAS) through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
The NSAA was a 17-item test that graded performance of various functional skills using the following scale: 0 (unable to achieve independently), 1 (modified method but achieves goal independent of physical assistance from another), and 2 ("normal"- no obvious modification of activity). Total score was calculated as the sum of all 17 individual item responses and ranged from 0 (worst) to 34 (fully independent function) with higher scores indicating better function. Baseline NSAA total score is defined as the last non-missing NSAA total score collected prior to Year 1 drug administration.
Outcome measures
| Measure |
Cohort 1
n=63 Participants
Participants were randomized to receive a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 1 (Year 1 Day 1) and a single dose of matching placebo on Day 390 (Year 2 Day 1).
|
Cohort 2
n=26 Participants
Participants were randomized to receive a single dose of matching placebo on Day 1 (Year 1 Day 1) and a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 390 (Year 2 Day 1).
|
|---|---|---|
|
Change From Baseline in North Star Ambulatory Assessment (NSAA) Total Score at Week 52
|
1.46 Score on a scale
Interval 0.61 to 2.3
|
1.37 Score on a scale
Interval 0.08 to 2.67
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
The LC-MS assay measured the LLQVAVEDR (LLQV) peptide that detected full-length endogenous dystrophin as well as the mini-dystrophin transgene protein.
Outcome measures
| Measure |
Cohort 1
n=11 Participants
Participants were randomized to receive a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 1 (Year 1 Day 1) and a single dose of matching placebo on Day 390 (Year 2 Day 1).
|
Cohort 2
n=7 Participants
Participants were randomized to receive a single dose of matching placebo on Day 1 (Year 1 Day 1) and a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 390 (Year 2 Day 1).
|
|---|---|---|
|
Change From Baseline in Percent Normal Dystrophin Expression Level in Muscle Biopsies by Liquid Chromatography Mass Spectrometry (LC-MS) Based on LLQV Peptide at Week 52
|
85.88 % normal dystrophin expression level
Interval 63.09 to 108.67
|
0.13 % normal dystrophin expression level
Interval -28.46 to 28.72
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Muscle fibers expressing mini-dystrophin transgene protein were evaluated by immunofluorescent staining using the mini-dystrophin specific antibody which only recognized the mini-dystrophin transgene protein.
Outcome measures
| Measure |
Cohort 1
n=12 Participants
Participants were randomized to receive a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 1 (Year 1 Day 1) and a single dose of matching placebo on Day 390 (Year 2 Day 1).
|
Cohort 2
n=8 Participants
Participants were randomized to receive a single dose of matching placebo on Day 1 (Year 1 Day 1) and a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 390 (Year 2 Day 1).
|
|---|---|---|
|
Change From Baseline in Percent of Muscle Fibers Expressing Mini-Dystrophin in Muscle Biopsies by Immunofluorescence at Week 52
|
50.15 Percentage of muscle fibers
Interval 37.48 to 62.81
|
-1.31 Percentage of muscle fibers
Interval -16.82 to 14.2
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
The CK results were analyzed by the central laboratory.
Outcome measures
| Measure |
Cohort 1
n=60 Participants
Participants were randomized to receive a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 1 (Year 1 Day 1) and a single dose of matching placebo on Day 390 (Year 2 Day 1).
|
Cohort 2
n=23 Participants
Participants were randomized to receive a single dose of matching placebo on Day 1 (Year 1 Day 1) and a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 390 (Year 2 Day 1).
|
|---|---|---|
|
Change From Baseline in Serum Creatine Kinase (CK) Concentration at Week 52
|
0.68 Units per Liter (U/L)
Interval 0.6 to 0.77
|
1.06 Units per Liter (U/L)
Interval 0.87 to 1.29
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Here, "Overall Number of Participants" signifies participants evaluable for this outcome measure.
Proportion of skills gained at Week 52 were expressed as a proportion of the number of skills at Baseline that could be gained (numerator was number of items on NSAA gained at Week 52, with response 1 or 2 and denominator was number of items on NSAA with score 0 at baseline). The NSAA was a 17-item test that graded performance of various functional skills using the following scale: 0 (unable to achieve independently), 1 (modified method but achieves goal independent of physical assistance from another), and 2 ("normal"- no obvious modification of activity). Total score was calculated as the sum of all 17 individual item responses and ranged from 0 (worst) to 34 (fully independent function) with higher scores indicating better function.
