Trial Outcomes & Findings for Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia (NCT NCT03409744)
NCT ID: NCT03409744
Last Updated: 2025-04-08
Results Overview
The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
116 participants
Primary outcome timeframe
Up to 216 weeks
Results posted on
2025-04-08
Participant Flow
A total of 118 participants were planned to be enrolled. 116 participants were enrolled \& treated. Reasons for screen fail were: 1 participant was unwilling to use protocol defined contraception, and 1 participant had a Low-density lipoprotein cholesterol (LDL-C) level less than the lower limit required for inclusion.
Participant milestones
| Measure |
Total Evinacumab
Includes all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
|
|---|---|
|
Overall Study
STARTED
|
116
|
|
Overall Study
COMPLETED
|
106
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Total Evinacumab
Includes all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Physician Decision
|
5
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
Baseline characteristics by cohort
| Measure |
Total Evinacumab
n=116 Participants
Includes all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
|
|---|---|
|
Age, Continuous
|
38.8 Years
STANDARD_DEVIATION 15.92 • n=99 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
80 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
11 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 216 weeksThe safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
Outcome measures
| Measure |
Overall Study Total Evinacumab
n=116 Participants
Includes all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Up to Week 216
Participants with any TEAE
|
93 Number of participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Up to Week 216
Participants with at least one serious TEAE
|
27 Number of participants
|
SECONDARY outcome
Timeframe: Up to 120 weeksPopulation: Here 'n' = number of evaluable participants at the specified timepoint
The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
Outcome measures
| Measure |
Overall Study Total Evinacumab
n=116 Participants
Includes all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
|
|---|---|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Over Time
Week 8
|
-46.45 Percentage of change
Standard Deviation 35.504
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Over Time
Week 24
|
-43.64 Percentage of change
Standard Deviation 37.606
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Over Time
Week 48
|
-43.88 Percentage of change
Standard Deviation 36.037
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Over Time
Week 72
|
-45.17 Percentage of change
Standard Deviation 31.571
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Over Time
Week 96
|
-38.00 Percentage of change
Standard Deviation 52.859
|
|
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Over Time
Week 120
|
-33.10 Percentage of change
Standard Deviation 65.888
|
SECONDARY outcome
Timeframe: Up to 120 weeksPopulation: Here 'n' = number of evaluable participants at the specified timepoint
The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
Outcome measures
| Measure |
Overall Study Total Evinacumab
n=116 Participants
Includes all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
|
|---|---|
|
Absolute Change in LDL-C Over Time
Week 8
|
-142.1 mg/dL
Standard Deviation 114.61
|
|
Absolute Change in LDL-C Over Time
Week 24
|
-132.0 mg/dL
Standard Deviation 124.37
|
|
Absolute Change in LDL-C Over Time
Week 48
|
-132.8 mg/dL
Standard Deviation 133.29
|
|
Absolute Change in LDL-C Over Time
Week 72
|
-135.1 mg/dL
Standard Deviation 121.91
|
|
Absolute Change in LDL-C Over Time
Week 96
|
-131.4 mg/dL
Standard Deviation 129.29
|
|
Absolute Change in LDL-C Over Time
Week 120
|
-132.5 mg/dL
Standard Deviation 132.03
|
SECONDARY outcome
Timeframe: Up to 120 weeksPopulation: Here 'n' = number of evaluable participants at the specified timepoint
The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
Outcome measures
| Measure |
Overall Study Total Evinacumab
n=116 Participants
Includes all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
|
|---|---|
|
Percent Change in Apolipoprotein B (Apo B) Over Time
Week 8
|
-39.74 Percentage of change
Standard Deviation 25.338
|
|
Percent Change in Apolipoprotein B (Apo B) Over Time
Week 24
|
-36.98 Percentage of change
Standard Deviation 27.574
|
|
Percent Change in Apolipoprotein B (Apo B) Over Time
Week 48
|
-35.85 Percentage of change
Standard Deviation 29.998
