AZD7442 for Inpatients With COVID-19 (An ACTIV-3/TICO Tre... | NCT05780437

Status Module

Name	Class
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)	NETWORK
University of Copenhagen	OTHER
Medical Research Council	OTHER_GOV

Description Module

Detailed Description

This is a treatment trial of the ACTIV-3/TICO master protocol (NCT04501978) to evaluate the safety and efficacy of AZD7442 in hospitalized patients infected with COVID-19.

This is a randomized, blinded, controlled sub-study of AZD7442 plus current SOC against placebo plus current SOC. The placebo arm may be shared across other sub-studies of the ACTIV-3/TICO master protocol. When more than one drug is being tested at the same time, participants will be randomly allocated to treatments or placebo.

Randomization will be stratified by study site pharmacy and disease severity. There are 2 disease severity strata: participants without organ failure (severity stratum 1) and participants with organ failure (severity stratum 2).

An independent Data and Safety Monitoring Board (DSMB) will regularly review interim analyses and summarize safety and efficacy outcomes. The pace of enrollment with be initially restricted, and there will be an early review of safety data by the DSMB. At the outset of the trial, only participants in disease severity stratum 1 will be enrolled. This will continue until approximately 300 participants are enrolled and followed for 5 days. The exact number will vary according to the speed of enrollment and the timing of DSMB meetings. Prior to expanding enrollment to also include patients in disease severity stratum 2, safety will be evaluated and a pre-specified futility assessment by the DSMB will be carried out using 2 ordinal outcomes assessed at Day 5.

If AZD7442 passes the futility assessment, enrollment of participants will be expanded, seamlessly and without any data unblinding, to include participants in disease severity stratum 2 as well as those in disease severity stratum 1. Future interim analyses will be based on the primary endpoint of sustained recovery and will use pre-specified guidelines to determine early evidence of benefit, harm, or futility for the investigational agent. Participants will be followed for 18 months following randomization.

This trial will be conducted in several hundred clinical sites. Participating sites are affiliated with networks funded by the United States National Institutes of Health (NIH) and the US Department of Veterans Affairs.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AZD7442 plus SOC	Experimental	AZD7442 600 mg solution (4 separate vials, 2 containing 150 mg each of AZD88995 and 2 containing 150 mg each of AZD1061); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion	Biological: AZD7442 Biological: Remdesivir
Placebo plus SOC	Placebo Comparator	Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion	Biological: Placebo Biological: Remdesivir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD7442	Biological	AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Sustained Recovery	The primary endpoint is the proportion of subjects with sustained recovery, which is defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90. Home is defined as the level of residence or facility where the participant was residing prior to hospital admission leading to enrollment in this protocol. Readmission from "home" may occur, and if this occurs within 14 days of the first discharge to "home," then the primary endpoint will not be reached until such time as the participant has been at home for 14 consecutive days.	Through Day 90
Number of Participants With an Ordinal Outcome on Day 5	Ordinal outcome with 7 mutually exclusive categories	Status on Day 5

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With a Safety Outcome Through Day 5	Safety outcomes are defined as Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 5. Seriousness was based on the definition of the term at 21CFR312.32 AEs were graded for severity by the treating investigator, according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (also known at the DAIDS AE Grading Table), U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. [July 2017]. Available from: https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf). The following generic grading descriptions from the DAIDS AE Grading Table are provided for context: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life-threatening

Eligibility Module

Name	Affiliation	Role
Jens Lundgren, Prof.	INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen	Principal Investigator
James Neaton, Prof.	INSIGHT Statistical and Data Management Center, University of Minnesota	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue		Tucson	Arizona	85719	United States

PubMed Identifier	Type	Citation	Retractions
35817072	Result	ACTIV-3-Therapeutics for Inpatients with COVID-19 (TICO) Study Group. Tixagevimab-cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial. Lancet Respir Med. 2022 Oct;10(10):972-984. doi: 10.1016/S2213-2600(22)00215-6. Epub 2022 Jul 8.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	AZD7442 Plus SOC	AZD7442 600 mg solution (4 separate vials, 2 containing 150 mg each of AZD88995 and 2 containing 150 mg each of AZD1061); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion AZD7442: AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2. Remdesivir: Antiviral agent

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol: Trial H4 Protocol	Apr 9, 2021

Arm/Group Information

ID	Title	Description
BG000	AZD7442 Plus SOC	AZD7442 600 mg solution (separate vials containing 300 mg each of AZD88995 and AZD1061); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion AZD7442: AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2. Remdesivir: Antiviral agent
BG001	Placebo Plus SOC	Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00055.2± 14.7 BG00155.0± 15.0 BG00255.1± 14.8

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000299 BG001295 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0001 BG0013 BG002

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 Participants With Sustained Recovery

The primary endpoint is the proportion of subjects with sustained recovery, which is defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90. Home is defined as the level of residence or facility where the participant was residing prior to hospital admission leading to enrollment in this protocol. Readmission from "home" may occur, and if this occurs within 14 days of the first discharge to "home," then the primary endpoint will not be reached until such time as the participant has been at home for 14 consecutive days.

Posted

Count of Participants

Participants

Through Day 90

ID	Title	Description
OG000	AZD7442 Plus SOC	AZD7442 600 mg solution (4 separate vials, 2 containing 150 mg each of AZD88995 and 2 containing 150 mg each of AZD1061); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion AZD7442: AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2. Remdesivir: Antiviral agent
OG001	Placebo Plus SOC	Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent

Units	Counts
Participants	OG000710 OG001707

Title

Denominators

Categories

Title	Measurements
	OG000617 OG001594

Primary

Number of Participants With an Ordinal Outcome on Day 5

Ordinal outcome with 7 mutually exclusive categories

Posted

Count of Participants

Participants

Status on Day 5

ID	Title	Description
OG000	AZD7442 Plus SOC	AZD7442 600 mg solution (4 separate vials, 2 containing 150 mg each of AZD88995 and 2 containing 150 mg each of AZD1061); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion AZD7442: AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2. Remdesivir: Antiviral agent
OG001	Placebo Plus SOC	Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent

Units	Counts
Participants

Secondary

Number of Participants With a Safety Outcome Through Day 5

Safety outcomes are defined as Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 5. Seriousness was based on the definition of the term at 21CFR312.32

AEs were graded for severity by the treating investigator, according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (also known at the DAIDS AE Grading Table), U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. [July 2017]. Available from: https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf). The following generic grading descriptions from the DAIDS AE Grading Table are provided for context: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=potentially life-threatening

Posted

Count of Participants

Participants

Through Day 5

ID	Title	Description
OG000	AZD7442 Plus SOC	AZD7442 600 mg solution (4 separate vials, 2 containing 150 mg each of AZD88995 and 2 containing 150 mg each of AZD1061); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion AZD7442: AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2. Remdesivir: Antiviral agent

Secondary

Number of Participants With a Safety Outcome Through Day 28

Safety outcomes are defined as Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 28. Seriousness was based on the definition of the term at 21CFR312.32

Posted

Count of Participants

Participants

Through Day 28

ID	Title	Description
OG000	AZD7442 Plus SOC	AZD7442 600 mg solution (4 separate vials, 2 containing 150 mg each of AZD88995 and 2 containing 150 mg each of AZD1061); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion AZD7442: AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2. Remdesivir: Antiviral agent

Secondary

Number of Participants With a Safety Outcome Through Day 90

Safety outcomes are defined as Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 90. Seriousness was based on the definition of the term at 21CFR312.32

AEs were graded for severity according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (also known at the DAIDS AE Grading Table).

Posted

Count of Participants

Participants

Through Day 90

ID	Title	Description
OG000	AZD7442 Plus SOC	AZD7442 600 mg solution (4 separate vials, 2 containing 150 mg each of AZD88995 and 2 containing 150 mg each of AZD1061); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion AZD7442: AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2. Remdesivir: Antiviral agent
OG001	Placebo Plus SOC	Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent

Secondary

Number of Participants Who Died From All Causes

All-cause Mortality

Posted

Count of Participants

Participants

Through Day 90

ID	Title	Description
OG000	AZD7442 Plus SOC	AZD7442 600 mg solution (4 separate vials, 2 containing 150 mg each of AZD88995 and 2 containing 150 mg each of AZD1061); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion AZD7442: AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2. Remdesivir: Antiviral agent
OG001	Placebo Plus SOC	Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	AZD7442 Plus SOC	AZD7442 600 mg solution (separate vials containing 300 mg each of AZD88995 and AZD1061); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion AZD7442: AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2. Remdesivir: Antiviral agent	61	710	36	710	176	710
EG001	Placebo Plus SOC	Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent	86	707	39	707	184	707

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0012 events2 affected707 at risk
Anemia of chronic disease	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Normocytic anemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Pancytopenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Acute myocardial infarction	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Angina pectoris	Cardiac disorders	Non-systematic Assessment	EG0002 events1 affected710 at risk EG0010 events0 affected707 at risk
Atrial fibrillation	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Bradycardia	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Cardiac arrest	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected710 at risk EG0010 events0 affected707 at risk
Cardiac failure congestive	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Ventricular tachycardia	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Pulseless electrical activity	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Intestinal perforation	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Peptic ulcer	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Abdominal wall hematoma	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Asthenia	General disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Chest pain	General disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Fatigue	General disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Malaise	General disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Hypertransaminasemia	Hepatobiliary disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0012 events2 affected707 at risk
Appendicitis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Laryngitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Pyelonephritis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
COVID-19 pneumonia	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0011 events1 affected707 at risk
Accidental overdose	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Ankle fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Gun shot wound	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Post procedural hemorrhage	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Traumatic hemothorax	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Transaminases increased	Investigations	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Failure to thrive	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Hyperglycemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Hyponatremia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Arthritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Bursitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Hematoma muscle	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Guillain-Barre syndrome	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Migraine	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0011 events1 affected707 at risk
Seizure	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Syncope	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Carotid artery occlusion	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Status migrainosus	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Acute kidney injury	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0012 events2 affected707 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0011 events1 affected707 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0003 events3 affected710 at risk EG0014 events4 affected707 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0012 events2 affected707 at risk
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0011 events1 affected707 at risk
Urticaria	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Hypotension	Vascular disorders	Non-systematic Assessment	EG0004 events2 affected710 at risk EG0010 events0 affected707 at risk
Dry gangrene	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Deep vein thrombosis	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Peripheral artery occlusion	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Hypertensive urgency	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0008 events8 affected710 at risk EG0016 events5 affected707 at risk
Anemia macrocytic	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Anemia of chronic disease	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Leukocytosis	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Pancytopenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Thrombocytopenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0012 events2 affected707 at risk
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Blood loss anemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Acute myocardial infarction	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Atrial fibrillation	Cardiac disorders	Non-systematic Assessment	EG0003 events3 affected710 at risk EG0018 events8 affected707 at risk
Atrioventricular block second degree	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Bradycardia	Cardiac disorders	Non-systematic Assessment	EG0004 events4 affected710 at risk EG0010 events0 affected707 at risk
Cardiac arrest	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected710 at risk EG0010 events0 affected707 at risk
Cardiac failure	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Cardiogenic shock	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Myocardial infarction	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0013 events3 affected707 at risk
Palpitations	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Right ventricular failure	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Tachycardia	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected710 at risk EG0012 events2 affected707 at risk
Ventricular tachycardia	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0012 events2 affected707 at risk
Hypothyroidism	Endocrine disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Vision blurred	Eye disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Abdominal pain	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0013 events3 affected707 at risk
Abdominal pain lower	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Abdominal pain upper	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Constipation	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0012 events2 affected707 at risk
Diarrhea	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0015 events5 affected707 at risk
Dyspepsia	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Dysphagia	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Gastrointestinal hemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected710 at risk EG0011 events1 affected707 at risk
Hematemesis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Intestinal dilatation	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Intestinal perforation	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Mesenteric artery thrombosis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG0003 events3 affected710 at risk EG0014 events3 affected707 at risk
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Abdominal wall hemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Asthenia	General disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0013 events3 affected707 at risk
Chills	General disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0011 events1 affected707 at risk
Decreased activity	General disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Fatigue	General disorders	Non-systematic Assessment	EG00023 events22 affected710 at risk EG00126 events26 affected707 at risk
Gait disturbance	General disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Hypothermia	General disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Malaise	General disorders	Non-systematic Assessment	EG0002 events2 affected710 at risk EG0010 events0 affected707 at risk
Oedema	General disorders	Non-systematic Assessment	EG0002 events2 affected710 at risk EG0012 events2 affected707 at risk
Oedema peripheral	General disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Pain	General disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0012 events2 affected707 at risk
Pyrexia	General disorders	Non-systematic Assessment	EG00010 events8 affected710 at risk EG0015 events5 affected707 at risk
Swelling face	General disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Peripheral swelling	General disorders	Non-systematic Assessment	EG0002 events2 affected710 at risk EG0010 events0 affected707 at risk
Pneumatosis	General disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Non-cardiac chest pain	General disorders	Non-systematic Assessment	EG0002 events2 affected710 at risk EG0013 events1 affected707 at risk
Cholecystitis	Hepatobiliary disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Hepatic failure	Hepatobiliary disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Ischemic hepatitis	Hepatobiliary disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Liver injury	Hepatobiliary disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0012 events1 affected707 at risk
Hypertransaminasemia	Hepatobiliary disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0011 events1 affected707 at risk
Fungal skin infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Pelvic inflammatory disease	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Pneumonia	Infections and infestations	Non-systematic Assessment	EG0006 events6 affected710 at risk EG0014 events3 affected707 at risk
Pneumonia klebsiella	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0011 events1 affected707 at risk
Pneumonia staphylococcal	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected710 at risk EG0013 events3 affected707 at risk
Pneumonia viral	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Pyelonephritis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Pyelonephritis acute	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Sepsis	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected710 at risk EG0013 events3 affected707 at risk
Septic shock	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected710 at risk EG0010 events0 affected707 at risk
Sinusitis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Tooth abscess	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Staphylococcal bacteremia	Infections and infestations	Non-systematic Assessment	EG0003 events3 affected710 at risk EG0011 events1 affected707 at risk
Pneumonia bacterial	Infections and infestations	Non-systematic Assessment	EG0005 events5 affected710 at risk EG0019 events9 affected707 at risk
Enterococcal infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Klebsiella infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Viral sepsis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Candida infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Escherichia pyelonephritis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
COVID-19 pneumonia	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0014 events4 affected707 at risk
Ankle fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Fibula fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Subdural hemorrhage	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Blood glucose increased	Investigations	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Fibrin D dimer increased	Investigations	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Oxygen saturation decreased	Investigations	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0012 events2 affected707 at risk
Acidosis	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0012 events2 affected707 at risk
Dehydration	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Diabetes mellitus	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Gout	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Hyperglycemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0005 events5 affected710 at risk EG0019 events9 affected707 at risk
Hyperkaliemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Hypernatremia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Hypervolemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0003 events3 affected710 at risk EG0013 events3 affected707 at risk
Hypoglycemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0012 events2 affected707 at risk
Hyponatremia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0012 events2 affected707 at risk
Malnutrition	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Decreased appetite	Metabolism and nutrition disorders	Non-systematic Assessment	EG0004 events4 affected710 at risk EG0019 events9 affected707 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0011 events1 affected707 at risk
Back pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 events2 affected710 at risk EG0010 events0 affected707 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0011 events1 affected707 at risk
Flank pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Muscle pains	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0011 events1 affected707 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 events2 affected710 at risk EG0010 events0 affected707 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Hematoma muscle	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Cerebellar hemorrhage	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Cerebral ischemia	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Dizziness	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0013 events3 affected707 at risk
Embolic stroke	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Headache	Nervous system disorders	Non-systematic Assessment	EG0003 events3 affected710 at risk EG0016 events6 affected707 at risk
Lethargy	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0012 events2 affected707 at risk
Migraine	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0012 events2 affected707 at risk
Seizure	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0012 events2 affected707 at risk
Syncope	Nervous system disorders	Non-systematic Assessment	EG0002 events2 affected710 at risk EG0010 events0 affected707 at risk
Toxic encephalopathy	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Ischemic stroke	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Metabolic encephalopathy	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Seizure like phenomena	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Brain fog	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0011 events1 affected707 at risk
Acute psychosis	Psychiatric disorders	Non-systematic Assessment	EG0002 events1 affected710 at risk EG0010 events0 affected707 at risk
Agitation	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0012 events2 affected707 at risk
Anxiety	Psychiatric disorders	Non-systematic Assessment	EG0006 events6 affected710 at risk EG0010 events0 affected707 at risk
Confusional state	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Delirium	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Insomnia	Psychiatric disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0011 events1 affected707 at risk
Mental status change	Psychiatric disorders	Non-systematic Assessment	EG0009 events9 affected710 at risk EG0019 events9 affected707 at risk
Nephropathy toxic	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Renal failure	Renal and urinary disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0013 events3 affected707 at risk
Urinary retention	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Urinary tract obstruction	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Acute kidney injury	Renal and urinary disorders	Non-systematic Assessment	EG00011 events11 affected710 at risk EG00110 events10 affected707 at risk
Subcapsular renal hematoma	Renal and urinary disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0005 events5 affected710 at risk EG0016 events4 affected707 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0007 events7 affected710 at risk EG00110 events9 affected707 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG00016 events16 affected710 at risk EG00114 events14 affected707 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG00070 events64 affected710 at risk EG00165 events62 affected707 at risk
Dyspnea exertional	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0003 events2 affected710 at risk EG0010 events0 affected707 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG00022 events22 affected710 at risk EG00119 events18 affected707 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0015 events5 affected707 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0003 events3 affected710 at risk EG0015 events5 affected707 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0011 events1 affected707 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0004 events4 affected710 at risk EG0015 events5 affected707 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0005 events5 affected710 at risk EG0019 events9 affected707 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0003 events2 affected710 at risk EG0012 events2 affected707 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected710 at risk EG0011 events1 affected707 at risk
Eosinophilic pneumonia acute	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0013 events2 affected707 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected710 at risk EG0011 events1 affected707 at risk
Pruritus	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Rash	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 events1 affected710 at risk EG0011 events1 affected707 at risk
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Urticaria	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 events1 affected710 at risk EG0010 events0 affected707 at risk
Tracheostomy	Surgical and medical procedures	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Endotracheal intubation	Surgical and medical procedures	Non-systematic Assessment	EG0001 events1 affected710 at risk EG0010 events0 affected707 at risk
Hypertension	Vascular disorders	Non-systematic Assessment	EG0002 events2 affected710 at risk EG0015 events5 affected707 at risk
Hypotension	Vascular disorders	Non-systematic Assessment	EG00022 events20 affected710 at risk EG00123 events20 affected707 at risk
Deep vein thrombosis	Vascular disorders	Non-systematic Assessment	EG0003 events3 affected710 at risk EG0017 events7 affected707 at risk

ID	Term
D000086382	COVID-19
D003333	Coronaviridae Infections
D018352	Coronavirus Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D030341	Nidovirales Infections
D045169	Severe Acute Respiratory Syndrome

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
C000714168	cilgavimab and tixagevimab drug combination
C000606551	remdesivir