Trial Outcomes & Findings for An Active Treatment Study of SRK-015 in Patients With Type 2 or Type 3 Spinal Muscular Atrophy (NCT NCT03921528)
NCT ID: NCT03921528
Last Updated: 2024-12-02
Results Overview
The Revised Hammersmith Scale (RHS) is a 36 item clinical assessment of physical abilities in patients with Type 2 SMA and ambulatory or nonambulatory patients with Type 3 SMA. For the ambulatory Type 3 patients 5-21 years of age in Cohort 1 (N=23), the primary endpoint was the change from baseline in RHS total score at month 12. The RHS has a minimum achievable score of 0 and a maximum achievable score of 69. The RHS includes 33 items that are graded on a scale of 0, 1, 2, where 0 denotes the lowest level and 2 denotes the highest level of ability/function. The remaining 3 items are scored 0 or 1, where 0 denotes an inability and 1 denotes an ability to achieve. Higher scores indicate increased motor function. A positive change from Baseline indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
Baseline up to 12 months
Results posted on
2024-12-02
Participant Flow
Participant milestones
| Measure |
Cohort 1 - Monotherapy
Ambulatory Type 3 SMA apitegromab (SRK-015) 20mg/kg
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 1 - Dual Therapy
Ambulatory Type 3 SMA apitegromab (SRK-015) + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 2
Type 2 SMA / Non-Ambulatory Type 3 SMA apitegromab (SRK-015) 20 mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 3 - Low Dose
Type 2 SMA apitegromab (SRK-015) 2 mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 3 - High Dose
Type 2 SMA apitegromab (SRK-015) 20mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
15
|
10
|
10
|
|
Overall Study
COMPLETED
|
6
|
10
|
13
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
2
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Active Treatment Study of SRK-015 in Patients With Type 2 or Type 3 Spinal Muscular Atrophy
Baseline characteristics by cohort
| Measure |
Cohort 1 - Monotherapy
n=11 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) 20mg/kg
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 1 - Dual Therapy
n=12 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) 20mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 2
n=15 Participants
Type 2 SMA / Non-Ambulatory Type 3 SMA apitegromab (SRK-015) 20 mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 3 - Low Dose
n=10 Participants
Type 2 SMA apitegromab (SRK-015) 2 mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 3 - High Dose
n=10 Participants
Type 2 SMA apitegromab (SRK-015) 20mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
12.1 Years
n=5 Participants
|
13.1 Years
n=7 Participants
|
11.7 Years
n=5 Participants
|
4.1 Years
n=4 Participants
|
3.8 Years
n=21 Participants
|
9.67 Years
n=8 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
53 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 (NIH/OMB)
American Indian or Alaska Native
|
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 (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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 (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
47 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
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 (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
|
PRIMARY outcome
Timeframe: Baseline up to 12 monthsPopulation: The ITT Population: all enrolled/randomized patients who receive at least 1 dose of study drug. The ITT Population was the main population for analysis of efficacy endpoints; the analysis includes all assessments from all patients with the exception of assessments after missing 3 consecutive doses due to site access restrictions caused by COVID-19. The last observation carried forward (LOCF) method was used to impute the 12-month primary endpoint for data missing for other reasons.
The Revised Hammersmith Scale (RHS) is a 36 item clinical assessment of physical abilities in patients with Type 2 SMA and ambulatory or nonambulatory patients with Type 3 SMA. For the ambulatory Type 3 patients 5-21 years of age in Cohort 1 (N=23), the primary endpoint was the change from baseline in RHS total score at month 12. The RHS has a minimum achievable score of 0 and a maximum achievable score of 69. The RHS includes 33 items that are graded on a scale of 0, 1, 2, where 0 denotes the lowest level and 2 denotes the highest level of ability/function. The remaining 3 items are scored 0 or 1, where 0 denotes an inability and 1 denotes an ability to achieve. Higher scores indicate increased motor function. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Cohort 1 - Monotherapy
n=11 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) 20mg/kg
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 1 - Dual Therapy
n=12 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 3 - High Dose
Type 2 SMA apitegromab (SRK-015) 20mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
|---|---|---|---|
|
Cohort 1: Change From Baseline in the Revised Hammersmith Scale (RHS) Total Score at Day 364 (Visit 15) [Month 12]
|
-0.1 score on a scale
Standard Deviation 5.01
|
0.0 score on a scale
Standard Deviation 2.56
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 12 monthsPopulation: The ITT Population: all enrolled/randomized patients who receive at least one dose of study drug. The ITT Population was the main population for analysis of efficacy endpoints; the analysis included all assessments from all patients with the exception of assessments after missing 3 consecutive doses due to site access restrictions caused by COVID-19. The last observation carried forward (LOCF) method was used to impute the 12-month primary endpoint for data missing for other reasons.
Cohort 2: For the nonambulatory Type 2 and Type 3 patients 5-21 years of age in Cohort 2 (N=15), the primary efficacy endpoint was the change from baseline in HFMSE total score at month 12. Cohort 3: For the nonambulatory Type 2 patients ≥2 years of age in Cohort 3 (N=20), the primary efficacy endpoint was the change from baseline in HFMSE total score at month 12. The Hammersmith Functional Motor Scale Expanded (HFMSE) assesses the physical abilities of patients with Type 2 and Type 3 SMA comprises 33 items graded on a scale of 0, 1, or 2, where 0 denotes unable, 1 denotes performed with modification or adaptation, and 2 denotes performed without modification or adaptation.
Outcome measures
| Measure |
Cohort 1 - Monotherapy
n=14 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) 20mg/kg
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 1 - Dual Therapy
n=9 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 3 - High Dose
n=8 Participants
Type 2 SMA apitegromab (SRK-015) 20mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
|---|---|---|---|
|
Cohort 2 and Cohort 3: Change From Baseline in Hammersmith Functional Motor Scale Expanded (HFMSE) Total Score at Day 364 (Visit 15) [Month 12]
|
0.6 score on a scale
Standard Deviation 3.5
|
5.3 score on a scale
Standard Deviation 8.93
|
7.1 score on a scale
Standard Deviation 6.42
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: 1 patient in Cohort 1 Monotherapy did not complete Physical Therapy Assessments at V6 due to site imposed COVID-19 restrictions. 1 patient in Cohort 1 Dual Therapy withdrew consent following discontinuation of apitegromab after 3 months of treatment due to a nonserious TEAE of unresolved fatigue assessed as not related to apitegromab.
The Revised Hammersmith Scale (RHS) is a 36 item clinical assessment of physical abilities in patients with Type 2 SMA and ambulatory or nonambulatory patients with Type 3 SMA; it has a maximum achievable score of 69. The RHS includes 33 items that are graded on a scale of 0, 1, 2, where 0 denotes the lowest level and 2 denotes the highest level of ability/function. The remaining 3 items are scored 0 or 1, where 0 denotes an inability and 1 denotes an ability to achieve.
Outcome measures
| Measure |
Cohort 1 - Monotherapy
n=11 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) 20mg/kg
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 1 - Dual Therapy
n=12 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 3 - High Dose
Type 2 SMA apitegromab (SRK-015) 20mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
|---|---|---|---|
|
Cohort 1:Change From Baseline in the Revised Hammersmith Scale (RHS) Total Score at Other Prespecified Timepoints
≥5pt at Day 56 (V4)
|
1 Participants
|
1 Participants
|
—
|
|
Cohort 1:Change From Baseline in the Revised Hammersmith Scale (RHS) Total Score at Other Prespecified Timepoints
≥5pt at Day 112 (V6)
|
1 Participants
|
1 Participants
|
—
|
|
Cohort 1:Change From Baseline in the Revised Hammersmith Scale (RHS) Total Score at Other Prespecified Timepoints
≥5pt at Day 168 (V8)
|
2 Participants
|
1 Participants
|
—
|
|
Cohort 1:Change From Baseline in the Revised Hammersmith Scale (RHS) Total Score at Other Prespecified Timepoints
≥5pt Month 12 Endpoint
|
1 Participants
|
0 Participants
|
—
|
|
Cohort 1:Change From Baseline in the Revised Hammersmith Scale (RHS) Total Score at Other Prespecified Timepoints
≥3pt at Day 56 (V4)
|
3 Participants
|
3 Participants
|
—
|
|
Cohort 1:Change From Baseline in the Revised Hammersmith Scale (RHS) Total Score at Other Prespecified Timepoints
≥3pt at Day 112 (V6)
|
1 Participants
|
2 Participants
|
—
|
|
Cohort 1:Change From Baseline in the Revised Hammersmith Scale (RHS) Total Score at Other Prespecified Timepoints
≥3pt at Day 168 (V8)
|
4 Participants
|
1 Participants
|
—
|
|
Cohort 1:Change From Baseline in the Revised Hammersmith Scale (RHS) Total Score at Other Prespecified Timepoints
≥3pt at Month 12 Endpoint
|
3 Participants
|
3 Participants
|
—
|
|
Cohort 1:Change From Baseline in the Revised Hammersmith Scale (RHS) Total Score at Other Prespecified Timepoints
≥1pt at Day 56 (V4)
|
8 Participants
|
8 Participants
|
—
|
|
Cohort 1:Change From Baseline in the Revised Hammersmith Scale (RHS) Total Score at Other Prespecified Timepoints
≥1pt at Day 112 (V6)
|
3 Participants
|
5 Participants
|
—
|
|
Cohort 1:Change From Baseline in the Revised Hammersmith Scale (RHS) Total Score at Other Prespecified Timepoints
≥1pt at Day 168 (V8)
|
7 Participants
|
4 Participants
|
—
|
|
Cohort 1:Change From Baseline in the Revised Hammersmith Scale (RHS) Total Score at Other Prespecified Timepoints
≥1pt at Month 12 Endpoint
|
6 Participants
|
5 Participants
|
—
|
|
Cohort 1:Change From Baseline in the Revised Hammersmith Scale (RHS) Total Score at Other Prespecified Timepoints
No Change at Day 56 (V4)
|
1 Participants
|
1 Participants
|
—
|
|
Cohort 1:Change From Baseline in the Revised Hammersmith Scale (RHS) Total Score at Other Prespecified Timepoints
No Change at Day 112 (V6)
|
5 Participants
|
1 Participants
|
—
|
|
Cohort 1:Change From Baseline in the Revised Hammersmith Scale (RHS) Total Score at Other Prespecified Timepoints
No Change at Day 168 (V8)
|
1 Participants
|
5 Participants
|
—
|
|
Cohort 1:Change From Baseline in the Revised Hammersmith Scale (RHS) Total Score at Other Prespecified Timepoints
No Change at Month 12 Endpoint
|
0 Participants
|
2 Participants
|
—
|
|
Cohort 1:Change From Baseline in the Revised Hammersmith Scale (RHS) Total Score at Other Prespecified Timepoints
Decrease at Day 56 (V4)
|
2 Participants
|
3 Participants
|
—
|
|
Cohort 1:Change From Baseline in the Revised Hammersmith Scale (RHS) Total Score at Other Prespecified Timepoints
Decrease at Day 112 (V6)
|
2 Participants
|
5 Participants
|
—
|
|
Cohort 1:Change From Baseline in the Revised Hammersmith Scale (RHS) Total Score at Other Prespecified Timepoints
Decrease at Day 168 (V8)
|
3 Participants
|
2 Participants
|
—
|
|
Cohort 1:Change From Baseline in the Revised Hammersmith Scale (RHS) Total Score at Other Prespecified Timepoints
Decrease at Month 12 Endpoint
|
5 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsThe Revised Hammersmith Scale (RHS) is a 36 item clinical assessment of physical abilities in patients with Type 2 SMA and ambulatory or nonambulatory patients with Type 3 SMA; it has a maximum achievable score of 69. The RHS includes 33 items that are graded on a scale of 0, 1, 2, where 0 denotes the lowest level and 2 denotes the highest level of ability/function. The remaining 3 items are scored 0 or 1, where 0 denotes an inability and 1 denotes an ability to achieve.
Outcome measures
| Measure |
Cohort 1 - Monotherapy
n=11 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) 20mg/kg
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 1 - Dual Therapy
n=12 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 3 - High Dose
Type 2 SMA apitegromab (SRK-015) 20mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
|---|---|---|---|
|
Cohort 1: Proportion of Patients Achieving Various Magnitudes of Change in RHS Score From Baseline
≥3pt increase
|
3 Participants
|
3 Participants
|
—
|
|
Cohort 1: Proportion of Patients Achieving Various Magnitudes of Change in RHS Score From Baseline
≥1pt increase
|
6 Participants
|
5 Participants
|
—
|
|
Cohort 1: Proportion of Patients Achieving Various Magnitudes of Change in RHS Score From Baseline
No Change
|
0 Participants
|
2 Participants
|
—
|
|
Cohort 1: Proportion of Patients Achieving Various Magnitudes of Change in RHS Score From Baseline
Decrease
|
5 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 months6-Minute Walk Test The 6-Minute Walk Test (6MWT) is an assessment of exercise capacity and fatigue used for ambulatory patients with later-onset SMA who are directed to walk along a 25 meter course as fast as possible over 6 minutes.
Outcome measures
| Measure |
Cohort 1 - Monotherapy
n=8 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) 20mg/kg
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 1 - Dual Therapy
n=11 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 3 - High Dose
Type 2 SMA apitegromab (SRK-015) 20mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
|---|---|---|---|
|
Cohort 1: Change From Baseline in 6-Minute Walk Test (6MWT)
|
-20.6 Meters
Standard Deviation 44.96
|
11.0 Meters
Standard Deviation 33.67
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsThe 30-Second Sit-to-Stand Test is an assessment of functional lower-limb strength that measures the maximal number of times a patient can transition from sitting to standing in 30 seconds.
Outcome measures
| Measure |
Cohort 1 - Monotherapy
n=11 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) 20mg/kg
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 1 - Dual Therapy
n=12 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 3 - High Dose
Type 2 SMA apitegromab (SRK-015) 20mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
|---|---|---|---|
|
Cohort 1: Change From Baseline in 30-Second Sit-to-Stand
|
-0.6 Stands
Standard Deviation 1.63
|
-0.2 Stands
Standard Deviation 1.95
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsThe 10 Meter Walk/Run test is an enhanced function of the RHS used for ambulatory patients with Type 3 SMA. It is a measure of the time taken to walk/run 10 meters. The time to perform is summarized only for patients able to complete the RHS 10-meter walk/run item.
Outcome measures
| Measure |
Cohort 1 - Monotherapy
n=7 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) 20mg/kg
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 1 - Dual Therapy
n=11 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 3 - High Dose
Type 2 SMA apitegromab (SRK-015) 20mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
|---|---|---|---|
|
Cohort 1: Change From Baseline in 10-Meter Walk/Run (From RHS)
|
0.1 Seconds
Standard Deviation 0.32
|
0.9 Seconds
Standard Deviation 3.32
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsThe timed rise from floor test is an enhanced function of the RHS used for ambulatory patients with Type 3 SMA. It is a measure of the time taken to rise to standing from the floor. The time to rise from floor is summarized only for patients able to complete the RHS rise from floor item.
Outcome measures
| Measure |
Cohort 1 - Monotherapy
n=5 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) 20mg/kg
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 1 - Dual Therapy
n=6 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 3 - High Dose
Type 2 SMA apitegromab (SRK-015) 20mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
|---|---|---|---|
|
Cohort 1: Change From Baseline in Timed Rise From Floor (From RHS)
|
0.6 Seconds
Standard Deviation 1.75
|
-0.6 Seconds
Standard Deviation 1.43
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: 1 patient in Cohort 2 and 3 patients in Cohort 3 (1 low dose and 2 high dose) missed 3 consecutive doses of apitegromab during the 12-month treatment period due to COVID-19-related site access restrictions and were not included in the primary analysis. In addition, 2 cohort 3 low dose patients skipped motor assessments at Day 168 (V8) and 1 cohort low dose patient at Day 365 (V15) due to COVID restrictions.
The Hammersmith Functional Motor Scale Expanded (HFMSE) assesses the physical abilities of patients with Type 2 and Type 3 SMA comprises 33 items graded on a scale of 0, 1, or 2, where 0 denotes unable, 1 denotes performed with modification or adaptation, and 2 denotes performed without modification or adaptation.
Outcome measures
| Measure |
Cohort 1 - Monotherapy
n=15 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) 20mg/kg
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 1 - Dual Therapy
n=10 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 3 - High Dose
n=10 Participants
Type 2 SMA apitegromab (SRK-015) 20mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
|---|---|---|---|
|
Cohort 2 &3: Change From Baseline in HFMSE Total Score at Other Prespecified Timepoints
Decrease at Day 56 (V4)
|
7 Participants
|
3 Participants
|
1 Participants
|
|
Cohort 2 &3: Change From Baseline in HFMSE Total Score at Other Prespecified Timepoints
Decrease at Day 112 (V6)
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Cohort 2 &3: Change From Baseline in HFMSE Total Score at Other Prespecified Timepoints
Decrease at Day 168 (V8)
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Cohort 2 &3: Change From Baseline in HFMSE Total Score at Other Prespecified Timepoints
Decrease at Month 12 Endpoint
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Cohort 2 &3: Change From Baseline in HFMSE Total Score at Other Prespecified Timepoints
≥5pt at Day 56 (V4)
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Cohort 2 &3: Change From Baseline in HFMSE Total Score at Other Prespecified Timepoints
≥5pt at Day 112 (V6)
|
1 Participants
|
2 Participants
|
5 Participants
|
|
Cohort 2 &3: Change From Baseline in HFMSE Total Score at Other Prespecified Timepoints
≥5pt at Day 168 (V8)
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Cohort 2 &3: Change From Baseline in HFMSE Total Score at Other Prespecified Timepoints
≥5pt at Month 12 Endpoint
|
2 Participants
|
5 Participants
|
5 Participants
|
|
Cohort 2 &3: Change From Baseline in HFMSE Total Score at Other Prespecified Timepoints
≥3pt at Day 56 (V4)
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Cohort 2 &3: Change From Baseline in HFMSE Total Score at Other Prespecified Timepoints
≥3pt at Day 112 (V6)
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Cohort 2 &3: Change From Baseline in HFMSE Total Score at Other Prespecified Timepoints
≥3pt at Day 168 (V8)
|
2 Participants
|
4 Participants
|
5 Participants
|
|
Cohort 2 &3: Change From Baseline in HFMSE Total Score at Other Prespecified Timepoints
≥3pt at Month 12 Endpoint
|
4 Participants
|
5 Participants
|
5 Participants
|
|
Cohort 2 &3: Change From Baseline in HFMSE Total Score at Other Prespecified Timepoints
≥1pt at Day 56 (V4)
|
4 Participants
|
6 Participants
|
8 Participants
|
|
Cohort 2 &3: Change From Baseline in HFMSE Total Score at Other Prespecified Timepoints
≥1pt at Day 112 (V6)
|
6 Participants
|
5 Participants
|
9 Participants
|
|
Cohort 2 &3: Change From Baseline in HFMSE Total Score at Other Prespecified Timepoints
≥1pt at Day 168 (V8)
|
10 Participants
|
5 Participants
|
8 Participants
|
|
Cohort 2 &3: Change From Baseline in HFMSE Total Score at Other Prespecified Timepoints
≥1pt at Month 12 Endpoint
|
9 Participants
|
7 Participants
|
7 Participants
|
|
Cohort 2 &3: Change From Baseline in HFMSE Total Score at Other Prespecified Timepoints
No Change at Day 56 (V4)
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Cohort 2 &3: Change From Baseline in HFMSE Total Score at Other Prespecified Timepoints
No Change at Day 112 (V6)
|
5 Participants
|
2 Participants
|
1 Participants
|
|
Cohort 2 &3: Change From Baseline in HFMSE Total Score at Other Prespecified Timepoints
No Change at Day 168 (V8)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Cohort 2 &3: Change From Baseline in HFMSE Total Score at Other Prespecified Timepoints
No Change at Month 12 Endpoint
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: 1 patient in Cohort 2 and 3 patients in Cohort 3 missed 3 consecutive doses of apitegromab during the 12-month treatment period due to COVID-19-related site access restrictions and were not included in the primary analysis.
The Hammersmith Functional Motor Scale Expanded (HFMSE) assesses the physical abilities of patients with Type 2 and Type 3 SMA comprises 33 items graded on a scale of 0, 1, or 2, where 0 denotes unable, 1 denotes performed with modification or adaptation, and 2 denotes performed without modification or adaptation.
Outcome measures
| Measure |
Cohort 1 - Monotherapy
n=14 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) 20mg/kg
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 1 - Dual Therapy
n=9 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 3 - High Dose
n=8 Participants
Type 2 SMA apitegromab (SRK-015) 20mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
|---|---|---|---|
|
Cohort 2 & 3: Proportion of Patients Achieving Various Magnitudes of Change in HFMSE Score From Baseline
≥3pt increase
|
4 Participants
|
5 Participants
|
5 Participants
|
|
Cohort 2 & 3: Proportion of Patients Achieving Various Magnitudes of Change in HFMSE Score From Baseline
≥1pt increase
|
9 Participants
|
7 Participants
|
7 Participants
|
|
Cohort 2 & 3: Proportion of Patients Achieving Various Magnitudes of Change in HFMSE Score From Baseline
No Change
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort 2 & 3: Proportion of Patients Achieving Various Magnitudes of Change in HFMSE Score From Baseline
Decrease
|
4 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: 1 patient in Cohort 2 and 3 patients in Cohort 3 missed 3 consecutive doses of apitegromab during the 12-month treatment period due to COVID-19-related site access restrictions and were not included in the primary analysis.
The RULM is a 20 item assessment of upper limb function in nonambulatory patients with SMA that was performed for patients who were 30 months of age or older at baseline. The 19 scored items assess functions that relate to everyday life, such as pressing a button and picking up a token; these items are scored 0, 1, or 2, where 0 denotes unable, 1 denotes able with modification, and 2 denotes able with no modification. The maximum score achievable is 37.
Outcome measures
| Measure |
Cohort 1 - Monotherapy
n=14 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) 20mg/kg
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 1 - Dual Therapy
n=9 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 3 - High Dose
n=8 Participants
Type 2 SMA apitegromab (SRK-015) 20mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
|---|---|---|---|
|
Cohort 2 & 3: Change in Baseline in Revised Upper Limb Module (RULM) Total Score
|
1.2 Score on scale
Standard Deviation 2.99
|
0.9 Score on scale
Standard Deviation 2.62
|
1 Score on scale
Standard Deviation 2.94
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: 1 patient in Cohort 2 and 3 patients in Cohort 3 missed 3 consecutive doses of apitegromab during the 12-month treatment period due to COVID-19-related site access restrictions and were not included in the primary analysis.
The WHO Multicenter Growth Reference Study performance criteria is being utilized to assess the World Health Organization (WHO) motor development milestones of patients with Type 2 and nonambulatory Type 3 SMA enrolled in Cohort 2 and Cohort 3 relative to baseline. The WHO milestone assessment consists of six items which were selected because they have been considered to be universal, fundamental, and simple to test and evaluate, they include 1) sitting without support, 2) hands and knees crawling, 3) standing with assistance, 4) walking with assistance, 5) standing alone, and 6) walking without assistance. Each item is recorded as 1 (unable), 2 (refusal), 3 (Yes) or 9 (did not test). The number of 3s was counted as the final score. The minimum was 0, which means no motor milestones were achieved; the maximum was 6, which means all 6 milestones were achieved.
Outcome measures
| Measure |
Cohort 1 - Monotherapy
n=14 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) 20mg/kg
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 1 - Dual Therapy
n=9 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 3 - High Dose
n=8 Participants
Type 2 SMA apitegromab (SRK-015) 20mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
|---|---|---|---|
|
Cohort 2 & 3: Proportion of Patients Achieving a New WHO Motor Development Milestones Relative to Baseline
≥2pt increase
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Cohort 2 & 3: Proportion of Patients Achieving a New WHO Motor Development Milestones Relative to Baseline
≥1pt increase
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Cohort 2 & 3: Proportion of Patients Achieving a New WHO Motor Development Milestones Relative to Baseline
No Change
|
11 Participants
|
7 Participants
|
6 Participants
|
|
Cohort 2 & 3: Proportion of Patients Achieving a New WHO Motor Development Milestones Relative to Baseline
Decrease
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: 1 patient in Cohort 2 and 3 patients in Cohort 3 missed 3 consecutive doses of apitegromab during the 12-month treatment period due to COVID-19-related site access restrictions and were not included in the primary analysis.
The RULM is a 20 item assessment of upper limb function in nonambulatory patients with SMA that was performed for patients who were 30 months of age or older at baseline. The 19 scored items assess functions that relate to everyday life, such as pressing a button and picking up a token; these items are scored 0, 1, or 2, where 0 denotes unable, 1 denotes able with modification, and 2 denotes able with no modification. The maximum score achievable is 37.
Outcome measures
| Measure |
Cohort 1 - Monotherapy
n=14 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) 20mg/kg
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 1 - Dual Therapy
n=9 Participants
Ambulatory Type 3 SMA apitegromab (SRK-015) + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 3 - High Dose
n=7 Participants
Type 2 SMA apitegromab (SRK-015) 20mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
|---|---|---|---|
|
Cohort 2 & 3: Proportion of Patients Achieving Various Magnitudes of Change in RULM Score From Baseline
≥1pt increase
|
8 Participants
|
3 Participants
|
3 Participants
|
|
Cohort 2 & 3: Proportion of Patients Achieving Various Magnitudes of Change in RULM Score From Baseline
≥2pt increase
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Cohort 2 & 3: Proportion of Patients Achieving Various Magnitudes of Change in RULM Score From Baseline
No change
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Cohort 2 & 3: Proportion of Patients Achieving Various Magnitudes of Change in RULM Score From Baseline
Decrease
|
5 Participants
|
3 Participants
|
2 Participants
|
Adverse Events
Cohort 1 - Monotherapy
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort 1 - Dual Therapy
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort 2
Serious events: 9 serious events
Other events: 15 other events
Deaths: 0 deaths
Cohort 3 - Low Dose
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 3 - High Dose
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 - Monotherapy
n=11 participants at risk
Ambulatory Type 3 SMA apitegromab (SRK-015) 20 mg/kg
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 1 - Dual Therapy
n=12 participants at risk
Ambulatory Type 3 SMA apitegromab (SRK-015) 20 mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 2
n=15 participants at risk
Type 2 SMA / Non-Ambulatory Type 3 SMA apitegromab (SRK-015) 20mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 3 - Low Dose
n=10 participants at risk
Type 2 SMA apitegromab (SRK-015) 2 mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 3 - High Dose
n=10 participants at risk
Type 2 SMA apitegromab (SRK-015) 20 mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
|---|---|---|---|---|---|
|
General disorders
Gait Inability
|
18.2%
2/11 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Post Lumbar-Puncture Syndrome
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar Hypertrophy
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Congenital, familial and genetic disorders
Developmental hip dysplasia
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Hepatobiliary disorders
Liver Injury
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Influenza
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
3/15 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Psychiatric disorders
Major depression
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Surgical and medical procedures
Adenoidectomy
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Surgical and medical procedures
Hospitalization
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Surgical and medical procedures
Joint dislocation reduction
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Surgical and medical procedures
Scoliosis surgery
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
33.3%
5/15 • Number of events 5 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Surgical and medical procedures
Spinal implantation
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
Other adverse events
| Measure |
Cohort 1 - Monotherapy
n=11 participants at risk
Ambulatory Type 3 SMA apitegromab (SRK-015) 20 mg/kg
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 1 - Dual Therapy
n=12 participants at risk
Ambulatory Type 3 SMA apitegromab (SRK-015) 20 mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 2
n=15 participants at risk
Type 2 SMA / Non-Ambulatory Type 3 SMA apitegromab (SRK-015) 20mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 3 - Low Dose
n=10 participants at risk
Type 2 SMA apitegromab (SRK-015) 2 mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
Cohort 3 - High Dose
n=10 participants at risk
Type 2 SMA apitegromab (SRK-015) 20 mg/kg + nusinersen
SRK-015: SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 was administered every 4 weeks by intravenous infusion.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Otitis media
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
30.0%
3/10 • Number of events 5 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Vascular disorders
Muscle operation
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Vascular disorders
Tooth extraction
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Gait Inability
|
18.2%
2/11 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Hepatobiliary disorders
Liver Injury
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Upper respiratory tract infection
|
45.5%
5/11 • Number of events 9 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
41.7%
5/12 • Number of events 9 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
33.3%
5/15 • Number of events 10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
40.0%
4/10 • Number of events 12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
50.0%
5/10 • Number of events 10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Nasopharyngitis
|
36.4%
4/11 • Number of events 5 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 5 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
40.0%
6/15 • Number of events 13 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
60.0%
6/10 • Number of events 23 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
50.0%
5/10 • Number of events 19 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Influenza