|
|
Percent Change in Apolipoprotein B (Apo B) Over Time
Week 72
|
-37.60 Percentage of change
Standard Deviation 27.292
|
|
Percent Change in Apolipoprotein B (Apo B) Over Time
Week 96
|
-32.54 Percentage of change
Standard Deviation 39.969
|
|
Percent Change in Apolipoprotein B (Apo B) Over Time
Week 120
|
-27.73 Percentage of change
Standard Deviation 51.722
|
SECONDARY outcome
Timeframe: Up to 120 weeksPopulation: Here 'n' = number of evaluable participants at the specified timepoint
The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
Outcome measures
| Measure |
Overall Study Total Evinacumab
n=116 Participants
Includes all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
|
|---|---|
|
Absolute Change in Apo B Over Time
Week 8
|
-78.0 mg/dL
Standard Deviation 59.78
|
|
Absolute Change in Apo B Over Time
Week 24
|
-70.5 mg/dL
Standard Deviation 61.96
|
|
Absolute Change in Apo B Over Time
Week 48
|
-69.4 mg/dL
Standard Deviation 69.95
|
|
Absolute Change in Apo B Over Time
Week 72
|
-73.9 mg/dL
Standard Deviation 61.51
|
|
Absolute Change in Apo B Over Time
Week 96
|
-71.5 mg/dL
Standard Deviation 66.66
|
|
Absolute Change in Apo B Over Time
Week 120
|
-70.7 mg/dL
Standard Deviation 76.05
|
SECONDARY outcome
Timeframe: Up to 120 weeksPopulation: Here 'n' = number of evaluable participants at the specified timepoint
The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
Outcome measures
| Measure |
Overall Study Total Evinacumab
n=116 Participants
Includes all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
|
|---|---|
|
Percent Change in Non-High-Density Lipoprotein Cholesterol (HDL-C) Over Time
Week 8
|
-48.47 Percentage of change
Standard Deviation 28.369
|
|
Percent Change in Non-High-Density Lipoprotein Cholesterol (HDL-C) Over Time
Week 24
|
-46.14 Percentage of change
Standard Deviation 29.117
|
|
Percent Change in Non-High-Density Lipoprotein Cholesterol (HDL-C) Over Time
Week 48
|
-45.15 Percentage of change
Standard Deviation 33.566
|
|
Percent Change in Non-High-Density Lipoprotein Cholesterol (HDL-C) Over Time
Week 72
|
-46.69 Percentage of change
Standard Deviation 28.534
|
|
Percent Change in Non-High-Density Lipoprotein Cholesterol (HDL-C) Over Time
Week 96
|
-40.88 Percentage of change
Standard Deviation 46.588
|
|
Percent Change in Non-High-Density Lipoprotein Cholesterol (HDL-C) Over Time
Week 120
|
-35.85 Percentage of change
Standard Deviation 58.374
|
SECONDARY outcome
Timeframe: Up to 120 weeksPopulation: Here 'n' = number of evaluable participants at the specified timepoint
The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
Outcome measures
| Measure |
Overall Study Total Evinacumab
n=116 Participants
Includes all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
|
|---|---|
|
Absolute Change in Non-HDL-C Over Time
Week 8
|
-153.7 mg/dL
Standard Deviation 115.66
|
|
Absolute Change in Non-HDL-C Over Time
Week 24
|
-143.9 mg/dL
Standard Deviation 125.03
|
|
Absolute Change in Non-HDL-C Over Time
Week 48
|
-144.1 mg/dL
Standard Deviation 136.95
|
|
Absolute Change in Non-HDL-C Over Time
Week 72
|
-147.3 mg/dL
Standard Deviation 122.76
|
|
Absolute Change in Non-HDL-C Over Time
Week 96
|
-144.5 mg/dL
Standard Deviation 131.15
|
|
Absolute Change in Non-HDL-C Over Time
Week 120
|
-142.9 mg/dL
Standard Deviation 136.65
|
SECONDARY outcome
Timeframe: Up to 120 weeksPopulation: Here 'n' = number of evaluable participants at the specified timepoint
The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
Outcome measures
| Measure |
Overall Study Total Evinacumab
n=116 Participants
Includes all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
|
|---|---|
|
Percent Change in Total Cholesterol (TC) Over Time
Week 8
|
-47.04 Percentage of change
Standard Deviation 20.722
|
|
Percent Change in Total Cholesterol (TC) Over Time
Week 24
|
-44.17 Percentage of change
Standard Deviation 24.224
|
|
Percent Change in Total Cholesterol (TC) Over Time
Week 48
|
-43.78 Percentage of change
Standard Deviation 27.838
|
|
Percent Change in Total Cholesterol (TC) Over Time
Week 72
|
-44.58 Percentage of change
Standard Deviation 25.700
|
|
Percent Change in Total Cholesterol (TC) Over Time
Week 96
|
-40.33 Percentage of change
Standard Deviation 38.163
|
|
Percent Change in Total Cholesterol (TC) Over Time
Week 120
|
-36.92 Percentage of change
Standard Deviation 47.469
|
SECONDARY outcome
Timeframe: Up to 120 weeksPopulation: Here 'n' = number of evaluable participants at the specified timepoint
