Trial Outcomes & Findings for Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants (NCT NCT03169881)
NCT ID: NCT03169881
Last Updated: 2025-11-17
Results Overview
Bayley Scale of Infant and Toddler Development (BSID)-III composite cognitive score, where subjects who died prior to the follow-up assessment are assigned the lowest possible score of 54. This is a standardized scale where a score that is more than 1 normative standard deviation from the normative mean of 100 signifies mild developmental delay (score \< 85); 2 standard deviations below the mean, moderate delay (score \< 70); and 3 standard deviations below the mean, severe delay (score \< 55). This self-standing scale comprises the primary outcome for the Darbe study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
650 participants
Primary outcome timeframe
22-26 months corrected age (a median of 25 months corrected age, which corresponds to a median of 29 months calendar age in the analysis population), unless the subject died earlier
Results posted on
2025-11-17
Participant Flow
Participant milestones
| Measure |
Darbepoetin
Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks' PMA, intravenously when the infant had intravenous access, otherwise subcutaneously
|
Placebo
Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks' postmenstrual age as a sham subcutaneous dose
|
|---|---|---|
|
Overall Study
STARTED
|
322
|
328
|
|
Overall Study
Completed Assessment for Bayley Cognitive Score at Two-Year Follow-Up
|
239
|
239
|
|
Overall Study
Died After Hospital Discharge
|
2
|
3
|
|
Overall Study
Died Before Hospital Discharge
|
50
|
50
|
|
Overall Study
Started Study Drug and Data Not Withdrawn Prior to Hospital Discharge
|
316
|
325
|
|
Overall Study
Survived to Hospital Discharge (a Median of 94 Days)
|
269
|
277
|
|
Overall Study
COMPLETED
|
291
|
292
|
|
Overall Study
NOT COMPLETED
|
31
|
36
|
Reasons for withdrawal
| Measure |
Darbepoetin
Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks' PMA, intravenously when the infant had intravenous access, otherwise subcutaneously
|
Placebo
Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks' postmenstrual age as a sham subcutaneous dose
|
|---|---|---|
|
Overall Study
Incomplete Follow-up
|
10
|
15
|
|
Overall Study
Lost to Follow-up
|
18
|
20
|
|
Overall Study
Data withdrawn prior to hospital discharge
|
3
|
1
|
Baseline Characteristics
Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants
Baseline characteristics by cohort
| Measure |
Darbepoetin
n=322 Participants
Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou
|
Placebo
n=328 Participants
Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
|
Total
n=650 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.2 weeks
STANDARD_DEVIATION 1.7 • n=39 Participants
|
26.2 weeks
STANDARD_DEVIATION 1.6 • n=29 Participants
|
26.2 weeks
STANDARD_DEVIATION 1.7 • n=60 Participants
|
|
Sex/Gender, Customized
Female
|
166 Participants
n=39 Participants
|
162 Participants
n=29 Participants
|
328 Participants
n=60 Participants
|
|
Sex/Gender, Customized
Male
|
156 Participants
n=39 Participants
|
166 Participants
n=29 Participants
|
322 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
54 Participants
n=39 Participants
|
56 Participants
n=29 Participants
|
110 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
263 Participants
n=39 Participants
|
265 Participants
n=29 Participants
|
528 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
5 Participants
n=39 Participants
|
7 Participants
n=29 Participants
|
12 Participants
n=60 Participants
|
|
Birth weight, Continuous
|
838.2 grams
STANDARD_DEVIATION 252.9 • n=39 Participants
|
822.1 grams
STANDARD_DEVIATION 238.5 • n=29 Participants
|
830.1 grams
STANDARD_DEVIATION 245.7 • n=60 Participants
|
|
Race, Customized
American Indian or Alaska Native
|
7 Participants
n=39 Participants
|
11 Participants
n=29 Participants
|
18 Participants
n=60 Participants
|
|
Race, Customized
Asian, Native Hawaiian, or Other Pacific Islander
|
15 Participants
n=39 Participants
|
7 Participants
n=29 Participants
|
22 Participants
n=60 Participants
|
|
Race, Customized
Black or African American
|
96 Participants
n=39 Participants
|
102 Participants
n=29 Participants
|
198 Participants
n=60 Participants
|
|
Race, Customized
More Than One Race
|
7 Participants
n=39 Participants
|
2 Participants
n=29 Participants
|
9 Participants
n=60 Participants
|
|
Race, Customized
Unknown or Not Reported
|
7 Participants
n=39 Participants
|
9 Participants
n=29 Participants
|
16 Participants
n=60 Participants
|
|
Race, Customized
White
|
190 Participants
n=39 Participants
|
197 Participants
n=29 Participants
|
387 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 22-26 months corrected age (a median of 25 months corrected age, which corresponds to a median of 29 months calendar age in the analysis population), unless the subject died earlierPopulation: The analysis population includes all randomized infants with available data up to the two-year followup.
Bayley Scale of Infant and Toddler Development (BSID)-III composite cognitive score, where subjects who died prior to the follow-up assessment are assigned the lowest possible score of 54. This is a standardized scale where a score that is more than 1 normative standard deviation from the normative mean of 100 signifies mild developmental delay (score \< 85); 2 standard deviations below the mean, moderate delay (score \< 70); and 3 standard deviations below the mean, severe delay (score \< 55). This self-standing scale comprises the primary outcome for the Darbe study.
Outcome measures
| Measure |
Placebo
n=292 Participants
Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
|
Darbepoetin
n=291 Participants
Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou
|
|---|---|---|
|
Bayley III Composite Cognitive Score
|
80.1 score on a scale
Standard Deviation 18.7
|
80.7 score on a scale
Standard Deviation 19.5
|
SECONDARY outcome
Timeframe: Birth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks)Population: The analysis population includes all randomized infants with available data during the initial hospitalization.
The number of transfusions recorded during the study, up to 35 completed weeks gestational age
Outcome measures
| Measure |
Placebo
n=327 Participants
Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
|
Darbepoetin
n=319 Participants
Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou
|
|---|---|---|
|
Number of Transfusions Per Infant
|
3.3 Transfusions
Standard Deviation 3.5
|
2.3 Transfusions
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Birth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks)Population: The analysis population includes all randomized infants that were ever transfused.
The total volume of transfusions for the infant if ever transfused
Outcome measures
| Measure |
Placebo
n=257 Participants
Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
|
Darbepoetin
n=192 Participants
Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou
|
|---|---|---|
|
Total Volume of Transfusions Per Infant
|
69.0 mL
Standard Deviation 51.0
|
54.5 mL
Standard Deviation 51.9
|
SECONDARY outcome
Timeframe: Birth, up to the earliest of: death, hospital discharge, or 35 completed weeks gestational age (a median of 9 weeks)Population: The analysis population includes all randomized infants with available data during the initial hospitalization.
The number of donor exposures recorded during the study, up to 35 completed weeks gestational age
Outcome measures
| Measure |
Placebo
n=327 Participants
Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
|
Darbepoetin
n=319 Participants
Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou
|
|---|---|---|
|
Number of Donor Exposures Per Infant
|
2.2 Donors
Standard Deviation 2.3
|
1.6 Donors
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: at 2 and at 7 weeks in the studyPopulation: The analysis population includes all randomized infants with available data during the initial hospitalization.
Hematocrit adjusted for center, gestational age group, and familial clustering
Outcome measures
| Measure |
Placebo
n=319 Participants
Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
|
Darbepoetin
n=314 Participants
Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou
|
|---|---|---|
|
Hematocrit
week 2
|
33.88 Percent of blood volume made up of RBCs
Interval 33.4 to 34.36
|
36.84 Percent of blood volume made up of RBCs
Interval 36.35 to 37.33
|
|
Hematocrit
week 7
|
31.78 Percent of blood volume made up of RBCs
Interval 31.24 to 32.32
|
37.02 Percent of blood volume made up of RBCs
Interval 36.45 to 37.59
|
SECONDARY outcome
Timeframe: at 2 and at 7 weeks in the studyPopulation: The analysis population includes all randomized infants with available data during the initial hospitalization.
