Trial Outcomes & Findings for Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously vs. the Same Dose Administered Intravenously in Subjects With Chronic Heart Failure (NCT NCT02329834)
NCT ID: NCT02329834
Last Updated: 2022-12-02
Results Overview
Maximum observed plasma concentration of Furosemide
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
23 participants
Primary outcome timeframe
0, 5 min, 15 min, 30 min, 45 min, 60 min, 1.5 hours, 2 hours, 2:05 min, 2:15 min, 2:30 min, 2:45 min, 3 hours, 3:30 min, 4, 5, 6, 8, 10, 12, 14, and 16 hours post-dose
Results posted on
2022-12-02
Participant Flow
6 subjects did not meet inclusion/exclusion criteria after signing informed consent. * 2 subjects did not meet the inclusion criteria of BNP\>100pg/ml * 2 subjects met the exclusion criterion: Impaired renal function, defined as an eGFR on admission \<45 mL/min/1.73m2 * 1 subject withdrew consent * 1 subject was excluded by the investigator due to High Creatine Kinase
Participant milestones
| Measure |
Treatment Sequence 1 (SC Period 1; IV Period 2)
Furosemide Injection Solution for subcutaneous administration (80mg) over 5 hours followed by i.v. Furosemide Injection, USP (80 mg)by i.v. bolus in second period
Fursemide Injection Solution for subcutaneous administration (80 mg): Furosemide Injection Solution, 10mL of undiluted buffered furosemide solution (8mg/mL)
Furosemide Injection, USP: Furosemide Injection, USP (10mg/mL), 80 mg by intravenous administration.
|
Treatment Sequence 2 (IV Period 1; SC Period 2)
Furosemide Injection, USP (80 mg) by i.v. bolus, followed by Furosemide Injection Solution for subcutaneous administration (80mg) over 5 hours in second period.
Fursemide Injection Solution for subcutaneous administration (80 mg): Furosemide Injection Solution, 10mL of undiluted buffered furosemide solution (8mg/mL)
Furosemide Injection, USP: Furosemide Injection, USP (10mg/mL), 80 mg by intravenous administration.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence 1 (SC Period 1; IV Period 2)
Furosemide Injection Solution for subcutaneous administration (80mg) over 5 hours followed by i.v. Furosemide Injection, USP (80 mg)by i.v. bolus in second period
Fursemide Injection Solution for subcutaneous administration (80 mg): Furosemide Injection Solution, 10mL of undiluted buffered furosemide solution (8mg/mL)
Furosemide Injection, USP: Furosemide Injection, USP (10mg/mL), 80 mg by intravenous administration.
|
Treatment Sequence 2 (IV Period 1; SC Period 2)
Furosemide Injection, USP (80 mg) by i.v. bolus, followed by Furosemide Injection Solution for subcutaneous administration (80mg) over 5 hours in second period.
Fursemide Injection Solution for subcutaneous administration (80 mg): Furosemide Injection Solution, 10mL of undiluted buffered furosemide solution (8mg/mL)
Furosemide Injection, USP: Furosemide Injection, USP (10mg/mL), 80 mg by intravenous administration.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously vs. the Same Dose Administered Intravenously in Subjects With Chronic Heart Failure
Baseline characteristics by cohort
| Measure |
Treatment Sequence 1 (SC Period 1; IV Period 2)
n=8 Participants
Furosemide Injection Solution for subcutaneous administration (80mg) over 5 hours followed by i.v. Furosemide Injection, USP (80 mg)by i.v. bolus in second period
Fursemide Injection Solution for subcutaneous administration (80 mg): Furosemide Injection Solution, 10mL of undiluted buffered furosemide solution (8mg/mL)
Furosemide Injection, USP: Furosemide Injection, USP (10mg/mL), 80 mg by intravenous administration.
|
Treatment Sequence 2 (IV Period 1; SC Period 2)
n=9 Participants
Furosemide Injection, USP (80 mg) by i.v. bolus, followed by Furosemide Injection Solution for subcutaneous administration (80mg) over 5 hours in second period.
