Trial Outcomes & Findings for A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC) (NCT NCT02452476)
NCT ID: NCT02452476
Last Updated: 2021-08-13
Results Overview
SpO2/FiO2 ratio The oxygen requirement and ventilatory support were assessed through arterial oxygen saturation, measured by pulse oximetry (SpO2 \[%\]) and ventilator settings, by measuring fraction of inspired oxygen (FiO2\[%\]) and SpO2/FiO2. Results are shown as change from baseline, summarized at post-treatment timepoints. Definitions: SpO2=Arterial Oxygen saturation by pulse oximetry; FiO2=Fraction of inspired oxygen; Baseline=The last pre-dose measurement taken on Day -1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
123 participants
Primary outcome timeframe
Post-treatment Day 1: 30 min, at 1h, 3h, 6h, 12h, 18h, 24 h; Day 2, 3, 5, and 7
Results posted on
2021-08-13
Participant Flow
Participant milestones
| Measure |
CHF5633
Single dose within 24 hours from birth
CHF5633: Rescue treatment (if needed)
|
Poractant Alfa
Single dose within 24 hours from birth
Poractant alfa: Rescue treatment (if needed)
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
59
|
|
Overall Study
COMPLETED
|
53
|
49
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
Reasons for withdrawal
| Measure |
CHF5633
Single dose within 24 hours from birth
CHF5633: Rescue treatment (if needed)
|
Poractant Alfa
Single dose within 24 hours from birth
Poractant alfa: Rescue treatment (if needed)
|
|---|---|---|
|
Overall Study
Death
|
4
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Not treated
|
5
|
1
|
Baseline Characteristics
A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)
Baseline characteristics by cohort
| Measure |
CHF5633
n=56 Participants
Single dose within 24 hours from birth.
CHF5633: Rescue treatment (if needed)
|
Poractant Alfa
n=57 Participants
Single dose within 24 hours from birth.
Poractant alfa: Rescue treatment (if needed)
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.01 weeks
STANDARD_DEVIATION 1.79 • n=5 Participants
|
26.72 weeks
STANDARD_DEVIATION 1.90 • n=7 Participants
|
26.86 weeks
STANDARD_DEVIATION 1.84 • n=5 Participants
|
|
Age, Customized
24 to 26 Weeks
|
26 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Age, Customized
27 to 29 Weeks
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
57 participants
n=7 Participants
|
113 participants
n=5 Participants
|
|
APGAR Score
|
6.3 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 1.9 • n=7 Participants
|
6.1 units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Birth weight
|
862.0 gram
STANDARD_DEVIATION 247.2 • n=5 Participants
|
903.6 gram
STANDARD_DEVIATION 310.2 • n=7 Participants
|
883.0 gram
STANDARD_DEVIATION 280.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Post-treatment Day 1: 30 min, at 1h, 3h, 6h, 12h, 18h, 24 h; Day 2, 3, 5, and 7Population: Intention-to-Treat Population (ITT). All randomized patients who received at least one dose of study medication and with at least one available evaluation of efficacy after the baseline.
SpO2/FiO2 ratio The oxygen requirement and ventilatory support were assessed through arterial oxygen saturation, measured by pulse oximetry (SpO2 \[%\]) and ventilator settings, by measuring fraction of inspired oxygen (FiO2\[%\]) and SpO2/FiO2. Results are shown as change from baseline, summarized at post-treatment timepoints. Definitions: SpO2=Arterial Oxygen saturation by pulse oximetry; FiO2=Fraction of inspired oxygen; Baseline=The last pre-dose measurement taken on Day -1.
Outcome measures
| Measure |
CHF5633
n=56 Participants
Single dose within 24 hours from birth
CHF5633: Rescue treatment (if needed)
|
Poractant Alfa
n=57 Participants
Single dose within 24 hours from birth
Poractant alfa: Rescue treatment (if needed)
|
|---|---|---|
|
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio
Day 1, 30 min
|
3.33 SpO2/FiO2 ratio
Interval 3.02 to 3.63
|
3.31 SpO2/FiO2 ratio
Interval 3.0 to 3.61
|
|
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio
Day 1, 1 h
|
3.36 SpO2/FiO2 ratio
Interval 3.07 to 3.66
|
3.55 SpO2/FiO2 ratio
Interval 3.26 to 3.84
|
|
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio
Day 1, 3 h
|
3.58 SpO2/FiO2 ratio
Interval 3.33 to 3.83
|
3.68 SpO2/FiO2 ratio
Interval 3.44 to 3.93
|
|
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio
Day 1, 6 h
|
3.77 SpO2/FiO2 ratio
Interval 3.52 to 4.02
|
3.87 SpO2/FiO2 ratio
Interval 3.63 to 4.12
|
|
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio
Day 1, 12 h
|
3.89 SpO2/FiO2 ratio
Interval 3.65 to 4.13
|
3.78 SpO2/FiO2 ratio
Interval 3.54 to 4.01
|
|
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio
Day 1, 18 h
|
3.82 SpO2/FiO2 ratio
Interval 3.59 to 4.04
|
3.74 SpO2/FiO2 ratio
Interval 3.52 to 3.97
|
|
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio
Day 1, 24 h
|
3.72 SpO2/FiO2 ratio
Interval 3.47 to 3.98
|
3.64 SpO2/FiO2 ratio
Interval 3.38 to 3.89
|
|
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio
Day 2
|
3.61 SpO2/FiO2 ratio
Interval 3.35 to 3.86
|
3.63 SpO2/FiO2 ratio
Interval 3.38 to 3.88
|
|
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio
Day 3
|
3.75 SpO2/FiO2 ratio
Interval 3.48 to 4.01
|
3.78 SpO2/FiO2 ratio
Interval 3.52 to 4.05
|
|
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio
Day 5
|
3.83 SpO2/FiO2 ratio
Interval 3.56 to 4.1
|
3.88 SpO2/FiO2 ratio
Interval 3.61 to 4.15
|
|
Oxygen Requirement and Ventilatory Support -- SpO2/FiO2 Ratio
Day 7
|
3.74 SpO2/FiO2 ratio
Interval 3.47 to 4.0
|
3.73 SpO2/FiO2 ratio
Interval 3.46 to 3.99
|
PRIMARY outcome
Timeframe: Post-treatment Day 1: 30 min, at 1h, 3h, 6h, 12h, 18h, 24 h; Day 2, 3, 5, and 7Population: Intention-to-Treat Population (ITT). All randomized patients who received at least one dose of study medication and with at least one available evaluation of efficacy after the baseline.
Fraction of inspired oxygen (FiO2) (percent) during the first 24 h and up to Day 7. Fraction of inspired oxygen (FiO2 \[percent\]). Results are shown as change from baseline, summarized at post-treatment time points. Definitions: FiO2=Fraction of inspired oxygen (percent); Baseline=The last pre-dose measurement taken on Day -1;
Outcome measures
| Measure |
CHF5633
n=56 Participants
Single dose within 24 hours from birth
CHF5633: Rescue treatment (if needed)
|
Poractant Alfa
n=57 Participants
Single dose within 24 hours from birth
Poractant alfa: Rescue treatment (if needed)
|
|---|---|---|
|
Fraction of Inspired Oxygen (FiO2) (Percent) During the First 24 h and up to Day 7
Day 1, 30 min
|
32.15 Fraction of inspired oxygen (percent)
Interval 27.91 to 36.39
|
34.08 Fraction of inspired oxygen (percent)
Interval 29.88 to 38.29
|
|
Fraction of Inspired Oxygen (FiO2) (Percent) During the First 24 h and up to Day 7
Day 1, 1 h
|
31.41 Fraction of inspired oxygen (percent)
Interval 28.14 to 34.68
|
28.96 Fraction of inspired oxygen (percent)
Interval 25.76 to 32.16
|
|
Fraction of Inspired Oxygen (FiO2) (Percent) During the First 24 h and up to Day 7
Day 1, 3 h
|
29.29 Fraction of inspired oxygen (percent)
Interval 26.05 to 32.52
|
28.87 Fraction of inspired oxygen (percent)
Interval 25.68 to 32.06
|
|
Fraction of Inspired Oxygen (FiO2) (Percent) During the First 24 h and up to Day 7
Day 1, 6 h
|
27.76 Fraction of inspired oxygen (percent)
Interval 24.43 to 31.08
|
28.16 Fraction of inspired oxygen (percent)
Interval 24.88 to 31.45
|
|
Fraction of Inspired Oxygen (FiO2) (Percent) During the First 24 h and up to Day 7
Day 1, 12 h
|
25.28 Fraction of inspired oxygen (percent)
Interval 22.71 to 27.85
|
28.05 Fraction of inspired oxygen (percent)
Interval 25.53 to 30.58
|
|
Fraction of Inspired Oxygen (FiO2) (Percent) During the First 24 h and up to Day 7
Day 1, 18 h
|
26.18 Fraction of inspired oxygen (percent)
Interval 24.02 to 28.34
|
28.10 Fraction of inspired oxygen (percent)
Interval 25.97 to 30.23
|
|
Fraction of Inspired Oxygen (FiO2) (Percent) During the First 24 h and up to Day 7
Day 1, 24 h
|
28.49 Fraction of inspired oxygen (percent)
Interval 25.02 to 31.96
|
29.50 Fraction of inspired oxygen (percent)
Interval 26.05 to 32.95
|
|
Fraction of Inspired Oxygen (FiO2) (Percent) During the First 24 h and up to Day 7
Day 2
|
29.29 Fraction of inspired oxygen (percent)
Interval 26.52 to 32.06
|
29.20 Fraction of inspired oxygen (percent)
Interval 26.46 to 31.93
|
|
Fraction of Inspired Oxygen (FiO2) (Percent) During the First 24 h and up to Day 7
Day 3
|
27.54 Fraction of inspired oxygen (percent)
Interval 23.64 to 31.44
|
29.07 Fraction of inspired oxygen (percent)
Interval 25.28 to 32.86
|
|
Fraction of Inspired Oxygen (FiO2) (Percent) During the First 24 h and up to Day 7
Day 5
|
28.06 Fraction of inspired oxygen (percent)
Interval 24.13 to 31.99
|
26.32 Fraction of inspired oxygen (percent)
Interval 22.41 to 30.23
|
|
Fraction of Inspired Oxygen (FiO2) (Percent) During the First 24 h and up to Day 7
Day 7
|
29.25 Fraction of inspired oxygen (percent)
Interval 25.22 to 33.28
|
28.02 Fraction of inspired oxygen (percent)
Interval 24.02 to 32.01
|
PRIMARY outcome
Timeframe: 36 weeks post menstrual age, Day 14 Post-Natal Age, Day 28 Post-Natal AgePopulation: Intention-to-Treat Population (ITT). All randomized patients who received at least one dose of study medication and with at least one available evaluation of efficacy after the baseline.
Bronchopulmonary dysplasia and mortality. Results summarize the following items: Number of patients who died and the number of patients who had bronchopulmonary dysplasia (BPD) were assessed by treatment, at 36 weeks post menstrual age (PMA). Number of patients who died by Day 28 post-natal age (PNA). Number of patients with respiratory distress syndrome (RDS)-associated mortality by Day 14 post-natal age (PNA). Definitions: BPD=Bronchopulmonary dysplasia; Mortality/BPD incidence=The incidence of neonates dead within 36-week PMA or alive at 36-week PMA with a diagnosis of BPD; PMA=Post menstrual age; PNA=Post-natal age; RDS=Respiratory distress syndrome;
Outcome measures
| Measure |
CHF5633
n=56 Participants
Single dose within 24 hours from birth
CHF5633: Rescue treatment (if needed)
|
Poractant Alfa
n=57 Participants
Single dose within 24 hours from birth
Poractant alfa: Rescue treatment (if needed)
|
|---|---|---|
|
Number of Patients With Bronchopulmonary Dysplasia and Mortality
36 week PMA Incidence of BPD (Yes)
|
31 Participants
|
32 Participants
|
|
Number of Patients With Bronchopulmonary Dysplasia and Mortality
36 week PMA Mortality/BPD
|
35 Participants
|
38 Participants
|
|
Number of Patients With Bronchopulmonary Dysplasia and Mortality
36 week PMA Mortality
|
4 Participants
|
6 Participants
|
|
Number of Patients With Bronchopulmonary Dysplasia and Mortality
Day 28 (PNA) Mortality
|
4 Participants
|
3 Participants
|
|
Number of Patients With Bronchopulmonary Dysplasia and Mortality
Day 14 (PNA) RDS-associated mortality
|
1 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-treatment up to 24 hPopulation: Intention-to-Treat Population (ITT). All randomized patients who received at least one dose of study medication and with at least one available evaluation of efficacy after the baseline.
Normal breathing (room air) within 24 hours The number of patients with at least one reading of FiO2 equal to 21% (i.e. corresponding to room air for oxygen concentration) within 24 hours from first dose of surfactant was evaluated.
Outcome measures
| Measure |
CHF5633
n=56 Participants
Single dose within 24 hours from birth
CHF5633: Rescue treatment (if needed)
|
Poractant Alfa
n=57 Participants
Single dose within 24 hours from birth
Poractant alfa: Rescue treatment (if needed)
|
|---|---|---|
|
Number of Patients With Normal Breathing (Room Air) Within 24 Hours
|
38 Participants
|
43 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to Day 7Population: Intention-to-Treat Population (ITT). All randomized patients who received at least one dose of study medication and with at least one available evaluation of efficacy after the baseline.
Number of patients with the need for re-dosing (use of rescue surfactant). The number of patients requiring at least one surfactant rescue dose (i.e. re-dosing with the study drug) at any time during the study was evaluated.
Outcome measures
| Measure |
CHF5633
n=56 Participants
Single dose within 24 hours from birth
CHF5633: Rescue treatment (if needed)
|
Poractant Alfa
n=57 Participants
Single dose within 24 hours from birth
Poractant alfa: Rescue treatment (if needed)
|
|---|---|---|
|
Number of Patients With the Need for Re-dosing (Use of Rescue Surfactant)
Patients receiving rescue at any time during the study
|
19 Participants
|
17 Participants
|
|
Number of Patients With the Need for Re-dosing (Use of Rescue Surfactant)
1 rescue dose given
|
11 Participants
|
12 Participants
|
|
Number of Patients With the Need for Re-dosing (Use of Rescue Surfactant)
2 rescue doses given
|
8 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-treatment Day 1: up to 24 hPopulation: Intention-to-Treat Population (ITT). All randomized patients who received at least one dose of study medication and with at least one available evaluation of efficacy after the baseline.
Time to reach normal breathing (room air) within 24 hours. The median time to reach normal breathing (room air) within 24 hours from first dose of surfactant was evaluated. These are the patients who contributed to the results in the outcome measure 'Normal Breathing (room air) within 24 hours'.
Outcome measures
| Measure |
CHF5633
n=38 Participants
Single dose within 24 hours from birth
CHF5633: Rescue treatment (if needed)
|
Poractant Alfa
n=43 Participants
Single dose within 24 hours from birth
Poractant alfa: Rescue treatment (if needed)
|
|---|---|---|
|
Time to Reach Normal Breathing (Room Air) Within 24 Hours
|
2.980 hour
Interval 0.38 to 24.0
|
2.320 hour
Interval 0.22 to 24.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-treatment Day 1 (24 h), Day 2 (48 h)Population: Intention-to-Treat Population (ITT). All randomized patients who received at least one dose of study medication and with at least one available evaluation of efficacy after the baseline.
The inflammatory status of the patients was assessed (in a subgroup of babies who required endotracheal intubation for mechanical ventilation, when feasible). This was performed by measuring the concentration of specific biomarkers of inflammation in tracheal aspirates. The biomarkers measured were: Interleukin 1β, Interleukin 6, Interleukin 8, Myeloperoxidase, and Tumor Necrosis Factor-Alpha. The total protein content in tracheal aspirates was measured as an endogenous marker of dilution to calculate the extent to which epithelial lining fluid (ELF) was diluted during the tracheal aspirate procedure. To adjust for variation during the collection of tracheal aspirates, the measured cytokines values were normalized to the total protein. Results are presented as change from baseline in pg/mg total protein and were evaluated by descriptive statistics. Definition: Baseline=The last pre-dose measurement taken on Day -1;
Outcome measures
| Measure |
CHF5633
n=56 Participants
Single dose within 24 hours from birth
CHF5633: Rescue treatment (if needed)
|
Poractant Alfa
n=57 Participants
Single dose within 24 hours from birth
Poractant alfa: Rescue treatment (if needed)
|
|---|---|---|
|
Concentration of Biomarkers of Inflammation in Tracheal Aspirates
Interleukin 1β, Day 1, 24 h
|
-38.535 pg/mg total protein
Standard Deviation 93.111
|
-39.896 pg/mg total protein
Standard Deviation 134.659
|
|
Concentration of Biomarkers of Inflammation in Tracheal Aspirates
Interleukin 1β, Day 2, 48 h
|
3.681 pg/mg total protein
Standard Deviation 154.736
|
-40.564 pg/mg total protein
Standard Deviation 158.194
|
|
Concentration of Biomarkers of Inflammation in Tracheal Aspirates
Interleukin 6, Day 1, 24 h
|
-200.074 pg/mg total protein
Standard Deviation 761.436
|
-792.196 pg/mg total protein
Standard Deviation 2657.394
|
|
Concentration of Biomarkers of Inflammation in Tracheal Aspirates
Interleukin 6, Day 2, 48 h
|
-129.368 pg/mg total protein
Standard Deviation 954.282
|
-1089.753 pg/mg total protein
Standard Deviation 3222.013
|
|
Concentration of Biomarkers of Inflammation in Tracheal Aspirates
Interleukin 8, Day 1, 24 h
|
389.86 pg/mg total protein
Standard Deviation 5240.76
|
-843.74 pg/mg total protein
Standard Deviation 4720.36
|
|
Concentration of Biomarkers of Inflammation in Tracheal Aspirates
Interleukin 8,Day 2, 48 h
|
821.16 pg/mg total protein
Standard Deviation 5978.87
|
-243.71 pg/mg total protein
Standard Deviation 6425.90
|
|
Concentration of Biomarkers of Inflammation in Tracheal Aspirates
Tumor Necrosis Factor-Alpha, Day 1, 24 h
|
-16.047 pg/mg total protein
Standard Deviation 42.924
|
-19.985 pg/mg total protein
Standard Deviation 67.539
|
|
Concentration of Biomarkers of Inflammation in Tracheal Aspirates
Tumor Necrosis Factor-Alpha, Day 2, 48 h
|
2.899 pg/mg total protein
Standard Deviation 71.215
|
-25.573 pg/mg total protein
Standard Deviation 78.934
|
|
Concentration of Biomarkers of Inflammation in Tracheal Aspirates
Myeloperoxidase, Day 1, 24 h
|
267337.7 pg/mg total protein
Standard Deviation 399695.4
|
52663.5 pg/mg total protein
Standard Deviation 264660.9
|
|
Concentration of Biomarkers of Inflammation in Tracheal Aspirates
Myeloperoxidase, Day 2, 48 h
|
310323.0 pg/mg total protein
Standard Deviation 419874.0
|
508378.1 pg/mg total protein
Standard Deviation 381999.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At approximately 5 weeks after the administration of study drug (with a range from 3 to 6 weeks).Population: Safety Population. All randomized patients who took at least one dose of study medication and who had the assessment done on 28 day PNA.
Immunogenicity was assessed by measuring antibodies to SP-B analogue (CHF 5736.03) and to SP-C analogue (CHF 4902.03), contained in CHF 5633. Results are expressed as the titre (i.e. serum dilution) at which the sample had an absorbance of 0.069 (background) for SP-C Analogue (CHF 4902.03) CHF or an absorbance of 0.05 for SP-B Analogue (CHF 5736.03) in a microplate reader. The positive control serum was diluted in buffer solution and the maximum binding for the positive control was determined at dilutions \< 1/12.5 for SPC and \<1/100 for SPB. Test samples for immunogenicity were analyzed by using negative and positive controls. By definition, titer \<12.5 for CHF-4902.03 and \<100 for CHF-5736.02 show that the test serum had an absorbance equal to background at the same dilution at which the positive control had the maximum binding, implying absence of antibodies.
Outcome measures
| Measure |
CHF5633
n=60 Participants
Single dose within 24 hours from birth
CHF5633: Rescue treatment (if needed)
|
Poractant Alfa
n=61 Participants
Single dose within 24 hours from birth
Poractant alfa: Rescue treatment (if needed)
|
|---|---|---|
|
Immunogenicity: Assessment of Antibodies to Surfactant Protein B (SP-B) Analogue (CHF 5736.03) and to Surfactant Protein C (SP-C) Analogue (CHF 4902.03)
Antibody to SP-B (CHF 5736.03)
|
100 Titre (dilution with 0.050 absorbance)
|
100 Titre (dilution with 0.050 absorbance)
|
|
Immunogenicity: Assessment of Antibodies to Surfactant Protein B (SP-B) Analogue (CHF 5736.03) and to Surfactant Protein C (SP-C) Analogue (CHF 4902.03)
Antibody to SP-C (CHF 4902.03)
|
12.5 Titre (dilution with 0.050 absorbance)
|
12.5 Titre (dilution with 0.050 absorbance)
|
Adverse Events
CHF5633
Serious events: 20 serious events
Other events: 59 other events
Deaths: 4 deaths
Poractant Alfa
Serious events: 20 serious events
Other events: 58 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
CHF5633
n=59 participants at risk
Single dose within 24 hours from birth
CHF5633: Rescue treatment (if needed)
|
Poractant Alfa
n=58 participants at risk
Single dose within 24 hours from birth
Poractant alfa: Rescue treatment (if needed)
|
|---|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation in newborn
|
1.7%
1/59 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
0.00%
0/58 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Cardiac disorders
Bradycardia neonatal
|
1.7%
1/59 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
0.00%
0/58 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Congenital, familial and genetic disorders
Amniotic band syndrome
|
0.00%
0/59 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Congenital, familial and genetic disorders
Cerebellar hypoplasia
|
0.00%
0/59 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Congenital, familial and genetic disorders
Congenital cytomegalovirus infection
|
0.00%
0/59 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Congenital, familial and genetic disorders
Developmental glaucoma
|
1.7%
1/59 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
0.00%
0/58 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
1.7%
1/59 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
0.00%
0/58 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Eye disorders
Retinopathy of prematurity
|
3.4%
2/59 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Gastrointestinal disorders
Neonatal intestinal perforation
|
3.4%
2/59 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Gastrointestinal disorders
Necrotising enterocolitis neonatal
|
1.7%
1/59 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Gastrointestinal disorders
Neonatal gastrointestinal haemorrhage
|
0.00%
0/59 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/59 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Gastrointestinal disorders
Umbilical hernia
|
1.7%
1/59 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
0.00%
0/58 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Infections and infestations
Neonatal pneumonia
|
0.00%
0/59 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/59 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Infections and infestations
Serratia bacteraemia
|
1.7%
1/59 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
0.00%
0/58 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Infections and infestations
Sepsis neonatal
|
6.8%
4/59 • Number of events 5 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
3.4%
2/58 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Infections and infestations
Urinary tract infection neonatal
|
1.7%
1/59 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
0.00%
0/58 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Metabolism and nutrition disorders
Feeding disorder neonatal
|
1.7%
1/59 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
0.00%
0/58 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/59 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Nervous system disorders
Intraventricular haemorrhage neonatal
|
1.7%
1/59 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Nervous system disorders
Cerebral haemorrhage neonatal
|
1.7%
1/59 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
3.4%
2/58 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/59 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/59 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Renal and urinary disorders
Renal failure neonatal
|
1.7%
1/59 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
0.00%
0/58 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
6.8%
4/59 • Number of events 4 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.1%
3/59 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
1.7%
1/59 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
3.4%
2/58 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.7%
1/59 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
3.4%
2/58 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
|
3.4%
2/59 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
0.00%
0/58 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis neonatal
|
1.7%
1/59 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
0.00%
0/58 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal hypoxia
|
1.7%
1/59 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
0.00%
0/58 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.00%
0/59 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Vascular disorders
Neonatal hypotension
|
1.7%
1/59 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
0.00%
0/58 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
Other adverse events
| Measure |
CHF5633
n=59 participants at risk
Single dose within 24 hours from birth
CHF5633: Rescue treatment (if needed)
|
Poractant Alfa
n=58 participants at risk
Single dose within 24 hours from birth
Poractant alfa: Rescue treatment (if needed)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia neonatal
|
83.1%
49/59 • Number of events 52 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
81.0%
47/58 • Number of events 50 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Blood and lymphatic system disorders
Bandaemia
|
3.4%
2/59 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.8%
4/59 • Number of events 5 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
12.1%
7/58 • Number of events 7 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Blood and lymphatic system disorders
Neutropenia neonatal
|
3.4%
2/59 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
6.9%
4/58 • Number of events 4 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Blood and lymphatic system disorders
Thrombocytopenia neonatal
|
27.1%
16/59 • Number of events 18 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
27.6%
16/58 • Number of events 17 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