|
27.3%
3/11 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
3/15 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
30.0%
3/10 • Number of events 5 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
30.0%
3/10 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Ear infection
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 9 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Pyrexia
|
18.2%
2/11 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
41.7%
5/12 • Number of events 5 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
40.0%
6/15 • Number of events 10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
40.0%
4/10 • Number of events 18 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
90.0%
9/10 • Number of events 37 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Fatigue
|
18.2%
2/11 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
16.7%
2/12 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
13.3%
2/15 • Number of events 6 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
60.0%
6/10 • Number of events 11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
80.0%
8/10 • Number of events 21 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Nausea
|
36.4%
4/11 • Number of events 8 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
25.0%
3/12 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
3/15 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
50.0%
5/10 • Number of events 7 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
30.0%
3/10 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
18.2%
2/11 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
3/15 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
25.0%
3/12 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
3/15 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 6 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
2/11 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
41.7%
5/12 • Number of events 5 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
26.7%
4/15 • Number of events 5 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
50.0%
5/10 • Number of events 18 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
70.0%
7/10 • Number of events 22 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
18.2%
2/11 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 6 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
13.3%
2/15 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 5 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
40.0%
4/10 • Number of events 8 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.1%
1/11 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
30.0%
3/10 • Number of events 10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
40.0%
4/10 • Number of events 7 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.1%
1/11 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
3/15 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
40.0%
4/10 • Number of events 12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
27.3%
3/11 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
25.0%
3/12 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
33.3%
5/15 • Number of events 6 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
30.0%
3/10 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
26.7%
4/15 • Number of events 5 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
30.0%
3/10 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
16.7%
2/12 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
27.3%
3/11 • Number of events 8 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
3/15 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 5 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Nervous system disorders
Headache
|
63.6%
7/11 • Number of events 10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
41.7%
5/12 • Number of events 14 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
33.3%
5/15 • Number of events 18 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
40.0%
4/10 • Number of events 8 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
30.0%
3/10 • Number of events 9 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Nervous system disorders
Dizziness
|
36.4%
4/11 • Number of events 10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
13.3%
2/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.2%
2/11 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
26.7%
4/15 • Number of events 5 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
30.0%
3/10 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
40.0%
4/10 • Number of events 9 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
16.7%
2/12 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
3/15 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Fall
|
45.5%
5/11 • Number of events 11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
50.0%
6/12 • Number of events 54 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
27.3%
3/11 • Number of events 5 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
13.3%
2/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Contusion
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
25.0%
3/12 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
9.1%
1/11 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
30.0%
3/10 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Investigations
Heart rate increased
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
13.3%
2/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
13.3%
2/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Cardiac disorders
Sinus tachycardia
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Cardiac disorders
Tachycardia
|
9.1%
1/11 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
3/15 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Congenital, familial and genetic disorders
Developmental hip dysplasia
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Ear and labyrinth disorders
Vertigo
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Eye disorders
Astigmatism
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Eye disorders
Chalazion
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Eye disorders
Excessive eye blinking
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Eye disorders
Eye irritation
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Eye disorders
Eyelid disorder
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Eye disorders
Vision blurred
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
13.3%
2/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Constipation
|
18.2%
2/11 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
13.3%
2/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
30.0%
3/10 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
30.0%
3/10 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Eosinophilic oesophagitis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
13.3%
2/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Gingival ulceration
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Lip haematoma
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Loose tooth
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Teething
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Toothache
|
18.2%
2/11 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Application site rash
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Gastrointestinal disorders
Asthenia
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Chest discomfort
|
9.1%
1/11 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Chest pain
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
13.3%
2/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Discomfort
|
18.2%
2/11 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Gait inability
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Hyperpyrexia
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Infusion site bruising
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Infusion site nodule
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Infusion site pain
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Injection site rash
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Medical device site irritation
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Nodule
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Oedema peripheral
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Pain
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Peripheral swelling
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Tissue infiltration
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Vaccination site pain
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
13.3%
2/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Vessel puncture site rash
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Injection site injury
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Injection site nodule
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 5 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
General disorders
Injection site pain
|
9.1%
1/11 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Immune system disorders
Food allergy
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Immune system disorders
Seasonal allergy
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
3/15 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
COVID-19
|
45.5%
5/11 • Number of events 5 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
25.0%
3/12 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
40.0%
6/15 • Number of events 7 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
60.0%
6/10 • Number of events 7 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
60.0%
6/10 • Number of events 6 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Conjunctivitis
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Cystitis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Dysentery
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Enterobiasis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Folliculitis genital
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Gastroenteritis
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
13.3%
2/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Heliobacter infection
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Infected bite
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Myringitis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Nail infection
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Norovirus infection
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Paronychia
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Respiratory tract infection
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
30.0%
3/10 • Number of events 5 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Rhinitis
|
9.1%
1/11 • Number of events 5 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
13.3%
2/15 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Tooth infection
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Urinary tract infection
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
13.3%
2/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Viral infection
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Viral rash
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
13.3%
2/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Arthopod bite
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
3/15 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Head crushing injury
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
13.3%
2/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
40.0%
4/10 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Joint injury
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
27.3%
3/11 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
16.7%
2/12 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
9.1%
1/11 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
26.7%
4/15 • Number of events 5 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Injury, poisoning and procedural complications
Vascular access site bruising
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Investigations
Blood ketone body
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Investigations
Blood pressure increased
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Investigations
Bone density decreased
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Investigations
Hepatic enzyme abnormal
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Investigations
Transaminases increased
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Investigations
Urine analysis abnormal
|
9.1%
1/11 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Investigations
Weight decreased
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Investigations
Weight increased
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Metabolism and nutrition disorders
Calcium deficiency
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Metabolism and nutrition disorders
Feeding disorder
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
18.2%
2/11 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
3/15 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.2%
2/11 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
16.7%
2/12 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
33.3%
5/15 • Number of events 11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
13.3%
2/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
40.0%
4/10 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Musculoskeletal and connective tissue disorders
Hip deformity
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Musculoskeletal and connective tissue disorders
Joint laxity
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Musculoskeletal and connective tissue disorders
Neuromuscular scoliosis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Nervous system disorders
Brain fog
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Nervous system disorders
Drooling
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Nervous system disorders
Hypoaesthesia
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Nervous system disorders
Neuralgia
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Nervous system disorders
Somnolence
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Nervous system disorders
Syncope
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Nervous system disorders
Tremor
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
13.3%
2/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Psychiatric disorders
Autism spectrum disorder
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Psychiatric disorders
Fear of injection
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Psychiatric disorders
Obsessive-compulsive disorder
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Psychiatric disorders
Panic attack
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
1/11 • Number of events 4 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
18.2%
2/11 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar erythema
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
18.2%
2/11 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
13.3%
2/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
9.1%
1/11 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
2/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Hypohidrosis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Keloid scar
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
13.3%
2/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Skin striae
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 2 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Surgical and medical procedures
Bone operation
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
6.7%
1/15 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Vascular disorders
Flushing
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
8.3%
1/12 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Vascular disorders
Hypertension
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/15 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
|
Vascular disorders
Hypotension
|
0.00%
0/11 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/12 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
20.0%
3/15 • Number of events 3 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
10.0%
1/10 • Number of events 1 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
0.00%
0/10 • Day 0 (Visit 1) to 48 months (Visit EC14)
Classification based on the FDA regulatory definition of an AE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 45 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER