Trial Outcomes & Findings for Study of Sargramostim in Patients With COVID-19 (NCT NCT04411680)

Results Overview

The P(A-a)O2 gradient is a measure of how well the oxygen moves from the lungs into the bloodstream. Patients with a high gradient have less oxygen in the bloodstream.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

123 participants

Primary outcome timeframe

1-6 days

Results posted on

2023-08-23

Participant Flow

One participant was randomized to the sargramostim arm and then withdrew consent prior to treatment.

Participant milestones

Participant milestones
Measure	Sargramostim Arm Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period. Standard of care: Standard of care for COVID-19	Control Arm Standard of care for COVID-19 Standard of care: Standard of care for COVID-19
Treatment Period STARTED	78	44
Treatment Period COMPLETED	49	36
Treatment Period NOT COMPLETED	29	8
Follow up Period STARTED	78	44
Follow up Period COMPLETED	60	30
Follow up Period NOT COMPLETED	18	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Sargramostim Arm Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period. Standard of care: Standard of care for COVID-19	Control Arm Standard of care for COVID-19 Standard of care: Standard of care for COVID-19
Treatment Period Adverse Event	3	0
Treatment Period Discharged from hospital	18	7
Treatment Period Missed 1 or more doses	8	0
Treatment Period Transferred to another hospital	0	1
Follow up Period Withdrawal by Subject	2	0
Follow up Period Lost to Follow-up	5	6
Follow up Period Death	11	8

Baseline Characteristics

Data to calculate BMI is missing for 5 patients in sargramostim arm and 1 patient in control arm.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sargramostim Arm n=78 Participants Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period. Standard of care: Standard of care for COVID-19	Control Arm n=44 Participants Standard of care for COVID-19 Standard of care: Standard of care for COVID-19	Total n=122 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=78 Participants	0 Participants n=44 Participants	0 Participants n=122 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=78 Participants	30 Participants n=44 Participants	77 Participants n=122 Participants
Age, Categorical >=65 years	31 Participants n=78 Participants	14 Participants n=44 Participants	45 Participants n=122 Participants
Age, Continuous	61.7 years STANDARD_DEVIATION 13.00 • n=78 Participants	58.2 years STANDARD_DEVIATION 10.61 • n=44 Participants	60.4 years STANDARD_DEVIATION 12.26 • n=122 Participants
Sex: Female, Male Female	43 Participants n=78 Participants	18 Participants n=44 Participants	61 Participants n=122 Participants
Sex: Female, Male Male	35 Participants n=78 Participants	26 Participants n=44 Participants	61 Participants n=122 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=78 Participants	11 Participants n=44 Participants	35 Participants n=122 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=78 Participants	33 Participants n=44 Participants	86 Participants n=122 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=78 Participants	0 Participants n=44 Participants	1 Participants n=122 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=78 Participants	0 Participants n=44 Participants	2 Participants n=122 Participants
Race (NIH/OMB) Asian	2 Participants n=78 Participants	0 Participants n=44 Participants	2 Participants n=122 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=78 Participants	1 Participants n=44 Participants	1 Participants n=122 Participants
Race (NIH/OMB) Black or African American	6 Participants n=78 Participants	1 Participants n=44 Participants	7 Participants n=122 Participants
Race (NIH/OMB) White	48 Participants n=78 Participants	33 Participants n=44 Participants	81 Participants n=122 Participants
Race (NIH/OMB) More than one race	0 Participants n=78 Participants	0 Participants n=44 Participants	0 Participants n=122 Participants
Race (NIH/OMB) Unknown or Not Reported	20 Participants n=78 Participants	9 Participants n=44 Participants	29 Participants n=122 Participants
Body Mass Index	34.86 kilograms/meter squared STANDARD_DEVIATION 8.988 • n=73 Participants • Data to calculate BMI is missing for 5 patients in sargramostim arm and 1 patient in control arm.	35.44 kilograms/meter squared STANDARD_DEVIATION 9.647 • n=43 Participants • Data to calculate BMI is missing for 5 patients in sargramostim arm and 1 patient in control arm.	35.07 kilograms/meter squared STANDARD_DEVIATION 9.200 • n=116 Participants • Data to calculate BMI is missing for 5 patients in sargramostim arm and 1 patient in control arm.

PRIMARY outcome

Timeframe: 1-6 days

Population: Patients analyzed if they had both a baseline and at least 1 post-baseline measurement.

The P(A-a)O2 gradient is a measure of how well the oxygen moves from the lungs into the bloodstream. Patients with a high gradient have less oxygen in the bloodstream.

Outcome measures

Outcome measures
Measure	Sargramostim Arm n=63 Participants Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period. Standard of care: Standard of care for COVID-19	Control Arm n=33 Participants Standard of care for COVID-19 Standard of care: Standard of care for COVID-19
Change in Oxygenation Parameter of P(A-a)O2 Gradient by Day 6	-102.3 millimeters of mercury (mmHg) Standard Error 19.44	-30.5 millimeters of mercury (mmHg) Standard Error 26.88

PRIMARY outcome

Timeframe: 1-14 days

Outcome measures

Outcome measures
Measure	Sargramostim Arm n=78 Participants Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period. Standard of care: Standard of care for COVID-19	Control Arm n=44 Participants Standard of care for COVID-19 Standard of care: Standard of care for COVID-19
Number of Patients Who Have Been Intubated by Day 14	9 Participants	7 Participants

SECONDARY outcome

Timeframe: 1-28 days

Population: Only 86 patients had follow up data at Day 28

The ordinal scale was used, where 0 is not hospitalized, no clinical or virological evidence of infection, and 8 is death.

Outcome measures

Outcome measures
Measure	Sargramostim Arm n=61 Participants Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period. Standard of care: Standard of care for COVID-19	Control Arm n=25 Participants Standard of care for COVID-19 Standard of care: Standard of care for COVID-19
Change in Ordinal Scale	-2.6 score on a scale Standard Deviation 1.49	-2.5 score on a scale Standard Deviation 1.48

SECONDARY outcome

Timeframe: 1-28 days

Outcome measures

Outcome measures
Measure	Sargramostim Arm n=78 Participants Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period. Standard of care: Standard of care for COVID-19	Control Arm n=44 Participants Standard of care for COVID-19 Standard of care: Standard of care for COVID-19
All Cause 28-day Mortality	9 Participants	6 Participants

SECONDARY outcome

Timeframe: 1-58 days

Number of patients with side effects related to treatment with sargramostim. Patients on the control arm did not receive sargramostim.

Outcome measures

Outcome measures
Measure	Sargramostim Arm n=78 Participants Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period. Standard of care: Standard of care for COVID-19	Control Arm n=44 Participants Standard of care for COVID-19 Standard of care: Standard of care for COVID-19
Number of Patients With Treatment-related Adverse Events	5 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1-90

Outcome measures

Outcome measures
Measure	Sargramostim Arm n=78 Participants Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period. Standard of care: Standard of care for COVID-19	Control Arm n=44 Participants Standard of care for COVID-19 Standard of care: Standard of care for COVID-19
Survival Time of Patients	76.0 Days Standard Deviation 27.05	72.6 Days Standard Deviation 28.56

SECONDARY outcome

Timeframe: Day 1-90

Population: Patients alive at Day 90 were not analyzed

Outcome measures

Outcome measures
Measure	Sargramostim Arm n=11 Participants Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period. Standard of care: Standard of care for COVID-19	Control Arm n=8 Participants Standard of care for COVID-19 Standard of care: Standard of care for COVID-19
Causes of Death Acute respiratory distress syndrome	4 Participants	2 Participants
Causes of Death Respiratory failure	6 Participants	3 Participants
Causes of Death Cardiorespiratory arrest	1 Participants	2 Participants
Causes of Death Septic shock	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From Day 1 up to Day 6

Population: Patients were analyzed if they had both a baseline and at least 1 post-baseline measurement of P/F ratio.

The P/F ratio is a simple way to assess severity of low blood oxygen. It's the ratio of PaO2 (arterial oxygen partial pressure obtained from an arterial blood gas) to FiO2 (fraction of inspired oxygen expressed as a decimal). A normal arterial blood is gas 80 to 100 mm Hg. Normal room air has 21% or 0.21 oxygen. So a "normal" P/F ratio is about 380-475. A high P/F ratio means more oxygen in the bloodstream and a low P/F ratio means less oxygen in the bloodstream. This outcome measure compares the improvement (increase) in P/F ratio between treatment arms.

Outcome measures

Outcome measures
Measure	Sargramostim Arm n=63 Participants Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period. Standard of care: Standard of care for COVID-19	Control Arm n=33 Participants Standard of care for COVID-19 Standard of care: Standard of care for COVID-19
Change From Baseline in P/F Ratio	65.70 ratio Standard Deviation 97.964	47.24 ratio Standard Deviation 99.942

SECONDARY outcome

Timeframe: Day 1-90

Nosocomial infections also referred to as healthcare-associated infections (HAI), are infection(s) acquired during the process of receiving health care that was not present during the time of admission.

Outcome measures

Outcome measures
Measure	Sargramostim Arm n=78 Participants Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period. Standard of care: Standard of care for COVID-19	Control Arm n=44 Participants Standard of care for COVID-19 Standard of care: Standard of care for COVID-19
Number of Participants Wtih Nosocomial Infections	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1-90

The is the number of patients that needed to be placed on a ventilator.

Outcome measures

Outcome measures
Measure	Sargramostim Arm n=78 Participants Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period. Standard of care: Standard of care for COVID-19	Control Arm n=44 Participants Standard of care for COVID-19 Standard of care: Standard of care for COVID-19
Number of Patients Requiring Invasive Mechanical Ventilation	12 Participants	9 Participants

SECONDARY outcome

Timeframe: Day 1-90

This endpoint includes duration of any/all types of respiratory support

Outcome measures

Outcome measures
Measure	Sargramostim Arm n=78 Participants Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period. Standard of care: Standard of care for COVID-19	Control Arm n=44 Participants Standard of care for COVID-19 Standard of care: Standard of care for COVID-19
Duration of Invasive, Non-invasive and Supplemental Oxygen	37.9 Days Standard Deviation 35.64	32.8 Days Standard Deviation 34.25

SECONDARY outcome

Timeframe: Day 1-90

Outcome measures

Outcome measures
Measure	Sargramostim Arm n=78 Participants Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period. Standard of care: Standard of care for COVID-19	Control Arm n=44 Participants Standard of care for COVID-19 Standard of care: Standard of care for COVID-19
Duration of Hospitalization	12.1 Days Standard Deviation 9.39	11.8 Days Standard Deviation 8.63

SECONDARY outcome

Timeframe: Day 1-90

Population: Of 78 and 44 participants in the Sargramostim and Control Arms, respectively, only 28 (35.8%) and 17 (38.6%) had both baseline and post-baseline values available for evaluation at the Day 6 timepoint of interest.

Normalization of WBC and lymphocyte count is defined as whether WBC and lymphocyte count results are normal or below normal or above normal ranges at available visits.

Outcome measures

Outcome measures
Measure	Sargramostim Arm n=28 Participants Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period. Standard of care: Standard of care for COVID-19	Control Arm n=17 Participants Standard of care for COVID-19 Standard of care: Standard of care for COVID-19
Time to Normalization of White Blood Cells and Lymphocytes	NA Days Standard Deviation NA Insufficient number of participants with events	NA Days Standard Deviation NA Insufficient number of participants with events

Adverse Events

Sargramostim Arm

Serious events: 15 serious events

Other events: 47 other events

Deaths: 11 deaths

Control Arm

Serious events: 14 serious events

Other events: 30 other events

Deaths: 8 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Sargramostim Arm n=78 participants at risk Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period. Standard of care: Standard of care for COVID-19	Control Arm n=44 participants at risk Standard of care for COVID-19 Standard of care: Standard of care for COVID-19
Blood and lymphatic system disorders Anemia	6.4% 5/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	6.8% 3/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Gastrointestinal disorders Constipation	9.0% 7/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	6.8% 3/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Infections and infestations Septic shock	6.4% 5/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	2.3% 1/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Metabolism and nutrition disorders Hyperglycemia	10.3% 8/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	9.1% 4/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Metabolism and nutrition disorders Hypokalaemia	9.0% 7/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	6.8% 3/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Psychiatric disorders Anxiety	5.1% 4/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	9.1% 4/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Psychiatric disorders Insomnia	3.8% 3/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	9.1% 4/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Renal and urinary disorders Acute kidney injury	3.8% 3/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	9.1% 4/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Vascular disorders Hypotension	6.4% 5/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	9.1% 4/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90

Additional Information

Medical Information

Partner Therapeutics, Inc.

Phone: 1-888-479-5385

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Sargramostim Arm n=78 participants at risk Day 1 - 5: Sargramostim treatment in addition to standard of care for COVID-19 Sargramostim: Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period. Standard of care: Standard of care for COVID-19	Control Arm n=44 participants at risk Standard of care for COVID-19 Standard of care: Standard of care for COVID-19
Cardiac disorders Atrial fibrillation	1.3% 1/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	2.3% 1/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Cardiac disorders Atrial flutter	0.00% 0/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	2.3% 1/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Cardiac disorders Cardio-respiratory arrest	1.3% 1/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	2.3% 1/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
General disorders Cardiac death	0.00% 0/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	2.3% 1/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Infections and infestations Cellulitis	1.3% 1/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	0.00% 0/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Infections and infestations Septic shock	0.00% 0/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	4.5% 2/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Investigations False positive investigation result	1.3% 1/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	0.00% 0/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Metabolism and nutrition disorders Hyperkalaemia	1.3% 1/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	2.3% 1/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	2.3% 1/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Renal and urinary disorders Acute kidney injury	1.3% 1/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	4.5% 2/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Renal and urinary disorders Anuria	0.00% 0/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	2.3% 1/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	5.1% 4/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	6.8% 3/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.3% 1/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	0.00% 0/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	2.3% 1/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	4.5% 2/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90
Respiratory, thoracic and mediastinal disorders Respiratory failure	10.3% 8/78 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90	11.4% 5/44 • Adverse Events: Day 1-58, All-Cause Mortality: Day 1-90