Trial Outcomes & Findings for Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants (NCT NCT02579265)
NCT ID: NCT02579265
Last Updated: 2022-01-05
Results Overview
Analysis of patients with Event at any timepoint of sampling (i.e. Day 8, 15, 22, 29/end of Treatment) and subsequent (i.e. +7 days) confirmation.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
204 participants
Primary outcome timeframe
Screening, Day 8, 15, 22, 29/end of treatment + confirmatory sample: 7 days after conjugated bilirubin level exceeds 2 mg/dl
Results posted on
2022-01-05
Participant Flow
Participant milestones
| Measure |
Smoflipid 20%
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
|
Intralipid® 20%
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
78
|
|
Overall Study
COMPLETED
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
50
|
45
|
Reasons for withdrawal
| Measure |
Smoflipid 20%
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
|
Intralipid® 20%
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
|
|---|---|---|
|
Overall Study
Weaned off earlier than 28 days
|
44
|
43
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Any other reason not specified
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal due to increased conjugated bilirubin
|
1
|
0
|
Baseline Characteristics
Missing
Baseline characteristics by cohort
| Measure |
Intralipid® 20%
n=78 Participants
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
|
Smoflipid 20%
n=83 Participants
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.3 days
STANDARD_DEVIATION 12.16 • n=78 Participants
|
11.4 days
STANDARD_DEVIATION 21.58 • n=83 Participants
|
9.9 days
STANDARD_DEVIATION 17.67 • n=161 Participants
|
|
Age, Customized
Age category · Newborn (0-27 days)
|
75 Participants
n=78 Participants
|
77 Participants
n=83 Participants
|
152 Participants
n=161 Participants
|
|
Age, Customized
Age category · Infant (>=28 days)
|
3 Participants
n=78 Participants
|
6 Participants
n=83 Participants
|
9 Participants
n=161 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=78 Participants
|
39 Participants
n=83 Participants
|
84 Participants
n=161 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=78 Participants
|
44 Participants
n=83 Participants
|
77 Participants
n=161 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=78 Participants
|
17 Participants
n=83 Participants
|
25 Participants
n=161 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
70 Participants
n=78 Participants
|
66 Participants
n=83 Participants
|
136 Participants
n=161 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=78 Participants
|
0 Participants
n=83 Participants
|
0 Participants
n=161 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=78 Participants
|
2 Participants
n=83 Participants
|
4 Participants
n=161 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=78 Participants
|
2 Participants
n=83 Participants
|
3 Participants
n=161 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=78 Participants
|
0 Participants
n=83 Participants
|
1 Participants
n=161 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=78 Participants
|
4 Participants
n=83 Participants
|
15 Participants
n=161 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=78 Participants
|
65 Participants
n=83 Participants
|
122 Participants
n=161 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=78 Participants
|
0 Participants
n=83 Participants
|
0 Participants
n=161 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=78 Participants
|
10 Participants
n=83 Participants
|
16 Participants
n=161 Participants
|
|
Postmenstrual age at birth
|
238.4 days
STANDARD_DEVIATION 23.98 • n=78 Participants
|
243.2 days
STANDARD_DEVIATION 24.27 • n=83 Participants
|
240.9 days
STANDARD_DEVIATION 24.18 • n=161 Participants
|
|
Underlying disease type
No NEC
|
72 Participants
n=78 Participants
|
74 Participants
n=83 Participants
|
146 Participants
n=161 Participants
|
|
Underlying disease type
NEC
|
6 Participants
n=78 Participants
|
9 Participants
n=83 Participants
|
15 Participants
n=161 Participants
|
|
Body weight
|
2.25 kg
STANDARD_DEVIATION 0.663 • n=74 Participants • Missing
|
2.44 kg
STANDARD_DEVIATION 0.871 • n=82 Participants • Missing
|
2.35 kg
STANDARD_DEVIATION 0.783 • n=156 Participants • Missing
|
|
Body weight Z-score
|
-0.90 units on a scale
STANDARD_DEVIATION 0.969 • n=78 Participants
|
-1.06 units on a scale
STANDARD_DEVIATION 1.090 • n=83 Participants
|
-0.98 units on a scale
STANDARD_DEVIATION 1.034 • n=161 Participants
|
|
Body weight (category for age)
Low
|
12 Participants
n=74 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
20 Participants
n=82 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
32 Participants
n=156 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
|
Body weight (category for age)
Normal
|
62 Participants
n=74 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
62 Participants
n=82 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
124 Participants
n=156 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
|
Body weight (category for age)
High
|
0 Participants
n=74 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
0 Participants
n=82 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
0 Participants
n=156 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
|
Body length
|
44.36 cm
STANDARD_DEVIATION 4.407 • n=72 Participants • Missing
|
45.15 cm
STANDARD_DEVIATION 5.024 • n=78 Participants • Missing
|
44.77 cm
STANDARD_DEVIATION 4.739 • n=150 Participants • Missing
|
|
Body length Z-score
|
-1.02 units on a scale
STANDARD_DEVIATION 1.124 • n=72 Participants • Missing
|
-1.21 units on a scale
STANDARD_DEVIATION 1.339 • n=78 Participants • Missing
|
-1.11 units on a scale
STANDARD_DEVIATION 1.240 • n=150 Participants • Missing
|
|
Body length (category for age)
Low
|
12 Participants
n=72 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
25 Participants
n=78 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
37 Participants
n=150 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
|
Body length (category for age)
Normal
|
60 Participants
n=72 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
53 Participants
n=78 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
113 Participants
n=150 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
|
Body length (category for age)
High
|
0 Participants
n=72 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
0 Participants
n=78 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
0 Participants
n=150 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
|
Head circumference
|
31.28 cm
STANDARD_DEVIATION 2.798 • n=73 Participants • Missing
|
31.69 cm
STANDARD_DEVIATION 3.225 • n=78 Participants • Missing
|
31.49 cm
STANDARD_DEVIATION 3.024 • n=151 Participants • Missing
|
|
Head circumference Z-score
|
-0.76 units on a scale
STANDARD_DEVIATION 1.184 • n=73 Participants • Missing
|
-0.97 units on a scale
STANDARD_DEVIATION 1.249 • n=78 Participants • Missing
|
-0.87 units on a scale
STANDARD_DEVIATION 1.218 • n=151 Participants • Missing
|
|
Head circumference (category for age)
Low
|
9 Participants
n=73 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
20 Participants
n=78 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
29 Participants
n=151 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
|
Head circumference (category for age)
Normal
|
62 Participants
n=73 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
57 Participants
n=78 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
119 Participants
n=151 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
|
Head circumference (category for age)
High
|
2 Participants
n=73 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
1 Participants
n=78 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
3 Participants
n=151 Participants • Missing Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
|
|
Duration of pretreatment
|
8.8 days
STANDARD_DEVIATION 8.25 • n=45 Participants • Missing
|
7.3 days
STANDARD_DEVIATION 7.50 • n=49 Participants • Missing
|
8.0 days
STANDARD_DEVIATION 7.86 • n=94 Participants • Missing
|
PRIMARY outcome
Timeframe: Screening, Day 8, 15, 22, 29/end of treatment + confirmatory sample: 7 days after conjugated bilirubin level exceeds 2 mg/dlPopulation: The numbers in the subgroups refer to 100%
Analysis of patients with Event at any timepoint of sampling (i.e. Day 8, 15, 22, 29/end of Treatment) and subsequent (i.e. +7 days) confirmation.
Outcome measures
| Measure |
Intralipid® 20%
n=78 Participants
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
|
Smoflipid 20%
n=83 Participants
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
|
|---|---|---|
|
The Number of Patients in Each Treatment Group With Conjugated Bilirubin Levels > 2 mg/dL During the First 28 Days of Study Treatment, Confirmed by a Second Sample Collected 7 Days After the First Sample
Combined
|
3 Participants
|
2 Participants
|
|
The Number of Patients in Each Treatment Group With Conjugated Bilirubin Levels > 2 mg/dL During the First 28 Days of Study Treatment, Confirmed by a Second Sample Collected 7 Days After the First Sample
NEC
|
0 Participants
|
1 Participants
|
|
The Number of Patients in Each Treatment Group With Conjugated Bilirubin Levels > 2 mg/dL During the First 28 Days of Study Treatment, Confirmed by a Second Sample Collected 7 Days After the First Sample
No NEC
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1-29, and at Follow-up (+7 days) (if continued: until Day 85 + at Follow up)Population: The numbers at different timepoints refer to 100%. Timepoints \>10% of Subjects (overall) are displayed.
Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
Outcome measures
| Measure |
Intralipid® 20%
n=78 Participants
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
|
Smoflipid 20%
n=83 Participants
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
|
|---|---|---|
|
Body Weight (Change From Baseline)
Day 43 · Normal
|
15 Participants
|
8 Participants
|
|
Body Weight (Change From Baseline)
Baseline · High
|
0 Participants
|
0 Participants
|
|
Body Weight (Change From Baseline)
Day 64 · High
|
0 Participants
|
0 Participants
|
|
Body Weight (Change From Baseline)
Follow-up · Low
|
16 Participants
|
15 Participants
|
|
Body Weight (Change From Baseline)
Day 43 · High
|
0 Participants
|
1 Participants
|
|
Body Weight (Change From Baseline)
Day 50 · Low
|
2 Participants
|
3 Participants
|
|
Body Weight (Change From Baseline)
Baseline · Low
|
12 Participants
|
20 Participants
|
|
Body Weight (Change From Baseline)
Baseline · Normal
|
62 Participants
|
62 Participants
|
|
Body Weight (Change From Baseline)
Day 8 · Low
|
14 Participants
|
22 Participants
|
|
Body Weight (Change From Baseline)
Day 8 · Normal
|
61 Participants
|
55 Participants
|
|
Body Weight (Change From Baseline)
Day 8 · High
|
1 Participants
|
0 Participants
|
|
Body Weight (Change From Baseline)
Day 15 · Low
|
13 Participants
|
16 Participants
|
|
Body Weight (Change From Baseline)
Day 15 · Normal
|
45 Participants
|
48 Participants
|
|
Body Weight (Change From Baseline)
Day 15 · High
|
0 Participants
|
0 Participants
|
|
Body Weight (Change From Baseline)
Day 22 · Low
|
8 Participants
|
14 Participants
|
|
Body Weight (Change From Baseline)
Day 22 · Normal
|
31 Participants
|
31 Participants
|
|
Body Weight (Change From Baseline)
Day 22 · High
|
0 Participants
|
0 Participants
|
|
Body Weight (Change From Baseline)
Day 29 · Low
|
6 Participants
|
9 Participants
|
|
Body Weight (Change From Baseline)
Day 29 · Normal
|
25 Participants
|
24 Participants
|
|
Body Weight (Change From Baseline)
Day 29 · High
|
0 Participants
|
0 Participants
|
|
Body Weight (Change From Baseline)
Day 36 · Low
|
4 Participants
|
5 Participants
|
|
Body Weight (Change From Baseline)
Day 36 · Normal
|
16 Participants
|
13 Participants
|
|
Body Weight (Change From Baseline)
Day 36 · High
|
1 Participants
|
0 Participants
|
|
Body Weight (Change From Baseline)
Day 43 · Low
|
2 Participants
|
3 Participants
|
|
Body Weight (Change From Baseline)
Day 50 · Normal
|
10 Participants
|
7 Participants
|
|
Body Weight (Change From Baseline)
Day 50 · High
|
0 Participants
|
0 Participants
|
|
Body Weight (Change From Baseline)
Day 57 · Low
|
1 Participants
|
1 Participants
|
|
Body Weight (Change From Baseline)
Day 57 · Normal
|
10 Participants
|
7 Participants
|
|
Body Weight (Change From Baseline)
Day 57 · High
|
0 Participants
|
0 Participants
|
|
Body Weight (Change From Baseline)
Day 64 · Low
|
0 Participants
|
0 Participants
|
|
Body Weight (Change From Baseline)
Day 64 · Normal
|
9 Participants
|
6 Participants
|
|
Body Weight (Change From Baseline)
Follow-up · Normal
|
43 Participants
|
40 Participants
|
|
Body Weight (Change From Baseline)
Follow-up · High
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1, 8, 15, 22, 29/end of treatment, if continued: Day 36, 43, 50, 57, 64, 71, 78, 85/end of treatment, Follow-upPopulation: The numbers at different timepoints refer to 100%. Timepoints \>10% of Subjects (overall) are displayed.
Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
Outcome measures
| Measure |
Intralipid® 20%
n=78 Participants
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
|
Smoflipid 20%
n=83 Participants
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
|
|---|---|---|
|
Body Length (Change From Baseline)
Baseline · Low
|
12 Participants
|
25 Participants
|
|
Body Length (Change From Baseline)
Baseline · Normal
|
60 Participants
|
53 Participants
|
|
Body Length (Change From Baseline)
Baseline · High
|
0 Participants
|
0 Participants
|
|
Body Length (Change From Baseline)
Day 8 · Low
|
14 Participants
|
30 Participants
|
|
Body Length (Change From Baseline)
Day 8 · Normal
|
59 Participants
|
49 Participants
|
|
Body Length (Change From Baseline)
Day 8 · High
|
0 Participants
|
0 Participants
|
|
Body Length (Change From Baseline)
Day 15 · Low
|
14 Participants
|
25 Participants
|
|
Body Length (Change From Baseline)
Day 15 · Normal
|
47 Participants
|
39 Participants
|
|
Body Length (Change From Baseline)
Day 15 · High
|
0 Participants
|
0 Participants
|
|
Body Length (Change From Baseline)
Day 22 · Low
|
10 Participants
|
17 Participants
|
|
Body Length (Change From Baseline)
Day 22 · Normal
|
31 Participants
|
29 Participants
|
|
Body Length (Change From Baseline)
Day 22 · High
|
0 Participants
|
0 Participants
|
|
Body Length (Change From Baseline)
Day 29 · Low
|
6 Participants
|
13 Participants
|
|
Body Length (Change From Baseline)
Day 29 · Normal
|
27 Participants
|
20 Participants
|
|
Body Length (Change From Baseline)
Day 29 · High
|
0 Participants
|
0 Participants
|
|
Body Length (Change From Baseline)
Day 36 · Low
|
7 Participants
|
6 Participants
|
|
Body Length (Change From Baseline)
Day 36 · Normal
|
14 Participants
|
10 Participants
|
|
Body Length (Change From Baseline)
Day 36 · High
|
0 Participants
|
0 Participants
|
|
Body Length (Change From Baseline)
Day 43 · Low
|
4 Participants
|
4 Participants
|
|
Body Length (Change From Baseline)
Day 43 · Normal
|
13 Participants
|
9 Participants
|
|
Body Length (Change From Baseline)
Day 43 · High
|
0 Participants
|
0 Participants
|
|
Body Length (Change From Baseline)
Day 50 · Low
|
5 Participants
|
2 Participants
|
|
Body Length (Change From Baseline)
Day 50 · Normal
|
10 Participants
|
8 Participants
|
|
Body Length (Change From Baseline)
Day 50 · High
|
0 Participants
|
0 Participants
|
|
Body Length (Change From Baseline)
Day 57 · Low
|
1 Participants
|
1 Participants
|
|
Body Length (Change From Baseline)
Day 57 · Normal
|
9 Participants
|
6 Participants
|
|
Body Length (Change From Baseline)
Day 57 · High
|
1 Participants
|
1 Participants
|
|
Body Length (Change From Baseline)
Follow up · Low
|
16 Participants
|
26 Participants
|
|
Body Length (Change From Baseline)
Follow up · Normal
|
40 Participants
|
27 Participants
|
|
Body Length (Change From Baseline)
Follow up · High
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1, 8, 15, 22, 29/end of treatment, if continued: Day 36, 43, 50, 57, 64, 71, 78, 85/end of treatment, Follow-upPopulation: The numbers at different timepoints refer to 100%. Timepoints \>10% of Subjects (overall) are displayed.
Data were age-standardized using growth charts as suggested by Fenton (Fenton et al., 2013) and the World Health Organization (WHO) Multicenter Growth Reference Study (MGRS; WHO 2006, 2007).
Outcome measures
| Measure |
Intralipid® 20%
n=78 Participants
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
|
Smoflipid 20%
n=83 Participants
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
|
|---|---|---|
|
Head Circumference (Change From Baseline)
Baseline · Low
|
9 Participants
|
20 Participants
|
|
Head Circumference (Change From Baseline)
Baseline · Normal
|
62 Participants
|
57 Participants
|
|
Head Circumference (Change From Baseline)
Baseline · High
|
2 Participants
|
1 Participants
|
|
Head Circumference (Change From Baseline)
Day 8 · Low
|
10 Participants
|
21 Participants
|
|
Head Circumference (Change From Baseline)
Day 8 · Normal
|
63 Participants
|
59 Participants
|
|
Head Circumference (Change From Baseline)
Day 8 · High
|
0 Participants
|
1 Participants
|
|
Head Circumference (Change From Baseline)
Day 15 · Low
|
7 Participants
|
13 Participants
|
|
Head Circumference (Change From Baseline)
Day 15 · Normal
|
54 Participants
|
51 Participants
|
|
Head Circumference (Change From Baseline)
Day 15 · High
|
0 Participants
|
1 Participants
|
|
Head Circumference (Change From Baseline)
Day 22 · Low
|
5 Participants
|
12 Participants
|
|
Head Circumference (Change From Baseline)
Day 22 · Normal
|
36 Participants
|
34 Participants
|
|
Head Circumference (Change From Baseline)
Day 22 · High
|
0 Participants
|
0 Participants
|
|
Head Circumference (Change From Baseline)
Day 29 · Low
|
3 Participants
|
8 Participants
|
|
Head Circumference (Change From Baseline)
Day 29 · Normal
|
30 Participants
|
25 Participants
|
|
Head Circumference (Change From Baseline)
Day 29 · High
|
0 Participants
|
0 Participants
|
|
Head Circumference (Change From Baseline)
Day 36 · Low
|
2 Participants
|
5 Participants
|
|
Head Circumference (Change From Baseline)
Day 36 · Normal
|
18 Participants
|
10 Participants
|
|
Head Circumference (Change From Baseline)
Day 36 · High
|
0 Participants
|
1 Participants
|
|
Head Circumference (Change From Baseline)
Day 43 · Low
|
1 Participants
|
2 Participants
|
|
Head Circumference (Change From Baseline)
Day 43 · Normal
|
16 Participants
|
11 Participants
|
|
Head Circumference (Change From Baseline)
Day 43 · High
|
0 Participants
|
0 Participants
|
|
Head Circumference (Change From Baseline)
Day 50 · Low
|
1 Participants
|
1 Participants
|
|
Head Circumference (Change From Baseline)
Day 50 · Normal
|
14 Participants
|
8 Participants
|
|
Head Circumference (Change From Baseline)
Day 50 · High
|
0 Participants
|
1 Participants
|
|
Head Circumference (Change From Baseline)
Day 57 · Low
|
0 Participants
|
0 Participants
|
|
Head Circumference (Change From Baseline)
Day 57 · Normal
|
9 Participants
|
6 Participants
|
|
Head Circumference (Change From Baseline)
Day 57 · High
|
0 Participants
|
1 Participants
|
|
Head Circumference (Change From Baseline)
Day 64 · Low
|
0 Participants
|
0 Participants
|
|
Head Circumference (Change From Baseline)
Day 64 · Normal
|
8 Participants
|
5 Participants
|
|
Head Circumference (Change From Baseline)
Day 64 · High
|
0 Participants
|
0 Participants
|
|
Head Circumference (Change From Baseline)
Follow up · Low
|
9 Participants
|
9 Participants
|
|
Head Circumference (Change From Baseline)
Follow up · Normal
|
46 Participants
|
39 Participants
|
|
Head Circumference (Change From Baseline)
Follow up · High
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 29/end of treatment, if continued: Day 85/end of treatmentPopulation: The Standard Deviation for Time to Event was not calculated. NA=Not available
Time to full enteral or oral feeds (i.e. PN weaning) is the time from the randomization date to the date of the first full enteral or oral Feeds.
Outcome measures
| Measure |
Intralipid® 20%
n=58 Participants
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
|
Smoflipid 20%
n=58 Participants
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
|
|---|---|---|
|
Time to Full Enteral or Oral Feeds
|
21.95 Time to event in days
The cumulative incidence function for competing events (refer to Austin et al. Circulation. 2016 Feb 9; 133(6): 601-609) was used for the interpolation of the median time to event. 95% CIs were not calculated due to this approach.
|
23.29 Time to event in days
The cumulative incidence function for competing events (refer to Austin et al. Circulation. 2016 Feb 9; 133(6): 601-609) was used for the interpolation of the median time to event. 95% CIs were not calculated due to this approach.
|
SECONDARY outcome
Timeframe: Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatmentPopulation: Over time analysis of laboratory parameters were assessed at all timepoints as available
RBC refers to red blood cells. Timepoints \>10% of Subjects (overall) are displayed.
Outcome measures
| Measure |
Intralipid® 20%
n=70 Participants
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
|
Smoflipid 20%
n=78 Participants
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
|
|---|---|---|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
Mead acid Baseline
|
4.42 ug/mL
Standard Deviation 5.888
|
4.35 ug/mL
Standard Deviation 7.620
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
Eicosapentaenoic acid Baseline
|
7.36 ug/mL
Standard Deviation 6.545
|
14.52 ug/mL
Standard Deviation 16.480
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
Eicosapentaenoic acid Change to EoT
|
-1.57 ug/mL
Standard Deviation 7.336
|
30.44 ug/mL
Standard Deviation 38.615
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
Eicosapentaenoic acid Change to EoT extension phase
|
1.96 ug/mL
Standard Deviation 10.389
|
40.62 ug/mL
Standard Deviation 51.417
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
Docosahexaenoic acid Baseline
|
41.14 ug/mL
Standard Deviation 14.724
|
47.31 ug/mL
Standard Deviation 18.484
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
Docosahexaenoic Acid Change to Eot
|
-1.36 ug/mL
Standard Deviation 17.721
|
40.06 ug/mL
Standard Deviation 28.678
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
Docosahexaenoic Acid Change to EoT extension
|
9.55 ug/mL
Standard Deviation 19.462
|
49.93 ug/mL
Standard Deviation 41.868
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
Arachidonic Acid Baseline
|
148.80 ug/mL
Standard Deviation 52.531
|
149.42 ug/mL
Standard Deviation 47.438
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
Arachidonic Acid Change to EoT
|
-25.36 ug/mL
Standard Deviation 59.925
|
-31.47 ug/mL
Standard Deviation 54.249
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
Arachidonic Acid Change to EoT extension
|
-8.18 ug/mL
Standard Deviation 51.138
|
-60.00 ug/mL
Standard Deviation 73.737
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
Alpha-linolenic Acid Baseline
|
19.24 ug/mL
Standard Deviation 12.675
|
16.57 ug/mL
Standard Deviation 13.081
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
Alpha-linolenic Acid Change to EoT
|
-2.01 ug/mL
Standard Deviation 17.452
|
-3.31 ug/mL
Standard Deviation 13.250
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
Alpha-linolenic Acid Change to EoT extension
|
5.88 ug/mL
Standard Deviation 19.477
|
-0.55 ug/mL
Standard Deviation 11.454
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
Linoleic acid Baseline
|
460.62 ug/mL
Standard Deviation 211.354
|
427.44 ug/mL
Standard Deviation 185.206
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
Linoleic acid Change to EoT
|
50.95 ug/mL
Standard Deviation 270.029
|
-41.68 ug/mL
Standard Deviation 190.749
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
Linoleic acid Change to EoT extension
|
209.99 ug/mL
Standard Deviation 286.361
|
-50.25 ug/mL
Standard Deviation 2011.292
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
Mead acid Change to EoT
|
-2.46 ug/mL
Standard Deviation 6.816
|
-2.19 ug/mL
Standard Deviation 8.011
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
Mead Acid Change to EoT extension
|
1.82 ug/mL
Standard Deviation 9.045
|
-6.94 ug/mL
Standard Deviation 17.595
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
RBC Eicosapentaenoic acid Baseline
|
4.20 ug/mL
Standard Deviation 2.533
|
5.21 ug/mL
Standard Deviation 3.954
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
RBC Eicosapentaenoic acid Change to EoT
|
0.56 ug/mL
Standard Deviation 2.375
|
19.22 ug/mL
Standard Deviation 11.433
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
RBC Eicosapentaenoic acid Change to EoT extension
|
2.05 ug/mL
Standard Deviation 2.841
|
31.83 ug/mL
Standard Deviation 11.973
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
RBC Docosahexaenoic acid Baseline
|
94.18 ug/mL
Standard Deviation 26.246
|
92.53 ug/mL
Standard Deviation 28.435
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
RBC Docosahexaenoic acid Change to EoT
|
-41.60 ug/mL
Standard Deviation 53.983
|
-40.92 ug/mL
Standard Deviation 60.930
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
RBC Docosahexaenoic acid Change to EoT extension
|
-15.81 ug/mL
Standard Deviation 22.577
|
34.85 ug/mL
Standard Deviation 17.145
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
RBC Arachidonic acid Baseline
|
281.53 ug/mL
Standard Deviation 63.839
|
268.99 ug/mL
Standard Deviation 71.369
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
RBC Arachidonic acid Change to EoT
|
-41.60 ug/mL
Standard Deviation 53.983
|
-40.92 ug/mL
Standard Deviation 60.930
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
RBC Arachidonic acid Change to EoT extension
|
-47.30 ug/mL
Standard Deviation 62.470
|
-66.75 ug/mL
Standard Deviation 47.096
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
RBC Alpha-linolenic acid Baseline
|
2.31 ug/mL
Standard Deviation 1.014
|
2.12 ug/mL
Standard Deviation 1.060
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
RBC Alpha-linolenic acid Change to EoT
|
0.52 ug/mL
Standard Deviation 1.312
|
-0.04 ug/mL
Standard Deviation 1.049
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
RBC Alpha-linolenic acid Change to EoT extension
|
1.37 ug/mL
Standard Deviation 0.587
|
-0.17 ug/mL
Standard Deviation 1.365
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
RBC Linoleic acid Baseline
|
140.45 ug/mL
Standard Deviation 57.461
|
130.67 ug/mL
Standard Deviation 53.022
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
RBC Linoleic acid Change to EoT
|
57.04 ug/mL
Standard Deviation 64.201
|
4.29 ug/mL
Standard Deviation 42.276
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
RBC Linoleic acid Change to EoT extension
|
86.36 ug/mL
Standard Deviation 77.716
|
0.06 ug/mL
Standard Deviation 68.506
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
RBC Mead acid Baseline
|
9.21 ug/mL
Standard Deviation 4.378
|
8.30 ug/mL
Standard Deviation 4.289
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
RBC Mead acid Change to EoT
|
-4.19 ug/mL
Standard Deviation 3.315
|
-3.50 ug/mL
Standard Deviation 2.872
|
|
Fatty Acids in Plasma and Red Blood Cell Membranes (Change From Baseline)
RBC Mead acid Change to EoT extension
|
-7.45 ug/mL
Standard Deviation 4.576
|
-5.40 ug/mL
Standard Deviation 3.777
|
SECONDARY outcome
Timeframe: Day 1- Follow up (7 days after end of treatment)Length of stay in hospital (time from randomization to discharge) was be calculated. NA=Not available
Outcome measures
| Measure |
Intralipid® 20%
n=61 Participants
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
|
Smoflipid 20%
n=58 Participants
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
|
|---|---|---|
|
Length of Stay in Hospital
|
65.0 Median time (days) until discharge
The cumulative incidence function for competing events (refer to Austin et al. Circulation. 2016 Feb 9; 133(6): 601-609) was used for the interpolation of the median time to event. 95% CIs were not calculated due to this approach.
|
50.5 Median time (days) until discharge
The cumulative incidence function for competing events (refer to Austin et al. Circulation. 2016 Feb 9; 133(6): 601-609) was used for the interpolation of the median time to event. 95% CIs were not calculated due to this approach.
|
SECONDARY outcome
Timeframe: Day 1-29 or -85 if continued + Follow-upThe Ratio is the incidence of bloodstream infection by numbers of day on study medication.
Outcome measures
| Measure |
Intralipid® 20%
n=78 Participants
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
|
Smoflipid 20%
n=83 Participants
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
|
|---|---|---|
|
Ratio of Independent Bloodstream Infections to Number of Days on Study Medication
|
0.002 ratio
Standard Deviation 0.0105
|
0.003 ratio
Standard Deviation 0.0123
|
SECONDARY outcome
Timeframe: Day 1-29 or -85 if continued + Follow-upOutcome measures
| Measure |
Intralipid® 20%
n=78 Participants
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
|
Smoflipid 20%
n=83 Participants
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
|
|---|---|---|
|
Number of Patients With 1 or More Bloodstream Infections to Number of Patients on Study Medication
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 1-29 or -85 if continued + Follow-upThe Analysis was conducted over all study phases.
Outcome measures
| Measure |
Intralipid® 20%
n=78 Participants
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
|
Smoflipid 20%
n=83 Participants
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
|
|---|---|---|
|
Number of Patients Who Complete PN Treatment Without Lipid Minimization
|
73 Participants
|
79 Participants
|
SECONDARY outcome
Timeframe: Day 1-29 or -85 if continued + Follow-upOutcome measures
| Measure |
Intralipid® 20%
n=78 Participants
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
|
Smoflipid 20%
n=83 Participants
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
|
|---|---|---|
|
Number of Patients Needing to be Withdrawn From the Study Due to Elevated Conjugated Bilirubin Levels
Initial Treatment Phase
|
0 Participants
|
1 Participants
|
|
Number of Patients Needing to be Withdrawn From the Study Due to Elevated Conjugated Bilirubin Levels
Extension Phase
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1-29 or -85 if continued + Follow-upPopulation: Missing
The area under the curve (AUC\>1.5) is defined as the area between conjugated bilirubin concentrations \> 1.5 mg/dL and the horizontal line at 1.5 mg/dL, restricted by the time point of study withdrawal, if applicable. Analysis displays the summary of Area Under the Curve of Bilirubin Levels for the Time Period in Which Conjugated are \>1.5 mg/dL
Outcome measures
| Measure |
Intralipid® 20%
n=78 Participants
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
|
Smoflipid 20%
n=83 Participants
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
|
|---|---|---|
|
Area Under the Curve for Time Period in Which Conjugated Bilirubin Levels Are > 1.5 mg/dL in Patients Who Are Not Withdrawn From the Study
Initial Treatment Phase
|
0.587 mg/dl*days
Standard Deviation 2.6620
|
0.804 mg/dl*days
Standard Deviation 3.4700
|
|
Area Under the Curve for Time Period in Which Conjugated Bilirubin Levels Are > 1.5 mg/dL in Patients Who Are Not Withdrawn From the Study
Extended Treatment Phase
|
11.609 mg/dl*days
Standard Deviation 15.184
|
0.900 mg/dl*days
Standard Deviation 2.013
|
SECONDARY outcome
Timeframe: Day 1-29 or -85 if continued + Follow-upPopulation: Missing
The Analysis was performed over the entire study period.
Outcome measures
| Measure |
Intralipid® 20%
n=73 Participants
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
|
Smoflipid 20%
n=79 Participants
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
|
|---|---|---|
|
Cumulative Number of Days Patients Are Administered a Lipid Dose Without Lipid Minimization
|
27.8 Cumulative days
Standard Deviation 21.98
|
26.7 Cumulative days
Standard Deviation 19.94
|
SECONDARY outcome
Timeframe: Day 1-29 or -85 if continued + Follow-upPopulation: NA=Not available Since the number of events was not sufficient, no further analysis was performed.
Outcome measures
| Measure |
Intralipid® 20%
n=78 Participants
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
|
Smoflipid 20%
n=83 Participants
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
|
|---|---|---|
|
Time to Conjugated Bilirubin > 2 mg/dL (Confirmed by a Second Sample Collected 7 Days After the First)
|
NA Number of days
Not calculated due to due to low number of Events. The cumulative incidence function for competing events (refer to Austin et al. Circulation. 2016 Feb 9; 133(6): 601-609) was used for the interpolation of the median time to event. 95% CIs were not calculated due to this approach.
|
NA Number of days
Not calculated due to due to low number of Events. The cumulative incidence function for competing events (refer to Austin et al. Circulation. 2016 Feb 9; 133(6): 601-609) was used for the interpolation of the median time to event. 95% CIs were not calculated due to this approach.
|
SECONDARY outcome
Timeframe: Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatmentPopulation: Over time analysis of laboratory parameters were assessed at all timepoints as available. Timepoints \>10% of Subjects (overall) are displayed.
Outcome measures
| Measure |
Intralipid® 20%
n=70 Participants
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
|
Smoflipid 20%
n=78 Participants
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
|
|---|---|---|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Beta(b-) sitosterol Baseline
|
45.076 ug/mL
Standard Deviation 28.8520
|
41.900 ug/mL
Standard Deviation 28.7879
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
b-sitosterol Change to EoT
|
39.854 ug/mL
Standard Deviation 38.5996
|
-6.357 ug/mL
Standard Deviation 22.4175
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
b-sitosterol Change to EoT extension
|
129.938 ug/mL
Standard Deviation 52.8942
|
-14.247 ug/mL
Standard Deviation 46.0845
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Campesterol Baseline
|
12.396 ug/mL
Standard Deviation 10.1990
|
11.628 ug/mL
Standard Deviation 10.4005
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Campesterol Change to EoT
|
15.385 ug/mL
Standard Deviation 21.4772
|
-3.079 ug/mL
Standard Deviation 9.6125
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Campesterol Change to EoT extension
|
56.681 ug/mL
Standard Deviation 34.4784
|
-8.159 ug/mL
Standard Deviation 22.0449
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Stigmasterol Baseline
|
7.649 ug/mL
Standard Deviation 4.0597
|
6.473 ug/mL
Standard Deviation 3.5595
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Stigmasterol Change to EoT
|
4.830 ug/mL
Standard Deviation 5.6464
|
-2.658 ug/mL
Standard Deviation 3.2875
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Stigmasterol Change to EoT extension
|
17.862 ug/mL
Standard Deviation 3.0202
|
-2.422 ug/mL
Standard Deviation 5.1974
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Sitostanol Baseline
|
0.838 ug/mL
Standard Deviation 0.5692
|
0.710 ug/mL
Standard Deviation 0.4423
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Sitostanol Change to EoT
|
0.945 ug/mL
Standard Deviation 0.9989
|
-0.238 ug/mL
Standard Deviation 0.4344
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Sitostanol Change to Eot extension
|
0.134 ug/mL
Standard Deviation 0.0931
|
-0.169 ug/mL
Standard Deviation 0.2486
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Ergosterol Baseline
|
0.028 ug/mL
Standard Deviation 0.0210
|
0.025 ug/mL
Standard Deviation 0.0215
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Ergosterol Change to EoT
|
-0.007 ug/mL
Standard Deviation 0.0183
|
0.001 ug/mL
Standard Deviation 0.0214
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Ergosterol Change to EoT extension
|
0.002 ug/mL
Standard Deviation 0.0038
|
-0.010 ug/mL
Standard Deviation 0.0267
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Lathosterol Baseline
|
2.411 ug/mL
Standard Deviation 0.9417
|
2.215 ug/mL
Standard Deviation 1.0751
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Lathosterol Change to EoT
|
-0.366 ug/mL
Standard Deviation 1.1811
|
-0.279 ug/mL
Standard Deviation 1.1651
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Lathosterol Change to EoT extension
|
-0.801 ug/mL
Standard Deviation 0.8797
|
-0.956 ug/mL
Standard Deviation 2.2253
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Lanosterol Baseline
|
1.281 ug/mL
Standard Deviation 0.8046
|
1.135 ug/mL
Standard Deviation 0.5630
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Lanosterol Change to EoT
|
0.273 ug/mL
Standard Deviation 1.0466
|
-0.385 ug/mL
Standard Deviation 0.5471
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Lanosterol Change to EoT extension
|
1.039 ug/mL
Standard Deviation 0.9342
|
-0.548 ug/mL
Standard Deviation 0.7836
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Desmosterol Baseline
|
1.396 ug/mL
Standard Deviation 1.18371
|
1.196 ug/mL
Standard Deviation 1.0923
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Desmosterol Change to EoT
|
-0.508 ug/mL
Standard Deviation 2.0678
|
-0.014 ug/mL
Standard Deviation 1.3948
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Desmosterol Change to EoT extension
|
-2.337 ug/mL
Standard Deviation 4.2890
|
-0.562 ug/mL
Standard Deviation 1.6695
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Cholesterol Baseline
|
1159.638 ug/mL
Standard Deviation 293.2282
|
1163.654 ug/mL
Standard Deviation 334.7942
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Cholesterol Change to EoT
|
-129.433 ug/mL
Standard Deviation 295.6223
|
-23.072 ug/mL
Standard Deviation 358.8932
|
|
Blood Sampling for Special Analysis (Sterols Including Phytosterols, α-tocopherol)
Cholesterol Change to EoT extension
|
145.100 ug/mL
Standard Deviation 243.1133
|
-232.250 ug/mL
Standard Deviation 621.2414
|
SECONDARY outcome
Timeframe: Day 1, Day 29/end of treatment, if continued: Day 57, 85/end of treatmentEssential fatty acid deficiency is based on the ratio of Mead acid and Arachidonic acid (also called the triene/tetraene ratio or Holman index; Holman, 1960). A ratio of \> 0.2 was considered abnormal (=essential fatty acid deficiency; Holman et al., 1979). Timepoints with \>10% of patients are displayed.
Outcome measures
| Measure |
Intralipid® 20%
n=78 Participants
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
|
Smoflipid 20%
n=83 Participants
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
|
|---|---|---|
|
Holman Index
Baseline · <0.05
|
61 Participants
|
72 Participants
|
|
Holman Index
Baseline · >=0.05 <0.20
|
9 Participants
|
5 Participants
|
|
Holman Index
Baseline · >=0.20 <0.40
|
0 Participants
|
1 Participants
|
|
Holman Index
Baseline · >=0.40
|
0 Participants
|
0 Participants
|
|
Holman Index
Baseline · Not assessed
|
8 Participants
|
5 Participants
|
|
Holman Index
Day 29 · <0.05
|
27 Participants
|
27 Participants
|
|
Holman Index
Day 29 · >=0.05 <0.20
|
1 Participants
|
1 Participants
|
|
Holman Index
Day 29 · >=0.20 <0.40
|
0 Participants
|
0 Participants
|
|
Holman Index
Day 29 · >=0.40
|
0 Participants
|
0 Participants
|
|
Holman Index
Day 29 · Not assessed
|
50 Participants
|
55 Participants
|
|
Holman Index
EoT initial Treatment phase · <0.05
|
62 Participants
|
69 Participants
|
|
Holman Index
EoT initial Treatment phase · >=0.05 <0.20
|
2 Participants
|
2 Participants
|
|
Holman Index
EoT initial Treatment phase · >=0.20 <0.40
|
0 Participants
|
0 Participants
|
|
Holman Index
EoT initial Treatment phase · >=0.40
|
0 Participants
|
0 Participants
|
|
Holman Index
EoT initial Treatment phase · Not assessed
|
14 Participants
|
12 Participants
|
|
Holman Index
EoT Extension phase · <0.05
|
10 Participants
|
11 Participants
|
|
Holman Index
EoT Extension phase · >=0.05 <0.20
|
1 Participants
|
1 Participants
|
|
Holman Index
EoT Extension phase · >=0.20 <0.40
|
0 Participants
|
0 Participants
|
|
Holman Index
EoT Extension phase · >=0.40
|
0 Participants
|
0 Participants
|
|
Holman Index
EoT Extension phase · Not assessed
|
67 Participants
|
71 Participants
|
Adverse Events
Intralipid® 20%
Serious events: 5 serious events
Other events: 55 other events
Deaths: 1 deaths
Smoflipid 20%
Serious events: 8 serious events
Other events: 59 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Intralipid® 20%
n=78 participants at risk
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
|
Smoflipid 20%
n=83 participants at risk
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
|
|---|---|---|
|
Cardiac disorders
Cardiogenic shock
|
1.3%
1/78 • Number of events 1 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
0.00%
0/83 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/78 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
1.2%
1/83 • Number of events 1 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Gastrointestinal disorders
Necrotising colitis
|
1.3%
1/78 • Number of events 1 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
1.2%
1/83 • Number of events 1 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/78 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
1.2%
1/83 • Number of events 1 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Infections and infestations
Escherichia bacteraemia
|
1.3%
1/78 • Number of events 1 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
0.00%
0/83 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/78 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
1.2%
1/83 • Number of events 1 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Infections and infestations
Escherichia urinary tract infection
|
1.3%
1/78 • Number of events 1 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
0.00%
0/83 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Infections and infestations
Meningitis
|
0.00%
0/78 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
1.2%
1/83 • Number of events 1 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Infections and infestations
Sepsis
|
0.00%
0/78 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
1.2%
1/83 • Number of events 1 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Infections and infestations
Sepsis neonatal
|
0.00%
0/78 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
1.2%
1/83 • Number of events 1 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/78 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
1.2%
1/83 • Number of events 1 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Injury, poisoning and procedural complications
Tracheal injury
|
1.3%
1/78 • Number of events 1 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
0.00%
0/83 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Investigations
Candida test positive
|
1.3%
1/78 • Number of events 1 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
0.00%
0/83 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.3%
1/78 • Number of events 1 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
0.00%
0/83 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary vein stenosis
|
1.3%
1/78 • Number of events 1 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
0.00%
0/83 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.3%
1/78 • Number of events 1 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
0.00%
0/83 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
Other adverse events
| Measure |
Intralipid® 20%
n=78 participants at risk
Intralipid is a long-chain triglyceride emulsion derived from purified soybean oil and egg yolk phospholipids. Intralipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Intralipid® 20%: Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Intralipid® 20% will be infused into a central or peripheral vein.
|
Smoflipid 20%
n=83 participants at risk
Smoflipid is a lipid emulsion containing soybean oil, MCTs (medium-chain triglycerides), olive oil, and fish oil. Smoflipid belongs to the pharmacotherapeutic group: "Solutions for parenteral nutrition, fat emulsions".
Smoflipid 20% (investigational lipid for parenteral nutrition): Dose: The targeted maximal dose is 3.0 g/kg/day.
In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
Smoflipid 20% will be infused into a central or a peripheral vein.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
10.3%
8/78 • Number of events 11 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
4.8%
4/83 • Number of events 5 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Blood and lymphatic system disorders
Anemia neonatal
|
21.8%
17/78 • Number of events 20 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
18.1%
15/83 • Number of events 16 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Cardiac disorders
Tachycardia
|
5.1%
4/78 • Number of events 6 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
3.6%
3/83 • Number of events 3 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.8%
3/78 • Number of events 3 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
8.4%
7/83 • Number of events 8 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.4%
5/78 • Number of events 6 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
4.8%
4/83 • Number of events 4 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Gastrointestinal disorders
Constipation
|
9.0%
7/78 • Number of events 7 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
8.4%
7/83 • Number of events 9 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Gastrointestinal disorders
Diarrhea
|
5.1%
4/78 • Number of events 8 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
3.6%
3/83 • Number of events 4 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
9.0%
7/78 • Number of events 7 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
6.0%
5/83 • Number of events 5 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Gastrointestinal disorders
Vomiting
|
20.5%
16/78 • Number of events 25 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
18.1%
15/83 • Number of events 27 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Hepatobiliary disorders
Cholestasis
|
11.5%
9/78 • Number of events 9 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
8.4%
7/83 • Number of events 7 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Investigations
Bilirubin conjugated increased
|
9.0%
7/78 • Number of events 8 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
3.6%
3/83 • Number of events 3 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.7%
6/78 • Number of events 7 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
1.2%
1/83 • Number of events 1 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Investigations
C-reactive protein increased
|
9.0%
7/78 • Number of events 7 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
7.2%
6/83 • Number of events 8 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Investigations
Cardiac murmur
|
5.1%
4/78 • Number of events 4 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
1.2%
1/83 • Number of events 1 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Investigations
Gamma-glutamyltransferase increased
|
14.1%
11/78 • Number of events 12 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
12.0%
10/83 • Number of events 10 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Investigations
Hematocrit decreased
|
6.4%
5/78 • Number of events 6 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
2.4%
2/83 • Number of events 2 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.6%
2/78 • Number of events 2 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
6.0%
5/83 • Number of events 7 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.6%
2/78 • Number of events 2 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
6.0%
5/83 • Number of events 7 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
2.6%
2/78 • Number of events 2 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
7.2%
6/83 • Number of events 7 • Monitoring of AEs, including SAEs, was conducted throughout the study. The Investigator or designee recorded all AEs after informed consent and until the patient's last follow-up visit. The minimum monitoring period was 7 days after first treatment and the maximum period was up to day 92 after first treatment.
Analyses were focused on TEAEs and were performed by primary MedDRA SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once; when an AE occurs more than once for a patient, the maximum severity and causality was used. Data shown refer to Treatment Emergent Adverse Events (TEAEs) only.
|
Additional Information
Dr. Jean-Marc Lohse, Director Clinical Operations PN NAM & ELAMA
Fresenius Kabi Deutschland GmbH
Phone: +49 6172 686
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER