Trial Outcomes & Findings for Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn (NCT NCT02261883)
NCT ID: NCT02261883
Last Updated: 2024-03-05
Results Overview
Clinical worsening was a composite endpoint defined by the occurrence of 1 of the following: death, initiation of ECMO per institutional policies, or need for additional treatment (initiation of additional targeted pulmonary vasodilator therapy).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
From Baseline to Day 14
Results posted on
2024-03-05
Participant Flow
Participant milestones
| Measure |
IV Remodulin
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin.
|
Placebo
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
Placebo: Sodium citrate, sodium chloride, sodium hydroxide pellets, metacresol, and citric acid (anhydrous).
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
15
|
18
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
IV Remodulin
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin.
|
Placebo
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
Placebo: Sodium citrate, sodium chloride, sodium hydroxide pellets, metacresol, and citric acid (anhydrous).
|
|---|---|---|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Required ECMO Prior to Study Drug Administration
|
1
|
0
|
Baseline Characteristics
Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn
Baseline characteristics by cohort
| Measure |
IV Remodulin
n=20 Participants
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin.
|
Placebo
n=21 Participants
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
Placebo: Sodium citrate USP/EP/JP, sodium chloride USP/EP/JP, sodium hydroxide pellets, metacresol, and citric acid (anhydrous).
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
2.0 days
n=5 Participants
|
3.0 days
n=7 Participants
|
3.0 days
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Gestational Age
|
39.00 weeks
n=5 Participants
|
39.00 weeks
n=7 Participants
|
39.00 weeks
n=5 Participants
|
|
Birth Weight
|
3.08 kg
n=5 Participants
|
3.06 kg
n=7 Participants
|
3.06 kg
n=5 Participants
|
|
Oxygenation Index
|
25.5 units on a scale
n=5 Participants
|
22.0 units on a scale
n=7 Participants
|
23.0 units on a scale
n=5 Participants
|
|
Fraction of Inspired Oxygen (FiO2)
|
100.0 percentage of oxygen
n=5 Participants
|
100.0 percentage of oxygen
n=7 Participants
|
100.0 percentage of oxygen
n=5 Participants
|
|
Partial Pressure of Oxygen (PaO2)
|
51.0 mmHg
n=5 Participants
|
57.0 mmHg
n=7 Participants
|
56.0 mmHg
n=5 Participants
|
|
PaO2/FiO2 (P/F Ratio)
|
0.57 ratio
n=5 Participants
|
0.69 ratio
n=7 Participants
|
0.60 ratio
n=5 Participants
|
|
Inhaled Nitric Oxide (iNO)
|
20.00 ppm
n=5 Participants
|
20.00 ppm
n=7 Participants
|
20.00 ppm
n=5 Participants
|
|
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
|
11194.0 pg/mL
n=5 Participants
|
16646.0 pg/mL
n=7 Participants
|
13628.0 pg/mL
n=5 Participants
|
|
Time Since Diagnosis
|
2.0 days
n=5 Participants
|
2.0 days
n=7 Participants
|
2.0 days
n=5 Participants
|
|
PPHN Diagnosis
Idiopathic PPHN
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
PPHN Diagnosis
Associated with Meconium Aspiration Syndrome
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
PPHN Diagnosis
Associated with Respiratory Distress Syndrome
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
PPHN Diagnosis
Associated with Sepsis
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
PPHN Diagnosis
Associated with Birth Hypoxia
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
PPHN Diagnosis
Associated with Unilateral Congenital Diaphragmatic Hernia
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Day 14Population: Intent-to-Treat Population
Clinical worsening was a composite endpoint defined by the occurrence of 1 of the following: death, initiation of ECMO per institutional policies, or need for additional treatment (initiation of additional targeted pulmonary vasodilator therapy).
Outcome measures
| Measure |
IV Remodulin
n=20 Participants
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin.
|
Placebo
n=21 Participants
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
Placebo: Sodium citrate USP/EP/JP, sodium chloride USP/EP/JP, sodium hydroxide pellets, metacresol, and citric acid (anhydrous).
|
|---|---|---|
|
Number of Subjects Experiencing Clinical Worsening
Yes
|
8 Participants
|
12 Participants
|
|
Number of Subjects Experiencing Clinical Worsening
No
|
12 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From Baseline to Hours 12, 24, and 72; Days 7 and 14; and/or prior to study drug discontinuation/weaningPopulation: Intent-to-Treat Population
OI is an assessment of how much oxygen from the lungs enters the blood when a subject inhales, calculated as: mean airway pressure (MAP) multiplied by fraction of inspired oxygen (FiO2) divided by partial pressure of oxygen in the arterial blood (PaO2), then multiplying by 100. An OI of 15 or less indicates mild hypoxia, 16 to 25 indicates moderate hypoxia, 26 to 40 indicates severe hypoxia, and more than 40 indicates very severe hypoxia.
Outcome measures
| Measure |
IV Remodulin
n=20 Participants
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin.
|
Placebo
n=21 Participants
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
Placebo: Sodium citrate USP/EP/JP, sodium chloride USP/EP/JP, sodium hydroxide pellets, metacresol, and citric acid (anhydrous).
|
|---|---|---|
|
Change in Oxygenation Index (OI)
12 Hours
|
-2.0 units on a scale
Interval -41.0 to 37.0
|
-3.5 units on a scale
Interval -29.0 to 34.0
|
|
Change in Oxygenation Index (OI)
24 Hours
|
-8.5 units on a scale
Interval -40.0 to 23.0
|
-5.5 units on a scale
Interval -30.0 to 58.0
|
|
Change in Oxygenation Index (OI)
72 Hours
|
-7.0 units on a scale
Interval -40.0 to 65.0
|
-10.0 units on a scale
Interval -41.0 to 83.0
|
|
Change in Oxygenation Index (OI)
Day 7
|
-9.5 units on a scale
Interval -40.0 to 36.0
|
-11.0 units on a scale
Interval -43.0 to 42.0
|
|
Change in Oxygenation Index (OI)
Day 14
|
-12.0 units on a scale
Interval -40.0 to 36.0
|
-14.0 units on a scale
Interval -35.0 to 42.0
|
SECONDARY outcome
Timeframe: From Baseline to Hours 12, 24, and 72Population: Intent-to-Treat Population
PaO2/FiO2 ratio, also referred to as P/F Ratio, is a calculation used to assess the severity of hypoxemia, which is a condition characterized by low levels of oxygen in the blood. A low P/F ratio suggests that the patient's oxygen levels are compromised relative to the amount of oxygen being provided.
Outcome measures
| Measure |
IV Remodulin
n=20 Participants
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin.
|
Placebo
n=21 Participants
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
Placebo: Sodium citrate USP/EP/JP, sodium chloride USP/EP/JP, sodium hydroxide pellets, metacresol, and citric acid (anhydrous).
|
|---|---|---|
|
Change in P/F Ratio
12 Hours
|
0.11 ratio
Interval -0.5 to 10.5
|
0.10 ratio
Interval -2.3 to 4.1
|
|
Change in P/F Ratio
24 Hours
|
0.35 ratio
Interval -0.4 to 9.3
|
0.27 ratio
Interval -2.3 to 7.1
|
|
Change in P/F Ratio
72 Hours
|
0.50 ratio
Interval -0.4 to 4.8
|
0.65 ratio
Interval -2.3 to 7.5
|
SECONDARY outcome
Timeframe: From Baseline to Hours 6, 12, 24, and 72Population: Intent-to-Treat Population
SpO2 is an assessment of how much oxygen is in the blood, measured by a pulse oximeter. Pre-ductal SpO2 is measured in the right hand or foot and is a reflection of the amount of oxygen flowing to the brain. Post-ductal SpO2 is measured in the left hand or foot, after the blood has mixed with less oxygenated blood from the rest of the body.
Outcome measures
| Measure |
IV Remodulin
n=20 Participants
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin.
|
Placebo
n=21 Participants
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
Placebo: Sodium citrate USP/EP/JP, sodium chloride USP/EP/JP, sodium hydroxide pellets, metacresol, and citric acid (anhydrous).
|
|---|---|---|
|
Change in Pre- and Post-ductal Oxygen Saturation (SpO2)
6 Hours
|
3.0 percentage of oxygen
Interval -6.0 to 13.0
|
1.0 percentage of oxygen
Interval -10.0 to 7.0
|
|
Change in Pre- and Post-ductal Oxygen Saturation (SpO2)
12 Hours
|
3.0 percentage of oxygen
Interval -7.0 to 17.0
|
0.5 percentage of oxygen
Interval -7.0 to 12.0
|
|
Change in Pre- and Post-ductal Oxygen Saturation (SpO2)
24 Hours
|
3.0 percentage of oxygen
Interval -12.0 to 15.0
|
1.0 percentage of oxygen
Interval -17.0 to 11.0
|
|
Change in Pre- and Post-ductal Oxygen Saturation (SpO2)
72 Hours
|
0.0 percentage of oxygen
Interval -4.0 to 16.0
|
1.5 percentage of oxygen
Interval -21.0 to 8.0
|
SECONDARY outcome
Timeframe: From Baseline to Days 1, 2, 3, 7, and 14 (or prior to hospital discharge)Population: Intent-to-Treat Population
NT-proBNP is a hormone produced by the heart. Increased NT-proBNP concentration is associated with changes in right heart morphology and function. The main purpose of NT-proBNP testing is to see if the blood levels of this protein are within the expected range for a healthy individual.
Outcome measures
| Measure |
IV Remodulin
n=20 Participants
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin.
|
Placebo
n=21 Participants
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
Placebo: Sodium citrate USP/EP/JP, sodium chloride USP/EP/JP, sodium hydroxide pellets, metacresol, and citric acid (anhydrous).
|
|---|---|---|
|
Change in N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP)
Day 1
|
-1577.00 pg/mL
Interval -21322.0 to 43388.0
|
-1378.00 pg/mL
Interval -23206.0 to 17923.0
|
|
Change in N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP)
Day 2
|
-1955.00 pg/mL
Interval -24637.0 to 34599.0
|
-4090.00 pg/mL
Interval -37390.0 to 14163.0
|
|
Change in N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP)
Day 3
|
-252.00 pg/mL
Interval -24623.0 to 30629.0
|
-4090.00 pg/mL
Interval -49200.0 to 13550.0
|
|
Change in N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP)
Day 7
|
484.00 pg/mL
Interval -24623.0 to 19970.0
|
-11312.00 pg/mL
Interval -65387.0 to 12299.0
|
|
Change in N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP)
Day 14
|
-719.00 pg/mL
Interval -26283.0 to 56529.0
|
-9003.00 pg/mL
Interval -65387.0 to 12299.0
|
SECONDARY outcome
Timeframe: From Baseline to Day 56Population: Intent-to-Treat Population
Clinical worsening was assessed continuously during the study. Clinical worsening was a composite endpoint defined by the occurrence of 1 of the following: death, initiation of ECMO per institutional policies, or need for additional treatment (initiation of additional targeted pulmonary vasodilator therapy).
Outcome measures
| Measure |
IV Remodulin
n=8 Participants
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin.
|
Placebo
n=12 Participants
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
Placebo: Sodium citrate USP/EP/JP, sodium chloride USP/EP/JP, sodium hydroxide pellets, metacresol, and citric acid (anhydrous).
|
|---|---|---|
|
Time to Clinical Worsening
|
3.0 days
Interval 1.0 to 8.0
|
3.0 days
Interval 1.0 to 13.0
|
SECONDARY outcome
Timeframe: From Baseline to Day 56Population: Intent-to-Treat Population
Start of ECMO was assessed continuously during the study. ECMO is a life-support therapy that oxygenates blood by passing it through an artificial lung. The start time of ECMO, if needed, was recorded for each subject.
Outcome measures
| Measure |
IV Remodulin
n=6 Participants
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin.
|
Placebo
n=7 Participants
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
Placebo: Sodium citrate USP/EP/JP, sodium chloride USP/EP/JP, sodium hydroxide pellets, metacresol, and citric acid (anhydrous).
|
|---|---|---|
|
Time to Initiation of ECMO
|
2.5 days
Interval 1.0 to 8.0
|
3.0 days
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: From Baseline to Day 56Population: Intent-to-Treat Population
Discontinuation of iNO was assessed continuously during the study. iNO works by relaxing the blood vessels in the lungs, which makes it easier for oxygen to be delivered to the body. The stop time of iNO was recorded for each subject.