Outcome measures
| Measure |
Cohort 1
n=64 Participants
Participants were randomized to receive a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 1 (Year 1 Day 1) and a single dose of matching placebo on Day 390 (Year 2 Day 1).
|
Cohort 2
n=26 Participants
Participants were randomized to receive a single dose of matching placebo on Day 1 (Year 1 Day 1) and a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 390 (Year 2 Day 1).
|
|---|---|---|
|
Least Square Mean of Proportion of Skills Gained Based on the Individual Items of the NSAA at Week 52
|
0.55 Proportion of skills
Interval 0.41 to 0.68
|
0.42 Proportion of skills
Interval 0.24 to 0.62
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Proportion of skills either improved or maintained at Week 52 was expressed as a proportion of the number of items at Baseline that could be improved or maintained (numerator was the number of items on NSAA improved or maintained at Week 52 and denominator is number of items on NSAA which is 17). The NSAA was a 17-item test that graded performance of various functional skills using the following scale: 0 (unable to achieve independently), 1 (modified method but achieves goal independent of physical assistance from another), and 2 ("normal"- no obvious modification of activity). Total score was calculated as the sum of all 17 individual item responses and ranged from 0 (worst) to 34 (fully independent function) with higher scores indicating better function.
Outcome measures
| Measure |
Cohort 1
n=63 Participants
Participants were randomized to receive a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 1 (Year 1 Day 1) and a single dose of matching placebo on Day 390 (Year 2 Day 1).
|
Cohort 2
n=26 Participants
Participants were randomized to receive a single dose of matching placebo on Day 1 (Year 1 Day 1) and a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 390 (Year 2 Day 1).
|
|---|---|---|
|
Least Square Mean of Proportion of Skills Either Improved or Maintained Based on the Individual Items of the NSAA at Week 52
|
0.88 Proportion of skills
Interval 0.86 to 0.9
|
0.89 Proportion of skills
Interval 0.86 to 0.92
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Velocity was calculated based on the time it took to complete the 10-meter run/walk test.
Outcome measures
| Measure |
Cohort 1
n=63 Participants
Participants were randomized to receive a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 1 (Year 1 Day 1) and a single dose of matching placebo on Day 390 (Year 2 Day 1).
|
Cohort 2
n=26 Participants
Participants were randomized to receive a single dose of matching placebo on Day 1 (Year 1 Day 1) and a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 390 (Year 2 Day 1).
|
|---|---|---|
|
Change From Baseline in 10 Meter Run/Walk Velocity at Week 52
|
0.127 Meter per second
Interval 0.039 to 0.215
|
0.206 Meter per second
Interval 0.07 to 0.342
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Velocity was calculated based on the time it took to rise from floor.
Outcome measures
| Measure |
Cohort 1
n=63 Participants
Participants were randomized to receive a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 1 (Year 1 Day 1) and a single dose of matching placebo on Day 390 (Year 2 Day 1).
|
Cohort 2
n=26 Participants
Participants were randomized to receive a single dose of matching placebo on Day 1 (Year 1 Day 1) and a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 390 (Year 2 Day 1).
|
|---|---|---|
|
Change From Baseline in Rise From Floor Velocity at Week 52
|
0.025 Meter per second
Interval -0.001 to 0.051
|
0.029 Meter per second
Interval -0.012 to 0.069
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Modified PODCI- transfer and basic mobility core scale (parent of pediatric participant) consisted of 11 items that assessed how caregivers of participants evaluated a participant's ability to walk, stand, and perform activities of daily living. The scale produced an independent, standardized score ranging from 0-100, with lower scores representing lower levels of function.
Outcome measures
| Measure |
Cohort 1
n=62 Participants
Participants were randomized to receive a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 1 (Year 1 Day 1) and a single dose of matching placebo on Day 390 (Year 2 Day 1).
|
Cohort 2
n=27 Participants
Participants were randomized to receive a single dose of matching placebo on Day 1 (Year 1 Day 1) and a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 390 (Year 2 Day 1).
|
|---|---|---|
|
Change From Baseline in Modified Pediatric Outcome Data Collection Instrument (PODCI)- Transfer and Basic Mobility Core Scale at Week 52
|
2.18 Score on a scale
Interval 0.39 to 3.96
|
0.16 Score on a scale
Interval -2.53 to 2.86
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Modified PODCI- sports and physical functioning core scale (parent of pediatric participant) consisted of 21 items that assessed how caregivers of participants evaluated a participant's ability to perform recreational activities. The scale produced an independent, standardized score ranging from 0-100, with lower scores representing lower levels of function.
Outcome measures
| Measure |
Cohort 1
n=62 Participants
Participants were randomized to receive a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 1 (Year 1 Day 1) and a single dose of matching placebo on Day 390 (Year 2 Day 1).
|
Cohort 2
n=27 Participants
Participants were randomized to receive a single dose of matching placebo on Day 1 (Year 1 Day 1) and a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 390 (Year 2 Day 1).
|
|---|---|---|
|
Change From Baseline in Modified PODCI- Sports and Physical Functioning Core Scale at Week 52
|
2.95 Score on a scale
Interval -0.3 to 6.19
|
1.84 Score on a scale
Interval -3.07 to 6.74
|
Adverse Events
Cohort 1
Serious events: 25 serious events
Other events: 77 other events
Deaths: 0 deaths
Cohort 2
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=79 participants at risk
Participants were randomized to receive a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 1 (Year 1 Day 1) and a single dose of matching placebo on Day 390 (Year 2 Day 1).
|
Cohort 2
n=35 participants at risk
Participants were randomized to receive a single dose of matching placebo on Day 1 (Year 1 Day 1) and a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 390 (Year 2 Day 1).
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.8%
3/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
3.8%
3/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Bradycardia
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Myocarditis
|
5.1%
4/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.9%
1/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
4/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.9%
1/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Hepatitis
|
2.5%
2/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Hepatitis acute
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
COVID-19
|
2.5%
2/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.9%
1/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.9%
1/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.9%
1/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Viral infection
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Platelet count decreased
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Troponin I increased
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.9%
1/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypophagia
|
2.5%
2/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.5%
2/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
2.5%
2/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Migraine
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypertension
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Cohort 1
n=79 participants at risk
Participants were randomized to receive a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 1 (Year 1 Day 1) and a single dose of matching placebo on Day 390 (Year 2 Day 1).
|
Cohort 2
n=35 participants at risk
Participants were randomized to receive a single dose of matching placebo on Day 1 (Year 1 Day 1) and a single dose of fordadistrogene Movaparvovec 2E14 vg/kg on Day 390 (Year 2 Day 1).
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
17.7%
14/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
21.5%
17/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.6%
3/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.3%
5/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.9%
1/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
8.9%
7/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.7%
10/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.4%
4/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
29.1%
23/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.6%
3/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
74.7%
59/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.4%
4/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chest pain
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.7%
2/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
8.9%
7/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.7%
2/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Influenza like illness
|
0.00%
0/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.7%
2/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
60.8%
48/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.6%
3/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Ear infection
|
5.1%
4/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.7%
2/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
8.9%
7/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.7%
2/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
24.1%
19/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.1%
6/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Otitis media
|
0.00%
0/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.6%
3/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Rhinitis
|
1.3%
1/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.7%
2/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.9%
7/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.6%
3/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
5.1%
4/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.4%
4/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.7%
2/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.6%
6/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Glutamate dehydrogenase increased
|
24.1%
19/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Platelet count decreased
|
11.4%
9/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
SARS-CoV-2 test positive
|
11.4%
9/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.7%
2/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Troponin I increased
|
6.3%
5/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.9%
1/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
31.6%
25/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.9%
1/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.1%
4/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
3/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.4%
4/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
2/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.6%
3/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
4/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.6%
3/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.6%
6/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.7%
2/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
3.8%
3/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.7%
2/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
16.5%
13/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.4%
4/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.9%
7/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.4%
4/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.1%
4/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.9%
1/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.6%
6/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.9%
1/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypertension
|
8.9%
7/79 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/35 • From Year 1 Day 1 up to Week 52
Safety analysis set through Week 52 included all eligible participants who were randomly assigned and received a single dose of study drug on Day 1 (Year 1 Day 1). Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER