Trial Outcomes & Findings for A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD (NCT NCT03857841)

NCT ID: NCT03857841

Last Updated: 2021-10-12

Results Overview

The safety and tolerability of UNEX-42 in subjects with BPD was evaluated by the number of subjects with treatment-emergent adverse events, including death, computed by dose cohort and overall during the Post-treatment Phase.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 3 participants
• Primary outcome timeframe: From Day 1 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first
• Results posted on: 2021-10-12

Participant Flow

Participant milestones

Measure	20 Pmol Phospholipid/kg Body Weight UNEX-42 administered at 20 pmol phospholipid/kg body weight UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline.	60 Pmol Phospholipid/kg Body Weight UNEX-42 administered at 60 pmol phospholipid/kg body weight UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline.	200 Pmol Phospholipid/kg Body Weight UNEX-42 administered at 200 pmol phospholipid/kg body weight UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline.	Placebo Phosphate-buffered saline Phosphate-buffered saline: Phosphate-buffered saline
Overall Study STARTED	2	0	0	1
Overall Study COMPLETED	0	0	0	1
Overall Study NOT COMPLETED	2	0	0	0

Reasons for withdrawal

Measure	20 Pmol Phospholipid/kg Body Weight UNEX-42 administered at 20 pmol phospholipid/kg body weight UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline.	60 Pmol Phospholipid/kg Body Weight UNEX-42 administered at 60 pmol phospholipid/kg body weight UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline.	200 Pmol Phospholipid/kg Body Weight UNEX-42 administered at 200 pmol phospholipid/kg body weight UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline.	Placebo Phosphate-buffered saline Phosphate-buffered saline: Phosphate-buffered saline
Overall Study Death	1	0	0	0
Overall Study Study Terminated by Sponsor	1	0	0	0

Baseline Characteristics

A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD

Baseline characteristics by cohort

Measure	20 Pmol Phospholipid/kg Body Weight n=2 Participants UNEX-42 administered at 20 pmol phospholipid/kg body weight UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline.	60 Pmol Phospholipid/kg Body Weight UNEX-42 administered at 60 pmol phospholipid/kg body weight UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline.	200 Pmol Phospholipid/kg Body Weight UNEX-42 administered at 200 pmol phospholipid/kg body weight UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline.	Placebo n=1 Participants Phosphate-buffered saline Phosphate-buffered saline: Phosphate-buffered saline	Total n=3 Participants Total of all reporting groups
Age, Customized Postnatal Age - 5 Days	0 participants n=5 Participants	—	—	1 participants n=4 Participants	1 participants n=21 Participants
Age, Customized Postnatal Age - 7 Days	1 participants n=5 Participants	—	—	0 participants n=4 Participants	1 participants n=21 Participants
Age, Customized Postnatal Age - 12 Days	1 participants n=5 Participants	—	—	0 participants n=4 Participants	1 participants n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	—	—	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	—	—	1 Participants n=4 Participants	2 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	—	—	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	2 participants n=5 Participants	—	—	1 participants n=4 Participants	3 participants n=21 Participants
Gestation Age at Birth 23 Weeks/0 Days	0 participants n=5 Participants	—	—	1 participants n=4 Participants	1 participants n=21 Participants
Gestation Age at Birth 24 Weeks/1 Day	1 participants n=5 Participants	—	—	0 participants n=4 Participants	1 participants n=21 Participants
Gestation Age at Birth 24 Weeks/5 Days	1 participants n=5 Participants	—	—	0 participants n=4 Participants	1 participants n=21 Participants

PRIMARY outcome

Timeframe: From Day 1 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first

Population: All subjects randomized and received clinical study material.

The safety and tolerability of UNEX-42 in subjects with BPD was evaluated by the number of subjects with treatment-emergent adverse events, including death, computed by dose cohort and overall during the Post-treatment Phase.

Outcome measures

Measure	20 Pmol Phospholipid/kg Body Weight n=2 Participants UNEX-42 administered at 20 pmol phospholipid/kg body weight UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline.	60 Pmol Phospholipid/kg Body Weight UNEX-42 administered at 60 pmol phospholipid/kg body weight UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline.	200 Pmol Phospholipid/kg Body Weight UNEX-42 administered at 200 pmol phospholipid/kg body weight UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline.	Placebo n=1 Participants Phosphate-buffered saline Phosphate-buffered saline: Phosphate-buffered saline
Number of Subjects With Treatment-emergent Adverse Events During the Post-treatment Phase (Safety and Tolerability)	2 Participants	0 Participants	0 Participants	1 Participants

Adverse Events

20 Pmol Phospholipid/kg Body Weight

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

60 Pmol Phospholipid/kg Body Weight

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

200 Pmol Phospholipid/kg Body Weight

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	20 Pmol Phospholipid/kg Body Weight n=2 participants at risk UNEX-42 administered at 20 pmol phospholipid/kg body weight UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline.	60 Pmol Phospholipid/kg Body Weight UNEX-42 administered at 60 pmol phospholipid/kg body weight UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline.	200 Pmol Phospholipid/kg Body Weight UNEX-42 administered at 200 pmol phospholipid/kg body weight UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline.	Placebo n=1 participants at risk Phosphate-buffered saline Phosphate-buffered saline: Phosphate-buffered saline
Gastrointestinal disorders Necrotizing colitis	50.0% 1/2 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	0.00% 0/1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.

Other adverse events

Measure	20 Pmol Phospholipid/kg Body Weight n=2 participants at risk UNEX-42 administered at 20 pmol phospholipid/kg body weight UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline.	60 Pmol Phospholipid/kg Body Weight UNEX-42 administered at 60 pmol phospholipid/kg body weight UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline.	200 Pmol Phospholipid/kg Body Weight UNEX-42 administered at 200 pmol phospholipid/kg body weight UNEX-42: UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline.	Placebo n=1 participants at risk Phosphate-buffered saline Phosphate-buffered saline: Phosphate-buffered saline
Vascular disorders Hypotension	50.0% 1/2 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	100.0% 1/1 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
General disorders Generalized edema	0.00% 0/2 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	100.0% 1/1 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Congenital, familial and genetic disorders Atrial septal defect	50.0% 1/2 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	0.00% 0/1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/2 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	100.0% 1/1 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Hepatobiliary disorders Cholestasis	0.00% 0/2 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	100.0% 1/1 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Blood and lymphatic system disorders Coagulopathy	50.0% 1/2 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	0.00% 0/1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Metabolism and nutrition disorders Hypovolemia	50.0% 1/2 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	0.00% 0/1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Gastrointestinal disorders Gastroesophageal reflux disease	50.0% 1/2 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	0.00% 0/1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Hepatobiliary disorders Hyperbilirubinemia	0.00% 0/2 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	100.0% 1/1 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/2 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	100.0% 1/1 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/2 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	100.0% 1/1 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Metabolism and nutrition disorders Hypoalbuminemia	50.0% 1/2 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	0.00% 0/1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Metabolism and nutrition disorders Hypocalcemia	50.0% 1/2 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	0.00% 0/1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Metabolism and nutrition disorders Hyponatremia	50.0% 1/2 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	0.00% 0/1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Gastrointestinal disorders Intestinal obstruction	50.0% 1/2 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	100.0% 1/1 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Infections and infestations Beta hemolytic streptococcal infection	50.0% 1/2 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	0.00% 0/1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	50.0% 1/2 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	100.0% 1/1 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Nervous system disorders Hydrocephalus	0.00% 0/2 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	100.0% 1/1 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Injury, poisoning and procedural complications Head injury	50.0% 1/2 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	0.00% 0/1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Renal and urinary disorders Renal impairment	0.00% 0/2 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	100.0% 1/1 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Vascular disorders Thrombophlebitis superficial	50.0% 1/2 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	0.00% 0/1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Investigations Transaminases increased	0.00% 0/2 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	100.0% 1/1 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Metabolism and nutrition disorders Vitamin D deficiency	50.0% 1/2 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	0.00% 0/1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/2 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	100.0% 1/1 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Injury, poisoning and procedural complications Wound dehiscence	50.0% 1/2 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	0.00% 0/1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.
Infections and infestations Oral candidiasis	0.00% 0/2 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	— 0/0 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.	100.0% 1/1 • Number of events 1 • From Day -2 to 40 Weeks Post-menstrual Age or Hospital Discharge, whichever came first Specific complications of prematurity were assessed from Screening to 40 Weeks PMA/Hospital Discharge. Complications of prematurity were only recorded as an AE or SAE if the event was unusual with respect to intensity, frequency, duration as compared with symptoms in the subject's medical history, or if there was a reasonable possibility that the event was caused by the study drug. Congenital disorders were recorded as medical history, even if diagnosed after the subject had entered the study.

Additional Information

Global Medical Information

United Therapeutics Corp.

Phone: 919-485-8350

Email: clinicaltrials@unither.com

Results disclosure agreements

• Principal investigator is a sponsor employee Institution and/or Principal Investigator agree not to publish or publicly present any interim results of the study without the prior written consent of Sponsor, not to be unreasonably withheld or delayed. Institution and/or Principal Investigator further agree to provide Sponsor with drafts of any such publication or presentation for review and approval no less than 30 days prior to submission for publication or the date of public presentation.
• Publication restrictions are in place

Restriction type: OTHER