The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
Outcome measures
| Measure |
Overall Study Total Evinacumab
n=116 Participants
Includes all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
|
|---|---|
|
Absolute Change in TC Over Time
Week 8
|
-167.3 mg/dL
Standard Deviation 115.76
|
|
Absolute Change in TC Over Time
Week 24
|
-157.4 mg/dL
Standard Deviation 125.93
|
|
Absolute Change in TC Over Time
Week 48
|
-158.2 mg/dL
Standard Deviation 136.51
|
|
Absolute Change in TC Over Time
Week 72
|
-160.7 mg/dL
Standard Deviation 123.09
|
|
Absolute Change in TC Over Time
Week 96
|
-157.2 mg/dL
Standard Deviation 132.40
|
|
Absolute Change in TC Over Time
Week 120
|
-153.8 mg/dL
Standard Deviation 138.26
|
SECONDARY outcome
Timeframe: Up to 120 weeksPopulation: Here 'n' = number of evaluable participants at the specified timepoint
The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
Outcome measures
| Measure |
Overall Study Total Evinacumab
n=116 Participants
Includes all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
|
|---|---|
|
Percent Change in Triglycerides (TGs) Over Time
Week 72
|
-46.50 Percentage of change
Standard Deviation 25.826
|
|
Percent Change in Triglycerides (TGs) Over Time
Week 8
|
-45.97 Percentage of change
Standard Deviation 26.024
|
|
Percent Change in Triglycerides (TGs) Over Time
Week 24
|
-46.93 Percentage of change
Standard Deviation 24.582
|
|
Percent Change in Triglycerides (TGs) Over Time
Week 48
|
-43.25 Percentage of change
Standard Deviation 37.443
|
|
Percent Change in Triglycerides (TGs) Over Time
Week 96
|
-48.28 Percentage of change
Standard Deviation 24.136
|
|
Percent Change in Triglycerides (TGs) Over Time
Week 120
|
-42.06 Percentage of change
Standard Deviation 36.945
|
SECONDARY outcome
Timeframe: Up to 120 weeksPopulation: Here 'n' = number of evaluable participants at the specified timepoint
The safety analysis set (SAF) included all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
Outcome measures
| Measure |
Overall Study Total Evinacumab
n=116 Participants
Includes all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
|
|---|---|
|
Absolute Change in TGs Over Time
Week 8
|
-64.4 mg/dL
Standard Deviation 89.77
|
|
Absolute Change in TGs Over Time
Week 24
|
-68.1 mg/dL
Standard Deviation 97.29
|
|
Absolute Change in TGs Over Time
Week 48
|
-66.7 mg/dL
Standard Deviation 97.02
|
|
Absolute Change in TGs Over Time
Week 72
|
-68.8 mg/dL
Standard Deviation 91.52
|
|
Absolute Change in TGs Over Time
Week 96
|
-75.2 mg/dL
Standard Deviation 107.49
|
|
Absolute Change in TGs Over Time
Week 120
|
-66.7 mg/dL
Standard Deviation 110.95
|
Adverse Events
Overall
Serious events: 27 serious events
Other events: 79 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Overall
n=116 participants at risk
Includes all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
1.7%
2/116 • Number of events 2 • From signing of Informed Consent to week 216
|
|
Cardiac disorders
Angina unstable
|
1.7%
2/116 • Number of events 3 • From signing of Informed Consent to week 216
|
|
Cardiac disorders
Aortic valve disease
|
1.7%
2/116 • Number of events 2 • From signing of Informed Consent to week 216
|
|
Cardiac disorders
Coronary artery disease
|
1.7%
2/116 • Number of events 2 • From signing of Informed Consent to week 216
|
|
Cardiac disorders
Acute myocardial infarction
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Cardiac disorders
Atrial fibrillation
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Cardiac disorders
Cardiac arrest
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Cardiac disorders
Cardiac failure acute
|
0.86%
1/116 • Number of events 2 • From signing of Informed Consent to week 216
|
|
Cardiac disorders
Cardiac failure chronic
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Cardiac disorders
Cardiac failure congestive
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Cardiac disorders
Cardiac valve disease
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Cardiac disorders
Coronary artery occlusion
|
0.86%
1/116 • Number of events 2 • From signing of Informed Consent to week 216
|
|
Cardiac disorders
Coronary artery stenosis
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Cardiac disorders
Myocardial infarction
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Cardiac disorders
Supravalvular aortic stenosis
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Infections and infestations
Gastroenteritis
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Infections and infestations
