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| ID | Type | Description | Link |
|---|---|---|---|
| 1OT2HL156812-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Strategies to Innovate EmeRgENcy Care Clinical Trials Network | NETWORK |
| University of Pittsburgh | OTHER |
Not provided
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The overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization.The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration.
This study will enroll adults presenting to the emergency department (ED) with mild, symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management at randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Convalescent Plasma | Experimental | Participants receive 1 unit of convalescent plasma. |
|
| Placebo | Placebo Comparator | Participants receive 1 unit of saline with multivitamin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Convalescent Plasma | Biological | SARS-CoV-2 convalescent plasma with neutralizing SARS-CoV2 antibodies titers of ≥1:160 administered via intravenous (IV) infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Disease Progression (Intention-to-treat Population) | Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization. | 15 days |
| Number of Patients With Disease Progression (Per-protocol Population) | Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization. | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Worst Severity Rating on the WHO COVID Ordinal Scale for Clinical Improvement During the 30 Days Following Randomization | This scale was developed by a special World Health Organization (WHO) committee for quantifying COVID-19 illness severity.
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clifton W Callaway, MD, PhD | University of Pittsburgh | Principal Investigator |
| Valerie Durkalski-Mauldin, PhD | Medical University of South Carolina | Principal Investigator |
| Frederick Korley, MD, PhD | University of Michigan | Principal Investigator |
| Sharon Yeatts, PhD | Medical University of South Carolina | Principal Investigator |
| Robert Silbergleit, MD | University of Michigan | Principal Investigator |
| William Barsan, MD | University of Michigan | Principal Investigator |
| Kevin Schulman, MD | Stanford University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chandler Regional Medical Center | Chandler | Arizona | 85224 | United States | ||
| Valleywise Health Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34407339 | Result | Korley FK, Durkalski-Mauldin V, Yeatts SD, Schulman K, Davenport RD, Dumont LJ, El Kassar N, Foster LD, Hah JM, Jaiswal S, Kaplan A, Lowell E, McDyer JF, Quinn J, Triulzi DJ, Van Huysen C, Stevenson VLW, Yadav K, Jones CW, Kea B, Burnett A, Reynolds JC, Greineder CF, Haas NL, Beiser DG, Silbergleit R, Barsan W, Callaway CW; SIREN-C3PO Investigators. Early Convalescent Plasma for High-Risk Outpatients with Covid-19. N Engl J Med. 2021 Nov 18;385(21):1951-1960. doi: 10.1056/NEJMoa2103784. Epub 2021 Aug 18. |
| Label | URL |
|---|---|
| Statistical Design and Analysis Plan for Sequential Parallel-Group RCT for COVID-19 (Harrell and Lindsell, 2020) | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
The complete de-identified patient data set will be shared.
Data will be available indefinitely.
Data requests will be managed by National Heart, Lung, and Blood Institute (NHLBI).
Not provided
Patients were enrolled at 48 hospital emergency departments in 21 states.
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| ID | Title | Description |
|---|---|---|
| FG000 | Convalescent Plasma | Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion. |
| FG001 | Placebo | Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 16, 2021 |
Not provided
Not provided
| Medical University of South Carolina |
| OTHER |
Not provided
Not provided
Not provided
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| Saline | Biological | Saline with multivitamin administered via intravenous (IV) infusion.. |
|
| 30 days |
| Number of Patients With Worsening of Symptoms at Day 15 as a Measure of Time to Disease Progression | 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
| 15 days |
| Number of Hospital-free Days During the 30 Days Following Randomization | 30 days |
| All-cause Mortality | Assessed at 30 days |
| Phoenix |
| Arizona |
| 85008 |
| United States |
| UCSD Health La Jolla | La Jolla | California | 92037 | United States |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90211 | United States |
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
| Stanford University | Stanford | California | 94305 | United States |
| Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| UF Health Shands Hospital | Gainesville | Florida | 32608 | United States |
| Jackson Memorial Hospital | Miami | Florida | 33136 | United States |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Illinois Hospital | Chicago | Illinois | 60612 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | United States |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Newton-Wellesley Hospital | Newton | Massachusetts | 02462 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| University of Michigan University Hospital | Ann Arbor | Michigan | 48109 | United States |
| Detroit Receiving Hospital | Detroit | Michigan | 48201 | United States |
| Harper University Hospital | Detroit | Michigan | 48201 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Sinai-Grace Hospital | Detroit | Michigan | 48235 | United States |
| Spectrum Health Hospitals Butterworth Hospital | Grand Rapids | Michigan | 49503 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| William Beaumont Hospital-Troy | Troy | Michigan | 48085 | United States |
| HealthPartners Methodist Hospital | Saint Louis Park | Minnesota | 55426 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | United States |
| University of New Mexico Hospital | Albuquerque | New Mexico | 87106 | United States |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| OSU Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Mercy St. Vincent Medical Center | Toledo | Ohio | 43608 | United States |