Red Cell Mass (Circulating Erythrocyte Volume), adjusted for center, gestational age group, and familial clustering
Outcome measures
| Measure |
Placebo
n=327 Participants
Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
|
Darbepoetin
n=319 Participants
Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou
|
|---|---|---|
|
Red Cell Mass
week 2
|
24.74 mL
Interval 23.67 to 25.82
|
28.35 mL
Interval 27.26 to 29.43
|
|
Red Cell Mass
week 7
|
36.01 mL
Interval 34.9 to 37.12
|
42.78 mL
Interval 41.65 to 43.92
|
SECONDARY outcome
Timeframe: Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days)Population: The analysis population includes all randomized infants with available data during the initial hospitalization.
This is measured as Yes if experienced necrotizing enterocolitis, Bells stage \>=2 with surgery; Otherwise, No.
Outcome measures
| Measure |
Placebo
n=327 Participants
Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
|
Darbepoetin
n=319 Participants
Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou
|
|---|---|---|
|
Necrotizing Enterocolitis, Bells Stage >=2 With Surgery
Necrotizing Enterocolitis with Surgery
|
13 Participants
|
14 Participants
|
|
Necrotizing Enterocolitis, Bells Stage >=2 With Surgery
No Necrotizing Enterocolitis with Surgery
|
314 Participants
|
305 Participants
|
SECONDARY outcome
Timeframe: At 36 weeks postmenstrual agePopulation: The analysis population includes all randomized infants with available data during the initial hospitalization.
This is measured as Yes if infant is on invasive mechanical ventilation, nasal cannula \>2 L/min or noninvasive positive airway pressure at 36 weeks of postmenstrual age; Otherwise, No.
Outcome measures
| Measure |
Placebo
n=277 Participants
Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
|
Darbepoetin
n=261 Participants
Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou
|
|---|---|---|
|
Bronchopulmonary Dysplasia Grades 2 or 3
Bronchopulmonary Dysplasia at 36 Weeks Postmenstrual Age
|
128 Participants
|
91 Participants
|
|
Bronchopulmonary Dysplasia Grades 2 or 3
No Bronchopulmonary Dysplasia at 36 Weeks Postmenstrual Age
|
149 Participants
|
170 Participants
|
SECONDARY outcome
Timeframe: Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days)Population: The analysis population includes all randomized infants with available data during the initial hospitalization.
This is measured as Yes if experienced Retinopathy of prematurity stage \>=3 or treatment for that condition received; Otherwise, No. Higher stages of ROP indicate a worse outcome; the stages range from 1 for "mild" disease, to 5 for "severe" disease.
Outcome measures
| Measure |
Placebo
n=279 Participants
Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
|
Darbepoetin
n=273 Participants
Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou
|
|---|---|---|
|
Retinopathy of Prematurity Stage >=3 or Treatment for That Condition Received
No Retinopathy of Prematurity Stage At least stage 3 or Treatment for That Condition Received
|
234 Participants
|
238 Participants
|
|
Retinopathy of Prematurity Stage >=3 or Treatment for That Condition Received
Retinopathy of Prematurity At least stage 3 or Treatment for That Condition Received
|
45 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Birth to initial hospital discharge or to death if it occurs earlier (a median of 94 days)Population: The analysis population includes all randomized infants with available data during the initial hospitalization.
This is measured as Yes if experienced Grade I+ Intraventricular Hemorrhage; Otherwise, No.
Outcome measures
| Measure |
Placebo
n=318 Participants
Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
|
Darbepoetin
n=315 Participants
Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou
|
|---|---|---|
|
Intraventricular Hemorrhage Grade I+
Grade 1+ Intraventricular Hemorrhage
|
98 Participants
|
108 Participants
|
|
Intraventricular Hemorrhage Grade I+
No Intraventricular Hemorrhage
|
220 Participants
|
207 Participants
|
SECONDARY outcome
Timeframe: At initial hospital discharge or at death if it occurs earlier (a median of 94 days), assessed up to one year of life.Population: The analysis population includes all randomized infants with available data during the initial hospitalization.
