Phase III Double-blind, Placebo-controlled Study of AZD74... | NCT04625972

ID	Type	Description	Link
2020-004719-28	EudraCT Number

Name	Class
IQVIA Pty Ltd	INDUSTRY

Label	Type	Description	Intervention Names
AZD7442	Experimental	Participants will be randomized in a 2:1 ratio to receive a single dose (× 2 IM injections) of either 300 mg of AZD7442 (n = approximately 750) or saline placebo (n = approximately 375) on Day 1.	Drug: AZD7442
Placebo	Placebo Comparator	Participants will be randomized in a 2:1 ratio to receive a single dose (× 2 IM injections) of either 300 mg of AZD7442 (n = approximately 750) or saline placebo (n = approximately 375) on Day 1.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
AZD7442	Drug	Single dose (× 2 IM injections) of 300 mg of AZD7442 on Day 1.	AZD7442

Measure	Description	Time Frame
Number of Participants With First Case of SARS-CoV-2 RT-PCR Positive Symptomatic Illness	To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19	Planned to be evaluated through Day 183, however, the number of participants required was achieved 127 days after the study start date
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP		457 Days

Measure	Description	Time Frame
The Incidence of SARS-CoV-2 RT-PCR-positive Severe or Critical Symptomatic Illness Occurring After Dosing With IMP		183 Days
The Incidence of Participants Who Have a Post-treatment Response (Negative at Baseline to Positive at Any Time Post-baseline) for SARSCoV- 2 Nucleocapsid Antibodies

Name	Affiliation	Role
Myron Levin, MD	AstraZeneca	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Guntersville	Alabama	35976	United States
Research Site

PubMed Identifier	Type	Citation
	Background	CDC. (Centers for Disease Control and Prevention). Coronavirus Disease 2019 (COVID-19), Symptoms of Coronavrus. https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html. Published 2020. Accessed 01 July 2020.
32123347	Background	Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020 Apr;5(4):536-544. doi: 10.1038/s41564-020-0695-z. Epub 2020 Mar 2.
27578435

Label	URL
redacted CSR Synopsis	View source

ID	Title	Description
FG000	AZD7442	Single dose 300 mg IM (AZD8895 and AZD1061)
FG001	Placebo	Saline Placebo

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 12, 2021	Nov 17, 2023

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Allergy to arthropod sting	Immune system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Hypersensitivity	Immune system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Mycotic allergy	Immune system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Seasonal allergy	Immune system disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0012 events2 affected372 at risk
Abscess	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Abscess limb	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Acute sinusitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected749 at risk EG0010 events0 affected372 at risk
Normocytic anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Appendicitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Asymptomatic covid-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0007 events7 affected749 at risk EG0015 events5 affected372 at risk
Atypical pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Bacterial infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Bacterial vaginosis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Bacterial vulvovaginitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Bacteriuria	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Bronchitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0006 events6 affected749 at risk EG0013 events3 affected372 at risk
Covid-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG000125 events117 affected749 at risk EG00154 events53 affected372 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Cellulitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0004 events3 affected749 at risk EG0011 events1 affected372 at risk
Conjunctivitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Diverticulitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Ear infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0012 events2 affected372 at risk
Epstein-barr virus infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Eye infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Fungal skin infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Furuncle	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0011 events1 affected372 at risk
Gastroenteritis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0012 events2 affected372 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Hand-foot-and-mouth disease	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Herpes zoster	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0011 events1 affected372 at risk
Hordeolum	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 events1 affected749 at risk EG0010 events0 affected372 at risk
Influenza	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0011 events1 affected372 at risk
Labyrinthitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0012 events1 affected372 at risk
Localised infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Myringitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Nasopharyngitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG00017 events16 affected749 at risk EG0016 events4 affected372 at risk
Angina pectoris	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Onychomycosis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Oral herpes	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Otitis externa	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Otitis media	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0004 events4 affected749 at risk EG0011 events1 affected372 at risk
Periorbital cellulitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Pharyngitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0012 events2 affected372 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected749 at risk EG0012 events2 affected372 at risk
Pilonidal cyst	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Post procedural infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Pyelonephritis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Rhinitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0012 events2 affected372 at risk
Sepsis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Sinusitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0007 events7 affected749 at risk EG0015 events4 affected372 at risk
Sinusitis bacterial	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Skin infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Superinfection bacterial	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Suspected covid-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Tonsillitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Tooth abscess	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0011 events1 affected372 at risk
Tooth infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 events1 affected749 at risk EG0010 events0 affected372 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG00014 events14 affected749 at risk EG0013 events3 affected372 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG00024 events22 affected749 at risk EG00115 events13 affected372 at risk
Vaginal infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Viral infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Wound infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0012 events2 affected372 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Bone contusion	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0015 events3 affected372 at risk
Exposure to toxic agent	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0007 events5 affected749 at risk EG0011 events1 affected372 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0012 events2 affected372 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0012 events2 affected372 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0011 events1 affected372 at risk
Neck injury	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Chronic left ventricular failure	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0012 events2 affected372 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0006 events5 affected749 at risk EG0011 events1 affected372 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Traumatic haemorrhage	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Vaccination complication	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0007 events4 affected749 at risk EG00112 events5 affected372 at risk
Alanine aminotransferase abnormal	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Alanine aminotransferase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0015 events5 affected372 at risk
Aspartate aminotransferase abnormal	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0005 events5 affected749 at risk EG0014 events4 affected372 at risk
Blood cholesterol increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Blood creatine increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG00015 events12 affected749 at risk EG0014 events4 affected372 at risk
Blood creatinine increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0003 events2 affected749 at risk EG0011 events1 affected372 at risk
Blood glucose increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0005 events5 affected749 at risk EG0011 events1 affected372 at risk
Blood iron decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Blood phosphorus decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Blood potassium decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Palpitations	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Blood potassium increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Blood pressure diastolic increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Blood pressure increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected749 at risk EG0012 events2 affected372 at risk
Blood uric acid increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Body temperature increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
C-reactive protein increased	Investigations	MedDRA 24.0	Systematic Assessment	EG00010 events9 affected749 at risk EG0013 events3 affected372 at risk
Electrocardiogram t wave inversion	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0008 events8 affected749 at risk EG0014 events4 affected372 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0012 events2 affected372 at risk
Haematocrit decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0011 events1 affected372 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Haemoglobin decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0011 events1 affected372 at risk
Hepatic enzyme increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Influenza a virus test positive	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Liver function test abnormal	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Liver function test increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Lymph node palpable	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Neutrophil count increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Platelet count decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0011 events1 affected372 at risk
Red blood cell count decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0011 events1 affected372 at risk
Red blood cells urine	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Tachycardia	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0013 events3 affected372 at risk
Red blood cells urine positive	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Urine analysis abnormal	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Weight decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
White blood cell count increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected749 at risk EG0010 events0 affected372 at risk
White blood cells urine positive	Investigations	MedDRA 24.0	Systematic Assessment	EG0004 events4 affected749 at risk EG0011 events1 affected372 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0004 events4 affected749 at risk EG0015 events5 affected372 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0004 events4 affected749 at risk EG0011 events1 affected372 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected749 at risk EG0013 events3 affected372 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Ventricular hypokinesia	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Gout	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0012 events2 affected372 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected749 at risk EG0014 events4 affected372 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0012 events2 affected372 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0012 events2 affected372 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0004 events3 affected749 at risk EG0011 events1 affected372 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0011 events1 affected372 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0012 events2 affected372 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0004 events4 affected749 at risk EG0012 events2 affected372 at risk
Vitamin b12 deficiency	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG00013 events12 affected749 at risk EG0012 events2 affected372 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0011 events1 affected372 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG00012 events10 affected749 at risk EG0017 events7 affected372 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0003 events2 affected749 at risk EG0010 events0 affected372 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0012 events1 affected372 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0004 events4 affected749 at risk EG0010 events0 affected372 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0013 events2 affected372 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG00029 events25 affected749 at risk EG00130 events27 affected372 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0012 events2 affected372 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0005 events5 affected749 at risk EG0015 events5 affected372 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected749 at risk EG0011 events1 affected372 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Seronegative arthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Fibrous histiocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0012 events1 affected372 at risk
Middle ear effusion	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Ageusia	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG00018 events18 affected749 at risk EG00114 events14 affected372 at risk
Anosmia	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG00018 events18 affected749 at risk EG00113 events13 affected372 at risk
Balance disorder	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Bell's palsy	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Central pain syndrome	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Cerebral small vessel ischaemic disease	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Disturbance in attention	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Tympanic membrane disorder	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Dizziness	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0004 events4 affected749 at risk EG0013 events3 affected372 at risk
Dizziness exertional	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Dysgeusia	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Encephalopathy	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Headache	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG000109 events86 affected749 at risk EG00161 events52 affected372 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Lacunar infarction	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Lethargy	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Tympanic membrane hyperaemia	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Migraine	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0011 events1 affected372 at risk
Paraesthesia	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Presyncope	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Restless legs syndrome	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Sciatica	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0011 events1 affected372 at risk
Seizure	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Sinus headache	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Somnolence	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0011 events1 affected372 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected749 at risk EG0013 events2 affected372 at risk
Syncope	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0012 events2 affected372 at risk
Tremor	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Adjustment disorder	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Adjustment disorder with depressed mood	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Anxiety	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0006 events6 affected749 at risk EG0012 events2 affected372 at risk
Attention deficit hyperactivity disorder	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected749 at risk EG0010 events0 affected372 at risk
Confusional state	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Depressed mood	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Depression	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0014 events4 affected372 at risk
Insomnia	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Panic attack	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0011 events1 affected372 at risk
Panic disorder	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0012 events2 affected372 at risk
Dysuria	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0012 events2 affected372 at risk
Glycosuria	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0012 events2 affected372 at risk
Haematuria	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected749 at risk EG0012 events2 affected372 at risk
Hyperplasia adrenal	Endocrine disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Leukocyturia	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0014 events3 affected372 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Proteinuria	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0005 events5 affected749 at risk EG0010 events0 affected372 at risk
Renal cyst	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Urinary bladder polyp	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Hypothyroidism	Endocrine disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Heavy menstrual bleeding	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Menstruation irregular	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0011 events1 affected372 at risk
Pelvic congestion	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0011 events1 affected372 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Aphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0011 events1 affected372 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG00095 events80 affected749 at risk EG00158 events46 affected372 at risk
Eye movement disorder	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG00033 events29 affected749 at risk EG00118 events14 affected372 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0004 events4 affected749 at risk EG0011 events1 affected372 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG00064 events50 affected749 at risk EG00141 events34 affected372 at risk
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG00071 events59 affected749 at risk EG00134 events28 affected372 at risk
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Paranasal sinus inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0012 events2 affected372 at risk
Pharyngeal ulceration	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Eye pain	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0012 events1 affected372 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0012 events2 affected372 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Respiratory depression	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0011 events1 affected372 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected749 at risk EG0010 events0 affected372 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected749 at risk EG0010 events0 affected372 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG00073 events61 affected749 at risk EG00132 events27 affected372 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG00016 events13 affected749 at risk EG0013 events3 affected372 at risk
Eye pruritus	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Sinus pain	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0011 events1 affected372 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected749 at risk EG0011 events1 affected372 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0011 events1 affected372 at risk
Tonsillar inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0011 events1 affected372 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0011 events1 affected372 at risk
Eye swelling	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Cullen's sign	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0012 events2 affected372 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0011 events1 affected372 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0004 events1 affected749 at risk EG0014 events4 affected372 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected749 at risk EG0011 events1 affected372 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0011 events1 affected372 at risk
Accelerated hypertension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Increased tendency to bruise	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Lacrimation increased	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Behcet's syndrome	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0002 events1 affected749 at risk EG0010 events0 affected372 at risk
Flushing	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Haematoma	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0012 events2 affected372 at risk
Hot flush	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0013 events3 affected372 at risk
Hypertension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG00011 events11 affected749 at risk EG0015 events5 affected372 at risk
Hypotension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Pallor	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Visceral congestion	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0012 events2 affected372 at risk
Vision blurred	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Visual impairment	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0012 events2 affected372 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0012 events2 affected372 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Constipation	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0012 events2 affected372 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG00022 events19 affected749 at risk EG00128 events23 affected372 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0004 events4 affected749 at risk EG0011 events1 affected372 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Gastritis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Gingival swelling	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Nausea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG00024 events22 affected749 at risk EG00126 events23 affected372 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Stomach mass	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0011 events1 affected372 at risk
Toothache	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0004 events4 affected749 at risk EG0010 events0 affected372 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG00010 events8 affected749 at risk EG0017 events7 affected372 at risk
Asthenia	General disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Chest discomfort	General disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected749 at risk EG0010 events0 affected372 at risk
Chills	General disorders	MedDRA 24.0	Systematic Assessment	EG00034 events32 affected749 at risk EG00126 events23 affected372 at risk
Drug withdrawal syndrome	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Energy increased	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Fatigue	General disorders	MedDRA 24.0	Systematic Assessment	EG00067 events57 affected749 at risk EG00150 events39 affected372 at risk
Lymphocytosis	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Feeling abnormal	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Feeling cold	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Generalised oedema	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Impaired healing	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Influenza like illness	General disorders	MedDRA 24.0	Systematic Assessment	EG0004 events4 affected749 at risk EG0013 events2 affected372 at risk
Injection site pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0003 events3 affected749 at risk EG0011 events1 affected372 at risk
Injection site pruritus	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0012 events2 affected372 at risk
Injection site reaction	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Localised oedema	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Malaise	General disorders	MedDRA 24.0	Systematic Assessment	EG0007 events7 affected749 at risk EG0011 events1 affected372 at risk
Monocytosis	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Non-cardiac chest pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0010 events0 affected372 at risk
Pain	General disorders	MedDRA 24.0	Systematic Assessment	EG00044 events39 affected749 at risk EG00140 events35 affected372 at risk
Pyrexia	General disorders	MedDRA 24.0	Systematic Assessment	EG00057 events46 affected749 at risk EG00134 events32 affected372 at risk
Swelling	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Thirst	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Vaccination site pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected749 at risk EG0012 events2 affected372 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk
Gallbladder polyp	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected749 at risk EG0011 events1 affected372 at risk

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

ID	Term
C000714168	cilgavimab and tixagevimab drug combination
C000714167	tixagevimab
C000714149	cilgavimab

ID	Title	Description
BG000	AZD7442	Single dose 300 mg IM (AZD8895 and AZD1061)
BG001	Placebo	Saline Placebo
BG002	Total	Total of all reporting 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	Single dose 300 mg IM (AZD8895 and AZD1061)	3	749	20	749	345	749
EG001	Placebo	Saline Placebo	2	372	16	372	191	372