Trial Outcomes & Findings for Phase 2 a Study to Assess Safety and Pharmacokinetics of VAS203 in Patients With Traumatic Brain Injury (NCT NCT02012582)
NCT ID: NCT02012582
Last Updated: 2016-03-07
Results Overview
Tolerability (good, satisfactory, sufficient, poor) of VAS203 in patients with moderate and severe TBI, as judged by the investigators at day 14. Safety outcome measure description see safety section
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
14 days
Results posted on
2016-03-07
Participant Flow
Participant milestones
| Measure |
VAS203 15 mg/kg
Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg
VAS203
|
VAS203 20 mg/kg
10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg
VAS203
|
VAS203 30 mg/kg
10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg
VAS203
|
Placebo
0.9 % Sodium chloride infusion
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2 a Study to Assess Safety and Pharmacokinetics of VAS203 in Patients With Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
VAS203 15 mg/kg
n=8 Participants
Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg
VAS203
|
VAS203 20 mg/kg
n=8 Participants
10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg
VAS203
|
VAS203 30 mg/kg
n=8 Participants
10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg
VAS203
|
Placebo
n=8 Participants
0.9 % Sodium chloride infusion
Saline
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.6 years
n=5 Participants
|
34.8 years
n=7 Participants
|
45.3 years
n=5 Participants
|
35.9 years
n=4 Participants
|
38.9 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Region of Enrollment
Austria
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Region of Enrollment
France
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Region of Enrollment
Switzerland
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
9 participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
13 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 14 daysTolerability (good, satisfactory, sufficient, poor) of VAS203 in patients with moderate and severe TBI, as judged by the investigators at day 14. Safety outcome measure description see safety section
Outcome measures
| Measure |
VAS203 15 mg/kg
n=8 Participants
Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg
VAS203
|
VAS203 20 mg/kg
n=8 Participants
10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg
VAS203
|
VAS203 30 mg/kg
n=8 Participants
10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg
VAS203
|
Placebo
n=8 Participants
0.9 % Sodium chloride infusion
Placebo
|
|---|---|---|---|---|
|
Safety and Tolerability of VAS203 in Patients With Moderate and Severe TBI
Tolerability good
|
8 participants
|
8 participants
|
6 participants
|
8 participants
|
|
Safety and Tolerability of VAS203 in Patients With Moderate and Severe TBI
Tolerability poor
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Hourly from start of infusion to 144 hoursOutcome measures
| Measure |
VAS203 15 mg/kg
n=8 Participants
Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg
VAS203
|
VAS203 20 mg/kg
n=8 Participants
10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg
VAS203
|
VAS203 30 mg/kg
n=8 Participants
10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg
VAS203
|
Placebo
n=8 Participants
0.9 % Sodium chloride infusion
Placebo
|
|---|---|---|---|---|
|
Duration (Number of Time-points) of Intracranial Pressure (ICP) > 20 mmHg
|
9 hours
Standard Deviation 13.3
|
9 hours
Standard Deviation 13.8
|
12.9 hours
Standard Deviation 29.5
|
12.8 hours
Standard Deviation 16.4
|
SECONDARY outcome
Timeframe: Hourly from start of infusion to 144 hoursDuration (number of hours) of cerebral perfusion pressure (CPP) \< 60 mmHg calculated from ICP and mean arterial blood pressure (MAP): CPP = MAP - ICP)
Outcome measures
| Measure |
VAS203 15 mg/kg
n=8 Participants
Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg
VAS203
|
VAS203 20 mg/kg
n=8 Participants
10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg
VAS203
|
VAS203 30 mg/kg
n=8 Participants
10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg
VAS203
|
Placebo
n=8 Participants
0.9 % Sodium chloride infusion
Placebo
|
|---|---|---|---|---|
|
Duration (Number of Hours) of Cerebral Perfusion Pressure (CPP) < 60 mmHg
|
16.5 hours
Standard Deviation 26.9
|
5.9 hours
Standard Deviation 8
|
11.8 hours
Standard Deviation 14.4
|
9.4 hours
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Daily from day 1 to day 6Therapy Intensity Level Score: Total Score calculated daily as the sum of all individual measures, range from 3 (good outcome) to 50 (worst outcome): Scores: 0-2 Head elevation 0-8 Sedation 0-1 Paralysis 1-3 Hyperventilation 0-2 Increased Oxygenation 1-3 Cooling 0-2 Osmotherapy 0-3 CSF Drainage 0-1 Red Blood Cell Transfusion 1-3 Cerebral perfusion pressure 0-1 Surgery for mass lesion 0/5/10 none/unilateral/bilateral Decompressive Craniectomy 0/10 Laparatomy to treat intracranial hypertension due to abdominal hypertension
Outcome measures
| Measure |
VAS203 15 mg/kg
n=8 Participants
Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg
VAS203
|
VAS203 20 mg/kg
n=8 Participants
10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg
VAS203
|
VAS203 30 mg/kg
n=8 Participants
10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg
VAS203
|
Placebo
n=8 Participants
0.9 % Sodium chloride infusion
Placebo
|
|---|---|---|---|---|
|
Therapy Intensity Level Score
Day 1
|
11.4 units on a scale
Standard Deviation 3.5
|
11.8 units on a scale
Standard Deviation 3.5
|
10 units on a scale
Standard Deviation 2.6
|
11.3 units on a scale
Standard Deviation 2.6
|
|
Therapy Intensity Level Score
Day 2
|
11.1 units on a scale
Standard Deviation 1.6
|
10.5 units on a scale
Standard Deviation 3.7
|
10.3 units on a scale
Standard Deviation 3.5
|
11.5 units on a scale
Standard Deviation 3.2
|
|
Therapy Intensity Level Score
Day 3
|
10.5 units on a scale
Standard Deviation 2
|
9.1 units on a scale
Standard Deviation 4.1
|
9.3 units on a scale
Standard Deviation 2.6
|
12.3 units on a scale
Standard Deviation 5.7
|
|
Therapy Intensity Level Score
Day 4
|
10.4 units on a scale
Standard Deviation 3.2
|
9.6 units on a scale
Standard Deviation 4.5
|
8.9 units on a scale
Standard Deviation 3.3
|
12.4 units on a scale
Standard Deviation 6.5
|
|
Therapy Intensity Level Score
Day 5
|
9.6 units on a scale
Standard Deviation 3.1
|
9.5 units on a scale
Standard Deviation 4.7
|
8.8 units on a scale
Standard Deviation 3.5
|
12.7 units on a scale
Standard Deviation 5.5
|
|
Therapy Intensity Level Score
Day 6
|
9 units on a scale
Standard Deviation 2.8
|
9.5 units on a scale
Standard Deviation 4.7
|
8.1 units on a scale
Standard Deviation 4.7
|
12 units on a scale
Standard Deviation 3.6
|
POST_HOC outcome
Timeframe: 6 months after start of treatmentScoring: Range from 1 (worst outcome) to 8 (good outcome). The patient´s overall rating is based on the lowest outcome category indicated on the scale. Score Description 1. Dead 2. Vegetative State 3. Lower Severe Disability 4. Upper Severe Disability 5. Lower Moderate Disability 6. Upper Moderate Disability 7. Lower Good Recovery 8. Upper Good Recovery
Outcome measures
| Measure |
VAS203 15 mg/kg
n=8 Participants
Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg
VAS203
|
VAS203 20 mg/kg
n=8 Participants
10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg
VAS203
|
VAS203 30 mg/kg
n=8 Participants
10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg
VAS203
|
Placebo
n=8 Participants
0.9 % Sodium chloride infusion
Placebo
|
|---|---|---|---|---|
|
Extended Glasgow Outcome Score (eGOS)
|
6.5 units on a scale
Interval 3.0 to 7.0
|
7 units on a scale
Interval 4.0 to 8.0
|
6 units on a scale
Interval 3.0 to 7.0
|
4.5 units on a scale
Interval 1.0 to 6.0
|
Adverse Events
VAS203 15 mg/kg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
VAS203 20 mg/kg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
VAS203 30 mg/kg
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VAS203 15 mg/kg
n=8 participants at risk
Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg
VAS203
|
VAS203 20 mg/kg
n=8 participants at risk
10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg
VAS203
|
VAS203 30 mg/kg
n=8 participants at risk
10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg
VAS203
|
Placebo
n=8 participants at risk
0.9 % Sodium chloride infusion
Placebo
|
|---|---|---|---|---|
|
Nervous system disorders
Pupils unequal
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
|
Nervous system disorders
Brain death
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
|
Nervous system disorders
Brain oedema
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
25.0%
2/8 • Number of events 2 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
Other adverse events
| Measure |
VAS203 15 mg/kg
n=8 participants at risk
Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg
VAS203
|
VAS203 20 mg/kg
n=8 participants at risk
10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg
VAS203
|
VAS203 30 mg/kg
n=8 participants at risk
10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg
VAS203
|
Placebo
n=8 participants at risk
0.9 % Sodium chloride infusion
Placebo
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
37.5%
3/8 • Number of events 3 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
37.5%
3/8 • Number of events 4 • 14 days
Daily assessment by investigator
|
25.0%
2/8 • Number of events 3 • 14 days
Daily assessment by investigator
|
|
Blood and lymphatic system disorders
Coagulopathy
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 2 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 2 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
37.5%
3/8 • Number of events 3 • 14 days
Daily assessment by investigator
|
37.5%
3/8 • Number of events 3 • 14 days
Daily assessment by investigator
|
37.5%
3/8 • Number of events 3 • 14 days
Daily assessment by investigator
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
25.0%
2/8 • Number of events 2 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
|
Infections and infestations
Catheder site infection
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
|
Infections and infestations
Pneumonia
|
37.5%
3/8 • Number of events 3 • 14 days
Daily assessment by investigator
|
25.0%
2/8 • Number of events 2 • 14 days
Daily assessment by investigator
|
37.5%
3/8 • Number of events 3 • 14 days
Daily assessment by investigator
|
37.5%
3/8 • Number of events 3 • 14 days
Daily assessment by investigator
|
|
Infections and infestations
Tracheobronchitis
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
|
Investigations
Phosphorus decreased
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
25.0%
2/8 • Number of events 2 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
|
Investigations
Blood uric acid decreased
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
|
Investigations
CRP increased
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
25.0%
2/8 • Number of events 2 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
25.0%
2/8 • Number of events 2 • 14 days
Daily assessment by investigator
|
|
Investigations
Urine analysis abnormal
|
25.0%
2/8 • Number of events 2 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
2/8 • Number of events 2 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 2 • 14 days
Daily assessment by investigator
|
25.0%
2/8 • Number of events 3 • 14 days
Daily assessment by investigator
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
25.0%
2/8 • Number of events 2 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 3 • 14 days
Daily assessment by investigator
|
25.0%
2/8 • Number of events 2 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
|
Nervous system disorders
Adrenergic syndrome
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
|
Nervous system disorders
Convulsion
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
25.0%
2/8 • Number of events 2 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
|
Nervous system disorders
ICP increase
|
25.0%
2/8 • Number of events 3 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 3 • 14 days
Daily assessment by investigator
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
25.0%
2/8 • Number of events 3 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
25.0%
2/8 • Number of events 2 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
12.5%
1/8 • Number of events 2 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 1 • 14 days
Daily assessment by investigator
|
12.5%
1/8 • Number of events 2 • 14 days
Daily assessment by investigator
|
0.00%
0/8 • 14 days
Daily assessment by investigator
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place