Trial Outcomes & Findings for KL₄Surfactant Treatment in Patients With ARDS (NCT NCT00215553)
NCT ID: NCT00215553
Last Updated: 2018-08-09
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
Through 28 days
Results posted on
2018-08-09
Participant Flow
Recruitment occurred between May 2001 to February 2006 in hospital ICUs
Participant milestones
| Measure |
A.1 Lucinactant
3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
|
A.2 Lucinactant
3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
A.3 Lucinactant
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
A.4 Lucinactant
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
|
B.1 Lucinactant
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
B.2 Lucinactant
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
|
B.3 SoC
Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
6
|
5
|
28
|
38
|
36
|
|
Overall Study
COMPLETED
|
5
|
5
|
4
|
4
|
26
|
32
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
1
|
2
|
6
|
0
|
Reasons for withdrawal
| Measure |
A.1 Lucinactant
3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
|
A.2 Lucinactant
3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
A.3 Lucinactant
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
A.4 Lucinactant
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
|
B.1 Lucinactant
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
B.2 Lucinactant
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
|
B.3 SoC
Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
1
|
2
|
6
|
0
|
Baseline Characteristics
KL₄Surfactant Treatment in Patients With ARDS
Baseline characteristics by cohort
| Measure |
A.1 Lucinactant
n=5 Participants
3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
|
A.2 Lucinactant
n=6 Participants
3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
A.3 Lucinactant
n=6 Participants
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
A.4 Lucinactant
n=5 Participants
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
|
B.1 Lucinactant
n=28 Participants
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
B.2 Lucinactant
n=38 Participants
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
|
B.3 SoC
n=36 Participants
Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
32 Participants
n=115 Participants
|
107 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
16 Participants
n=24 Participants
|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 24.0 • n=5 Participants
|
50.5 years
STANDARD_DEVIATION 17.1 • n=7 Participants
|
45.6 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
41.6 years
STANDARD_DEVIATION 6.2 • n=4 Participants
|
46.3 years
STANDARD_DEVIATION 12.5 • n=21 Participants
|
51.8 years
STANDARD_DEVIATION 13.0 • n=10 Participants
|
47.3 years
STANDARD_DEVIATION 12.6 • n=115 Participants
|
48.5 years
STANDARD_DEVIATION 13.1 • n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
22 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
57 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
67 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
5 participants
n=4 Participants
|
25 participants
n=21 Participants
|
32 participants
n=10 Participants
|
23 participants
n=115 Participants
|
102 participants
n=24 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
5 participants
n=10 Participants
|
9 participants
n=115 Participants
|
17 participants
n=24 Participants
|
|
Region of Enrollment
Russian Federation
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
4 participants
n=115 Participants
|
5 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Through 28 daysPopulation: In Part A, 5 subjects provided a reasonable cohort to adequately examine the safety of each treatment regimen. In Part B, 30 subjects were planned to be enrolled in each treatment group (a total of 90 subjects), enough to calculate the dose response curve. Analyses conducted on Intent-to-Treat population (all enrolled subjects).
Outcome measures
| Measure |
A.1 Lucinactant
n=5 Participants
3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
|
A.2 Lucinactant
n=6 Participants
3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
A.3 Lucinactant
n=6 Participants
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
A.4 Lucinactant
n=5 Participants
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
|
B.1 Lucinactant
n=28 Participants
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
B.2 Lucinactant
n=38 Participants
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
|
B.3 SoC
n=36 Participants
Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
|
|---|---|---|---|---|---|---|---|
|
Incidence of Patients Being Alive and Not Receiving Mechanical Ventilation for ≥48 Hours at the End of Day 28.
|
2 participants
|
4 participants
|
4 participants
|
5 participants
|
20 participants
|
26 participants
|
29 participants
|
SECONDARY outcome
Timeframe: Through 28 daysPopulation: In Part A, 5 subjects provided a reasonable cohort to adequately examine the safety of each treatment regimen. In Part B, 30 subjects were planned to be enrolled in each treatment group (a total of 90 subjects), enough to calculate the dose response curve. Analyses conducted on Intent-to-Treat population (all enrolled subjects).
Outcome measures
| Measure |
A.1 Lucinactant
n=5 Participants
3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
|
A.2 Lucinactant
n=6 Participants
3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
A.3 Lucinactant
n=6 Participants
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
A.4 Lucinactant
n=5 Participants
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
|
B.1 Lucinactant
n=28 Participants
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
B.2 Lucinactant
n=38 Participants
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
|
B.3 SoC
n=36 Participants
Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
|
|---|---|---|---|---|---|---|---|
|
Mortality
|
3 participants
|
2 participants
|
0 participants
|
0 participants
|
4 participants
|
9 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Through 28 daysPopulation: In Part A, 5 subjects provided a reasonable cohort to adequately examine the safety of each treatment regimen. In Part B, 30 subjects were planned to be enrolled in each treatment group (a total of 90 subjects), enough to calculate the dose response curve. Analyses conducted on Intent-to-Treat population (all enrolled subjects).
Number of days in ICU
Outcome measures
| Measure |
A.1 Lucinactant
n=5 Participants
3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
|
A.2 Lucinactant
n=6 Participants
3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
A.3 Lucinactant
n=6 Participants
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
A.4 Lucinactant
n=5 Participants
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
|
B.1 Lucinactant
n=28 Participants
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
B.2 Lucinactant
n=38 Participants
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
|
B.3 SoC
n=36 Participants
Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
|
|---|---|---|---|---|---|---|---|
|
Days in ICU
|
23.4 days
Standard Deviation 7.06
|
20.5 days
Standard Deviation 7.53
|
14.3 days
Standard Deviation 9.81
|
20.0 days
Standard Deviation 2.74
|
15.3 days
Standard Deviation 9.01
|
19.9 days
Standard Deviation 7.66
|
17.4 days
Standard Deviation 8.10
|
Adverse Events
A.1 Lucinactant
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
A.2 Lucinactant
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
A.3 Lucinactant
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
A.4 Lucinactant
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
B.1 Lucinactant
Serious events: 10 serious events
Other events: 24 other events
Deaths: 0 deaths
B.2 Lucinactant
Serious events: 19 serious events
Other events: 37 other events
Deaths: 0 deaths
B.3 SoC
Serious events: 13 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A.1 Lucinactant
n=5 participants at risk
3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
|
A.2 Lucinactant
n=6 participants at risk
3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
A.3 Lucinactant
n=6 participants at risk
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
A.4 Lucinactant
n=5 participants at risk
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
|
B.1 Lucinactant
n=28 participants at risk
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
B.2 Lucinactant
n=38 participants at risk
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
|
B.3 SoC
n=36 participants at risk
Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Death NOS
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
5.3%
2/38 • Number of events 2 • 28 days
|
0.00%
0/36 • 28 days
|
|
General disorders
Multi-organ failure
|
40.0%
2/5 • Number of events 2 • 28 days
|
16.7%
1/6 • Number of events 1 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
3.6%
1/28 • Number of events 1 • 28 days
|
5.3%
2/38 • Number of events 2 • 28 days
|
2.8%
1/36 • Number of events 1 • 28 days
|
|
Infections and infestations
Sepsis NOS
|
0.00%
0/5 • 28 days
|
16.7%
1/6 • Number of events 1 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
7.1%
2/28 • Number of events 2 • 28 days
|
5.3%
2/38 • Number of events 2 • 28 days
|
0.00%
0/36 • 28 days
|
|
Infections and infestations
Septic shock
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
2.6%
1/38 • Number of events 1 • 28 days
|
2.8%
1/36 • Number of events 1 • 28 days
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/5 • 28 days
|
16.7%
1/6 • Number of events 1 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
2.6%
1/38 • Number of events 1 • 28 days
|
0.00%
0/36 • 28 days
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
5.3%
2/38 • Number of events 2 • 28 days
|
0.00%
0/36 • 28 days
|
|
Nervous system disorders
Metabolic encephalopathy
|
20.0%
1/5 • Number of events 1 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
0.00%
0/38 • 28 days
|
0.00%
0/36 • 28 days
|
|
Renal and urinary disorders
Renal failure NOS
|
20.0%
1/5 • Number of events 1 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
3.6%
1/28 • Number of events 1 • 28 days
|
2.6%
1/38 • Number of events 1 • 28 days
|
2.8%
1/36 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
20.0%
1/5 • Number of events 2 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
3.6%
1/28 • Number of events 1 • 28 days
|
2.6%
1/38 • Number of events 1 • 28 days
|
2.8%
1/36 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
1/5 • Number of events 1 • 28 days
|
16.7%
1/6 • Number of events 1 • 28 days
|
16.7%
1/6 • Number of events 1 • 28 days
|
0.00%
0/5 • 28 days
|
14.3%
4/28 • Number of events 4 • 28 days
|
5.3%
2/38 • Number of events 2 • 28 days
|
5.6%
2/36 • Number of events 2 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
5.3%
2/38 • Number of events 2 • 28 days
|
5.6%
2/36 • Number of events 3 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax NOS
|
20.0%
1/5 • Number of events 2 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
14.3%
4/28 • Number of events 4 • 28 days
|
18.4%
7/38 • Number of events 10 • 28 days
|
0.00%
0/36 • 28 days
|
|
Vascular disorders
Hypotension NOS
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
16.7%
1/6 • Number of events 1 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
2.6%
1/38 • Number of events 1 • 28 days
|
0.00%
0/36 • 28 days
|
|
Vascular disorders
Pulmonary embolism
|
20.0%
1/5 • Number of events 2 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
3.6%
1/28 • Number of events 1 • 28 days
|
0.00%
0/38 • 28 days
|
0.00%
0/36 • 28 days
|
|
Vascular disorders
Ischaemic stroke NEC
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
3.6%
1/28 • Number of events 1 • 28 days
|
0.00%
0/38 • 28 days
|
0.00%
0/36 • 28 days
|
|
Vascular disorders
Venous thrombosis deep limb
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
0.00%
0/38 • 28 days
|
2.8%
1/36 • Number of events 1 • 28 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage NOS
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
3.6%
1/28 • Number of events 1 • 28 days
|
0.00%
0/38 • 28 days
|
0.00%
0/36 • 28 days
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
2.6%
1/38 • Number of events 1 • 28 days
|
2.8%
1/36 • Number of events 1 • 28 days
|
|
Gastrointestinal disorders
Necrotising enterocolitis
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
3.6%
1/28 • Number of events 1 • 28 days
|
0.00%
0/38 • 28 days
|
0.00%
0/36 • 28 days
|
|
Cardiac disorders
Bradycardia NOS
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
2.6%
1/38 • Number of events 1 • 28 days
|
0.00%
0/36 • 28 days
|
|
Cardiac disorders
Pulmonary oedema
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
2.6%
1/38 • Number of events 1 • 28 days
|
0.00%
0/36 • 28 days
|
|
Infections and infestations
Empyema NOS
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
2.6%
1/38 • Number of events 1 • 28 days
|
0.00%
0/36 • 28 days
|
|
Infections and infestations
Lung abscess NOS
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
2.6%
1/38 • Number of events 1 • 28 days
|
0.00%
0/36 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure (exc neonatal)
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
2.6%
1/38 • Number of events 1 • 28 days
|
2.8%
1/36 • Number of events 1 • 28 days
|
|
Investigations
Neurologic examination abnormality
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
0.00%
0/38 • 28 days
|
2.8%
1/36 • Number of events 1 • 28 days
|
|
Psychiatric disorders
Agitation aggravated
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
3.6%
1/28 • Number of events 1 • 28 days
|
0.00%
0/38 • 28 days
|
0.00%
0/36 • 28 days
|
|
Nervous system disorders
Confusion
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
3.6%
1/28 • Number of events 1 • 28 days
|
0.00%
0/38 • 28 days
|
0.00%
0/36 • 28 days
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/5 • 28 days
|
16.7%
1/6 • Number of events 1 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
0.00%
0/38 • 28 days
|
0.00%
0/36 • 28 days
|
|
Nervous system disorders
Hypoxic encephelopathy
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
2.6%
1/38 • Number of events 1 • 28 days
|
0.00%
0/36 • 28 days
|
|
General disorders
Haemorrhage NOS
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
2.6%
1/38 • Number of events 1 • 28 days
|
0.00%
0/36 • 28 days
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
2.6%
1/38 • Number of events 1 • 28 days
|
0.00%
0/36 • 28 days
|
|
Injury, poisoning and procedural complications
Haemothorax
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
0.00%
0/38 • 28 days
|
2.8%
1/36 • Number of events 1 • 28 days
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
2.6%
1/38 • Number of events 1 • 28 days
|
0.00%
0/36 • 28 days
|
|
Nervous system disorders
Polyneuropathy NOS
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
2.6%
1/38 • Number of events 1 • 28 days
|
0.00%
0/36 • 28 days
|
|
Cardiac disorders
Ventricular arrythmia NOS
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
2.6%
1/38 • Number of events 1 • 28 days
|
0.00%
0/36 • 28 days
|
|
Investigations
Blood pressure decreased
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
2.6%
1/38 • Number of events 1 • 28 days
|
0.00%
0/36 • 28 days
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
3.6%
1/28 • Number of events 1 • 28 days
|
0.00%
0/38 • 28 days
|
0.00%
0/36 • 28 days
|
|
Surgical and medical procedures
Wound dehiscence
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
2.6%
1/38 • Number of events 1 • 28 days
|
0.00%
0/36 • 28 days
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
0.00%
0/38 • 28 days
|
2.8%
1/36 • Number of events 1 • 28 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma NOS
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
0.00%
0/38 • 28 days
|
2.8%
1/36 • Number of events 1 • 28 days
|
|
Vascular disorders
Gangrene NOS
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
0.00%
0/38 • 28 days
|
2.8%
1/36 • Number of events 1 • 28 days
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
0.00%
0/38 • 28 days
|
2.8%
1/36 • Number of events 1 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory gas exchange disorder
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
0.00%
0/38 • 28 days
|
2.8%
1/36 • Number of events 1 • 28 days
|
|
Surgical and medical procedures
Tracheostomy
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
0.00%
0/38 • 28 days
|
2.8%
1/36 • Number of events 1 • 28 days
|
|
Surgical and medical procedures
Subcutaneous emphysema
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
0.00%
0/38 • 28 days
|
2.8%
1/36 • Number of events 1 • 28 days
|
|
Infections and infestations
Pneumonia NOS
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
0.00%
0/38 • 28 days
|
2.8%
1/36 • Number of events 1 • 28 days
|
Other adverse events
| Measure |
A.1 Lucinactant
n=5 participants at risk
3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
|
A.2 Lucinactant
n=6 participants at risk
3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
A.3 Lucinactant
n=6 participants at risk
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
A.4 Lucinactant
n=5 participants at risk
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
|
B.1 Lucinactant
n=28 participants at risk
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
|
B.2 Lucinactant
n=38 participants at risk
2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
|
B.3 SoC
n=36 participants at risk
Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia NOS
|
40.0%
2/5 • 28 days
|
16.7%
1/6 • 28 days
|
33.3%
2/6 • 28 days
|
60.0%
3/5 • 28 days
|
17.9%
5/28 • 28 days
|
21.1%
8/38 • 28 days
|
13.9%
5/36 • 28 days
|
|
Blood and lymphatic system disorders
Leucocytosis NOS
|
20.0%
1/5 • 28 days
|
16.7%
1/6 • 28 days
|
16.7%
1/6 • 28 days
|
20.0%
1/5 • 28 days
|
3.6%
1/28 • 28 days
|
0.00%
0/38 • 28 days
|
0.00%
0/36 • 28 days
|
|
Blood and lymphatic system disorders
Thrombocythaemia
|
0.00%
0/5 • 28 days
|
16.7%
1/6 • 28 days
|
0.00%
0/6 • 28 days
|
20.0%
1/5 • 28 days
|
7.1%
2/28 • 28 days
|
7.9%
3/38 • 28 days
|
2.8%
1/36 • 28 days
|
|
Cardiac disorders
Atrial fibrillation
|
20.0%
1/5 • 28 days
|
16.7%
1/6 • 28 days
|
16.7%
1/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
5.3%
2/38 • 28 days
|
0.00%
0/36 • 28 days
|
|
Cardiac disorders
Bradycardia NOS
|
20.0%
1/5 • 28 days
|
16.7%
1/6 • 28 days
|
16.7%
1/6 • 28 days
|
0.00%
0/5 • 28 days
|
7.1%
2/28 • 28 days
|
5.3%
2/38 • 28 days
|
2.8%
1/36 • 28 days
|
|
Cardiac disorders
Pulmonary oedema NOS
|
20.0%
1/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
2.6%
1/38 • 28 days
|
8.3%
3/36 • 28 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
16.7%
1/6 • 28 days
|
20.0%
1/5 • 28 days
|
7.1%
2/28 • 28 days
|
2.6%
1/38 • 28 days
|
5.6%
2/36 • 28 days
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
0.00%
0/5 • 28 days
|
33.3%
2/6 • 28 days
|
33.3%
2/6 • 28 days
|
20.0%
1/5 • 28 days
|
17.9%
5/28 • 28 days
|
10.5%
4/38 • 28 days
|
16.7%
6/36 • 28 days
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/5 • 28 days
|
16.7%
1/6 • 28 days
|
0.00%
0/6 • 28 days
|
20.0%
1/5 • 28 days
|
3.6%
1/28 • 28 days
|
5.3%
2/38 • 28 days
|
2.8%
1/36 • 28 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
16.7%
1/6 • 28 days
|
0.00%
0/5 • 28 days
|
3.6%
1/28 • 28 days
|
0.00%
0/38 • 28 days
|
5.6%
2/36 • 28 days
|
|
General disorders
Multi-organ failure
|
40.0%
2/5 • 28 days
|
16.7%
1/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
3.6%
1/28 • 28 days
|
5.3%
2/38 • 28 days
|
2.8%
1/36 • 28 days
|
|
General disorders
Pyrexia
|
0.00%
0/5 • 28 days
|
16.7%
1/6 • 28 days
|
16.7%
1/6 • 28 days
|
60.0%
3/5 • 28 days
|
10.7%
3/28 • 28 days
|
5.3%
2/38 • 28 days
|
8.3%
3/36 • 28 days
|
|
Infections and infestations
Colitis pseudomembranous
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
20.0%
1/5 • 28 days
|
3.6%
1/28 • 28 days
|
2.6%
1/38 • 28 days
|
5.6%
2/36 • 28 days
|
|
Infections and infestations
Methicillin-resistant Staphyloccal aureus infection
|
20.0%
1/5 • 28 days
|
0.00%
0/6 • 28 days
|
33.3%
2/6 • 28 days
|
0.00%
0/5 • 28 days
|
7.1%
2/28 • 28 days
|
2.6%
1/38 • 28 days
|
2.8%
1/36 • 28 days
|
|
Infections and infestations
Pneumonia NOS
|
40.0%
2/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
3.6%
1/28 • 28 days
|
7.9%
3/38 • 28 days
|
5.6%
2/36 • 28 days
|
|
Infections and infestations
Sepsis NOS
|
40.0%
2/5 • 28 days
|
16.7%
1/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
7.1%
2/28 • 28 days
|
10.5%
4/38 • 28 days
|
2.8%
1/36 • 28 days
|
|
Infections and infestations
Sinusitis NOS
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
3.6%
1/28 • 28 days
|
7.9%
3/38 • 28 days
|
5.6%
2/36 • 28 days
|
|
Infections and infestations
Urinary tract infection NOS
|
0.00%
0/5 • 28 days
|
16.7%
1/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
7.9%
3/38 • 28 days
|
8.3%
3/36 • 28 days
|
|
Investigations
Bacteria NOS sputum identified
|
20.0%
1/5 • 28 days
|
33.3%
2/6 • 28 days
|
0.00%
0/6 • 28 days
|
20.0%
1/5 • 28 days
|
7.1%