This is measured as the length of stay up to hospital discharge or death, whichever occurred first.
Outcome measures
| Measure |
Placebo
n=318 Participants
Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
|
Darbepoetin
n=304 Participants
Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou
|
|---|---|---|
|
Length of Hospital Stay
|
104.8 Days
Standard Deviation 67.3
|
96.2 Days
Standard Deviation 58.5
|
SECONDARY outcome
Timeframe: Birth, through the 22-26 months corrected age follow-up window, which corresponds to a median of 29 months calendar age in the analysis populationPopulation: The analysis population includes all randomized infants with available data up to the two-year followup.
This is measured as Yes if an infant died between birth and 22-26 months corrected age; Otherwise, No.
Outcome measures
| Measure |
Placebo
n=327 Participants
Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
|
Darbepoetin
n=319 Participants
Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou
|
|---|---|---|
|
Death
Death
|
53 Participants
|
52 Participants
|
|
Death
No Death
|
274 Participants
|
267 Participants
|
SECONDARY outcome
Timeframe: At 22-26 months corrected age (a median of 25 months corrected age)Population: The analysis population includes all randomized infants with available data at the two-year followup.
This is a 4-level outcome, where Severe NDI denotes a BSID III cognitive score less than 70, a Gross Motor Functional (GMF) level of 3-5 (where higher scores indicate worse outcomes), blindness (less than 20/200 vision), and/or profound hearing loss, Moderate NDI denotes a BSID III cognitive score from 70-84 and either a GMF level of 2 or limited blindness / moderate hearing loss, Mild NDI denotes a BSID III cognitive score from 70-84, or a cognitive score \>=85 with a GMF level of 1 and/or mild hearing loss, and No NDI denotes a cognitive score \>= 85 and an absence of neurosensory deficits.
Outcome measures
| Measure |
Placebo
n=237 Participants
Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
|
Darbepoetin
n=231 Participants
Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou
|
|---|---|---|
|
Neurodevelopmental Impairment
Mild
|
68 Participants
|
72 Participants
|
|
Neurodevelopmental Impairment
Moderate
|
3 Participants
|
1 Participants
|
|
Neurodevelopmental Impairment
None
|
124 Participants
|
121 Participants
|
|
Neurodevelopmental Impairment
Severe/profound
|
42 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: At 22-26 months corrected age (a median of 25 months corrected age)Population: The analysis population includes all randomized infants with available data at the two-year followup.
This is measured as Yes if the child has been deemed by the medical examiner as having Cerebral Palsy; Otherwise, No.
Outcome measures
| Measure |
Placebo
n=247 Participants
Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
|
Darbepoetin
n=244 Participants
Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks PMA, intravenously when the infant had intravenous access, otherwise subcutaneou
|
|---|---|---|
|
Any Cerebral Palsy
Any Cerebral Palsy
|
38 Participants
|
40 Participants
|
|
Any Cerebral Palsy
No Cerebral Palsy
|
209 Participants
|
204 Participants
|
Adverse Events
Darbepoetin
Serious events: 85 serious events
Other events: 16 other events
Deaths: 52 deaths
Placebo
Serious events: 92 serious events
Other events: 21 other events
Deaths: 53 deaths
Serious adverse events
| Measure |
Darbepoetin
n=316 participants at risk
Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age, intravenously when the infant had intravenous access, otherwise subcutaneously
|
Placebo
n=325 participants at risk
Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
|
|---|---|---|
|
Blood and lymphatic system disorders
Acute anemia
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Blood and lymphatic system disorders
DIC
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Blood and lymphatic system disorders
Twin-twin transfusion syndrome
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Cardiac disorders
Cardiac arrest
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Cardiac disorders
Cardiopulmonary arrest
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.62%
2/325 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Cardiac disorders
Ventricular dysfunction
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Congenital, familial and genetic disorders
Congenital anomaly
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Congenital, familial and genetic disorders
Newborn persistent pulmonary hypertension
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Gastrointestinal disorders
Esophageal perforation
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.63%
2/316 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Gastrointestinal disorders
Ileal perforation
|
0.63%
2/316 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Gastrointestinal disorders
Necrotizing enterocolitis neonatal
|
2.2%
7/316 • Number of events 7 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
4.0%
13/325 • Number of events 13 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Gastrointestinal disorders
Neonatal intestinal perforation
|
3.5%
11/316 • Number of events 11 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
3.7%
12/325 • Number of events 12 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.63%
2/316 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
General disorders
Multi-organ failure
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Hepatobiliary disorders
Direct hyperbilirubinemia
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.62%
2/325 • Number of events 3 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Hepatobiliary disorders
Failure liver
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Infections and infestations
Aspergillosis
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Infections and infestations
Enterovirus infection
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Infections and infestations
Infection
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Infections and infestations
Klebsiella infection
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Infections and infestations
Neonatal sepsis
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.62%
2/325 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Infections and infestations
Pneumonia
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Infections and infestations
Sepsis neonatal
|
10.1%
32/316 • Number of events 34 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
8.0%
26/325 • Number of events 27 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Infections and infestations
Staphylococcus aureus pneumonia
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.62%
2/325 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Infections and infestations
Urinary tract infection
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Injury, poisoning and procedural complications
Stoma site bleeding
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Investigations
Cerebrospinal fluid volume increased
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Nervous system disorders
Hydrocephalus
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Nervous system disorders
Intraventricular hemorrhage neonatal
|
1.9%
6/316 • Number of events 6 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
1.2%
4/325 • Number of events 4 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Nervous system disorders
Posthaemorrhagic hydrocephalus
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Nervous system disorders
Seizure
|
0.95%
3/316 • Number of events 3 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.62%
2/325 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Pregnancy, puerperium and perinatal conditions
Extreme immaturity
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Renal and urinary disorders
Oliguria
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Vascular disorders
Hemorrhage
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Respiratory, thoracic and mediastinal disorders
Acute lung injury
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory decompensation
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
0.63%
2/316 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.62%
2/325 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.00%
0/325 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.95%
3/316 • Number of events 3 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
1.5%
5/325 • Number of events 5 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
2.8%
9/316 • Number of events 9 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
2.5%
8/325 • Number of events 8 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary air leakage
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Respiratory, thoracic and mediastinal disorders
Syndrome respiratory distress newborn
|
0.00%
0/316 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.31%
1/325 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Vascular disorders
Hypertension neonatal
|
1.3%
4/316 • Number of events 4 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.62%
2/325 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Vascular disorders
Hypotension
|
0.32%
1/316 • Number of events 1 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
1.2%
4/325 • Number of events 4 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
|
Vascular disorders
Thrombosis
|
1.3%
4/316 • Number of events 4 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
0.62%
2/325 • Number of events 2 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
Other adverse events
| Measure |
Darbepoetin
n=316 participants at risk
Darbepoetin (Amgen, Thousand Oaks, CA), 10 mcg per kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age, intravenously when the infant had intravenous access, otherwise subcutaneously
|
Placebo
n=325 participants at risk
Normal saline, 0.4 mL/kg, administered once weekly from 36 hours of birth through 35 weeks postmenstrual age as a sham subcutaneous dose
|
|---|---|---|
|
Infections and infestations
Sepsis neonatal
|
5.1%
16/316 • Number of events 18 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
6.5%
21/325 • Number of events 22 • SAEs and Other AEs were monitored from the first dose of study drug through 36 completed weeks PMA (7 days after administration of the last dose of study drug). All-cause mortality was monitored through 22-26 months corrected age.
Denominators for SAEs and Other AEs were set to the number of randomized subjects who started study drug and did not withdraw from the study prior to hospital discharge. Thus, a total of 9 randomized subjects (5 who never started study drug, and an additional 4 who withdrew from the study prior to discharge) were excluded from these denominators. The denominator for all-cause mortality is the randomized population, excluding the four subjects that withdrew from the study prior to discharge.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place