Trial Outcomes & Findings for FRDA Investigator Initiated Study (IIS) With Elamipretide (NCT NCT05168774)
NCT ID: NCT05168774
Last Updated: 2025-12-12
Results Overview
Change in High Contrast Visual Acuity will be measured by assessing the differences in the number of letters read (binocular) on the ETDRS High Contrast Visual Acuity Chart between groups (low dose and high dose).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Baseline to 52 weeks
Results posted on
2025-12-12
Participant Flow
Of the 20 enrolled participants, 4 subjects screen failed and did not meet the study inclusion criteria. Of the 16 subjects who received treatment and 8 subjects withdrew after consenting and starting treatment from the study. 8 subjects completed all study visits.
Participant milestones
| Measure |
Low Dose (20-30mg)
Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (20-30 mg) for 52 weeks
Elamipretide: Elamipretide is a tetra peptide with limited blood brain barrier penetration being developed for use in a variety of mitochondrial disorders, including FRDA, mitochondrial myopathy and Barth Syndrome.
|
High Dose (40-60 mg)
Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (40-60 mg) for 52 weeks
Elamipretide: Elamipretide is a tetra peptide with limited blood brain barrier penetration being developed for use in a variety of mitochondrial disorders, including FRDA, mitochondrial myopathy and Barth Syndrome.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Low Dose (20-30mg)
Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (20-30 mg) for 52 weeks
Elamipretide: Elamipretide is a tetra peptide with limited blood brain barrier penetration being developed for use in a variety of mitochondrial disorders, including FRDA, mitochondrial myopathy and Barth Syndrome.
|
High Dose (40-60 mg)
Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (40-60 mg) for 52 weeks
Elamipretide: Elamipretide is a tetra peptide with limited blood brain barrier penetration being developed for use in a variety of mitochondrial disorders, including FRDA, mitochondrial myopathy and Barth Syndrome.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
FRDA Investigator Initiated Study (IIS) With Elamipretide
Baseline characteristics by cohort
| Measure |
Low Dose (20-30mg)
n=8 Participants
Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (20-30 mg) for 52 weeks
Elamipretide: Elamipretide is a tetra peptide with limited blood brain barrier penetration being developed for use in a variety of mitochondrial disorders, including FRDA, mitochondrial myopathy and Barth Syndrome.
|
High Dose (40-60 mg)
n=8 Participants
Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (40-60 mg) for 52 weeks
Elamipretide: Elamipretide is a tetra peptide with limited blood brain barrier penetration being developed for use in a variety of mitochondrial disorders, including FRDA, mitochondrial myopathy and Barth Syndrome.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-24 (years)
|
3 Participants
n=26 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=50 Participants
|
|
Age, Customized
25-34 (years)
|
2 Participants
n=26 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=50 Participants
|
|
Age, Customized
35-44 (years)
|
2 Participants
n=26 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=50 Participants
|
|
Age, Customized
45-54 (years)
|
0 Participants
n=26 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=50 Participants
|
|
Age, Customized
55-64 (years)
|
1 Participants
n=26 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=50 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=26 Participants
|
2 Participants
n=24 Participants
|
8 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=26 Participants
|
6 Participants
n=24 Participants
|
8 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=26 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=26 Participants
|
7 Participants
n=24 Participants
|
14 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=26 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=26 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=26 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=26 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=26 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=26 Participants
|
8 Participants
n=24 Participants
|
14 Participants
n=50 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=26 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=26 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: Baseline to 52 weeksPopulation: 2 subjects in low dose and 1 subject in the high dose did not complete Week 52 study visit
Change in High Contrast Visual Acuity will be measured by assessing the differences in the number of letters read (binocular) on the ETDRS High Contrast Visual Acuity Chart between groups (low dose and high dose).
Outcome measures
| Measure |
Low Dose (20-30mg)
n=6 Participants
Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (20-30 mg) for 52 weeks
Elamipretide: Elamipretide is a tetra peptide with limited blood brain barrier penetration being developed for use in a variety of mitochondrial disorders, including FRDA, mitochondrial myopathy and Barth Syndrome.
|
High Dose (40-60 mg)
n=7 Participants
Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (40-60 mg) for 52 weeks
Elamipretide: Elamipretide is a tetra peptide with limited blood brain barrier penetration being developed for use in a variety of mitochondrial disorders, including FRDA, mitochondrial myopathy and Barth Syndrome.
|
|---|---|---|
|
Change in High Contrast Visual Acuity
|
5.5 Number of Letters Read on a Vision Board
Interval 0.0 to 6.0
|
0 Number of Letters Read on a Vision Board
Interval -5.0 to 6.0
|
SECONDARY outcome
Timeframe: Baseline to 52 weeksPopulation: All subjects in both low dose and high dose were unable to read a single letter on the low contrast vision board
Change in Low Contrast Visual Acuity will be measured by assessing the differences in the number of letters read (binocular) on the ETDRS Low Contrast Visual Acuity Chart between groups (low dose and high dose).
Outcome measures
| Measure |
Low Dose (20-30mg)
n=6 Participants
Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (20-30 mg) for 52 weeks
Elamipretide: Elamipretide is a tetra peptide with limited blood brain barrier penetration being developed for use in a variety of mitochondrial disorders, including FRDA, mitochondrial myopathy and Barth Syndrome.
|
High Dose (40-60 mg)
n=7 Participants
Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (40-60 mg) for 52 weeks
Elamipretide: Elamipretide is a tetra peptide with limited blood brain barrier penetration being developed for use in a variety of mitochondrial disorders, including FRDA, mitochondrial myopathy and Barth Syndrome.
|
|---|---|---|
|
Change in Low Contrast Visual Acuity
|
0 Number of Letters Read on a Vision Board
Interval 0.0 to 0.0
|
0 Number of Letters Read on a Vision Board
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline to 52 weeksPopulation: 2 subjects in low dose and 1 subject in the high dose did not complete Week 52 study visit
Change in Low Luminescence Visual Acuity will be measured by assessing the difference in the number of letters read (binocular) on the ETDRS High Contrast Visual Acuity Chart with Low Luminescence Filter between groups (low dose and high dose).
Outcome measures
| Measure |
Low Dose (20-30mg)
n=6 Participants
Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (20-30 mg) for 52 weeks
Elamipretide: Elamipretide is a tetra peptide with limited blood brain barrier penetration being developed for use in a variety of mitochondrial disorders, including FRDA, mitochondrial myopathy and Barth Syndrome.
|
High Dose (40-60 mg)
n=7 Participants
Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (40-60 mg) for 52 weeks
Elamipretide: Elamipretide is a tetra peptide with limited blood brain barrier penetration being developed for use in a variety of mitochondrial disorders, including FRDA, mitochondrial myopathy and Barth Syndrome.
|
|---|---|---|
|
Change in Low Luminescence Visual Activity
|
0.5 Number of Letters Read on a Vision Board
Interval 0.0 to 2.0
|
0 Number of Letters Read on a Vision Board
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline to 52 weeksPopulation: 6 low-dose and 7 high-dose subjects attempted to complete this procedure. However, due to disease progression (abnormal eye movements) and visual impairment (unable to focus on visual target) subjects were unable to perform the OCT exam in both low dose and high dose, thus resulting in poor quality images that were unable to be analyzed and will never be analyzed in the future.
The change in thickness of the retinal nerve fiber layer between groups (low dose and high dose) will be measured using the OCT, a non-invasive imaging test that uses light waves to take cross-section pictures of the retina.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 52 weeksPopulation: 2 subjects in low dose and 1 subject in the high dose did not complete Week 52 study visit
The VFQ is a 25-item patient reported outcome on visual symptomology to assess change in patient self-report of visual ability over time compared to baseline between groups (low dose and high dose). The VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. Each item is then converted to a 0 to 100 scale. The summary statistic is the difference in mean values from Baseline to Week 52. A negative value represents a worsening over time and a positive value represents improvement.
Outcome measures
| Measure |
Low Dose (20-30mg)
n=6 Participants
Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (20-30 mg) for 52 weeks
Elamipretide: Elamipretide is a tetra peptide with limited blood brain barrier penetration being developed for use in a variety of mitochondrial disorders, including FRDA, mitochondrial myopathy and Barth Syndrome.
|
High Dose (40-60 mg)
n=7 Participants
Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (40-60 mg) for 52 weeks
Elamipretide: Elamipretide is a tetra peptide with limited blood brain barrier penetration being developed for use in a variety of mitochondrial disorders, including FRDA, mitochondrial myopathy and Barth Syndrome.
|
|---|---|---|
|
Change in Visual Quality of Life by Visual Functioning Questionnaire (VFQ)
|
-2.42 Units on a scale
Standard Deviation 3.85
|
2.08 Units on a scale
Standard Deviation 5.77
|
SECONDARY outcome
Timeframe: Baseline to 36 weeksPopulation: Due to insufficient number of high quality reproducible scans we were unable to conduct a systematic analysis. The speckle tracking needed for this analysis was not done because reproducible scans were unobtainable in individuals with advanced FA due to inability to lie still for sufficient amounts of time and will never be analyzed in the future.
The change in cardiac strain (dL/L) in each dimension per cardiac cycle between groups (low dose and high dose) is measured by speckle tracking on imaging.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 36 weeksPopulation: Due to insufficient number of high quality reproducible scans we were unable to conduct a systematic analysis. The T1 mapping using late gadolinium enhancement needed for this analysis was not done because reproducible scans were unobtainable in individuals with advanced FA due to inability to lie still for sufficient amounts of time and will never be analyzed in the future.
The change in cardiac fibrosis over time by T1 mapping using late gadolinium enhancement between groups (low dose and high dose).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 36 weeksPopulation: 2 subjects in low dose and 2 subject in the high dose did not complete cardiac testing at the Week 36 study visit
The change in stroke volume will be calculated by Ejection Fraction x Ventricular Volume x Pulse Rate, over time between groups (low dose and high dose).
Outcome measures
| Measure |
Low Dose (20-30mg)
n=6 Participants
Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (20-30 mg) for 52 weeks
Elamipretide: Elamipretide is a tetra peptide with limited blood brain barrier penetration being developed for use in a variety of mitochondrial disorders, including FRDA, mitochondrial myopathy and Barth Syndrome.
|
High Dose (40-60 mg)
n=6 Participants
Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (40-60 mg) for 52 weeks
Elamipretide: Elamipretide is a tetra peptide with limited blood brain barrier penetration being developed for use in a variety of mitochondrial disorders, including FRDA, mitochondrial myopathy and Barth Syndrome.
|
|---|---|---|
|
Change Cardiac Stroke Volume
|
0.12 percentage of change in stroke volume
Standard Deviation 0.16
|
-0.02 percentage of change in stroke volume
Standard Deviation 0.29
|
Adverse Events
Low Dose (20-30mg)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
High Dose (40-60 mg)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Dose (20-30mg)
n=8 participants at risk
Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (20-30 mg) for 52 weeks
Elamipretide: Elamipretide is a tetra peptide with limited blood brain barrier penetration being developed for use in a variety of mitochondrial disorders, including FRDA, mitochondrial myopathy and Barth Syndrome.
|
High Dose (40-60 mg)
n=8 participants at risk
Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (40-60 mg) for 52 weeks
Elamipretide: Elamipretide is a tetra peptide with limited blood brain barrier penetration being developed for use in a variety of mitochondrial disorders, including FRDA, mitochondrial myopathy and Barth Syndrome.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonia
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Surgical and medical procedures
Acute Perforated Appendicitis
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
12.5%
1/8 • Number of events 3 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Nervous system disorders
Vasovagal Episode
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
12.5%
1/8 • Number of events 3 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
Other adverse events
| Measure |
Low Dose (20-30mg)
n=8 participants at risk
Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (20-30 mg) for 52 weeks
Elamipretide: Elamipretide is a tetra peptide with limited blood brain barrier penetration being developed for use in a variety of mitochondrial disorders, including FRDA, mitochondrial myopathy and Barth Syndrome.
|
High Dose (40-60 mg)
n=8 participants at risk
Subjects will receive daily subcutaneous (SC) dosing of Elamipretide (40-60 mg) for 52 weeks
Elamipretide: Elamipretide is a tetra peptide with limited blood brain barrier penetration being developed for use in a variety of mitochondrial disorders, including FRDA, mitochondrial myopathy and Barth Syndrome.
|
|---|---|---|
|
Vascular disorders
Edema
|
37.5%
3/8 • Number of events 3 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Endocrine disorders
Hyperglycemia
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Nervous system disorders
Metallic Dysgeusia
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Metabolism and nutrition disorders
Lactic Acidosis
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Gastrointestinal disorders
Weight Loss (<10% of Body Weight)
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Gastrointestinal disorders
Hematochezia
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction: Pain, Tenderness, or Burning
|
37.5%
3/8 • Number of events 3 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction: Erythema or Redness
|
37.5%
3/8 • Number of events 3 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
75.0%
6/8 • Number of events 6 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction: Induration or Swelling
|
50.0%
4/8 • Number of events 4 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
75.0%
6/8 • Number of events 6 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction: Pruritus or Itching
|
75.0%
6/8 • Number of events 6 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
75.0%
6/8 • Number of events 6 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction: Urticaria or Hives
|
37.5%
3/8 • Number of events 3 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
25.0%
2/8 • Number of events 2 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction: Bruising
|
25.0%
2/8 • Number of events 2 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction: Blister
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Gastrointestinal disorders
Increased Bowel Frequency
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Gastrointestinal disorders
Viral Gastroenteritis
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
25.0%
2/8 • Number of events 2 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Gastrointestinal disorders
Increased Appetite
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Gastrointestinal disorders
Weight Gain (>10% of Body Weight)
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mucocele
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Musculoskeletal and connective tissue disorders
Increased Fatigue
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Infections and infestations
Sore Throat
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Immune system disorders
Fever
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
25.0%
2/8 • Number of events 2 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Viral Rhinitis or Upper Respiratory Infection
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
50.0%
4/8 • Number of events 4 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Psychiatric disorders
Altered Mental Status
|
25.0%
2/8 • Number of events 2 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Infections and infestations
COVID-19
|
25.0%
2/8 • Number of events 2 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
62.5%
5/8 • Number of events 5 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Injury, poisoning and procedural complications
Black Eye
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Injury, poisoning and procedural complications
Chipped Teeth
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Ear and labyrinth disorders
Ear Infection
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity or Photodermatitis
|
25.0%
2/8 • Number of events 2 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Nervous system disorders
Syncope
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Eye disorders
Blepharitis
|
12.5%
1/8 • Number of events 2 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Skin and subcutaneous tissue disorders
Blisters on Feet
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
|
Infections and infestations
Leg Infection
|
0.00%
0/8 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
12.5%
1/8 • Number of events 1 • AE's were assessed for approximately 104 weeks (2 years).
The same subject reported both the pneumonia and pulmonary embolism SAEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place