3.4%
2/59 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Cardiac disorders
Bradycardia neonatal
|
18.6%
11/59 • Number of events 11 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
13.8%
8/58 • Number of events 8 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Cardiac disorders
Neonatal tachycardia
|
5.1%
3/59 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
8.6%
5/58 • Number of events 5 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Cardiac disorders
Tricuspid valve incompetence
|
5.1%
3/59 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Congenital, familial and genetic disorders
Adrenal insufficiency neonatal
|
6.8%
4/59 • Number of events 5 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
35.6%
21/59 • Number of events 22 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
32.8%
19/58 • Number of events 21 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Congenital, familial and genetic disorders
Hydrocele
|
6.8%
4/59 • Number of events 4 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
44.1%
26/59 • Number of events 26 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
58.6%
34/58 • Number of events 37 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Congenital, familial and genetic disorders
Sickle cell trait
|
6.8%
4/59 • Number of events 4 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
0.00%
0/58 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Endocrine disorders
Hypothyroidism
|
3.4%
2/59 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
8.6%
5/58 • Number of events 5 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Endocrine disorders
Transient hypothyroxinaemia of prematurity
|
3.4%
2/59 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Eye disorders
Retinopathy of prematurity
|
33.9%
20/59 • Number of events 24 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
31.0%
18/58 • Number of events 18 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Gastrointestinal disorders
Abdominal distension
|
11.9%
7/59 • Number of events 7 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
8.6%
5/58 • Number of events 5 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Gastrointestinal disorders
Constipation
|
8.5%
5/59 • Number of events 5 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
8.6%
5/58 • Number of events 5 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
5.1%
3/59 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
5.1%
3/59 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
13.6%
8/59 • Number of events 8 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
8.6%
5/58 • Number of events 5 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Gastrointestinal disorders
Haematochezia
|
6.8%
4/59 • Number of events 4 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Gastrointestinal disorders
Inguinal hernia
|
15.3%
9/59 • Number of events 9 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
15.5%
9/58 • Number of events 9 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Gastrointestinal disorders
Umbilical hernia
|
5.1%
3/59 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
3.4%
2/58 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/59 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
6.9%
4/58 • Number of events 4 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
2/59 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
General disorders
Peripheral oedema neonatal
|
6.8%
4/59 • Number of events 4 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
8.6%
5/58 • Number of events 5 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia neonatal
|
67.8%
40/59 • Number of events 44 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
55.2%
32/58 • Number of events 35 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/59 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Infections and infestations
Bacterial disease carrier
|
1.7%
1/59 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Infections and infestations
Neonatal pneumonia
|
11.9%
7/59 • Number of events 8 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
8.6%
5/58 • Number of events 7 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Infections and infestations
Oral candidiasis
|
5.1%
3/59 • Number of events 5 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Infections and infestations
Sepsis neonatal
|
22.0%
13/59 • Number of events 14 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
29.3%
17/58 • Number of events 23 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Infections and infestations
Staphylococcal bacteraemia
|
5.1%
3/59 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Infections and infestations
Tracheitis
|
1.7%
1/59 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Infections and infestations
Urinary tract infection neonatal
|
8.5%
5/59 • Number of events 5 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
13.8%
8/58 • Number of events 9 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
5.1%
3/59 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
3.4%
2/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Investigations
Blood creatinine increased
|
5.1%
3/59 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
3.4%
2/58 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Investigations
Blood urea increased
|
5.1%
3/59 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Investigations
C-reactive protein increased
|
6.8%
4/59 • Number of events 5 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
12.1%
7/58 • Number of events 10 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Investigations
Chest X-ray abnormal
|
10.2%
6/59 • Number of events 6 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Metabolism and nutrition disorders
Alkalosis hypochloraemic
|
1.7%
1/59 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Metabolism and nutrition disorders
Feeding disorder neonatal
|
8.5%
5/59 • Number of events 5 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Metabolism and nutrition disorders
Feeding disorder of infancy or early childhood
|
3.4%
2/59 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.1%
3/59 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
1.7%
1/58 • Number of events 1 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.9%
20/59 • Number of events 26 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
22.4%
13/58 • Number of events 16 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.5%
5/59 • Number of events 6 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
13.8%
8/58 • Number of events 9 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
6.8%
4/59 • Number of events 4 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
12.1%
7/58 • Number of events 7 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
27.1%
16/59 • Number of events 20 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
17.2%
10/58 • Number of events 10 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