Fursemide Injection Solution for subcutaneous administration (80 mg): Furosemide Injection Solution, 10mL of undiluted buffered furosemide solution (8mg/mL)
Furosemide Injection, USP: Furosemide Injection, USP (10mg/mL), 80 mg by intravenous administration.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.4 Years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
64.1 Years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
68 Years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
NYHA Class
NYHA II
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
NYHA Class
NYHA III
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Participants with History of Ischemic Heart Disease
Ischemic
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Participants with History of Ischemic Heart Disease
Non-Ischemic
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Participants with History of Hypertension
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Participants with History of Arrhythmia
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Participants with History of Acute Myocardial Infarction
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
BMI
|
31.5 kg/m^2
STANDARD_DEVIATION 4.6 • n=5 Participants
|
30.9 kg/m^2
STANDARD_DEVIATION 4.8 • n=7 Participants
|
31 kg/m^2
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
BMI
<=30kg/m^2
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
BMI
>30kg/m^2
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
proBNP
|
891 pg/mL
STANDARD_DEVIATION 805 • n=5 Participants
|
903.2 pg/mL
STANDARD_DEVIATION 1037.5 • n=7 Participants
|
897 pg/mL
STANDARD_DEVIATION 906.5 • n=5 Participants
|
|
Participants with History of Diabetes
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 5 min, 15 min, 30 min, 45 min, 60 min, 1.5 hours, 2 hours, 2:05 min, 2:15 min, 2:30 min, 2:45 min, 3 hours, 3:30 min, 4, 5, 6, 8, 10, 12, 14, and 16 hours post-dosePopulation: PK Population: All randomized subjects who receive study drug and have sufficient samples collected for estimation of pharmacokinetic parameters
Maximum observed plasma concentration of Furosemide
Outcome measures
| Measure |
IV Furosemide
n=15 Participants
Pharmacokinetic Assessments after a successful IV dosing regimen
|
SC Furosemide
n=15 Participants
Pharmacokinetic Assessments after a successful SC dosing regimen
|
|---|---|---|
|
Cmax
|
8580 ng/mL
Standard Deviation 2540
|
2040 ng/mL
Standard Deviation 449
|
PRIMARY outcome
Timeframe: 0, 5 min, 15 min, 30 min, 45 min, 60 min, 1.5 hours, 2 hours, 2:05 min, 2:15 min, 2:30 min, 2:45 min, 3 hours, 3:30 min, 4, 5, 6, 8, 10, 12, 14, and 16 hours post-dosePopulation: PK Population: All randomized subjects who receive study drug and have sufficient samples collected for estimation of pharmacokinetic parameters
Time to achieve maximum observed Furosemide plasma concentration
Outcome measures
| Measure |
IV Furosemide
n=15 Participants
Pharmacokinetic Assessments after a successful IV dosing regimen
|
SC Furosemide
n=15 Participants
Pharmacokinetic Assessments after a successful SC dosing regimen
|
|---|---|---|
|
Tmax
|
2.08 hours
Interval 0.08 to 2.08
|
4 hours
Interval 1.0 to 5.08
|
PRIMARY outcome
Timeframe: 0, 5 min, 15 min, 30 min, 45 min, 60 min, 1.5 hours, 2 hours, 2:05 min, 2:15 min, 2:30 min, 2:45 min, 3 hours, 3:30 min, 4, 5, 6, 8, 10, 12, 14, and 16 hours post-dosePopulation: PK Population: All randomized subjects who receive study drug and have sufficient samples collected for estimation of pharmacokinetic parameters
The area under the plasma concentration versus time curve from time 0 (pre-dose) to the last quantifiable time point.
Outcome measures
| Measure |
IV Furosemide
n=15 Participants
Pharmacokinetic Assessments after a successful IV dosing regimen
|
SC Furosemide
n=15 Participants
Pharmacokinetic Assessments after a successful SC dosing regimen
|
|---|---|---|
|
AUClast
|
13000 h*ng/mL
Standard Deviation 4050
|
13000 h*ng/mL
Standard Deviation 4000
|
PRIMARY outcome
Timeframe: 0, 5 min, 15 min, 30 min, 45 min, 60 min, 1.5 hours, 2 hours, 2:05 min, 2:15 min, 2:30 min, 2:45 min, 3 hours, 3:30 min, 4, 5, 6, 8, 10, 12, 14, and 16 hours post-dosePopulation: PK Population: All randomized subjects who receive study drug and have sufficient samples collected for estimation of pharmacokinetic parameters
The area under the plasma concentration-time curve from time 0 (pre-dose) to time of last measurable plasma concentration.
Outcome measures
| Measure |
IV Furosemide
n=15 Participants
Pharmacokinetic Assessments after a successful IV dosing regimen
|
SC Furosemide
n=15 Participants
Pharmacokinetic Assessments after a successful SC dosing regimen
|
|---|---|---|
|
AUCinf
|
13200 h*ng/mL
Standard Deviation 4170
|
13100 h*ng/mL
Standard Deviation 4010
|
PRIMARY outcome
Timeframe: 0, 5 min, 15 min, 30 min, 45 min, 60 min, 1.5 hours, 2 hours, 2:05 min, 2:15 min, 2:30 min, 2:45 min, 3 hours, 3:30 min, 4, 5, 6, 8, 10, 12, 14, and 16 hours post-dosePopulation: PK Population: All randomized subjects who receive study drug and have sufficient samples collected for estimation of pharmacokinetic parameters
The percentage of AUC that is extrapolated beyond the last measurable concentration
Outcome measures
| Measure |
IV Furosemide
n=15 Participants
Pharmacokinetic Assessments after a successful IV dosing regimen
|
SC Furosemide
n=15 Participants
Pharmacokinetic Assessments after a successful SC dosing regimen
|
|---|---|---|
|
AUCext
|
0.912 percentage of AUC
Standard Deviation 0.631
|
1.05 percentage of AUC
Standard Deviation 1.29
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: PK Population: All randomized subjects who receive study drug and have sufficient samples collected for estimation of pharmacokinetic parameters
Apparent plasma terminal-phase elimination rate constant
Outcome measures
| Measure |
IV Furosemide
n=15 Participants
Pharmacokinetic Assessments after a successful IV dosing regimen
|
SC Furosemide
n=15 Participants
Pharmacokinetic Assessments after a successful SC dosing regimen
|
|---|---|---|
|
λz
|
0.277 1/h
Standard Deviation 0.0365
|
0.238 1/h
Standard Deviation 0.0732
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: PK Population: All randomized subjects who receive study drug and have sufficient samples collected for estimation of pharmacokinetic parameters
Terminal-phase half life
Outcome measures
| Measure |
IV Furosemide
n=15 Participants
Pharmacokinetic Assessments after a successful IV dosing regimen
|
SC Furosemide
n=15 Participants
Pharmacokinetic Assessments after a successful SC dosing regimen
|
|---|---|---|
|
t 1/2
|
2.55 hours
Standard Deviation 0.339
|
3.16 hours
Standard Deviation 0.911
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: PK Population: All randomized subjects who receive study drug and have sufficient samples collected for estimation of pharmacokinetic parameters
Systemic Volume of distribution, terminal phase for IV furosemide and Apparent Volume of distribution, terminal phase for SC furosemide
Outcome measures
| Measure |
IV Furosemide
n=15 Participants
Pharmacokinetic Assessments after a successful IV dosing regimen
|
SC Furosemide
n=15 Participants
Pharmacokinetic Assessments after a successful SC dosing regimen
|
|---|---|---|
|
Volume of Distribution, Terminal Phase
|
24.4 Litres
Standard Deviation 9.15
|
28.5 Litres
Standard Deviation 5.28
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: PK Population: All randomized subjects who receive study drug and have sufficient samples collected for estimation of pharmacokinetic parameters
Systemic Clearance for IV furosemide and Apparent Systemic Clearance for SC furosemide
Outcome measures
| Measure |
IV Furosemide
n=15 Participants
Pharmacokinetic Assessments after a successful IV dosing regimen
|
SC Furosemide
n=15 Participants
Pharmacokinetic Assessments after a successful SC dosing regimen
|
|---|---|---|
|
CL
|
6.71 liter per hour
Standard Deviation 2.31
|
6.71 liter per hour
Standard Deviation 2.21
|
Adverse Events
IV Furosemide
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SC Furosemide
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
During Washout or Follow-up
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IV Furosemide
n=16 participants at risk
Pharmacokinetic Assessments after a successful IV dosing regimen
|
SC Furosemide
n=16 participants at risk
Pharmacokinetic Assessments after a successful SC dosing regimen
|
During Washout or Follow-up
n=16 participants at risk
During washout or follow-up periods
|
|---|---|---|---|
|
General disorders
Application site erythema
|
6.2%
1/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
50.0%
8/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
0.00%
0/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
|
General disorders
Application site edema
|
0.00%
0/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
43.8%
7/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
0.00%
0/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
|
General disorders
Nodule
|
0.00%
0/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
0.00%
0/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
6.2%
1/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
|
Investigations
BNP elevated
|
0.00%
0/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
0.00%
0/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
6.2%
1/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
|
Investigations
Peripheral pulse decreased
|
0.00%
0/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
0.00%
0/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
6.2%
1/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
|
Investigations
Total CK elevated
|
0.00%
0/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
0.00%
0/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
6.2%
1/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
|
Investigations
Troponin elevated
|
0.00%
0/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
0.00%
0/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
6.2%
1/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.00%
0/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
0.00%
0/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
6.2%
1/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
6.2%
1/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
0.00%
0/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
|
0.00%
0/16 • Day 0 through Day-19 visit
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An SAE is any AE occurring at any dose that results in any of the following outcomes: * Death * Life threatening AE * Inpatient hospitalization or prolongation * Disability * Congenital anomaly or birth defect * Any important medical events based on investigator's clinical judgement.
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Additional Information
Sr. Vice President of Clinical Development and Medical Affairs
scPharmaceuticals
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place