Trial Outcomes & Findings for Safety and Efficacy of USB002 for Respiratory Distress Due to COVID-19 (NCT NCT04778059)
NCT ID: NCT04778059
Last Updated: 2023-12-01
Results Overview
Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Day 1 to Day 70 (or date of final measurement, if sooner)
Results posted on
2023-12-01
Participant Flow
Participant milestones
| Measure |
USB002 90 ug/kg/Day
Subjects received standard of care plus a continuous IV infusion of 90 ug/kg/day USB002 for up to 96 hours.
|
USB002 300 ug/kg/Day
Subjects received standard of care plus a continuous IV infusion of 300 ug/kg/day USB002 for up to 96 hours.
|
USB002 600 ug/kg/Day
Subjects received standard of care plus a continuous IV infusion of 600 ug/kg/day USB002 for up to 96 hours.
|
USB002 900 ug/kg/Day
Subjects received standard of care plus a continuous IV infusion of 900 ug/kg/day USB002 for up to 96 hours.
|
Placebo
Subjects received standard of care plus a continuous IV infusion of USB002 placebo for up to 96 hours.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
2
|
10
|
|
Overall Study
COMPLETED
|
1
|
1
|
2
|
1
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
1
|
3
|
Reasons for withdrawal
| Measure |
USB002 90 ug/kg/Day
Subjects received standard of care plus a continuous IV infusion of 90 ug/kg/day USB002 for up to 96 hours.
|
USB002 300 ug/kg/Day
Subjects received standard of care plus a continuous IV infusion of 300 ug/kg/day USB002 for up to 96 hours.
|
USB002 600 ug/kg/Day
Subjects received standard of care plus a continuous IV infusion of 600 ug/kg/day USB002 for up to 96 hours.
|
USB002 900 ug/kg/Day
Subjects received standard of care plus a continuous IV infusion of 900 ug/kg/day USB002 for up to 96 hours.
|
Placebo
Subjects received standard of care plus a continuous IV infusion of USB002 placebo for up to 96 hours.
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
2
|
2
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Telemed not done due to internal miscommunication.
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of USB002 for Respiratory Distress Due to COVID-19
Baseline characteristics by cohort
| Measure |
USB002 90 ug/kg/Day
n=3 Participants
Subjects received standard of care plus a continuous IV infusion of 90 ug/kg/day USB002 for up to 96 hours.
|
USB002 300 ug/kg/Day
n=3 Participants
Subjects received standard of care plus a continuous IV infusion of 300 ug/kg/day USB002 for up to 96 hours.
|
USB002 600 ug/kg/Day
n=3 Participants
Subjects received standard of care plus a continuous IV infusion of 600 ug/kg/day USB002 for up to 96 hours.
|
USB002 900 ug/kg/Day
n=2 Participants
Subjects received standard of care plus a continuous IV infusion of 900 ug/kg/day USB002 for up to 96 hours.
|
Placebo
n=10 Participants
Subjects received standard of care plus a continuous IV infusion of USB002 placebo for up to 96 hours.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 18.25 • n=5 Participants
|
57.0 years
STANDARD_DEVIATION 8.66 • n=7 Participants
|
61.0 years
STANDARD_DEVIATION 12.17 • n=5 Participants
|
78.5 years
STANDARD_DEVIATION 0.71 • n=4 Participants
|
59.8 years
STANDARD_DEVIATION 8.18 • n=21 Participants
|
57.9 years
STANDARD_DEVIATION 16.2 • n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
10 participants
n=21 Participants
|
21 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 70 (or date of final measurement, if sooner)Population: All enrolled subjects who received a USB002 or Placebo infusion were included in the analysis population for all outcomes analyzed.
Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)
Outcome measures
| Measure |
USB002 90 ug/kg/Day
n=3 Participants
Subjects received standard of care plus a continuous IV infusion of 90 ug/kg/day USB002 for up to 96 hours.
|
USB002 300 ug/kg/Day
n=3 Participants
Subjects received standard of care plus a continuous IV infusion of 300 ug/kg/day USB002 for up to 96 hours.
|
USB002 600 ug/kg/Day
n=3 Participants
Subjects received standard of care plus a continuous IV infusion of 600 ug/kg/day USB002 for up to 96 hours.
|
USB002 900 ug/kg/Day
n=2 Participants
Subjects received standard of care plus a continuous IV infusion of 900 ug/kg/day USB002 for up to 96 hours.
|
Placebo
n=10 Participants
Subjects received standard of care plus a continuous IV infusion of USB002 placebo for up to 96 hours.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE)
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
8 Participants
|
Adverse Events
USB002 90 ug/kg/Day
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
USB002 300 ug/kg/Day
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
USB002 600 ug/kg/Day
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
USB002 900 ug/kg/Day
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
USB002 90 ug/kg/Day
n=3 participants at risk
Subjects received standard of care plus a continuous IV infusion of 90 ug/kg/day USB002 for up to 96 hours.
|
USB002 300 ug/kg/Day
n=3 participants at risk
Subjects received standard of care plus a continuous IV infusion of 300 ug/kg/day USB002 for up to 96 hours.
|
USB002 600 ug/kg/Day
n=3 participants at risk
Subjects received standard of care plus a continuous IV infusion of 600 ug/kg/day USB002 for up to 96 hours.
|
USB002 900 ug/kg/Day
n=2 participants at risk
Subjects received standard of care plus a continuous IV infusion of 900 ug/kg/day USB002 for up to 96 hours.
|
Placebo
n=10 participants at risk
Subjects received standard of care plus a continuous IV infusion of USB002 placebo for up to 96 hours.
|
|---|---|---|---|---|---|
|
Surgical and medical procedures
Withdrawal of life support
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
General disorders
Multiple organ dysfunction syndrome
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
General disorders
Death
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
50.0%
1/2 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
Other adverse events
| Measure |
USB002 90 ug/kg/Day
n=3 participants at risk
Subjects received standard of care plus a continuous IV infusion of 90 ug/kg/day USB002 for up to 96 hours.
|
USB002 300 ug/kg/Day
n=3 participants at risk
Subjects received standard of care plus a continuous IV infusion of 300 ug/kg/day USB002 for up to 96 hours.
|
USB002 600 ug/kg/Day
n=3 participants at risk
Subjects received standard of care plus a continuous IV infusion of 600 ug/kg/day USB002 for up to 96 hours.
|
USB002 900 ug/kg/Day
n=2 participants at risk
Subjects received standard of care plus a continuous IV infusion of 900 ug/kg/day USB002 for up to 96 hours.
|
Placebo
n=10 participants at risk
Subjects received standard of care plus a continuous IV infusion of USB002 placebo for up to 96 hours.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
66.7%
2/3 • Number of events 2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
General disorders
Swelling face
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Infections and infestations
Pneumonia
|
66.7%
2/3 • Number of events 3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
66.7%
2/3 • Number of events 2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Infections and infestations
Pneumonia klebsiella
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Infections and infestations
Septic shock
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
20.0%
2/10 • Number of events 2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
20.0%
2/10 • Number of events 4 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
50.0%
1/2 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
30.0%
3/10 • Number of events 3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
66.7%
2/3 • Number of events 2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
50.0%
1/2 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
50.0%
1/2 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
33.3%
1/3 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/10 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
|
Vascular disorders
Shock
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/3 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
0.00%
0/2 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
10.0%
1/10 • Number of events 1 • Up to 70 days
AEs were collected at all study visits from the time of dosing.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place