Trial Outcomes & Findings for Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Preterm Neonates 26 to 28 Weeks PMA (NCT NCT02528318)
NCT ID: NCT02528318
Last Updated: 2019-07-23
Results Overview
Number of Participants with adverse events that were experienced during the initial study treatment
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Randomization to 24 Hours Post Randomization
Results posted on
2019-07-23
Participant Flow
Participant milestones
| Measure |
50 mg/kg
Lucinactant for inhalation 50 mg total phospholipids (TPL)/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
75 mg/kg
Lucinactant for inhalation 75 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
100 mg/kg
Lucinactant for inhalation 100 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
150 mg/kg
Lucinactant for inhalation 150 mg TPL/kg with nCPAP
1 repeat dose will be allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
nCPAP Alone
nCPAP therapy alone
nCPAP alone: nCPAP therapy
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
0
|
24
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
0
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Preterm Neonates 26 to 28 Weeks PMA
Baseline characteristics by cohort
| Measure |
50 mg/kg
n=8 Participants
Lucinactant for inhalation 50 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
75 mg/kg
n=8 Participants
Lucinactant for inhalation 75 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
100 mg/kg
n=8 Participants
Lucinactant for inhalation 100 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
150 mg/kg
Lucinactant for inhalation 150 mg TPL/kg with nCPAP
1 repeat dose will be allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
nCPAP Alone
n=24 Participants
nCPAP therapy alone
nCPAP alone: nCPAP therapy
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
48 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Customized
Gestational Age
|
27.6 weeks
STANDARD_DEVIATION 0.61 • n=5 Participants
|
27.2 weeks
STANDARD_DEVIATION 1.06 • n=7 Participants
|
27.2 weeks
STANDARD_DEVIATION 0.84 • n=5 Participants
|
—
|
27.5 weeks
STANDARD_DEVIATION 0.76 • n=21 Participants
|
27.4 weeks
STANDARD_DEVIATION 0.84 • n=10 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
—
|
8 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
—
|
16 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
—
|
7 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
—
|
17 Participants
n=21 Participants
|
35 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
—
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
—
|
20 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
—
|
2 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
—
|
8 participants
n=21 Participants
|
16 participants
n=10 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
—
|
12 participants
n=21 Participants
|
26 participants
n=10 Participants
|
|
Region of Enrollment
Poland
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
3 participants
n=21 Participants
|
5 participants
n=10 Participants
|
|
Region of Enrollment
Chile
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
1 participants
n=21 Participants
|
1 participants
n=10 Participants
|
|
Birth Weight
|
1052 g
STANDARD_DEVIATION 174.7 • n=5 Participants
|
855 g
STANDARD_DEVIATION 84.6 • n=7 Participants
|
839 g
STANDARD_DEVIATION 224.9 • n=5 Participants
|
—
|
1005 g
STANDARD_DEVIATION 238.8 • n=21 Participants
|
960 g
STANDARD_DEVIATION 209.4 • n=10 Participants
|
|
Apgar Score at One Minute
|
5.4 Scores on a scale
n=5 Participants
|
5.5 Scores on a scale
n=7 Participants
|
6.4 Scores on a scale
n=5 Participants
|
—
|
5.8 Scores on a scale
n=21 Participants
|
5.8 Scores on a scale
n=10 Participants
|
|
Apgar Score at Five Minutes
|
7.8 Scores on a scale
n=5 Participants
|
6.4 Scores on a scale
n=7 Participants
|
8.1 Scores on a scale
n=5 Participants
|
—
|
7.9 Scores on a scale
n=21 Participants
|
7.7 Scores on a scale
n=10 Participants
|
PRIMARY outcome
Timeframe: Randomization to 24 Hours Post RandomizationPopulation: Safety Population. Peri-dosing events are events that occur during study treatment. Since this was an open-label study, no peri-dosing events were recorded for nCPAP alone. Any adverse events that occurred during the corresponding time for nCPAP alone were recorded as adverse events but not peri-dosing events.
Number of Participants with adverse events that were experienced during the initial study treatment
Outcome measures
| Measure |
50 mg/kg
n=8 Participants
Lucinactant for inhalation 50 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
75 mg/kg
n=8 Participants
Lucinactant for inhalation 75 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
100 mg/kg
n=8 Participants
Lucinactant for inhalation 100 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
150 mg/kg
Lucinactant for inhalation 150 mg TPL/kg with nCPAP
1 repeat dose will be allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
nCPAP Alone
nCPAP therapy alone
nCPAP alone: nCPAP therapy
|
|---|---|---|---|---|---|
|
Number of Participants With Peri-Dosing Adverse Events - Initial Dose
Bradycardia
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Peri-Dosing Adverse Events - Initial Dose
Desaturation
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Peri-Dosing Adverse Events - Initial Dose
Gagging/regurgitation
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Peri-Dosing Adverse Events - Initial Dose
Apnea
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Peri-Dosing Adverse Events - Initial Dose
Pallor
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 7 daysPopulation: This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
Number of participants with air leak (includes pneumothorax, pulmonary interstitial emphysema (PIE), pneumomediastinum, pneumopericardium, subcutaneous emphysema)
Outcome measures
| Measure |
50 mg/kg
n=8 Participants
Lucinactant for inhalation 50 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
75 mg/kg
n=8 Participants
Lucinactant for inhalation 75 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
100 mg/kg
n=8 Participants
Lucinactant for inhalation 100 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
150 mg/kg
Lucinactant for inhalation 150 mg TPL/kg with nCPAP
1 repeat dose will be allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
nCPAP Alone
n=24 Participants
nCPAP therapy alone
nCPAP alone: nCPAP therapy
|
|---|---|---|---|---|---|
|
Number of Participants With Air Leak
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
4 Participants
|
SECONDARY outcome
Timeframe: Randomization to 72 Hours Post RandomizationPopulation: Intent-to-Treat Population
Number of participants with worsening in one of 12 respiratory status criteria through 72 hours post randomization (need for additional surfactant therapy, desaturation \< 80%, heart rate \< 100 bpm, sustained fraction of inspired oxygen (FiO2) \> 0.50, arterial carbon dioxide (PCO2) \> 65 mmHg, sustained apnea, persistent arterial pH \< 7.2, intubation for any reason, nCPAP \> 7 cmH2O, initiation of intermittent positive pressure ventilation, death, principal investigator determination of worsening status)
Outcome measures
| Measure |
50 mg/kg
n=8 Participants
Lucinactant for inhalation 50 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
75 mg/kg
n=8 Participants
Lucinactant for inhalation 75 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
100 mg/kg
n=8 Participants
Lucinactant for inhalation 100 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
150 mg/kg
Lucinactant for inhalation 150 mg TPL/kg with nCPAP
1 repeat dose will be allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
nCPAP Alone
n=24 Participants
nCPAP therapy alone
nCPAP alone: nCPAP therapy
|
|---|---|---|---|---|---|
|
Number of Participants With Worsening of Respiratory Status Criteria
|
6 Participants
|
7 Participants
|
6 Participants
|
—
|
18 Participants
|
SECONDARY outcome
Timeframe: Randomization to 36 weeks PMAPopulation: Intent-to-Treat Population
Number of participants with bronchopulmonary dysplasia (BPD) and number of participants alive and without BPD at 36 weeks post-menstrual age (PMA)
Outcome measures
| Measure |
50 mg/kg
n=8 Participants
Lucinactant for inhalation 50 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
75 mg/kg
n=8 Participants
Lucinactant for inhalation 75 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
100 mg/kg
n=8 Participants
Lucinactant for inhalation 100 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
150 mg/kg
Lucinactant for inhalation 150 mg TPL/kg with nCPAP
1 repeat dose will be allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
nCPAP Alone
n=24 Participants
nCPAP therapy alone
nCPAP alone: nCPAP therapy
|
|---|---|---|---|---|---|
|
Bronchopulmonary Dysplasia
BPD
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
6 Participants
|
|
Bronchopulmonary Dysplasia
Alive and Without BPD
|
7 Participants
|
7 Participants
|
8 Participants
|
—
|
18 Participants
|
SECONDARY outcome
Timeframe: Randomization to 72 Hours Post RandomizationPopulation: Intent-to-Treat Population
Participants who required intubation for mechanical ventilation or surfactant administration were defined as having failed nCPAP
Outcome measures
| Measure |
50 mg/kg
n=8 Participants
Lucinactant for inhalation 50 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
75 mg/kg
n=8 Participants
Lucinactant for inhalation 75 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
100 mg/kg
n=8 Participants
Lucinactant for inhalation 100 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
150 mg/kg
Lucinactant for inhalation 150 mg TPL/kg with nCPAP
1 repeat dose will be allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
nCPAP Alone
n=24 Participants
nCPAP therapy alone
nCPAP alone: nCPAP therapy
|
|---|---|---|---|---|---|
|
Number of Participants With Nasal Continuous Positive Airway Pressure (nCPAP) Failure
|
5 Participants
|
7 Participants
|
5 Participants
|
—
|
16 Participants
|
SECONDARY outcome
Timeframe: Randomization to 36 weeks PMAPopulation: Safety Population
Number of participants who died during the study
Outcome measures
| Measure |
50 mg/kg
n=8 Participants
Lucinactant for inhalation 50 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
75 mg/kg
n=8 Participants
Lucinactant for inhalation 75 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
100 mg/kg
n=8 Participants
Lucinactant for inhalation 100 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
150 mg/kg
Lucinactant for inhalation 150 mg TPL/kg with nCPAP
1 repeat dose will be allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
nCPAP Alone
n=24 Participants
nCPAP therapy alone
nCPAP alone: nCPAP therapy
|
|---|---|---|---|---|---|
|
Death
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Randomization to 72 hours post randomizationPopulation: Safety Population
Observed and change from baseline measurements for fraction of inspired oxygen (FiO2). Values represent the amount (fraction) of oxygen in the air the participant inspires; the values themselves do not have units. The normal amount of oxygen in air ("room air") is 21%, or 0.21.
Outcome measures
| Measure |
50 mg/kg
n=8 Participants
Lucinactant for inhalation 50 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
75 mg/kg
n=8 Participants
Lucinactant for inhalation 75 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
100 mg/kg
n=8 Participants
Lucinactant for inhalation 100 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
150 mg/kg
Lucinactant for inhalation 150 mg TPL/kg with nCPAP
1 repeat dose will be allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
nCPAP Alone
n=24 Participants
nCPAP therapy alone
nCPAP alone: nCPAP therapy
|
|---|---|---|---|---|---|
|
FiO2
Baseline (Randomization)
|
0.31 Fraction of oxygen in inspired air
Standard Deviation 0.058
|
0.33 Fraction of oxygen in inspired air
Standard Deviation 0.071
|
0.37 Fraction of oxygen in inspired air
Standard Deviation 0.072
|
—
|
0.32 Fraction of oxygen in inspired air
Standard Deviation 0.061
|
|
FiO2
60 Minutes Post Randomization - Observed
|
0.31 Fraction of oxygen in inspired air
Standard Deviation 0.064
|
0.35 Fraction of oxygen in inspired air
Standard Deviation 0.063
|
0.37 Fraction of oxygen in inspired air
Standard Deviation 0.090
|
—
|
0.34 Fraction of oxygen in inspired air
Standard Deviation 0.159
|
|
FiO2
60 Minutes Post Randomizati - Change from Baseline
|
0.01 Fraction of oxygen in inspired air
Standard Deviation 0.010
|
0.02 Fraction of oxygen in inspired air
Standard Deviation 0.024
|
0.01 Fraction of oxygen in inspired air
Standard Deviation 0.044
|
—
|
0.01 Fraction of oxygen in inspired air
Standard Deviation 0.162
|
|
FiO2
3 Hours Post Randomization - Observed
|
0.37 Fraction of oxygen in inspired air
Standard Deviation 0.191
|
0.37 Fraction of oxygen in inspired air
Standard Deviation 0.120
|
0.37 Fraction of oxygen in inspired air
Standard Deviation 0.107
|
—
|
0.29 Fraction of oxygen in inspired air
Standard Deviation 0.082
|
|
FiO2
3 Hours Post Randomizaiton - Change from Baseline
|
0.06 Fraction of oxygen in inspired air
Standard Deviation 0.154
|
0.00 Fraction of oxygen in inspired air
Standard Deviation 0.066
|
0.00 Fraction of oxygen in inspired air
Standard Deviation 0.047
|
—
|
-0.03 Fraction of oxygen in inspired air
Standard Deviation 0.082
|
|
FiO2
12 Hours Post Randomization - Observed
|
0.30 Fraction of oxygen in inspired air
Standard Deviation 0.114
|
0.30 Fraction of oxygen in inspired air
Standard Deviation 0.117
|
0.30 Fraction of oxygen in inspired air
Standard Deviation 0.068
|
—
|
0.33 Fraction of oxygen in inspired air
Standard Deviation 0.181
|
|
FiO2
12 Hours Post Randomization - Change from Baseline
|
-0.02 Fraction of oxygen in inspired air
Standard Deviation 0.137
|
-0.07 Fraction of oxygen in inspired air
Standard Deviation 0.074
|
-0.08 Fraction of oxygen in inspired air
Standard Deviation 0.090
|
—
|
0.00 Fraction of oxygen in inspired air
Standard Deviation 0.172
|
|
FiO2
24 Hours Post Randomized - Observed
|
0.28 Fraction of oxygen in inspired air
Standard Deviation 0.093
|
0.25 Fraction of oxygen in inspired air
Standard Deviation 0.044
|
0.28 Fraction of oxygen in inspired air
Standard Deviation 0.077
|
—
|
0.29 Fraction of oxygen in inspired air
Standard Deviation 0.143
|
|
FiO2
24 Hours Post Randomized - Change from Baseline
|
-0.03 Fraction of oxygen in inspired air
Standard Deviation 0.072
|
-0.09 Fraction of oxygen in inspired air
Standard Deviation 0.046
|
-0.08 Fraction of oxygen in inspired air
Standard Deviation 0.105
|
—
|
-0.04 Fraction of oxygen in inspired air
Standard Deviation 0.140
|
|
FiO2
48 Hours Post Randomized - Observed
|
0.28 Fraction of oxygen in inspired air
Standard Deviation 0.058
|
0.24 Fraction of oxygen in inspired air
Standard Deviation 0.038
|
0.29 Fraction of oxygen in inspired air
Standard Deviation 0.071
|
—
|
0.31 Fraction of oxygen in inspired air
Standard Deviation 0.188
|
|
FiO2
48 Hours Post Randomized - Change from Baseline
|
-0.03 Fraction of oxygen in inspired air
Standard Deviation 0.083
|
-0.09 Fraction of oxygen in inspired air
Standard Deviation 0.075
|
-0.09 Fraction of oxygen in inspired air
Standard Deviation 0.091
|
—
|
-0.02 Fraction of oxygen in inspired air
Standard Deviation 0.191
|
|
FiO2
72 Hours Post Randomized - Observed
|
0.30 Fraction of oxygen in inspired air
Standard Deviation 0.105
|
0.23 Fraction of oxygen in inspired air
Standard Deviation 0.023
|
0.25 Fraction of oxygen in inspired air
Standard Deviation 0.050
|
—
|
0.27 Fraction of oxygen in inspired air
Standard Deviation 0.119
|
|
FiO2
72 Hours Post Randomized - Change from Baseline
|
-0.02 Fraction of oxygen in inspired air
Standard Deviation 0.133
|
-0.10 Fraction of oxygen in inspired air
Standard Deviation 0.071
|
-0.12 Fraction of oxygen in inspired air
Standard Deviation 0.066
|
—
|
-0.05 Fraction of oxygen in inspired air
Standard Deviation 0.133
|
SECONDARY outcome
Timeframe: Randomization to 36 weeks PMAPopulation: Safety Population
Number of participants with pre-specified common complications of prematurity.
Outcome measures
| Measure |
50 mg/kg
n=8 Participants
Lucinactant for inhalation 50 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
75 mg/kg
n=8 Participants
Lucinactant for inhalation 75 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
100 mg/kg
n=8 Participants
Lucinactant for inhalation 100 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
150 mg/kg
Lucinactant for inhalation 150 mg TPL/kg with nCPAP
1 repeat dose will be allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
nCPAP Alone
n=24 Participants
nCPAP therapy alone
nCPAP alone: nCPAP therapy
|
|---|---|---|---|---|---|
|
Number of Participants With Complications of Prematurity
Patent Ductus Arteriosus
|
3 Participants
|
3 Participants
|
4 Participants
|
—
|
10 Participants
|
|
Number of Participants With Complications of Prematurity
Subjects with Any Complication
|
8 Participants
|
7 Participants
|
7 Participants
|
—
|
22 Participants
|
|
Number of Participants With Complications of Prematurity
Acquired Sepsis
|
2 Participants
|
2 Participants
|
2 Participants
|
—
|
5 Participants
|
|
Number of Participants With Complications of Prematurity
Apnea
|
8 Participants
|
5 Participants
|
6 Participants
|
—
|
19 Participants
|
|
Number of Participants With Complications of Prematurity
Cystic Periventricular Leukomalcia
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Participants With Complications of Prematurity
Pulmonary Hemorrhage
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
1 Participants
|
|
Number of Participants With Complications of Prematurity
Intraventicular Hemorrhage
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
4 Participants
|
|
Number of Participants With Complications of Prematurity
Necrotizing Enterocolitis
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
1 Participants
|
|
Number of Participants With Complications of Prematurity
Retinopathy of Prematurity
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Randomization to 72 Hours Post RandomizationPopulation: Intent-to-Treat Without Treatment Interruption
Number of subjects requiring mechanical ventilation or surfactant administration (nCPAP failure) but did not have a treatment interruption
Outcome measures
| Measure |
50 mg/kg
n=7 Participants
Lucinactant for inhalation 50 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
75 mg/kg
n=3 Participants
Lucinactant for inhalation 75 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
100 mg/kg
n=6 Participants
Lucinactant for inhalation 100 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
150 mg/kg
Lucinactant for inhalation 150 mg TPL/kg with nCPAP
1 repeat dose will be allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
nCPAP Alone
n=24 Participants
nCPAP therapy alone
nCPAP alone: nCPAP therapy
|
|---|---|---|---|---|---|
|
nCPAP Failure Without Treatment Interruptions
|
4 Participants
|
3 Participants
|
3 Participants
|
—
|
16 Participants
|
Adverse Events
50 mg/kg
Serious events: 4 serious events
Other events: 8 other events
Deaths: 1 deaths
75 mg/kg
Serious events: 3 serious events
Other events: 8 other events
Deaths: 1 deaths
100 mg/kg
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
150 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
nCPAP Alone
Serious events: 6 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
50 mg/kg
n=8 participants at risk
Lucinactant for inhalation 50 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
75 mg/kg
n=8 participants at risk
Lucinactant for inhalation 75 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
100 mg/kg
n=8 participants at risk
Lucinactant for inhalation 100 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
150 mg/kg
Lucinactant for inhalation 150 mg TPL/kg with nCPAP
1 repeat dose will be allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
nCPAP Alone
n=24 participants at risk
nCPAP therapy alone
nCPAP alone: nCPAP therapy
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia neonatal
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Gastrointestinal disorders
Intestinal perforation
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Infections and infestations
Sepsis neonatal
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Injury, poisoning and procedural complications
Hepatic haemorrhage
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Injury, poisoning and procedural complications
Laryngeal injury
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Pregnancy, puerperium and perinatal conditions
Intraventricular haemorrhage neonatal
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
25.0%
2/8 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Pregnancy, puerperium and perinatal conditions
Necrotising enterocolitis neonatal
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal respiratory distress syndrome
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
25.0%
2/8 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal respiratory failure
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea neonatal
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
8.3%
2/24 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Vascular disorders
Shock
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
Other adverse events
| Measure |
50 mg/kg
n=8 participants at risk
Lucinactant for inhalation 50 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
75 mg/kg
n=8 participants at risk
Lucinactant for inhalation 75 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
100 mg/kg
n=8 participants at risk
Lucinactant for inhalation 100 mg TPL/kg with nCPAP
1 repeat dose allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
150 mg/kg
Lucinactant for inhalation 150 mg TPL/kg with nCPAP
1 repeat dose will be allowed if repeat dosing criteria are met.
Lucinactant for inhalation: Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
|
nCPAP Alone
n=24 participants at risk
nCPAP therapy alone
nCPAP alone: nCPAP therapy
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Blood and lymphatic system disorders
Anaemia neonatal
|
75.0%
6/8 • Number of events 6 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
50.0%
4/8 • Number of events 6 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
25.0%
2/8 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
50.0%
12/24 • Number of events 16 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Blood and lymphatic system disorders
Bandaemia
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
8.3%
2/24 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
2/8 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
25.0%
2/8 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
16.7%
4/24 • Number of events 4 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Congenital, familial and genetic disorders
Cardiac septal defect
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
37.5%
3/8 • Number of events 3 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
37.5%
3/8 • Number of events 3 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
50.0%
4/8 • Number of events 4 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
41.7%
10/24 • Number of events 10 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Gastrointestinal disorders
Constipation
|
62.5%
5/8 • Number of events 13 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
8.3%
2/24 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Gastrointestinal disorders
Gastric hypomotility
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Gastrointestinal disorders
Haematemesis
|
25.0%
2/8 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
8.3%
2/24 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Gastrointestinal disorders
Salivary hypersection
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
General disorders
Endotracheal intubation complication
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
General disorders
Face oedema
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
General disorders
Hypothermia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
8.3%
2/24 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
General disorders
Oedema
|
37.5%
3/8 • Number of events 3 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
General disorders
Pain
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
3/24 • Number of events 3 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
25.0%
2/8 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Infections and infestations
Nosocomial infection
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
3/24 • Number of events 3 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Infections and infestations
Sepsis neonatal
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
16.7%
4/24 • Number of events 4 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Infections and infestations
Septic shock
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Injury, poisoning and procedural complications
Blister
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Injury, poisoning and procedural complications
Ear abrasion
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Injury, poisoning and procedural complications
Infusion site extravasation
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Injury, poisoning and procedural complications
Laceration
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Injury, poisoning and procedural complications
Tracheal injury
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Investigations
Anticonvulsant drug level above therapeutic level
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Investigations
Blood urea increased
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Investigations
Cardiac murmur
|
25.0%
2/8 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Investigations
Coagulation time prolonged
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Investigations
Oxygen saturation decreased
|
25.0%
2/8 • Number of events 3 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
50.0%
4/8 • Number of events 6 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
75.0%
6/8 • Number of events 11 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
37.5%
9/24 • Number of events 11 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Investigations
PO2 increased
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Investigations
Reticulocyte count increased
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Feeding intolerance
|
37.5%
3/8 • Number of events 3 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
3/24 • Number of events 3 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
25.0%
2/8 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
3/24 • Number of events 5 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
8.3%
2/24 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
25.0%
2/8 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
16.7%
4/24 • Number of events 5 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
8.3%
2/24 • Number of events 3 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
3/24 • Number of events 3 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
8.3%
2/24 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
25.0%
2/8 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
3/24 • Number of events 4 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
3/24 • Number of events 3 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
25.0%
2/8 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
3/24 • Number of events 4 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
37.5%
3/8 • Number of events 3 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
29.2%
7/24 • Number of events 7 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.0%
2/8 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
37.5%
3/8 • Number of events 3 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
20.8%
5/24 • Number of events 5 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Osteopenia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
8.3%
2/24 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Nervous system disorders
Hypotonia
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Nervous system disorders
Lethargy
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Nervous system disorders
Periventricular leukomalacia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Nervous system disorders
Seizure
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Pregnancy, puerperium and perinatal conditions
Agitation neonatal
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Pregnancy, puerperium and perinatal conditions
Bradycardia neonatal
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
62.5%
5/8 • Number of events 7 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
37.5%
3/8 • Number of events 5 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
37.5%
9/24 • Number of events 9 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Pregnancy, puerperium and perinatal conditions
Fixed bowel loop
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Pregnancy, puerperium and perinatal conditions
Intraventricular haemorrhage neonatal
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
8.3%
2/24 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
62.5%
5/8 • Number of events 5 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
37.5%
3/8 • Number of events 3 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
45.8%
11/24 • Number of events 12 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Pregnancy, puerperium and perinatal conditions
Necrotising enterocolitis neonatal
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal respiratory distress syndrome
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
25.0%
2/8 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
25.0%
2/8 • Number of events 3 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
37.5%
9/24 • Number of events 12 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Pregnancy, puerperium and perinatal conditions
Periventricular haemorrhage neonatal
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Pregnancy, puerperium and perinatal conditions
Retinopathy of prematurity
|
25.0%
2/8 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
37.5%
9/24 • Number of events 9 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Pregnancy, puerperium and perinatal conditions
Small for dates baby
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
8.3%
2/24 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
8.3%
2/24 • Number of events 3 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea neonatal
|
87.5%
7/8 • Number of events 7 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
50.0%
4/8 • Number of events 5 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
75.0%
6/8 • Number of events 9 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
79.2%
19/24 • Number of events 21 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
29.2%
7/24 • Number of events 8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
8.3%
2/24 • Number of events 4 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
25.0%
2/8 • Number of events 3 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
8.3%
2/24 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal ulcer
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal tachypnoea
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
8.3%
2/24 • Number of events 3 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary interstitial emphysema syndrome
|
37.5%
3/8 • Number of events 3 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
3/24 • Number of events 3 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema neonatal
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
8.3%
2/24 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
25.0%
2/8 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/24 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
50.0%
4/8 • Number of events 5 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
25.0%
2/8 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
8.3%
2/24 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Vascular disorders
Haemangioma
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
4.2%
1/24 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • Number of events 1 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
25.0%
2/8 • Number of events 2 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
0.00%
0/8 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
—
0/0 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
16.7%
4/24 • Number of events 7 • From randomization to 36 weeks PMA
This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The preparation and submittal for publication of a manuscript containing the study results shall be in accordance with a process determined by a mutual written agreement among Windtree Therapeutics, Inc. and participating institutions. The publication or presentation of any study results shall comply with all applicable privacy laws, including, but not limited to, HIPAA.
- Publication restrictions are in place
Restriction type: OTHER