Oesophageal candidiasis
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Infections and infestations
Pneumonia
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Vascular disorders
Aortic stenosis
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Vascular disorders
Arteriosclerosis
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Vascular disorders
Peripheral artery stenosis
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
General disorders
Chest pain
|
1.7%
2/116 • Number of events 3 • From signing of Informed Consent to week 216
|
|
Nervous system disorders
Ischaemic stroke
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Nervous system disorders
Spinal epidural haematoma
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Eye disorders
Cataract
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Eye disorders
Glaucoma
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Immune system disorders
Food allergy
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Psychiatric disorders
Mental status changes
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Renal and urinary disorders
Renal infarct
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.86%
1/116 • Number of events 1 • From signing of Informed Consent to week 216
|
Other adverse events
| Measure |
Overall
n=116 participants at risk
Includes all participants who were enrolled and received at least 1 dose or part of a dose of open-label study treatment.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
19.8%
23/116 • Number of events 42 • From signing of Informed Consent to week 216
|
|
Infections and infestations
COVID-19
|
16.4%
19/116 • Number of events 20 • From signing of Informed Consent to week 216
|
|
Infections and infestations
Gastroenteritis
|
8.6%
10/116 • Number of events 11 • From signing of Informed Consent to week 216
|
|
Infections and infestations
Urinary tract infection
|
8.6%
10/116 • Number of events 16 • From signing of Informed Consent to week 216
|
|
Infections and infestations
Upper respiratory tract infection
|
7.8%
9/116 • Number of events 14 • From signing of Informed Consent to week 216
|
|
Gastrointestinal disorders
Nausea
|
12.1%
14/116 • Number of events 17 • From signing of Informed Consent to week 216
|
|
Gastrointestinal disorders
Diarrhoea
|
8.6%
10/116 • Number of events 21 • From signing of Informed Consent to week 216
|
|
Gastrointestinal disorders
Abdominal pain
|
6.0%
7/116 • Number of events 10 • From signing of Informed Consent to week 216
|
|
Gastrointestinal disorders
Toothache
|
6.0%
7/116 • Number of events 10 • From signing of Informed Consent to week 216
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
7/116 • Number of events 11 • From signing of Informed Consent to week 216
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.2%
6/116 • Number of events 6 • From signing of Informed Consent to week 216
|
|
General disorders
Influenza like illness
|
14.7%
17/116 • Number of events 23 • From signing of Informed Consent to week 216
|
|
General disorders
Pyrexia
|
8.6%
10/116 • Number of events 16 • From signing of Informed Consent to week 216
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.9%
15/116 • Number of events 22 • From signing of Informed Consent to week 216
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.1%
14/116 • Number of events 20 • From signing of Informed Consent to week 216
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
8/116 • Number of events 10 • From signing of Informed Consent to week 216
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.0%
7/116 • Number of events 10 • From signing of Informed Consent to week 216
|
|
Nervous system disorders
Headache
|
16.4%
19/116 • Number of events 29 • From signing of Informed Consent to week 216
|
|
Nervous system disorders
Dizziness
|
6.0%
7/116 • Number of events 9 • From signing of Informed Consent to week 216
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.3%
12/116 • Number of events 16 • From signing of Informed Consent to week 216
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.2%
6/116 • Number of events 7 • From signing of Informed Consent to week 216
|
|
Injury, poisoning and procedural complications
Contusion
|
5.2%
6/116 • Number of events 6 • From signing of Informed Consent to week 216
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Additional Information
Clinical Trials Administrator
Regeneron Pharmaceuticals, Inc.
Phone: 844-734-6643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER