Trial Outcomes & Findings for Multiple Dosing of Mesenchymal Stromal Cells in Patients With ARDS (COVID-19) (NCT NCT04466098)
NCT ID: NCT04466098
Last Updated: 2025-01-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Within 6 hours of the start of the infusion
Results posted on
2025-01-29
Participant Flow
Participant milestones
| Measure |
Mesenchymal Stromal Cells
Three fixed doses of MSC approximately 48 hours apart.
Mesenchymal stromal cells: Thawed product containing MSC(300x10\^6) in DMSO resuspended 1:1 with Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
Placebo
Three fixed doses of placebo control approximately 48 hours apart.
Placebo: Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multiple Dosing of Mesenchymal Stromal Cells in Patients With ARDS (COVID-19)
Baseline characteristics by cohort
| Measure |
Mesenchymal Stromal Cells
n=6 Participants
Three fixed doses of MSC approximately 48 hours apart.
Mesenchymal stromal cells: Thawed product containing MSC(300x10\^6) in DMSO resuspended 1:1 with Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
Placebo
n=2 Participants
Three fixed doses of placebo control approximately 48 hours apart.
Placebo: Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
2 participants
n=107 Participants
|
8 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Within 6 hours of the start of the infusionOutcome measures
| Measure |
Mesenchymal Stromal Cells
n=6 Participants
Three fixed doses of MSC approximately 48 hours apart.
Mesenchymal stromal cells: Thawed product containing MSC(300x10\^6) in DMSO resuspended 1:1 with Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
Placebo
n=2 Participants
Three fixed doses of placebo control approximately 48 hours apart.
Placebo: Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
|---|---|---|
|
Incidence of Grade 3-5 Infusional Toxicities and Predefined Hemodynamic or Respiratory Adverse Events Related to the Infusion of MSC
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 7 after first infusionPopulation: One participant in 'Mesenchymal Stromal Cells' arm unable to be evaluated.
Mean (SD) represents the change on day 7 after treatment compared to pretreatment value for each biomarker of inflammation. (IL-1, IL-6, IL-8 and TNFa) Measured in pg/mL.
Outcome measures
| Measure |
Mesenchymal Stromal Cells
n=6 Participants
Three fixed doses of MSC approximately 48 hours apart.
Mesenchymal stromal cells: Thawed product containing MSC(300x10\^6) in DMSO resuspended 1:1 with Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
Placebo
n=2 Participants
Three fixed doses of placebo control approximately 48 hours apart.
Placebo: Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
|---|---|---|
|
Change in Biomarkers of Inflammation From Day 0 to Day 7
Change in IL-1
|
0 pg/mL
Standard Deviation 0.55
|
0.4 pg/mL
Standard Deviation 0.99
|
|
Change in Biomarkers of Inflammation From Day 0 to Day 7
Change in IL-6
|
-61 pg/mL
Standard Deviation 190
|
102 pg/mL
Standard Deviation 75
|
|
Change in Biomarkers of Inflammation From Day 0 to Day 7
Change in TNFa
|
0 pg/mL
Standard Deviation 12
|
2 pg/mL
Standard Deviation 2
|
|
Change in Biomarkers of Inflammation From Day 0 to Day 7
Change in IL-8
|
6 pg/mL
Standard Deviation 53
|
145 pg/mL
Standard Deviation 33
|
SECONDARY outcome
Timeframe: On the day of screening and on days 3, 7 and 14 after first infusionTrend change was determined by evaluating PaO2:FiO2 ratios at prespecified time points and determining the slope of the line of best fit across data points for each patient, followed by taking the mean and SD across patients in each treatment group. Negative and positive slopes indicating decreasing or increasing values over time, respectively.
Outcome measures
| Measure |
Mesenchymal Stromal Cells
n=6 Participants
Three fixed doses of MSC approximately 48 hours apart.
Mesenchymal stromal cells: Thawed product containing MSC(300x10\^6) in DMSO resuspended 1:1 with Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
Placebo
n=2 Participants
Three fixed doses of placebo control approximately 48 hours apart.
Placebo: Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
|---|---|---|
|
Trend Changes in PaO2:FiO2 Ratio
|
-7 ratio/day
Standard Deviation 8
|
8 ratio/day
Standard Deviation 7
|
SECONDARY outcome
Timeframe: On the day of screening and on days 3, 7 and 14 after first infusionTrend change was determined by evaluating mean airway pressure values at prespecified time points and determining the slope of the line of best fit across data points for each patient, followed by taking the mean and SD across patients in each treatment group. Negative and positive slopes indicating decreasing or increasing values over time, respectively.
Outcome measures
| Measure |
Mesenchymal Stromal Cells
n=6 Participants
Three fixed doses of MSC approximately 48 hours apart.
Mesenchymal stromal cells: Thawed product containing MSC(300x10\^6) in DMSO resuspended 1:1 with Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
Placebo
n=2 Participants
Three fixed doses of placebo control approximately 48 hours apart.
Placebo: Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
|---|---|---|
|
Trend Changes in Mean Airway Pressure
|
-2.7 ratio/day
Standard Deviation 6
|
0.3 ratio/day
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: On the day of screening and on days 3, 7 and 14 after first infusionTrend change was determined by evaluating peak pressure values at prespecified time points and determining the slope of the line of best fit across data points for each patient, followed by taking the mean and SD across patients in each treatment group. Negative and positive slopes indicating decreasing or increasing values over time, respectively.
Outcome measures
| Measure |
Mesenchymal Stromal Cells
n=6 Participants
Three fixed doses of MSC approximately 48 hours apart.
Mesenchymal stromal cells: Thawed product containing MSC(300x10\^6) in DMSO resuspended 1:1 with Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
Placebo
n=2 Participants
Three fixed doses of placebo control approximately 48 hours apart.
Placebo: Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
|---|---|---|
|
Trend Changes in Peak Pressure
|
-0.28 ratio/day
Standard Deviation 1.51
|
0.19 ratio/day
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: On the day of screening (baseline) and on days 3, 7 and 14 after first infusionTrend change was determined by evaluating plateau pressure values at prespecified time points and determining the slope of the line of best fit across data points for each patient, followed by taking the mean and SD across patients in each treatment group. Negative and positive slopes indicating decreasing or increasing values over time, respectively.
Outcome measures
| Measure |
Mesenchymal Stromal Cells
n=6 Participants
Three fixed doses of MSC approximately 48 hours apart.
Mesenchymal stromal cells: Thawed product containing MSC(300x10\^6) in DMSO resuspended 1:1 with Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
Placebo
n=2 Participants
Three fixed doses of placebo control approximately 48 hours apart.
Placebo: Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
|---|---|---|
|
Trend Changes in Plateau Pressure
|
0.08 ratio/day
Standard Deviation 2.91
|
0.38 ratio/day
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: On the day of screening and on days 3, 7 and 14 after first infusionTrend change was determined by evaluating Positive end-expiratory airway pressure (PEEP) values at prespecified time points and determining the slope of the line of best fit across data points for each patient, followed by taking the mean and SD across patients in each treatment group. Negative and positive slopes indicating decreasing or increasing values over time, respectively.
Outcome measures
| Measure |
Mesenchymal Stromal Cells
n=6 Participants
Three fixed doses of MSC approximately 48 hours apart.
Mesenchymal stromal cells: Thawed product containing MSC(300x10\^6) in DMSO resuspended 1:1 with Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
Placebo
n=2 Participants
Three fixed doses of placebo control approximately 48 hours apart.
Placebo: Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
|---|---|---|
|
Trend Changes in Positive End-expiratory Airway Pressure (PEEP)
|
-0.68 ratio/day
Standard Deviation 0.90
|
0.14 ratio/day
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: 50 days after first infusionOutcome measures
| Measure |
Mesenchymal Stromal Cells
n=6 Participants
Three fixed doses of MSC approximately 48 hours apart.
Mesenchymal stromal cells: Thawed product containing MSC(300x10\^6) in DMSO resuspended 1:1 with Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
Placebo
n=2 Participants
Three fixed doses of placebo control approximately 48 hours apart.
Placebo: Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
|---|---|---|
|
Incidence of Mortality
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 28 days after first infusionOutcome measures
| Measure |
Mesenchymal Stromal Cells
n=6 Participants
Three fixed doses of MSC approximately 48 hours apart.
Mesenchymal stromal cells: Thawed product containing MSC(300x10\^6) in DMSO resuspended 1:1 with Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
Placebo
n=2 Participants
Three fixed doses of placebo control approximately 48 hours apart.
Placebo: Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
|---|---|---|
|
Number of ICU-free Days
0 days
|
3 Participants
|
2 Participants
|
|
Number of ICU-free Days
7 days
|
1 Participants
|
0 Participants
|
|
Number of ICU-free Days
18 days
|
1 Participants
|
0 Participants
|
|
Number of ICU-free Days
22 days
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 days after first infusionOutcome measures
| Measure |
Mesenchymal Stromal Cells
n=6 Participants
Three fixed doses of MSC approximately 48 hours apart.
Mesenchymal stromal cells: Thawed product containing MSC(300x10\^6) in DMSO resuspended 1:1 with Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
Placebo
n=2 Participants
Three fixed doses of placebo control approximately 48 hours apart.
Placebo: Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
|---|---|---|
|
Number of Days Alive and Ventilator Free
0 days
|
3 Participants
|
1 Participants
|
|
Number of Days Alive and Ventilator Free
1 day
|
0 Participants
|
1 Participants
|
|
Number of Days Alive and Ventilator Free
4 days
|
1 Participants
|
0 Participants
|
|
Number of Days Alive and Ventilator Free
23 days
|
1 Participants
|
0 Participants
|
|
Number of Days Alive and Ventilator Free
24 days
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 28 after first infusionAcute Lung Injury Score is a composite 4 point scoring system validated by the NHLBI ARDS Network that considers PaO2/FiO2, the level of positive end-expiratory airway pressure, respiratory compliance, and the extent of pulmonary infiltrates on the chest radiograph. Each criterion is scored from 0-4 based on the severity of the condition. The final score is calculated by dividing the total score by the number of criteria used. A score of 0 indicates no lung injury, and a score over 2.5 indicates Acute respiratory distress syndrome (ARDS). The scoring ranges from 0 to a maximum score of 3.
Outcome measures
| Measure |
Mesenchymal Stromal Cells
n=3 Participants
Three fixed doses of MSC approximately 48 hours apart.
Mesenchymal stromal cells: Thawed product containing MSC(300x10\^6) in DMSO resuspended 1:1 with Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
Placebo
n=1 Participants
Three fixed doses of placebo control approximately 48 hours apart.
Placebo: Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
|---|---|---|
|
Change in Acute Lung Injury (ALI) Score 2
|
-0.25 Scores on a scale
Standard Deviation 0.43
|
-1.5 Scores on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 28 days after first infusionOutcome measures
| Measure |
Mesenchymal Stromal Cells
n=6 Participants
Three fixed doses of MSC approximately 48 hours apart.
Mesenchymal stromal cells: Thawed product containing MSC(300x10\^6) in DMSO resuspended 1:1 with Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
Placebo
n=2 Participants
Three fixed doses of placebo control approximately 48 hours apart.
Placebo: Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
|---|---|---|
|
Incidence of Serious Adverse Events
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 100 days after first infusionOutcome measures
| Measure |
Mesenchymal Stromal Cells
n=6 Participants
Three fixed doses of MSC approximately 48 hours apart.
Mesenchymal stromal cells: Thawed product containing MSC(300x10\^6) in DMSO resuspended 1:1 with Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
Placebo
n=2 Participants
Three fixed doses of placebo control approximately 48 hours apart.
Placebo: Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
|---|---|---|
|
Number of Days Alive Off Supplemental Oxygen
88 days
|
1 Participants
|
0 Participants
|
|
Number of Days Alive Off Supplemental Oxygen
0 days
|
2 Participants
|
1 Participants
|
|
Number of Days Alive Off Supplemental Oxygen
10 days
|
1 Participants
|
0 Participants
|
|
Number of Days Alive Off Supplemental Oxygen
53 days
|
0 Participants
|
1 Participants
|
|
Number of Days Alive Off Supplemental Oxygen
61 days
|
1 Participants
|
0 Participants
|
|
Number of Days Alive Off Supplemental Oxygen
87 days
|
1 Participants
|
0 Participants
|
Adverse Events
Mesenchymal Stromal Cells
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Mesenchymal Stromal Cells
n=6 participants at risk
Three fixed doses of MSC approximately 48 hours apart.
Mesenchymal stromal cells: Thawed product containing MSC(300x10\^6) in DMSO resuspended 1:1 with Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
Placebo
n=2 participants at risk
Three fixed doses of placebo control approximately 48 hours apart.
Placebo: Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
16.7%
1/6 • Number of events 1 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Infections and infestations
Lung infection
|
16.7%
1/6 • Number of events 2 • 6 months
|
0.00%
0/2 • 6 months
|
Other adverse events
| Measure |
Mesenchymal Stromal Cells
n=6 participants at risk
Three fixed doses of MSC approximately 48 hours apart.
Mesenchymal stromal cells: Thawed product containing MSC(300x10\^6) in DMSO resuspended 1:1 with Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
Placebo
n=2 participants at risk
Three fixed doses of placebo control approximately 48 hours apart.
Placebo: Dextran 40 + 5% human serum albumin \[total volume 60 mL\]
|
|---|---|---|
|
Infections and infestations
Lung infection
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
|
Infections and infestations
Sepsis
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
|
Investigations
Investigations - Other, specify
|
50.0%
3/6 • Number of events 3 • 6 months
|
0.00%
0/2 • 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
4/6 • Number of events 4 • 6 months
|
100.0%
2/2 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/6 • 6 months
|
100.0%
2/2 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
1/6 • Number of events 1 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
16.7%
1/6 • Number of events 1 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
1/6 • Number of events 1 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/6 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Infections and infestations
Bacteremia
|
33.3%
2/6 • Number of events 2 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Infections and infestations
Bronchial infection
|
16.7%
1/6 • Number of events 1 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
2/6 • Number of events 2 • 6 months
|
0.00%
0/2 • 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
2/6 • Number of events 2 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • Number of events 2 • 6 months
|
0.00%
0/2 • 6 months
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
33.3%
2/6 • Number of events 2 • 6 months
|
0.00%
0/2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
33.3%
2/6 • Number of events 2 • 6 months
|
0.00%
0/2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fistula
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
1/6 • Number of events 1 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Cardiac disorders
Pericardial effusion
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
|
Renal and urinary disorders
Acute kidney injury
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/6 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Renal hemorrhage
|
0.00%
0/6 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Vascular disorders
Hematoma
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
|
Vascular disorders
Thromboembolic event
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
|
Endocrine disorders
Adrenal insufficiency
|
16.7%
1/6 • Number of events 1 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
General disorders
Fever
|
0.00%
0/6 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
General disorders
Hypothermia
|
0.00%
0/6 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
|
Nervous system disorders
Stroke
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/6 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
Additional Information
Dr. David Ingbar
University of Minnesota, Masonic Cancer Center
Phone: 612-624-9452
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place