MedTrace Logo

Trial Outcomes & Findings for Safety of Sildenafil in Premature Infants (NCT NCT03142568)

NCT ID: NCT03142568

Last Updated: 2026-03-30

Results Overview

Description of safety of sildenafil in premature infants and assessed by frequency and incidence of adverse events (AEs) and serious adverse events. Both non-serious and serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

109 participants

Primary outcome timeframe

Nonserious AEs were collected through Day 14 post last intervention; SAEs through Day 28. Retinopathy of prematurity was assessed through discharge/transfer, up to 575 days after first treatment.

Results posted on

2026-03-30

Participant Flow

In total, 109 individuals provided informed consent. Three were not randomized and therefore did not receive study intervention, 106 participants were consented and randomized to a study arm/group (started).

Participant milestones

Participant milestones
Measure
Sildenafil Cohort 1
Within cohort 1 infants will be randomized using a 3:1 scheme to receive sildenafil or placebo. Infants randomized to sildenafil will receive 0.125 mg/kg daily every 8 hours intravenously (IV), or 0.25 mg/kg daily every 8 hours enterally for 28 days. Sildenafil: Infants will be randomized using a 3:1 scheme to receive sildenafil or placebo.
Placebo Cohort 1
Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use. Placebo: Infants randomized to the placebo group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).
Sildenafil Cohort 2
Cohort 2 infants will receive sildenafil 0.5 mg/kg daily every 8 hours intravenously (IV) or 1 mg/kg daily every 8 hours enterally for 28 days. Sildenafil: Infants will be randomized using a 3:1 scheme to receive sildenafil or placebo.
Placebo Cohort 2
Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use. Placebo: Infants randomized to the placebo group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).
Sildenafil Cohort 3
Cohort 3 infants will receive sildenafil 1 mg/kg daily every 8 hours intravenously (IV) or 2 mg/kg daily every 8 hours enterally for 28 days. Sildenafil: Infants will be randomized using a 3:1 scheme to receive sildenafil or placebo.
Placebo Cohort 3
Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use. Placebo: Infants randomized to the placebo group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).
Overall Study
STARTED
30
10
33
10
17
6
Overall Study
Received Intervention
30
10
30
10
16
6
Overall Study
Pharmacokinetics Population
23
0
18
0
11
0
Overall Study
COMPLETED
23
10
27
10
10
4
Overall Study
NOT COMPLETED
7
0
6
0
7
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety of Sildenafil in Premature Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sildenafil Cohort 1
n=30 Participants
Within cohort 1 infants will be randomized using a 3:1 scheme to receive sildenafil or placebo. Infants randomized to sildenafil will receive 0.125 mg/kg daily every 8 hours intravenously (IV), or 0.25 mg/kg daily every 8 hours enterally for 28 days. Sildenafil: Infants will be randomized using a 3:1 scheme to receive sildenafil or placebo.
Placebo Cohort 1
n=10 Participants
Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use. Placebo: Infants randomized to the placebo group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).
Sildenafil Cohort 2
n=30 Participants
Cohort 2 infants will receive sildenafil 0.5 mg/kg daily every 8 hours intravenously (IV) or 1 mg/kg daily every 8 hours enterally for 28 days. Sildenafil: Infants will be randomized using a 3:1 scheme to receive sildenafil or placebo.
Placebo Cohort 2
n=10 Participants
Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use. Placebo: Infants randomized to the placebo group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).
Sildenafil Cohort 3
n=16 Participants
Cohort 3 infants will receive sildenafil 1 mg/kg daily every 8 hours intravenously (IV) or 2 mg/kg daily every 8 hours enterally for 28 days. Sildenafil: Infants will be randomized using a 3:1 scheme to receive sildenafil or placebo.
Placebo Cohort 3
n=6 Participants
Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use. Placebo: Infants randomized to the placebo group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).
Total
n=102 Participants
Total of all reporting groups
Age, Continuous
26.5 Weeks
STANDARD_DEVIATION 1.4 • n=4 Participants
25.9 Weeks
STANDARD_DEVIATION 1.4 • n=28 Participants
26 Weeks
STANDARD_DEVIATION 1.5 • n=10 Participants
26.9 Weeks
STANDARD_DEVIATION 1.7 • n=38 Participants
26.4 Weeks
STANDARD_DEVIATION 1.6 • n=33 Participants
25.0 Weeks
STANDARD_DEVIATION 1.0 • n=100 Participants
26.2 Weeks
STANDARD_DEVIATION 1.5 • n=48 Participants
Age, Customized
Post Natal Age
19.6 Days
STANDARD_DEVIATION 6.0 • n=4 Participants
21.0 Days
STANDARD_DEVIATION 7.5 • n=28 Participants
21.6 Days
STANDARD_DEVIATION 5.7 • n=10 Participants
22.3 Days
STANDARD_DEVIATION 6.4 • n=38 Participants
18.9 Days
STANDARD_DEVIATION 6.6 • n=33 Participants
22.0 Days
STANDARD_DEVIATION 7.1 • n=100 Participants
20.6 Days
STANDARD_DEVIATION 6.3 • n=48 Participants
Sex: Female, Male
Female
22 Participants
n=4 Participants
4 Participants
n=28 Participants
18 Participants
n=10 Participants
2 Participants
n=38 Participants
10 Participants
n=33 Participants
3 Participants
n=100 Participants
59 Participants
n=48 Participants
Sex: Female, Male
Male
8 Participants
n=4 Participants
6 Participants
n=28 Participants
12 Participants
n=10 Participants
8 Participants
n=38 Participants
6 Participants
n=33 Participants
3 Participants
n=100 Participants
43 Participants
n=48 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
n=4 Participants
1 Participants
n=28 Participants
6 Participants
n=10 Participants
1 Participants
n=38 Participants
1 Participants
n=33 Participants
1 Participants
n=100 Participants
16 Participants
n=48 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
23 Participants
n=4 Participants
7 Participants
n=28 Participants
21 Participants
n=10 Participants
8 Participants
n=38 Participants
13 Participants
n=33 Participants
4 Participants
n=100 Participants
76 Participants
n=48 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=4 Participants
2 Participants
n=28 Participants
3 Participants
n=10 Participants
1 Participants
n=38 Participants
2 Participants
n=33 Participants
1 Participants
n=100 Participants
10 Participants
n=48 Participants
Race (NIH/OMB)
American Indian or Alaska Native
16 Participants
n=4 Participants
0 Participants
n=28 Participants
14 Participants
n=10 Participants
0 Participants
n=38 Participants
6 Participants
n=33 Participants
0 Participants
n=100 Participants
36 Participants
n=48 Participants
Race (NIH/OMB)
Asian
11 Participants
n=4 Participants
0 Participants
n=28 Participants
8 Participants
n=10 Participants
1 Participants
n=38 Participants
7 Participants
n=33 Participants
0 Participants
n=100 Participants
27 Participants
n=48 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=4 Participants
0 Participants
n=28 Participants
0 Participants
n=10 Participants
0 Participants
n=38 Participants
0 Participants
n=33 Participants
0 Participants
n=100 Participants
0 Participants
n=48 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=4 Participants
4 Participants
n=28 Participants
0 Participants
n=10 Participants
2 Participants
n=38 Participants
0 Participants
n=33 Participants
2 Participants
n=100 Participants
9 Participants
n=48 Participants
Race (NIH/OMB)
White
0 Participants
n=4 Participants
2 Participants
n=28 Participants
3 Participants
n=10 Participants
6 Participants
n=38 Participants
2 Participants
n=33 Participants
2 Participants
n=100 Participants
15 Participants
n=48 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=4 Participants
4 Participants
n=28 Participants
2 Participants
n=10 Participants
1 Participants
n=38 Participants
1 Participants
n=33 Participants
0 Participants
n=100 Participants
9 Participants
n=48 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=4 Participants
0 Participants
n=28 Participants
3 Participants
n=10 Participants
0 Participants
n=38 Participants
0 Participants
n=33 Participants
2 Participants
n=100 Participants
6 Participants
n=48 Participants

PRIMARY outcome

Timeframe: Nonserious AEs were collected through Day 14 post last intervention; SAEs through Day 28. Retinopathy of prematurity was assessed through discharge/transfer, up to 575 days after first treatment.

Population: Outcome measures are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while outcome analyses follow the protocol-defined grouping.

Description of safety of sildenafil in premature infants and assessed by frequency and incidence of adverse events (AEs) and serious adverse events. Both non-serious and serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.

Outcome measures

Outcome measures
Measure
Sildenafil Cohort 1
n=30 Participants
Within cohort 1 infants will be randomized using a 3:1 scheme to receive sildenafil or placebo. Infants randomized to sildenafil will receive 0.125 mg/kg daily every 8 hours intravenously (IV), or 0.25 mg/kg daily every 8 hours enterally for 28 days.
Sildenafil Cohort 2
n=30 Participants
Cohort 2 infants will receive sildenafil 0.5 mg/kg daily every 8 hours intravenously (IV) or 1 mg/kg daily every 8 hours enterally for 28 days.
Sildenafil Cohort 3
n=16 Participants
Cohort 3 infants will receive sildenafil 1 mg/kg daily every 8 hours intravenously (IV) or 2 mg/kg daily every 8 hours enterally for 28 days.
Placebo Total
n=26 Participants
Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use.
Safety as Determined by Adverse Event Experienced by Participants
71 Events
83 Events
53 Events
60 Events

SECONDARY outcome

Timeframe: Pharmacokinetic samples were collected after any dose following completion of 7 days of study drug administration through Day 28 of study drug administration.

Population: The number of participants analyzed for each pharmacokinetic outcome may differ from the overall number enrolled because only participants with valid data for that specific time point are included. Variations occur due to missed visits or assessments, early withdrawal, discontinuation, death, and/or missing data elements required to calculate volume of distribution. Pharmacokinetic outcomes only assessed in participants who received active study drug.

Volume of distribution was estimated for participants receiving active study drug using a population pharmacokinetic model. Pharmacokinetic samples were collected after approximately 7 days on study drug at protocol-defined time points (0-15 minutes, 30-60 minutes, 1-2 hours, 2-3 hours, 3-4 hours, 4-5 hours, within 15 minutes prior to the next dose, and 16-24 hours after the last dose) through 28 days of treatment.

Outcome measures

Outcome measures
Measure
Sildenafil Cohort 1
n=23 Participants
Within cohort 1 infants will be randomized using a 3:1 scheme to receive sildenafil or placebo. Infants randomized to sildenafil will receive 0.125 mg/kg daily every 8 hours intravenously (IV), or 0.25 mg/kg daily every 8 hours enterally for 28 days.
Sildenafil Cohort 2
n=18 Participants
Cohort 2 infants will receive sildenafil 0.5 mg/kg daily every 8 hours intravenously (IV) or 1 mg/kg daily every 8 hours enterally for 28 days.
Sildenafil Cohort 3
n=11 Participants
Cohort 3 infants will receive sildenafil 1 mg/kg daily every 8 hours intravenously (IV) or 2 mg/kg daily every 8 hours enterally for 28 days.
Placebo Total
Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use.
Volume of Distribution
3.01 L/kg
Interval 1.78 to 17.25
3.67 L/kg
Interval 1.62 to 24.52
3.07 L/kg
Interval 1.71 to 8.78
—

SECONDARY outcome

Timeframe: Pharmacokinetic samples were collected after any dose following completion of 7 days of study drug administration through Day 28 of study drug administration.

Population: The number of participants analyzed for each pharmacokinetic outcome may differ from the overall number enrolled because only participants with valid data for that specific time point are included. Variations occur due to missed visits or assessments, early withdrawal, discontinuation, death, and/or missing data elements required to calculate clearance. Pharmacokinetic outcomes only assessed in participants who received active study drug.

Clearance was estimated for participants receiving active study drug using a population pharmacokinetic model. Pharmacokinetic samples were collected after approximately 7 days on study drug at protocol-defined time points (0-15 minutes, 30-60 minutes, 1-2 hours, 2-3 hours, 3-4 hours, 4-5 hours, within 15 minutes prior to the next dose, and 16-24 hours after the last dose) through 28 days of treatment.

Outcome measures

Outcome measures
Measure
Sildenafil Cohort 1
n=23 Participants
Within cohort 1 infants will be randomized using a 3:1 scheme to receive sildenafil or placebo. Infants randomized to sildenafil will receive 0.125 mg/kg daily every 8 hours intravenously (IV), or 0.25 mg/kg daily every 8 hours enterally for 28 days.
Sildenafil Cohort 2
n=18 Participants
Cohort 2 infants will receive sildenafil 0.5 mg/kg daily every 8 hours intravenously (IV) or 1 mg/kg daily every 8 hours enterally for 28 days.
Sildenafil Cohort 3
n=11 Participants
Cohort 3 infants will receive sildenafil 1 mg/kg daily every 8 hours intravenously (IV) or 2 mg/kg daily every 8 hours enterally for 28 days.
Placebo Total
Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use.
Clearance
1.23 L/h/kg
Interval 0.46 to 4.24
1.54 L/h/kg
Interval 0.46 to 4.2
1.30 L/h/kg
Interval 0.41 to 6.73
—

SECONDARY outcome

Timeframe: Pharmacokinetic samples were collected after any dose following completion of 7 days of study drug administration through Day 28 of study drug administration.

Population: The number of participants analyzed for each pharmacokinetic outcome may differ from the overall number enrolled because only participants with valid data for that specific time point are included. Variations occur due to missed visits or assessments, early withdrawal, discontinuation, death, and/or missing data elements required to calculate half-life. Pharmacokinetic outcomes only assessed in participants who received active study drug.

Half-life was estimated for participants receiving active study drug using a population pharmacokinetic model. Pharmacokinetic samples were collected after approximately 7 days on study drug at protocol-defined time points (0-15 minutes, 30-60 minutes, 1-2 hours, 2-3 hours, 3-4 hours, 4-5 hours, within 15 minutes prior to the next dose, and 16-24 hours after the last dose) through 28 days of treatment.

Outcome measures

Outcome measures
Measure
Sildenafil Cohort 1
n=23 Participants
Within cohort 1 infants will be randomized using a 3:1 scheme to receive sildenafil or placebo. Infants randomized to sildenafil will receive 0.125 mg/kg daily every 8 hours intravenously (IV), or 0.25 mg/kg daily every 8 hours enterally for 28 days.
Sildenafil Cohort 2
n=18 Participants
Cohort 2 infants will receive sildenafil 0.5 mg/kg daily every 8 hours intravenously (IV) or 1 mg/kg daily every 8 hours enterally for 28 days.
Sildenafil Cohort 3
n=11 Participants
Cohort 3 infants will receive sildenafil 1 mg/kg daily every 8 hours intravenously (IV) or 2 mg/kg daily every 8 hours enterally for 28 days.
Placebo Total
Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use.
Half-Life
7.89 hours
Interval 6.14 to 11.19
7.87 hours
Interval 5.02 to 11.45
7.46 hours
Interval 6.62 to 12.14
—

SECONDARY outcome

Timeframe: Pharmacokinetic samples were collected after any dose following completion of 7 days of study drug administration through Day 28 of study drug administration.

Population: The number of participants analyzed for each pharmacokinetic outcome may differ from the overall number enrolled because only participants with valid data for that specific time point are included. Variations occur due to missed visits or assessments, early withdrawal, discontinuation, death, and/or missing data elements required to calculate area under the curve. Pharmacokinetic outcomes only assessed in participants who received active study drug.

Exposure, as measured by area under the plasma concentration-time curve (AUC), was estimated for participants receiving active study drug using a population pharmacokinetic model. Pharmacokinetic samples were collected after approximately 7 days on study drug at protocol-defined time points (0-15 minutes, 30-60 minutes, 1-2 hours, 2-3 hours, 3-4 hours, 4-5 hours, within 15 minutes prior to the next dose, and 16-24 hours after the last dose) through 28 days of treatment.

Outcome measures

Outcome measures
Measure
Sildenafil Cohort 1
n=23 Participants
Within cohort 1 infants will be randomized using a 3:1 scheme to receive sildenafil or placebo. Infants randomized to sildenafil will receive 0.125 mg/kg daily every 8 hours intravenously (IV), or 0.25 mg/kg daily every 8 hours enterally for 28 days.
Sildenafil Cohort 2
n=18 Participants
Cohort 2 infants will receive sildenafil 0.5 mg/kg daily every 8 hours intravenously (IV) or 1 mg/kg daily every 8 hours enterally for 28 days.
Sildenafil Cohort 3
n=11 Participants
Cohort 3 infants will receive sildenafil 1 mg/kg daily every 8 hours intravenously (IV) or 2 mg/kg daily every 8 hours enterally for 28 days.
Placebo Total
Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use.
Area Under the Curve (AUC)
174.0 ng*h/mL
Interval 46.94 to 452.13
610.50 ng*h/mL
Interval 245.86 to 2342.48
1196.78 ng*h/mL
Interval 254.74 to 1983.73
—

SECONDARY outcome

Timeframe: Pharmacokinetic samples were collected after any dose following completion of 7 days of study drug administration through Day 28 of study drug administration.

Population: The number of participants analyzed for each pharmacokinetic outcome may differ from the overall number enrolled because only participants with valid data for that specific time point are included. Variations occur due to missed visits or assessments, early withdrawal, discontinuation, death, and/or missing data elements required to calculate peak plasma concentration. Pharmacokinetic outcomes only assessed in participants who received active study drug.

Maximum plasma concentration (Cmax) was estimated for participants receiving active study drug using a population pharmacokinetic model. Pharmacokinetic samples were collected after approximately 7 days on study drug at protocol-defined time points (0-15 minutes, 30-60 minutes, 1-2 hours, 2-3 hours, 3-4 hours, 4-5 hours, within 15 minutes prior to the next dose, and 16-24 hours after the last dose) through 28 days of treatment.

Outcome measures

Outcome measures
Measure
Sildenafil Cohort 1
n=23 Participants
Within cohort 1 infants will be randomized using a 3:1 scheme to receive sildenafil or placebo. Infants randomized to sildenafil will receive 0.125 mg/kg daily every 8 hours intravenously (IV), or 0.25 mg/kg daily every 8 hours enterally for 28 days.
Sildenafil Cohort 2
n=18 Participants
Cohort 2 infants will receive sildenafil 0.5 mg/kg daily every 8 hours intravenously (IV) or 1 mg/kg daily every 8 hours enterally for 28 days.
Sildenafil Cohort 3
n=11 Participants
Cohort 3 infants will receive sildenafil 1 mg/kg daily every 8 hours intravenously (IV) or 2 mg/kg daily every 8 hours enterally for 28 days.
Placebo Total
Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use.
Peak Plasma Concentration
11.51 ng/mL
Interval 5.17 to 53.62
39.72 ng/mL
Interval 23.5 to 301.82
84.36 ng/mL
Interval 20.36 to 134.89
—

SECONDARY outcome

Timeframe: From the first day of study drug administration to the end of study drug administration, up to 28 days

Population: The number of participants analyzed at each study week may differ from the overall number enrolled because only participants with valid data for that specific time point are included. Variations occur due to missed visits, early termination, and/or missing data elements. Participants in Sildenafil Cohort 1 did not undergo a weaning period due to the low sildenafil doses administered and the minimal risk of rebound effects. No data were collected or analyzed for this outcome in Cohort 1.

Moderate-severe bronchopulmonary dysplasia (BPD) or death risk will be defined by the National Institute of Child Health and Human Development (NICHD) Neonatal Research Network (NRN) BPD outcome estimator. https://neonatal.rti.org/. The outcome measure is a reduction in moderate-severe BPD or death risk from day 1 of study drug to end of study drug administration. The BPD outcome estimator uses the following to calculate risk of BPD: Gestational age, Birth weight, Sex, Maternal Race/EthnicitylmPostnatal day, Ventilation type, Fraction of Inspired Oxygen The NICHD NRN BPD estimator calculates the risk of BPD (none, mild, moderate, severe) or death by postnatal day, as a percentage. For this protocol, outcomes will be dichotomized as none-mild vs. moderate-severe-death. Risk estimates will be recorded on days 7, 14, 21, and 28 of the study drug period, using the day closest to the participants postnatal age. For infants older than 28 days, the day 28 estimate will be applied.

Outcome measures

Outcome measures
Measure
Sildenafil Cohort 1
n=30 Participants
Within cohort 1 infants will be randomized using a 3:1 scheme to receive sildenafil or placebo. Infants randomized to sildenafil will receive 0.125 mg/kg daily every 8 hours intravenously (IV), or 0.25 mg/kg daily every 8 hours enterally for 28 days.
Sildenafil Cohort 2
n=30 Participants
Cohort 2 infants will receive sildenafil 0.5 mg/kg daily every 8 hours intravenously (IV) or 1 mg/kg daily every 8 hours enterally for 28 days.
Sildenafil Cohort 3
n=16 Participants
Cohort 3 infants will receive sildenafil 1 mg/kg daily every 8 hours intravenously (IV) or 2 mg/kg daily every 8 hours enterally for 28 days.
Placebo Total
n=26 Participants
Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use.
Change in Moderate-severe BPD or Death
Risk of moderate BPD, severe BPD or Death (%) at study week 0
66.3 Percent probability of risk BPD or death
Standard Deviation 20.1
68.4 Percent probability of risk BPD or death
Standard Deviation 14.6
55.2 Percent probability of risk BPD or death
Standard Deviation 25.2
70.9 Percent probability of risk BPD or death
Standard Deviation 21.3
Change in Moderate-severe BPD or Death
Risk of moderate BPD, severe BPD or Death (%) at study week 1
66.0 Percent probability of risk BPD or death
Standard Deviation 22.5
60.2 Percent probability of risk BPD or death
Standard Deviation 21.4
47.2 Percent probability of risk BPD or death
Standard Deviation 26.1
66.0 Percent probability of risk BPD or death
Standard Deviation 66.8
Change in Moderate-severe BPD or Death
Risk of moderate BPD, severe BPD or Death (%) at study week 2
62.1 Percent probability of risk BPD or death
Standard Deviation 21.1
61.3 Percent probability of risk BPD or death
Standard Deviation 21.0
53.0 Percent probability of risk BPD or death
Standard Deviation 30.1
58.4 Percent probability of risk BPD or death
Standard Deviation 19.7
Change in Moderate-severe BPD or Death
Risk of moderate BPD, severe BPD or Death (%) at study week 3
56.2 Percent probability of risk BPD or death
Standard Deviation 26.2
58.5 Percent probability of risk BPD or death
Standard Deviation 61.0
49.9 Percent probability of risk BPD or death
Standard Deviation 49.1
61.1 Percent probability of risk BPD or death
Standard Deviation 64.3
Change in Moderate-severe BPD or Death
Risk of moderate BPD, severe BPD or Death (%) at study week 4
45.7 Percent probability of risk BPD or death
Standard Deviation 30.3
58.4 Percent probability of risk BPD or death
Standard Deviation 22.6
45.6 Percent probability of risk BPD or death
Standard Deviation 29.9
55.9 Percent probability of risk BPD or death
Standard Deviation 19.7
Change in Moderate-severe BPD or Death
Risk of moderate BPD, severe BPD or Death (%) at Weaning Period days 1-6
—
56.5 Percent probability of risk BPD or death
Standard Deviation 27.3
44.5 Percent probability of risk BPD or death
Standard Deviation 33.5
43.4 Percent probability of risk BPD or death
Standard Deviation 22.4

Adverse Events

Sildenafil Cohort 1

Serious events: 3 serious events
Other events: 27 other events
Deaths: 1 deaths

Sildenafil Cohort 2

Serious events: 8 serious events
Other events: 27 other events
Deaths: 1 deaths

Sildenafil Cohort 3

Serious events: 2 serious events
Other events: 14 other events
Deaths: 2 deaths

Placebo Total

Serious events: 2 serious events
Other events: 21 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Sildenafil Cohort 1
n=30 participants at risk
Within cohort 1 infants will be randomized using a 3:1 scheme to receive sildenafil or placebo. Infants randomized to sildenafil will receive 0.125 mg/kg daily every 8 hours intravenously (IV), or 0.25 mg/kg daily every 8 hours enterally for 28 days.
Sildenafil Cohort 2
n=30 participants at risk
Cohort 2 infants will receive sildenafil 0.5 mg/kg daily every 8 hours intravenously (IV) or 1 mg/kg daily every 8 hours enterally for 28 days.
Sildenafil Cohort 3
n=16 participants at risk
Cohort 3 infants will receive sildenafil 1 mg/kg daily every 8 hours intravenously (IV) or 2 mg/kg daily every 8 hours enterally for 28 days.
Placebo Total
n=26 participants at risk
Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use.
Eye disorders
Retinopathy of prematurity
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Gastrointestinal disorders
Necrotising colitis
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.7%
2/30 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
12.5%
2/16 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Group B streptococcus neonatal sepsis
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Metapneumovirus infection
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Pneumonia
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Pneumonia cytomegaloviral
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Serratia sepsis
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Nervous system disorders
Seizure
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Respiratory, thoracic and mediastinal disorders
Apnoea
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Vascular disorders
Hypotension
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.

Other adverse events

Other adverse events
Measure
Sildenafil Cohort 1
n=30 participants at risk
Within cohort 1 infants will be randomized using a 3:1 scheme to receive sildenafil or placebo. Infants randomized to sildenafil will receive 0.125 mg/kg daily every 8 hours intravenously (IV), or 0.25 mg/kg daily every 8 hours enterally for 28 days.
Sildenafil Cohort 2
n=30 participants at risk
Cohort 2 infants will receive sildenafil 0.5 mg/kg daily every 8 hours intravenously (IV) or 1 mg/kg daily every 8 hours enterally for 28 days.
Sildenafil Cohort 3
n=16 participants at risk
Cohort 3 infants will receive sildenafil 1 mg/kg daily every 8 hours intravenously (IV) or 2 mg/kg daily every 8 hours enterally for 28 days.
Placebo Total
n=26 participants at risk
Infants randomized to the placebo treatment group will receive the equivalent of dextrose 5% (sugar water) to be administered IV or enteral use.
Blood and lymphatic system disorders
Anaemia
10.0%
3/30 • Number of events 3 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.2%
1/16 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
11.5%
3/26 • Number of events 3 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Blood and lymphatic system disorders
Anaemia neonatal
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.7%
2/30 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
12.5%
2/16 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.7%
2/30 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Cardiac disorders
Bradycardia
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.7%
2/30 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Cardiac disorders
Bradycardia neonatal
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.2%
1/16 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Cardiac disorders
Right ventricular hypertension
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Cardiac disorders
Tachycardia
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Congenital, familial and genetic disorders
Hydrocele
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Congenital, familial and genetic disorders
Left-to-right cardiac shunt
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Congenital, familial and genetic disorders
Patent ductus arteriosus
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.7%
2/30 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
25.0%
4/16 • Number of events 4 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Congenital, familial and genetic disorders
Ventricular septal defect
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.2%
1/16 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Ear and labyrinth disorders
Otorrhoea
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Endocrine disorders
Adrenal insufficiency
6.7%
2/30 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Endocrine disorders
Adrenocorticotropic hormone deficiency
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Eye disorders
Retinopathy of prematurity
20.0%
6/30 • Number of events 6 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
16.7%
5/30 • Number of events 5 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
43.8%
7/16 • Number of events 7 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
23.1%
6/26 • Number of events 6 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Gastrointestinal disorders
Abdominal distension
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Gastrointestinal disorders
Constipation
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Gastrointestinal disorders
Gastrooesophageal reflux disease
10.0%
3/30 • Number of events 3 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Gastrointestinal disorders
Inguinal hernia
6.7%
2/30 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
7.7%
2/26 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Gastrointestinal disorders
Necrotising colitis
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
10.0%
3/30 • Number of events 3 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
18.8%
3/16 • Number of events 3 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Gastrointestinal disorders
Umbilical hernia
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.7%
2/30 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.2%
1/16 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
General disorders
Injection site extravasation
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.7%
2/30 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Bacterial disease carrier
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Candida infection
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Conjunctivitis
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.2%
1/16 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Ear infection
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Enterobacter pneumonia
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.2%
1/16 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Fungal skin infection
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Group B streptococcus neonatal sepsis
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Klebsiella infection
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Metapneumovirus infection
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Otitis media
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.2%
1/16 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Pneumonia
10.0%
3/30 • Number of events 3 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.2%
1/16 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Pneumonia cytomegaloviral
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Pneumonia klebsiella
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Sepsis
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
13.3%
4/30 • Number of events 5 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.2%
1/16 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
11.5%
3/26 • Number of events 3 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Serratia sepsis
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Staphylococcal infection
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.2%
1/16 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Staphylococcal sepsis
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.2%
1/16 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Tracheitis
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Urinary tract infection
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
12.5%
2/16 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Infections and infestations
Urinary tract infection neonatal
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.2%
1/16 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Injury, poisoning and procedural complications
Skin abrasion
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.2%
1/16 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Investigations
Blood alkaline phosphatase increased
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Investigations
Blood phosphorus increased
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.2%
1/16 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Investigations
Cardiac murmur
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Investigations
Electrocardiogram T wave abnormal
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Investigations
Fecal occult blood positive
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Investigations
Oxygen consumption increased
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Metabolism and nutrition disorders
Carnitine deficiency
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Metabolism and nutrition disorders
Feeding disorder
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Metabolism and nutrition disorders
Feeding intolerance
10.0%
3/30 • Number of events 3 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Metabolism and nutrition disorders
Hyperkalaemia
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Metabolism and nutrition disorders
Hypernatraemia
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Metabolism and nutrition disorders
Hypoalbuminaemia
10.0%
3/30 • Number of events 3 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
7.7%
2/26 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Metabolism and nutrition disorders
Hypochloraemia
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.2%
1/16 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Metabolism and nutrition disorders
Hypokalaemia
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.7%
2/30 • Number of events 3 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Metabolism and nutrition disorders
Hyponatraemia
30.0%
9/30 • Number of events 9 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
10.0%
3/30 • Number of events 3 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
12.5%
2/16 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
15.4%
4/26 • Number of events 4 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Metabolism and nutrition disorders
Hypophosphataemia
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Metabolism and nutrition disorders
Malnutrition
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.2%
1/16 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Metabolism and nutrition disorders
Metabolic acidosis
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
7.7%
2/26 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Metabolism and nutrition disorders
Vitamin D deficiency
10.0%
3/30 • Number of events 3 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Musculoskeletal and connective tissue disorders
Osteopenia
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.7%
2/30 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
25.0%
4/16 • Number of events 4 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
6.7%
2/30 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.2%
1/16 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Nervous system disorders
Encephalomalacia
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Nervous system disorders
Intraventricular haemorrhage neonatal
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.7%
2/30 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.2%
1/16 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Nervous system disorders
Periventricular leukomalacia
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Nervous system disorders
Posthaemorrhagic hydrocephalus
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.2%
1/16 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Nervous system disorders
Seizure
10.0%
3/30 • Number of events 3 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Renal and urinary disorders
Hydronephrosis
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Renal and urinary disorders
Nephrocalcinosis
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.2%
1/16 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Renal and urinary disorders
Renal impairment
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Reproductive system and breast disorders
Erection increased
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.7%
2/30 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Respiratory, thoracic and mediastinal disorders
Apnoea
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
10.0%
3/30 • Number of events 3 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
25.0%
4/16 • Number of events 4 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
11.5%
3/26 • Number of events 3 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Respiratory, thoracic and mediastinal disorders
Chronic respiratory disease
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.7%
2/30 • Number of events 4 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Respiratory, thoracic and mediastinal disorders
Hypoxia
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Respiratory, thoracic and mediastinal disorders
Infantile apnoea
6.7%
2/30 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
7.7%
2/26 • Number of events 2 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Respiratory, thoracic and mediastinal disorders
Respiratory distress
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
6.2%
1/16 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Respiratory, thoracic and mediastinal disorders
Stridor
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Skin and subcutaneous tissue disorders
Dermatitis diaper
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
10.0%
3/30 • Number of events 3 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Skin and subcutaneous tissue disorders
Skin disorder
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.8%
1/26 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Skin and subcutaneous tissue disorders
Skin irritation
0.00%
0/30 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
3.3%
1/30 • Number of events 1 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/16 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
0.00%
0/26 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
Vascular disorders
Hypotension
6.7%
2/30 • Number of events 4 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
13.3%
4/30 • Number of events 5 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
25.0%
4/16 • Number of events 4 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.
11.5%
3/26 • Number of events 4 • Non-serious adverse events were collected from the time of informed consent through Day 14 after the last study intervention. Serious adverse events were additionally collected through 28 days after the last study intervention. Retinopathy of prematurity (ROP), whether serious or non-serious, was collected through hospital discharge or transfer; hospitalization duration varied based on clinical course, the longest duration was up to 575 days.
Safety events are presented by treatment group as defined in the protocol, which specifies 4 planned groups: 3 sildenafil groups and 1 combined placebo group. Participant flow, however, is shown by randomization cohort to provide transparency regarding enrollment and completion by cohort. Placebo participants were randomized separately within each cohort, displaying them individually in participant flow reflects the study design, while safety analyses follow the protocol-defined grouping.

Additional Information

Talaya McCright-Gill

Duke University

Phone: 321-566-3091

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place