Trial Outcomes & Findings for Convalescent Plasma in Outpatients With COVID-19 (NCT NCT04355767)
NCT ID: NCT04355767
Last Updated: 2021-10-19
Results Overview
Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
511 participants
Primary outcome timeframe
15 days
Results posted on
2021-10-19
Participant Flow
Patients were enrolled at 48 hospital emergency departments in 21 states.
Participant milestones
| Measure |
Convalescent Plasma
Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.
|
Placebo
Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
257
|
254
|
|
Overall Study
Intention-to-treat Population
|
257
|
254
|
|
Overall Study
Had Data for 15-day Outcome
|
257
|
254
|
|
Overall Study
COMPLETED
|
250
|
251
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
Convalescent Plasma
Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.
|
Placebo
Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Death
|
5
|
1
|
Baseline Characteristics
Convalescent Plasma in Outpatients With COVID-19
Baseline characteristics by cohort
| Measure |
Convalescent Plasma
n=257 Participants
Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.
|
Placebo
n=254 Participants
Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
|
Total
n=511 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
54 years
n=7 Participants
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
135 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
274 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
237 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
83 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
170 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
349 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
49 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
172 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
337 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
257 Participants
n=5 Participants
|
254 Participants
n=7 Participants
|
511 Participants
n=5 Participants
|
|
Eligibility risk factor
Age .50 yr
|
155 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
310 Participants
n=5 Participants
|
|
Eligibility risk factor
Body-mass index ≥30
|
152 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
|
Eligibility risk factor
Hypertension
|
105 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
|
Eligibility risk factor
Current or former tobacco use
|
81 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Eligibility risk factor
Diabetes mellitus
|
76 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Eligibility risk factor
COPD or asthma
|
56 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Eligibility risk factor
Coronary artery disease
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Eligibility risk factor
Immunosuppression
|
33 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Eligibility risk factor
Chronic lung disease
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Eligibility risk factor
Chronic kidney disease
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Eligibility risk factor
Congestive heart disease
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Eligibility risk factor
Currently pregnant
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Eligibility risk factor
Organ transplant recipient
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Eligibility risk factor
Active cancer
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Eligibility risk factor
Sickle-cell disease
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Number of eligibility risk factors
1
|
51 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Number of eligibility risk factors
3
|
65 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Number of eligibility risk factors
≥3
|
141 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
264 Participants
n=5 Participants
|
|
Other coexisting illness
Current or former alcohol abuse
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Other coexisting illness
Current or former drug abuse
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Other coexisting illness
Thromboembolic disorder
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Other coexisting illness
Liver disease
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Other coexisting illness
Other hematologic disorder
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Symptom duration before randomization
|
4 days
n=5 Participants
|
3 days
n=7 Participants
|
4 days
n=5 Participants
|
|
Interval between randomization and infusion
|
92 minutes
n=5 Participants
|
69 minutes
n=7 Participants
|
81 minutes
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 daysPopulation: Intention-to-treat population included all randomized participants.
Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.
Outcome measures
| Measure |
Convalescent Plasma
n=257 Participants
Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.
|
Placebo
n=254 Participants
Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
|
|---|---|---|
|
Number of Patients With Disease Progression (Intention-to-treat Population)
Patients with a disease-progression event
|
77 Participants
|
81 Participants
|
|
Number of Patients With Disease Progression (Intention-to-treat Population)
Hospital admission for any reason
|
51 Participants
|
56 Participants
|
|
Number of Patients With Disease Progression (Intention-to-treat Population)
Seeking emergency or urgent care
|
25 Participants
|
25 Participants
|
|
Number of Patients With Disease Progression (Intention-to-treat Population)
Death without hospitalization
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 15 daysPopulation: Per-protocol population included all the patients who had undergone randomization after the exclusion of those who did not receive the assigned trial product, had an identified eligibility violation, or had a disease-progression event before the initiation of treatment.
Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.
Outcome measures
| Measure |
Convalescent Plasma
n=246 Participants
Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.
|
Placebo
n=251 Participants
Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
|
|---|---|---|
|
Number of Patients With Disease Progression (Per-protocol Population)
Patients with a disease-progression event
|
71 Participants
|
80 Participants
|
|
Number of Patients With Disease Progression (Per-protocol Population)
Hospital admission for any reason
|
47 Participants
|
55 Participants
|
|
Number of Patients With Disease Progression (Per-protocol Population)
Seeking emergency or urgent care
|
24 Participants
|
25 Participants
|
|
Number of Patients With Disease Progression (Per-protocol Population)
Death without hospitalization
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Participants with available data are included in the analysis.
This scale was developed by a special World Health Organization (WHO) committee for quantifying COVID-19 illness severity. * 1 = Not hospitalized without limitation in activity (no symptoms) * 2 = Not hospitalized with limitation in activity (continued symptoms) * 3 = Hospitalized not on supplemental oxygen * 4 = Hospitalized on supplemental oxygen by mask or nasal prongs * 5 = Hospitalized on non-invasive ventilation or high flow nasal cannula * 6 = Hospitalized, intubated and mechanically ventilated * 7 = Hospitalized, intubated, mechanically ventilated and requiring additional organ support (pressors, renal replacement therapy) * 8 = Death
Outcome measures
| Measure |
Convalescent Plasma
n=250 Participants
Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.
|
Placebo
n=248 Participants
Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
|
|---|---|---|
|
Worst Severity Rating on the WHO COVID Ordinal Scale for Clinical Improvement During the 30 Days Following Randomization
Severity rating 1
|
55 Participants
|
55 Participants
|
|
Worst Severity Rating on the WHO COVID Ordinal Scale for Clinical Improvement During the 30 Days Following Randomization
Severity rating 2
|
141 Participants
|
133 Participants
|
|
Worst Severity Rating on the WHO COVID Ordinal Scale for Clinical Improvement During the 30 Days Following Randomization
Severity rating 3
|
12 Participants
|
17 Participants
|
|
Worst Severity Rating on the WHO COVID Ordinal Scale for Clinical Improvement During the 30 Days Following Randomization
Severity rating 5
|
6 Participants
|
5 Participants
|
|
Worst Severity Rating on the WHO COVID Ordinal Scale for Clinical Improvement During the 30 Days Following Randomization
Severity rating 8
|
5 Participants
|
1 Participants
|
|
Worst Severity Rating on the WHO COVID Ordinal Scale for Clinical Improvement During the 30 Days Following Randomization
Severity rating 4
|
28 Participants
|
35 Participants
|
|
Worst Severity Rating on the WHO COVID Ordinal Scale for Clinical Improvement During the 30 Days Following Randomization
Severity rating 6
|
1 Participants
|
0 Participants
|
|
Worst Severity Rating on the WHO COVID Ordinal Scale for Clinical Improvement During the 30 Days Following Randomization
Severity rating 7
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 15 daysPopulation: Intention-to-treat population
Assessed on the COVID Outpatient Ordinal Outcome Scale censored at 15 days after randomization. Scale provides more granular detail for outpatients than the WHO scale (adapted from Harrell and Lindsell, 2020). Worsening of symptoms is defined as any subject admitted to the hospital (level 1), seen in the emergency room (level 2), a patient who reports increased symptoms of 2 levels on the scale over a 24 hour period, or a patient who reports increased symptoms of 1 level observed for a 48 hour period. COVID Outpatient Ordinal Outcomes Scale * 1 = patient requires care in the hospital * 2 = patient requires care in the emergency department or urgent care * 3 = patient at home with symptoms rated as moderate (defined as fever, shortness of breath, abdominal pain) * 4 = patient at home with symptoms rated as mild (defined as afebrile, constitutional symptoms (flu-like illness) without shortness * 5 = patient in their usual state of health
Outcome measures
| Measure |
Convalescent Plasma
n=257 Participants
Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.
|
Placebo
n=254 Participants
Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
|
|---|---|---|
|
Number of Patients With Worsening of Symptoms at Day 15 as a Measure of Time to Disease Progression
|
107 Participants
|
116 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Intention-to-treat population
Outcome measures
| Measure |
Convalescent Plasma
n=257 Participants
Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.
|
Placebo
n=254 Participants
Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
|
|---|---|---|
|
Number of Hospital-free Days During the 30 Days Following Randomization
|
28.3 days
Standard Deviation 4.9
|
28.6 days
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Assessed at 30 daysPopulation: Intention-to-treat population
Outcome measures
| Measure |
Convalescent Plasma
n=257 Participants
Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.
|
Placebo
n=254 Participants
Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
|
|---|---|---|
|
All-cause Mortality
|
5 Participants
|
1 Participants
|
Adverse Events
Convalescent Plasma
Serious events: 59 serious events
Other events: 51 other events
Deaths: 5 deaths
Placebo
Serious events: 64 serious events
Other events: 35 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Convalescent Plasma
n=257 participants at risk
Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.
|
Placebo
n=254 participants at risk
Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
|
|---|---|---|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Renal and urinary disorders
Acute kidney injury
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.39%
1/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Gastrointestinal disorders
Vomiting
|
0.78%
2/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
General disorders
Fatigue
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
General disorders
Influenza like illness
|
0.00%
0/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Immune system disorders
Anaphylactic reaction
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Infections and infestations
Pneumonia
|
11.7%
30/257 • 30 days
|
15.4%
39/254 • 30 days
|
|
Infections and infestations
Septic shock
|
0.00%
0/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Infections and infestations
Tooth abscess
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Infections and infestations
Viral diarrhoea
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.6%
4/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Investigations
Oesophagoscopy
|
0.00%
0/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.78%
2/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Nervous system disorders
Epilepsy
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Psychiatric disorders
Anxiety
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Renal and urinary disorders
End stage renal disease, could not get outpatient dialysis
|
0.00%
0/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.2%
3/257 • 30 days
|
0.79%
2/254 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.39%
1/257 • 30 days
|
3.1%
8/254 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
6/257 • 30 days
|
2.0%
5/254 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
3/257 • 30 days
|
0.79%
2/254 • 30 days
|
|
Vascular disorders
Hypotension
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/257 • 30 days
|
0.39%
1/254 • 30 days
|
Other adverse events
| Measure |
Convalescent Plasma
n=257 participants at risk
Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.
|
Placebo
n=254 participants at risk
Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.39%
1/257 • 30 days
|
0.79%
2/254 • 30 days
|
|
Gastrointestinal disorders
Dysphagia
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Gastrointestinal disorders
Vomiting
|
0.39%
1/257 • 30 days
|
1.2%
3/254 • 30 days
|
|
General disorders
Chest pain
|
1.2%
3/257 • 30 days
|
2.8%
7/254 • 30 days
|
|
General disorders
Fatigue
|
0.78%
2/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
General disorders
Infusion site extravasation
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
General disorders
Pyrexia
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Infections and infestations
Nasopharyngitis
|
0.39%
1/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Infections and infestations
Pneumonia
|
2.7%
7/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Infections and infestations
Sinusitis
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.3%
11/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Investigations
Coronavirus test positive
|
0.39%
1/257 • 30 days
|
0.79%
2/254 • 30 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/257 • 30 days
|
0.79%
2/254 • 30 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.78%
2/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Nervous system disorders
Dizziness
|
0.78%
2/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Nervous system disorders
Migraine
|
1.2%
3/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Nervous system disorders
Presyncope
|
0.00%
0/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Psychiatric disorders
Depression
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/257 • 30 days
|
0.39%
1/254 • 30 days
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/257 • 30 days
|
1.2%
3/254 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.9%
5/257 • 30 days
|
3.5%
9/254 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/257 • 30 days
|
1.2%
3/254 • 30 days
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Surgical and medical procedures
Tooth extraction
|
0.39%
1/257 • 30 days
|
0.00%
0/254 • 30 days
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/257 • 30 days
|
0.39%
1/254 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place