| Oregon Health & Science University Hospital | Portland | Oregon | 97239 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| William P. Clements Jr. University Hospital | Dallas | Texas | 75235 | United States |
| Ben Taub General Hospital | Houston | Texas | 77030 | United States |
| Memorial Hermann Texas Medical Center | Houston | Texas | 77030 | United States |
| University of Utah Healthcare | Salt Lake City | Utah | 84132 | United States |
| Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| Intention-to-treat Population |
|
| Had Data for 15-day Outcome |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Convalescent Plasma | Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion. |
| BG001 | Placebo | Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Eligibility risk factor | Count of Participants | Participants |
| ||||||||||||||||
| Number of eligibility risk factors | Count of Participants | Participants |
| ||||||||||||||||
| Other coexisting illness | Count of Participants | Participants |
| ||||||||||||||||
| Symptom duration before randomization | Median | Inter-Quartile Range | days |
| |||||||||||||||
| Interval between randomization and infusion | Median | Inter-Quartile Range | minutes |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Disease Progression (Intention-to-treat Population) | Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization. | Intention-to-treat population included all randomized participants. | Posted | Count of Participants | Participants | 15 days |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Disease Progression (Per-protocol Population) | Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization. | 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. | Posted | Count of Participants | Participants | 15 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Worst Severity Rating on the WHO COVID Ordinal Scale for Clinical Improvement During the 30 Days Following Randomization | This scale was developed by a special World Health Organization (WHO) committee for quantifying COVID-19 illness severity.
| Participants with available data are included in the analysis. | Posted | Count of Participants | Participants | 30 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Worsening of Symptoms at Day 15 as a Measure of Time to Disease Progression | 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
| Intention-to-treat population | Posted | Count of Participants | Participants | 15 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Hospital-free Days During the 30 Days Following Randomization | Intention-to-treat population | Posted | Mean | Standard Deviation | days | 30 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | All-cause Mortality | Intention-to-treat population | Posted | Count of Participants | Participants | Assessed at 30 days |
|
|
30 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Convalescent Plasma | Participants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion. | 5 | 257 | 59 | 257 | 51 | 257 |
| EG001 | Placebo | Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion. | 1 | 254 | 64 | 254 | 35 | 254 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Influenza like illness | General disorders | Systematic Assessment |
| ||
| Anaphylactic reaction | Immune system disorders | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Septic shock | Infections and infestations | Systematic Assessment |
| ||
| Tooth abscess | Infections and infestations | Systematic Assessment |
| ||
| Viral diarrhoea | Infections and infestations | Systematic Assessment |
| ||
| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Oesophagoscopy | Investigations | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Epilepsy | Nervous system disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Psychotic disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| End stage renal disease, could not get outpatient dialysis | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Iliac artery occlusion | Vascular disorders | Systematic Assessment |
| ||
| Thrombophlebitis superficial | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Infusion site extravasation | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Alcohol poisoning | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Coronavirus test positive | Investigations | Systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Migraine | Nervous system disorders | Systematic Assessment |
| ||
| Presyncope | Nervous system disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Paranoia | Psychiatric disorders | Systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Ecchymosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Tooth extraction | Surgical and medical procedures | Systematic Assessment |
| ||
| Venous thrombosis limb | Vascular disorders | Systematic Assessment |
|
This study did not meet its maximum sample size of 900 participants due to a planned interim analysis that indicated that it was unlikely that there would be a difference in the rate of disease progression between the two groups if continued to the planned sample size.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Schulman, MD | Stanford University | (650) 724-0543 | kevin.schulman@stanford.edu |
| Sep 28, 2021 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 4, 2020 | May 7, 2021 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black |
|
| Other |
|
| White |
|
| Body-mass index ≥30 |
|
| Hypertension |
|
| Current or former tobacco use |
|
| Diabetes mellitus |
|
| COPD or asthma |
|
| Coronary artery disease |
|
| Immunosuppression |
|
| Chronic lung disease |
|
| Chronic kidney disease |
|
| Congestive heart disease |
|
| Currently pregnant |
|
| Organ transplant recipient |
|
| Active cancer |
|
| Sickle-cell disease |
|
| 3 |
|
| ≥3 |
|
| Current or former drug abuse |
|
| Thromboembolic disorder |
|
| Liver disease |
|
| Other hematologic disorder |
|
| Seeking emergency or urgent care |
|
| Death without hospitalization |
|
| Analysis is of patients with a disease-progression event. | Risk Difference (RD) | 2.2 | 2-Sided | 95 | -5.9 | 10.4 | Risk difference after adjustment for age, sex, symptom duration. | Superiority |
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|