Trial Outcomes & Findings for Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress Syndrome (NCT NCT01438853)
NCT ID: NCT01438853
Last Updated: 2025-01-06
Results Overview
To evaluate the safety of escalating dose levels of TNX-832 in subjects with suspected or proven bacteria-induced ALI/ARDS. Safety was assessed by number of treatment emergent adverse events, and changes in vital signs, ECGs, laboratory, coagulation and pulmonary function parameters from baseline. Immunogenicity (serum anti-TNX-832 antibody response) was evalutated.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Up to 4 weeks
Results posted on
2025-01-06
Participant Flow
Participant milestones
| Measure |
Placebo
TNX-832
|
0.06 MG/KG Dose
TNX-832
|
0.1 MG/KG Dose
TNX-832
|
0.08 MG/KG Dose
TNX-832
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
3
|
5
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
TNX-832
|
0.06 MG/KG Dose
TNX-832
|
0.1 MG/KG Dose
TNX-832
|
0.08 MG/KG Dose
TNX-832
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Effects of TNX-832 (Sunol cH36) in Subjects With Acute Lung Injury/Acute Respiratory Distress Syndrome
Baseline characteristics by cohort
| Measure |
Placebo
n=3 Participants
TNX-832
|
0.06 MG/KG Dose
n=5 Participants
TNX-832
|
0.1 MG/KG Dose
n=5 Participants
TNX-832
|
0.08 MG/KG Dose
n=5 Participants
TNX-832
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.67 years
STANDARD_DEVIATION 24.3 • n=99 Participants
|
40.40 years
STANDARD_DEVIATION 18.2 • n=107 Participants
|
54.60 years
STANDARD_DEVIATION 13.7 • n=206 Participants
|
54.00 years
STANDARD_DEVIATION 16.9 • n=7 Participants
|
49.53 years
STANDARD_DEVIATION 17.26 • n=31 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Subjects with Acute Lung Injury/Acute Respiratory Distress Syndrome
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksTo evaluate the safety of escalating dose levels of TNX-832 in subjects with suspected or proven bacteria-induced ALI/ARDS. Safety was assessed by number of treatment emergent adverse events, and changes in vital signs, ECGs, laboratory, coagulation and pulmonary function parameters from baseline. Immunogenicity (serum anti-TNX-832 antibody response) was evalutated.
Outcome measures
| Measure |
Placebo
n=3 Participants
TNX-832
|
0.06 MG/KG Dose
n=5 Participants
TNX-832
|
0.1 MG/KG Dose
n=5 Participants
TNX-832
|
0.08 MG/KG Dose
n=5 Participants
TNX-832
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
3 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: predose; 15 and 30 min; 1, 4, 6, 12 and 24 hrs; 2, 3, 4, 5, 6, and 7 days, 2, 3, 4 weeksPopulation: O participants were analyzed for placebo pk
maximum observed concentration (Cmax)
Outcome measures
| Measure |
Placebo
TNX-832
|
0.06 MG/KG Dose
n=5 Participants
TNX-832
|
0.1 MG/KG Dose
n=5 Participants
TNX-832
|
0.08 MG/KG Dose
n=5 Participants
TNX-832
|
|---|---|---|---|---|
|
Cmax
|
—
|
1297 ng/mL
Standard Deviation 560
|
1800 ng/mL
Standard Deviation 253
|
1492 ng/mL
Standard Deviation 344
|
PRIMARY outcome
Timeframe: Up 163.3 hoursPopulation: 0 participants were analyzed in the placebo AUCinf. Two participants in the 0.06 mg/kg and 1participant in the 0.1 mg/kg cohort did not meet the criteria for reliable estimation of PK parameters and are not included in calculation of Cohort mean values.
Area under the plasma concentration curve from time 0 extrapolated to infinite time (AUC0-inf). AUClast (area under the serum concentration-time curve from the time of dosing to the time of the last observed concentration).
Outcome measures
| Measure |
Placebo
TNX-832
|
0.06 MG/KG Dose
n=3 Participants
TNX-832
|
0.1 MG/KG Dose
n=4 Participants
TNX-832
|
0.08 MG/KG Dose
n=5 Participants
TNX-832
|
|---|---|---|---|---|
|
AUCinf and AUClast
AUCinf
|
—
|
39031 mcg*hr/mL
Standard Deviation 24178
|
59921 mcg*hr/mL
Standard Deviation 16629
|
59851 mcg*hr/mL
Standard Deviation 20459
|
|
AUCinf and AUClast
AUClast
|
—
|
35868 mcg*hr/mL
Standard Deviation 22950
|
53973 mcg*hr/mL
Standard Deviation 17289
|
56860 mcg*hr/mL
Standard Deviation 21705
|
PRIMARY outcome
Timeframe: predose; 15 and 30 min; 1, 4, 6, 12 and 24 hrs; 2, 3, 4, 5, 6, and 7 days, 2, 3, 4 weeksPopulation: 0 participants were analyzed in placebo Terminal t1/2
t1/2 (terminal elimination phase half life). Tmax (time to maximum serum concentration).
Outcome measures
| Measure |
Placebo
TNX-832
|
0.06 MG/KG Dose
n=3 Participants
TNX-832
|
0.1 MG/KG Dose
n=4 Participants
TNX-832
|
0.08 MG/KG Dose
n=5 Participants
TNX-832
|
|---|---|---|---|---|
|
Terminal t1/2 and Tmax
T1/2
|
—
|
18.5 hr
Standard Deviation 5.9
|
22.6 hr
Standard Deviation 6.2
|
22.6 hr
Standard Deviation 3.1
|
|
Terminal t1/2 and Tmax
Tmax
|
—
|
1.0 hr
Standard Deviation 0.0
|
0.9 hr
Standard Deviation 0.4
|
4.2 hr
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: predose; 15 and 30 min; 1, 4, 6, 12 and 24 hrs; 2, 3, 4, 5, 6, and 7 days, 2, 3, 4 weeksPopulation: 0 participants were analyzed in placebo Vd and Vss
Volume of distribution (Vd) based on the terminal elimination phase, also referred to as VZ; in mL/kg. Volume of distribution at steady state (Vss), calculated as the Mean residence Time times Clearance; in mL/kg.
Outcome measures
| Measure |
Placebo
TNX-832
|
0.06 MG/KG Dose
n=3 Participants
TNX-832
|
0.1 MG/KG Dose
n=4 Participants
TNX-832
|
0.08 MG/KG Dose
n=5 Participants
TNX-832
|
|---|---|---|---|---|
|
Vd and Vss
Vd
|
—
|
46.1 mL/kg
Standard Deviation 13.1
|
54.5 mL/kg
Standard Deviation 6.6
|
47.7 mL/kg
Standard Deviation 16.0
|
|
Vd and Vss
Vss
|
—
|
44.9 mL/kg
Standard Deviation 12.29
|
53.0 mL/kg
Standard Deviation 5.3
|
46.7 mL/kg
Standard Deviation 14.7
|
PRIMARY outcome
Timeframe: up to 1 weekPopulation: 0 participants were analyzed in placebo Cl
Total body clearance, CL=Dose/AUC; in mL/hr/kg
Outcome measures
| Measure |
Placebo
TNX-832
|
0.06 MG/KG Dose
n=3 Participants
TNX-832
|
0.1 MG/KG Dose
n=4 Participants
TNX-832
|
0.08 MG/KG Dose
n=5 Participants
TNX-832
|
|---|---|---|---|---|
|
Cl
|
—
|
1.9 mL/hr/kg
Standard Deviation 1.0
|
1.8 mL/hr/kg
Standard Deviation 0.4
|
1.5 mL/hr/kg
Standard Deviation 0.7
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
0.06 MG/KG Dose
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
0.1 MG/KG Dose
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
0.08 MG/KG Dose
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=3 participants at risk
TNX-832
|
0.06 MG/KG Dose
n=5 participants at risk
TNX-832
|
0.1 MG/KG Dose
n=5 participants at risk
TNX-832
|
0.08 MG/KG Dose
n=5 participants at risk
TNX-832
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
|
Renal and urinary disorders
acute renal failure
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
Other adverse events
| Measure |
Placebo
n=3 participants at risk
TNX-832
|
0.06 MG/KG Dose
n=5 participants at risk
TNX-832
|
0.1 MG/KG Dose
n=5 participants at risk
TNX-832
|
0.08 MG/KG Dose
n=5 participants at risk
TNX-832
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
40.0%
2/5 • Up to 4 weeks
|
|
Blood and lymphatic system disorders
Lymphocytic infiltration
|
33.3%
1/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
1/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
40.0%
2/5 • Up to 4 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Congenital, familial and genetic disorders
Macroglossia
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
33.3%
1/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
General disorders
Bloody discharge
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
General disorders
Edema peripheral
|
33.3%
1/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Infections and infestations
Bacteremia
|
0.00%
0/3 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Infections and infestations
Candiduria
|
0.00%
0/3 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Infections and infestations
Empyema
|
33.3%
1/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Infections and infestations
Oral candidiasis
|
33.3%
1/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Injury, poisoning and procedural complications
Weaning failure
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
|
Investigations
Hematocrit decreased
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Investigations
Hemoglobin decreased
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Metabolism and nutrition disorders
Hypernatremia
|
33.3%
1/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
60.0%
3/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Nervous system disorders
Hemiparesis
|
33.3%
1/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
40.0%
2/5 • Up to 4 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
|
Psychiatric disorders
Delirium
|
33.3%
1/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • Up to 4 weeks
|
40.0%
2/5 • Up to 4 weeks
|
100.0%
5/5 • Up to 4 weeks
|
40.0%
2/5 • Up to 4 weeks
|
|
Renal and urinary disorders
Renal failure acute
|
33.3%
1/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/3 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
33.3%
1/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
40.0%
2/5 • Up to 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
33.3%
1/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
0.00%
0/3 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
0.00%
0/5 • Up to 4 weeks
|
20.0%
1/5 • Up to 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place