15.3%
9/59 • Number of events 11 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
15.5%
9/58 • Number of events 10 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Investigations
Hypoglycaemia neonatal
|
13.6%
8/59 • Number of events 8 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
17.2%
10/58 • Number of events 12 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.3%
12/59 • Number of events 14 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
12.1%
7/58 • Number of events 7 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.5%
5/59 • Number of events 5 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
8.6%
5/58 • Number of events 5 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
30.5%
18/59 • Number of events 19 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
39.7%
23/58 • Number of events 23 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
6.8%
4/59 • Number of events 4 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
3.4%
2/58 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Metabolism and nutrition disorders
Neonatal hyponatraemia
|
28.8%
17/59 • Number of events 23 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
32.8%
19/58 • Number of events 21 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Metabolism and nutrition disorders
Poor feeding infant
|
3.4%
2/59 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
10.3%
6/58 • Number of events 6 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
5.1%
3/59 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/59 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Nervous system disorders
Cerebral ventricle dilatation
|
5.1%
3/59 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Nervous system disorders
Convulsion neonatal
|
10.2%
6/59 • Number of events 7 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
8.6%
5/58 • Number of events 5 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Nervous system disorders
Intraventricular haemorrhage neonatal
|
30.5%
18/59 • Number of events 22 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
32.8%
19/58 • Number of events 23 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
15.3%
9/59 • Number of events 9 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
24.1%
14/58 • Number of events 16 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Pregnancy, puerperium and perinatal conditions
Leukopenia neonatal
|
5.1%
3/59 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
6.9%
4/58 • Number of events 4 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Psychiatric disorders
Agitation neonatal
|
11.9%
7/59 • Number of events 7 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Renal and urinary disorders
Hydronephrosis
|
6.8%
4/59 • Number of events 4 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea neonatal
|
25.4%
15/59 • Number of events 15 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
22.4%
13/58 • Number of events 13 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis neonatal
|
10.2%
6/59 • Number of events 6 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
8.6%
5/58 • Number of events 5 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
55.9%
33/59 • Number of events 35 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
55.2%
32/58 • Number of events 32 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
5.1%
3/59 • Number of events 4 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
3.4%
2/58 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal hypoxia
|
18.6%
11/59 • Number of events 11 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
19.0%
11/58 • Number of events 12 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory acidosis
|
8.5%
5/59 • Number of events 5 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
12.1%
7/58 • Number of events 8 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
22.0%
13/59 • Number of events 14 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
20.7%
12/58 • Number of events 13 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
|
8.5%
5/59 • Number of events 5 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
10.3%
6/58 • Number of events 6 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal tachypnoea
|
5.1%
3/59 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
3.4%
2/58 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
6.8%
4/59 • Number of events 4 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary interstitial emphysema syndrome
|
10.2%
6/59 • Number of events 6 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
6.9%
4/58 • Number of events 4 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema neonatal
|
5.1%
3/59 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
3.4%
2/58 • Number of events 2 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
8.5%
5/59 • Number of events 7 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
13.8%
8/58 • Number of events 10 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Vascular disorders
Hypertension neonatal
|
5.1%
3/59 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
5.2%
3/58 • Number of events 3 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
|
Vascular disorders
Neonatal hypotension
|
30.5%
18/59 • Number of events 22 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
29.3%
17/58 • Number of events 18 • Adverse events were reported from the time of the informed consent signature* up to the study completion or discontinuation. The study duration was from minutes after birth and up to 36 week post menstrual age (PMA) *The written informed consent was obtained from parents/legal representative (according to local regulation) prior to any study-related procedures.
Analysis of adverse events (AEs) was performed on treatment emergent AEs (TEAEs). Safety population=All randomized subjects who received at least one dose of study treatment, was used for the evaluation of adverse events. An Independent Safety Monitoring Board (ISMB) was established on an ongoing basis to ensure the safety of study patients, with regard to the incidence of major adverse outcomes after the administration of the study drug (such as serious adverse events \[SAEs\]).
|
Additional Information
Clinical Trial Transparency
Chiesi Farmaceutici S.p.A.
Phone: +39 0521 2791
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Chiesi Farmaceutici S.p.A. (Sponsor) can publish or present results of this study at scientific meetings and submit the data to national and international Regulatory Authorities. The Sponsor reserves the right to use the data for industry purposes. Investigators will inform the Sponsor before using the results of the study for publication or presentation, and will provide the Sponsor with a copy of the proposed presentation. Data from individual study sites must not be published separately.
- Publication restrictions are in place
Restriction type: OTHER