2/28 • 28 days
|
0.00%
0/38 • 28 days
|
0.00%
0/36 • 28 days
|
|
Investigations
Blood pH decreased
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
3.6%
1/28 • 28 days
|
2.6%
1/38 • 28 days
|
5.6%
2/36 • 28 days
|
|
Investigations
Liver function tests NOS abnormal
|
0.00%
0/5 • 28 days
|
16.7%
1/6 • 28 days
|
16.7%
1/6 • 28 days
|
0.00%
0/5 • 28 days
|
10.7%
3/28 • 28 days
|
5.3%
2/38 • 28 days
|
2.8%
1/36 • 28 days
|
|
Investigations
Oxygen saturation decreased
|
20.0%
1/5 • 28 days
|
33.3%
2/6 • 28 days
|
50.0%
3/6 • 28 days
|
80.0%
4/5 • 28 days
|
10.7%
3/28 • 28 days
|
13.2%
5/38 • 28 days
|
0.00%
0/36 • 28 days
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
60.0%
3/5 • 28 days
|
33.3%
2/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
10.5%
4/38 • 28 days
|
2.8%
1/36 • 28 days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
1/5 • 28 days
|
50.0%
3/6 • 28 days
|
33.3%
2/6 • 28 days
|
20.0%
1/5 • 28 days
|
10.7%
3/28 • 28 days
|
7.9%
3/38 • 28 days
|
11.1%
4/36 • 28 days
|
|
Nervous system disorders
Confusion
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
10.7%
3/28 • 28 days
|
5.3%
2/38 • 28 days
|
8.3%
3/36 • 28 days
|
|
Renal and urinary disorders
Renal failure NOS
|
60.0%
3/5 • 28 days
|
16.7%
1/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
14.3%
4/28 • 28 days
|
7.9%
3/38 • 28 days
|
8.3%
3/36 • 28 days
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
0.00%
0/38 • 28 days
|
8.3%
3/36 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
20.0%
1/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
10.7%
3/28 • 28 days
|
2.6%
1/38 • 28 days
|
2.8%
1/36 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
40.0%
2/5 • 28 days
|
16.7%
1/6 • 28 days
|
50.0%
3/6 • 28 days
|
0.00%
0/5 • 28 days
|
25.0%
7/28 • 28 days
|
10.5%
4/38 • 28 days
|
5.6%
2/36 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration NOS
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
2.6%
1/38 • 28 days
|
5.6%
2/36 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
16.7%
1/6 • 28 days
|
20.0%
1/5 • 28 days
|
7.1%
2/28 • 28 days
|
15.8%
6/38 • 28 days
|
11.1%
4/36 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax NOS
|
60.0%
3/5 • 28 days
|
16.7%
1/6 • 28 days
|
0.00%
0/6 • 28 days
|
20.0%
1/5 • 28 days
|
17.9%
5/28 • 28 days
|
23.7%
9/38 • 28 days
|
13.9%
5/36 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
16.7%
1/6 • 28 days
|
0.00%
0/5 • 28 days
|
14.3%
4/28 • 28 days
|
13.2%
5/38 • 28 days
|
5.6%
2/36 • 28 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis NOS
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
16.7%
1/6 • 28 days
|
20.0%
1/5 • 28 days
|
14.3%
4/28 • 28 days
|
7.9%
3/38 • 28 days
|
13.9%
5/36 • 28 days
|
|
Skin and subcutaneous tissue disorders
Pressure sore
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
16.7%
1/6 • 28 days
|
40.0%
2/5 • 28 days
|
3.6%
1/28 • 28 days
|
2.6%
1/38 • 28 days
|
5.6%
2/36 • 28 days
|
|
Surgical and medical procedures
Subcutaneous emphysema
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
3.6%
1/28 • 28 days
|
5.3%
2/38 • 28 days
|
5.6%
2/36 • 28 days
|
|
Surgical and medical procedures
Tracheostomy
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
16.7%
1/6 • 28 days
|
0.00%
0/5 • 28 days
|
3.6%
1/28 • 28 days
|
2.6%
1/38 • 28 days
|
5.6%
2/36 • 28 days
|
|
Vascular disorders
Hypertension NOS
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
33.3%
2/6 • 28 days
|
20.0%
1/5 • 28 days
|
10.7%
3/28 • 28 days
|
2.6%
1/38 • 28 days
|
11.1%
4/36 • 28 days
|
|
Vascular disorders
Hypotension NOS
|
0.00%
0/5 • 28 days
|
16.7%
1/6 • 28 days
|
50.0%
3/6 • 28 days
|
20.0%
1/5 • 28 days
|
17.9%
5/28 • 28 days
|
18.4%
7/38 • 28 days
|
13.9%
5/36 • 28 days
|
|
Infections and infestations
Septic shock
|
0.00%
0/5 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/6 • 28 days
|
0.00%
0/5 • 28 days
|
0.00%
0/28 • 28 days
|
2.6%
1/38 • 28 days
|
5.6%
2/36 • 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60