Outcome measures
| Measure |
IV Remodulin
n=20 Participants
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin.
|
Placebo
n=21 Participants
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
Placebo: Sodium citrate USP/EP/JP, sodium chloride USP/EP/JP, sodium hydroxide pellets, metacresol, and citric acid (anhydrous).
|
|---|---|---|
|
Time to Discontinuation of Inhaled Nitric Oxide (iNO)
|
7.5 days
Interval 1.0 to 12.0
|
7.0 days
Interval 1.0 to 11.0
|
Adverse Events
IV Remodulin
Serious events: 8 serious events
Other events: 19 other events
Deaths: 4 deaths
Placebo
Serious events: 3 serious events
Other events: 17 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
IV Remodulin
n=20 participants at risk
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin.
|
Placebo
n=21 participants at risk
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
Placebo: Sodium citrate USP/EP/JP, sodium chloride USP/EP/JP, sodium hydroxide pellets, metacresol, and citric acid (anhydrous).
|
|---|---|---|
|
Cardiac disorders
Cardio-respiratory arrest
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
0.00%
0/21 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Congenital, familial and genetic disorders
Congenital diaphragmatic hernia
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
0.00%
0/21 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
0.00%
0/21 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
4.8%
1/21 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
0.00%
0/21 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
0.00%
0/21 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
4.8%
1/21 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
0.00%
0/21 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
0.00%
0/21 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Infections and infestations
Sepsis
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
0.00%
0/21 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/20 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
4.8%
1/21 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/20 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
4.8%
1/21 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/20 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
4.8%
1/21 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
Other adverse events
| Measure |
IV Remodulin
n=20 participants at risk
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
IV Remodulin: Treprostinil is a chemically stable tricyclic analogue of prostacyclin.
|
Placebo
n=21 participants at risk
The starting dose was 1 ng/kg/min (not to exceed to 2 ng/kg/min) and was titrated by up to 2 ng/kg/min every 2 hours, as tolerated and clinically indicated by the Investigator. Doses were titrated and maximized throughout the study until the desired clinical effect was observed or to each individual subject's maximally tolerated dose. There was no maximum dose.
Placebo: Sodium citrate USP/EP/JP, sodium chloride USP/EP/JP, sodium hydroxide pellets, metacresol, and citric acid (anhydrous).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
5/20 • Number of events 5 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
19.0%
4/21 • Number of events 4 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
4/20 • Number of events 4 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
4.8%
1/21 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
0.00%
0/21 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
General disorders
Drug withdrawal syndrome neonatal
|
15.0%
3/20 • Number of events 3 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
0.00%
0/21 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
General disorders
Drug withdrawal syndrome
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
9.5%
2/21 • Number of events 2 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
General disorders
Oedema
|
0.00%
0/20 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
9.5%
2/21 • Number of events 2 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
15.0%
3/20 • Number of events 3 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
0.00%
0/21 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
15.0%
3/20 • Number of events 3 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
0.00%
0/21 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Nervous system disorders
Seizure
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
4.8%
1/21 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
2/20 • Number of events 2 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
4.8%
1/21 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
9.5%
2/21 • Number of events 2 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
5.0%
1/20 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
9.5%
2/21 • Number of events 2 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
15.0%
3/20 • Number of events 3 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
4.8%
1/21 • Number of events 1 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
|
Vascular disorders
Hypotension
|
30.0%
6/20 • Number of events 7 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
|
14.3%
3/21 • Number of events 3 • Adverse events (AEs) were captured from when the subject signed the informed consent form until the subject completed the study or was withdrawn from the study, up to 56 days.
AEs were followed until either resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for at least 4 weeks after the last dose of study drug. All serious adverse events (SAEs) were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 4 weeks after completion of the last dose of study drug.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution and/or Principal Investigator agree not to publish or publicly present any results of the Study without the prior written consent of Sponsor, not to be unreasonably withheld or delayed. Institution and/or Principal Investigator further agree to provide Sponsor with drafts of any such publication or presentation for review and approval no less than 30 days prior to submission for publication or the date of public presentation.
- Publication restrictions are in place
Restriction type: OTHER