Trial Outcomes & Findings for Study of AG10 in Amyloid Cardiomyopathy (NCT NCT03458130)
NCT ID: NCT03458130
Last Updated: 2022-11-16
Results Overview
Change in Diastolic Blood Pressure from Baseline to Day 28 (Postdose)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Baseline to Day 28
Results posted on
2022-11-16
Participant Flow
Participant milestones
| Measure |
AG10 400mg
AG10 400mg twice daily for 28 days; tablets
AG10: Transthyretin (TTR) stabilizer
|
AG10 800mg
AG10 800mg twice daily for 28 days; tablets
AG10: Transthyretin (TTR) stabilizer
|
Placebo
Placebo twice daily for 28 days; tablets
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
17
|
|
Overall Study
Screening
|
16
|
16
|
17
|
|
Overall Study
Double Blind Treatment
|
16
|
16
|
17
|
|
Overall Study
Follow-Up
|
16
|
16
|
17
|
|
Overall Study
COMPLETED
|
16
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of AG10 in Amyloid Cardiomyopathy
Baseline characteristics by cohort
| Measure |
AG10 400mg
n=16 Participants
AG10 400mg twice daily for 28 days; tablets
AG10: TTR stabilizer
|
AG10 800mg
n=16 Participants
AG10 800mg twice daily for 28 days; tablets
AG10: TTR stabilizer
|
Placebo
n=17 Participants
Placebo twice daily for 28 days; tablets
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73.8 Years
STANDARD_DEVIATION 5.65 • n=99 Participants
|
75.4 Years
STANDARD_DEVIATION 6.81 • n=107 Participants
|
73.2 Years
STANDARD_DEVIATION 7.35 • n=206 Participants
|
74.1 Years
STANDARD_DEVIATION 6.58 • n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
45 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
43 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race (NIH/OMB) · American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race (NIH/OMB) · Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race (NIH/OMB) · Native Hawaiian or Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race (NIH/OMB) · Black or African American
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race (NIH/OMB) · White
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race (NIH/OMB) · Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race (NIH/OMB) · More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race (NIH/OMB) · Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
16 participants
n=107 Participants
|
17 participants
n=206 Participants
|
49 participants
n=7 Participants
|
|
Body Mass Index (BMI)
|
25.42 kg/meters squared
STANDARD_DEVIATION 3.284 • n=99 Participants
|
26.29 kg/meters squared
STANDARD_DEVIATION 3.705 • n=107 Participants
|
27.05 kg/meters squared
STANDARD_DEVIATION 3.604 • n=206 Participants
|
26.27 kg/meters squared
STANDARD_DEVIATION 3.528 • n=7 Participants
|
|
Height
|
172.68 Centimeters
STANDARD_DEVIATION 7.055 • n=99 Participants
|
175.59 Centimeters
STANDARD_DEVIATION 9.738 • n=107 Participants
|
174.52 Centimeters
STANDARD_DEVIATION 8.220 • n=206 Participants
|
174.27 Centimeters
STANDARD_DEVIATION 8.317 • n=7 Participants
|
|
TTR Genotype Status
Wild Type
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
|
TTR Genotype Status
Mutant
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
TTR Genotype Status
Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Weight
|
75.93 Kilograms
STANDARD_DEVIATION 12.080 • n=99 Participants
|
81.71 Kilograms
STANDARD_DEVIATION 15.948 • n=107 Participants
|
82.34 Kilograms
STANDARD_DEVIATION 12.018 • n=206 Participants
|
80.04 Kilograms
STANDARD_DEVIATION 13.478 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 28Change in Diastolic Blood Pressure from Baseline to Day 28 (Postdose)
Outcome measures
| Measure |
AG10 400mg
n=16 Participants
AG10 400mg twice daily for 28 days; tablets
AG10: TTR stabilizer
|
AG10 800mg
n=16 Participants
AG10 800mg twice daily for 28 days; tablets
AG10: TTR stabilizer
|
Placebo
n=17 Participants
Placebo twice daily for 28 days; tablets
|
|---|---|---|---|
|
Change in Diastolic Blood Pressure
Change in Diastolic Blood Pressure from Baseline to Day 28 (Postdose)
|
-2.6 mm Hg
Standard Deviation 9.66
|
0.3 mm Hg
Standard Deviation 8.54
|
-4.9 mm Hg
Standard Deviation 9.17
|
|
Change in Diastolic Blood Pressure
Change in Diastolic Blood Pressure from Baseline to Day 28 (Predose)
|
-3.1 mm Hg
Standard Deviation 10.06
|
-3.3 mm Hg
Standard Deviation 11.19
|
-4.3 mm Hg
Standard Deviation 7.78
|
PRIMARY outcome
Timeframe: Baseline to Day 28Change in Heart Rate from Baseline to Day 28 (Postdose)
Outcome measures
| Measure |
AG10 400mg
n=16 Participants
AG10 400mg twice daily for 28 days; tablets
AG10: TTR stabilizer
|
AG10 800mg
n=16 Participants
AG10 800mg twice daily for 28 days; tablets
AG10: TTR stabilizer
|
Placebo
n=17 Participants
Placebo twice daily for 28 days; tablets
|
|---|---|---|---|
|
Change in Heart Rate
Change in heart rate from Baseline to Day 28 (Predose)
|
-2.7 beats/minute
Standard Deviation 6.88
|
-3.8 beats/minute
Standard Deviation 6.55
|
-0.4 beats/minute
Standard Deviation 6.34
|
|
Change in Heart Rate
Change in heart rate from Baseline to Day 28 (Postdose)
|
-7.3 beats/minute
Standard Deviation 9.84
|
-4.9 beats/minute
Standard Deviation 5.84
|
-1.1 beats/minute
Standard Deviation 8.89
|
PRIMARY outcome
Timeframe: Baseline to Day 28Change in Respiratory Rate from Baseline to Day 28 (Postdose)
Outcome measures
| Measure |
AG10 400mg
n=16 Participants
AG10 400mg twice daily for 28 days; tablets
AG10: TTR stabilizer
|
AG10 800mg
n=16 Participants
AG10 800mg twice daily for 28 days; tablets
AG10: TTR stabilizer
|
Placebo
n=17 Participants
Placebo twice daily for 28 days; tablets
|
|---|---|---|---|
|
Change in Respiratory Rate
Change in Respiratory Rate from Baseline to Day 28 (Predose)
|
-0.1 breaths/minute
Standard Deviation 2.23
|
-0.8 breaths/minute
Standard Deviation 3.12
|
-0.4 breaths/minute
Standard Deviation 2.35
|
|
Change in Respiratory Rate
Change in Respiratory Rate from Baseline to Day 28 (Postdose)
|
-0.7 breaths/minute
Standard Deviation 1.68
|
-1.1 breaths/minute
Standard Deviation 3.11
|
-1.1 breaths/minute
Standard Deviation 2.93
|
PRIMARY outcome
Timeframe: Baseline to Day 28Change in Temperature from Baseline to Day 28
Outcome measures
| Measure |
AG10 400mg
n=16 Participants
AG10 400mg twice daily for 28 days; tablets
AG10: TTR stabilizer
|
AG10 800mg
n=16 Participants
AG10 800mg twice daily for 28 days; tablets
AG10: TTR stabilizer
|
Placebo
n=17 Participants
Placebo twice daily for 28 days; tablets
|
|---|---|---|---|
|
Change in Temperature
Change in Temperature from Baseline to Day 28 (Predose)
|
0.17 degrees Celsius
Standard Deviation 0.793
|
0.06 degrees Celsius
Standard Deviation 0.316
|
-0.08 degrees Celsius
Standard Deviation 0.506
|
|
Change in Temperature
Change in Temperature from Baseline to Day 28 (Postdose)
|
0.22 degrees Celsius
Standard Deviation 0.781
|
-0.02 degrees Celsius
Standard Deviation 0.357
|
0.02 degrees Celsius
Standard Deviation 0.194
|
PRIMARY outcome
Timeframe: Baseline to Day 28Change in Systolic Blood Pressure from Baseline to Day 28
Outcome measures
| Measure |
AG10 400mg
n=16 Participants
AG10 400mg twice daily for 28 days; tablets
AG10: TTR stabilizer
|
AG10 800mg
n=16 Participants
AG10 800mg twice daily for 28 days; tablets
AG10: TTR stabilizer
|
Placebo
n=17 Participants
Placebo twice daily for 28 days; tablets
|
|---|---|---|---|
|
Change in Systolic Blood Pressure
Change in Systolic Blood Pressure from Baseline to Day 28 (Predose)
|
-2.7 mm Hg
Standard Deviation 12.05
|
-8.1 mm Hg
Standard Deviation 12.36
|
-5.3 mm Hg
Standard Deviation 13.50
|
|
Change in Systolic Blood Pressure
Change in Systolic Blood Pressure from Baseline to Day 28 (Postdose)
|
-2.8 mm Hg
Standard Deviation 18.41
|
-4.1 mm Hg
Standard Deviation 8.88
|
-3.4 mm Hg
Standard Deviation 17.51
|
SECONDARY outcome
Timeframe: Day 1 to Day 28In specialized lab tests on patient samples that measure the stability of the healthy form of TTR, both doses of AG10 were able to reach near complete stabilization.
Outcome measures
| Measure |
AG10 400mg
n=16 Participants
AG10 400mg twice daily for 28 days; tablets
AG10: TTR stabilizer
|
AG10 800mg
n=16 Participants
AG10 800mg twice daily for 28 days; tablets
AG10: TTR stabilizer
|
Placebo
n=17 Participants
Placebo twice daily for 28 days; tablets
|
|---|---|---|---|
|
Number of Participants With Threshold Levels of Overall % Stabilization >= 95% and >= 99% by Fluorescent Probe Exclusion (FPE)
% Stabilization > = 95 %
|
14 Participants
|
15 Participants
|
0 Participants
|
|
Number of Participants With Threshold Levels of Overall % Stabilization >= 95% and >= 99% by Fluorescent Probe Exclusion (FPE)
% Stabilization > = 99 %
|
11 Participants
|
13 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 14 and Day 28Non-fluctuating minimal amount of AG10 in blood at Day 14 and Day 28
Outcome measures
| Measure |
AG10 400mg
n=16 Participants
AG10 400mg twice daily for 28 days; tablets
AG10: TTR stabilizer
|
AG10 800mg
n=16 Participants
AG10 800mg twice daily for 28 days; tablets
AG10: TTR stabilizer
|
Placebo
Placebo twice daily for 28 days; tablets
|
|---|---|---|---|
|
Pharmacokinetic (PK): Steady State Trough Concentration of AG10
AG10: PK Plasma Concentration at Day 14 (Pre-Dose)
|
1924.4 ng/mL
Standard Deviation 837.3
|
2257.3 ng/mL
Standard Deviation 982.81
|
—
|
|
Pharmacokinetic (PK): Steady State Trough Concentration of AG10
AG10: PK Plasma Concentration at Day 28 (Pre-Dose)
|
1841.3 ng/mL
Standard Deviation 483.88
|
2439.4 ng/mL
Standard Deviation 900.08
|
—
|
Adverse Events
AG10 400mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
AG10 800mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AG10 400mg
n=16 participants at risk
AG10 400mg twice daily for 28 days; tablets
AG10: TTR stabilizer
|
AG10 800mg
n=16 participants at risk
AG10 800mg twice daily for 28 days; tablets
AG10: TTR stabilizer
|
Placebo
n=17 participants at risk
Placebo twice daily for 28 days; tablets
|
|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
5.9%
1/17 • Number of events 1 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
5.9%
1/17 • Number of events 1 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
5.9%
1/17 • Number of events 1 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
1/16 • Number of events 1 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
0.00%
0/17 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
Other adverse events
| Measure |
AG10 400mg
n=16 participants at risk
AG10 400mg twice daily for 28 days; tablets
AG10: TTR stabilizer
|
AG10 800mg
n=16 participants at risk
AG10 800mg twice daily for 28 days; tablets
AG10: TTR stabilizer
|
Placebo
n=17 participants at risk
Placebo twice daily for 28 days; tablets
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 1 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
18.8%
3/16 • Number of events 3 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
11.8%
2/17 • Number of events 2 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
2/16 • Number of events 3 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
18.8%
3/16 • Number of events 3 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
0.00%
0/17 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
6.2%
1/16 • Number of events 1 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
6.2%
1/16 • Number of events 1 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
11.8%
2/17 • Number of events 2 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
Cardiac disorders
Atrial Fibrillation
|
6.2%
1/16 • Number of events 2 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
12.5%
2/16 • Number of events 2 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
0.00%
0/17 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
6.2%
1/16 • Number of events 2 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
11.8%
2/17 • Number of events 2 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
General disorders
Fatigue
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
6.2%
1/16 • Number of events 1 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
11.8%
2/17 • Number of events 2 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
Metabolism and nutrition disorders
Fluid Retention
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
6.2%
1/16 • Number of events 1 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
11.8%
2/17 • Number of events 2 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
12.5%
2/16 • Number of events 2 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
5.9%
1/17 • Number of events 1 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
17.6%
3/17 • Number of events 3 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
6.2%
1/16 • Number of events 1 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
5.9%
1/17 • Number of events 2 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
6.2%
1/16 • Number of events 1 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
5.9%
1/17 • Number of events 1 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
6.2%
1/16 • Number of events 1 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
5.9%
1/17 • Number of events 1 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
11.8%
2/17 • Number of events 2 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
11.8%
2/17 • Number of events 2 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
12.5%
2/16 • Number of events 2 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
0.00%
0/17 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
11.8%
2/17 • Number of events 2 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
11.8%
2/17 • Number of events 2 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
6.2%
1/16 • Number of events 1 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
5.9%
1/17 • Number of events 1 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
General disorders
Oedema Peripheral
|
12.5%
2/16 • Number of events 2 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
0.00%
0/17 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
11.8%
2/17 • Number of events 2 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
|
Investigations
Venous Pressure Jugular Increased
|
12.5%
2/16 • Number of events 2 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
0.00%
0/16 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
0.00%
0/17 • Onset date on or after first dose of study drug and not more than 30 days after last dose of study drug, up to day 58.
|
Additional Information
Mark McGovern, Vice President of Clinical Operations
Eidos Therapeutics
Phone: 415-887-1471
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of the results by the PI will be subject to mutual agreement between the PI and the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER