Efficacy and Safety of Clesrovimab (MK-1654) in Infants (... | NCT04767373

ID	Type	Description
MK-1654-004	Other Identifier	MSD
jRCT2051210019	Registry Identifier	jRCT
PHRR210706-003684	Registry Identifier	PHRR
2022-500350-42-00	Registry Identifier	EU CT
U1111-1275-5918	Registry Identifier	UTN
2020-002405-26	EudraCT Number

Label	Type	Description	Intervention Names
Clesrovimab 105 mg	Experimental	Participants receive a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1. An eligible subset of participants from RSV Season 1 will enter RSV season 2.	Biological: Clesrovimab
Placebo	Placebo Comparator	Participants receive a single IM administration of placebo on Day 1. An eligible subset of participants from RSV Season 1 will enter RSV season 2.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Clesrovimab	Biological	Clesrovimab solution	Clesrovimab 105 mg	MK-1654

Measure	Description	Time Frame
RSV Season 1: Number of Participants With Respiratory Syncytial Virus (RSV)-Associated Medically Attended Lower Respiratory Infection (MALRI)	Outpatient and inpatient MALRI was defined as the presence of the following in a clinical setting: 1) cough or difficulty breathing; AND 2) 1 or more of wheezing, chest wall in-drawing/retraction, rales/crackles, hypoxemia, tachypnea, or dehydration due to respiratory symptoms; AND 3) RSV-positive reverse transcriptase polymerase chain reaction (RT-PCR) nasopharyngeal sample. Per protocol, the participants with outpatient and inpatient RSV-associated MALRI were reported together for RSV season 1 participants.	From Day 1 (postdose) to Day 150
RSV Season 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included redness/erythema, swelling, and pain/tenderness. Per protocol, the percentage of RSV season 1 participants with solicited injection-site AEs were reported.	From Day 1 (postdose) to Day 5
RSV Season 1: Percentage of Participants With Fever	Fever was defined as rectal temperature ≥102.2°F (≥39.0°C) or axillary temperature ≥101.7°F (≥38.7°C). Per protocol, the percentage of RSV season 1 participants with fever were reported.	From Day 1 (postdose) to Day 5
RSV Season 1: Percentage of Participants With Solicited Systemic AEs	An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included irritability, somnolence/drowsiness, and appetite lost. Per protocol, the percentage of RSV season 1 participants with solicited systemic AEs were reported.	From Day 1 (postdose) to Day 5

Measure	Description	Time Frame
RSV Season 1: Number of Participants With RSV-Associated Hospitalization	RSV-associated hospitalization is defined as a hospital admission for respiratory illness and RSV-positive RT-PCR nasopharyngeal sample. Per protocol, the number of participants with RSV-associated hospitalization were reported for RSV season 1.	From Day 1 (postdose) to Day 150

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Southeastern Pediatric Associates, P.A. ( Site 0008)		Dothan	Alabama	36303	United States
Northwest Arkansas Pediatric Clinic ( Site 0050)

PubMed Identifier	Type	Citation	Retractions
40961446	Derived	Zar HJ, Simoes EAF, Madhi SA, Ramilo O, Senders SD, Shepard JS, Laoprasopwattana K, Piedrahita J, Novoa JM, Vargas SL, Dionne M, Jackowska T, Liu E, Ishihara Y, Ikeda K, Zhang Y, Railkar RA, Lutkiewicz J, Vora KA, Zang X, Maas BM, Lee AW, Guerra A, Sinha A; CLEVER (MK-1654-004) Study Group. Clesrovimab for Prevention of RSV Disease in Healthy Infants. N Engl J Med. 2025 Oct 2;393(13):1292-1303. doi: 10.1056/NEJMoa2502984. Epub 2025 Sep 17.
34774184

Label	URL
Merck Clinical Trials Information	View source

ID	Title	Description
FG000	Clesrovimab 105 mg	Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1. An eligible subset of participants will be followed through RSV season 2.
FG001	Placebo

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 2, 2022

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

RSV Season 1: Number of Participants With Respiratory Syncytial Virus (RSV)-Associated Medically Attended Lower Respiratory Infection (MALRI)

Outpatient and inpatient MALRI was defined as the presence of the following in a clinical setting: 1) cough or difficulty breathing; AND 2) 1 or more of wheezing, chest wall in-drawing/retraction, rales/crackles, hypoxemia, tachypnea, or dehydration due to respiratory symptoms; AND 3) RSV-positive reverse transcriptase polymerase chain reaction (RT-PCR) nasopharyngeal sample. Per protocol, the participants with outpatient and inpatient RSV-associated MALRI were reported together for RSV season 1 participants.

All randomized participants who received a dose of study treatment and were protocol compliant.

Posted

Count of Participants

Participants

From Day 1 (postdose) to Day 150

ID	Title	Description
OG000	RSV Season 1: Clesrovimab 105 mg	Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
OG001	RSV Season 1: Placebo	Participants received a single IM administration of placebo on Day 1.

Units	Counts
Participants	OG0002398 OG0011201

Title

Denominators

Categories

Title	Measurements
	OG00060 OG00174

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Exact method	One-sided p-value was estimated using an exact method.	<0.001		Efficacy estimate	60.4			2-Sided	95	44.1	71.9			A modified Poisson regression with robust variance method was used to generate efficacy estimate (1- Relative Risk [RR]) & 95% confidence interval (CI). The model included region, gestational age, and age at randomization as covariates.		Other

Primary

RSV Season 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included redness/erythema, swelling, and pain/tenderness. Per protocol, the percentage of RSV season 1 participants with solicited injection-site AEs were reported.

Safety analysis population included all randomized participants who received a dose of protocol specified study treatment. Per protocol, in the safety analysis population, participants with protocol deviation were excluded.

Posted

Number

Percentage of participants

From Day 1 (postdose) to Day 5

ID	Title	Description
OG000	RSV Season 1: Clesrovimab 105 mg	Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
OG001	RSV Season 1: Placebo	Participants received a single IM administration of placebo on Day 1.

Units	Counts
Participants

Primary

RSV Season 1: Percentage of Participants With Fever

Fever was defined as rectal temperature ≥102.2°F (≥39.0°C) or axillary temperature ≥101.7°F (≥38.7°C). Per protocol, the percentage of RSV season 1 participants with fever were reported.

Safety analysis population included all randomized participants who received a dose of protocol specified study treatment and had temperature data available. Per protocol, in the safety analysis population, participants with protocol deviation were excluded.

Posted

Number

Percentage of participants

From Day 1 (postdose) to Day 5

ID	Title	Description
OG000	RSV Season 1: Clesrovimab 105 mg	Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
OG001	RSV Season 1: Placebo	Participants received a single IM administration of placebo on Day 1.

Units	Counts
Participants	OG000

Primary

RSV Season 1: Percentage of Participants With Solicited Systemic AEs

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included irritability, somnolence/drowsiness, and appetite lost. Per protocol, the percentage of RSV season 1 participants with solicited systemic AEs were reported.

Posted

Number

Percentage of participants

From Day 1 (postdose) to Day 5

ID	Title	Description
OG000	RSV Season 1: Clesrovimab 105 mg	Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
OG001	RSV Season 1: Placebo	Participants received a single IM administration of placebo on Day 1.

Units	Counts
Participants

Primary

RSV Season 1: Percentage of Participants With Anaphylaxis/Hypersensitivity AE of Special Interest (AESI)

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Anaphylaxis/Hypersensitivity AESI included anaphylaxis, angioedema, bronchospasm, drug hypersensitivity, dyspnea, hypersensitivity, dysphonia, and wheezing. Per protocol, the percentage of RSV season 1 participants with anaphylaxis/hypersensitivity AESI were reported.

Posted

Number

Percentage of participants

From Day 1 (postdose) to Day 42

ID	Title	Description
OG000	RSV Season 1: Clesrovimab 105 mg	Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
OG001	RSV Season 1: Placebo	Participants received a single IM administration of placebo on Day 1.

Units	Counts

Primary

RSV Season 1: Percentage of Participants With Rash AESI

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Rash AESI included acute generalized exanthematous pustulosis, drug eruption, drug reaction with eosinophilia and systemic symptoms, erythema multiforme, generalized rash of exfoliative nature, Stevens-Johnson syndrome, toxic epidermal necrolysis, and urticaria. Per protocol, the percentage of RSV season 1 participants with rash AESI were reported.

Posted

Number

Percentage of participants

From Day 1 (postdose) to Day 42

ID	Title	Description
OG000	RSV Season 1: Clesrovimab 105 mg	Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
OG001	RSV Season 1: Placebo	Participants received a single IM administration of placebo on Day 1.

Units	Counts

Primary

RSV Season 1: Percentage of Participants With ≥1 Nonserious AE

Posted

Number

Percentage of participants

From Day 1 (postdose) to Day 42

ID	Title	Description
OG000	RSV Season 1: Clesrovimab 105 mg	Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
OG001	RSV Season 1: Placebo	Participants received a single IM administration of placebo on Day 1.

Units	Counts
Participants

Primary

Percentage of Participants With Serious Adverse Events (SAEs)

An SAE was any untoward medical occurrence that results in death; is life-threatening; required inpatient hospitalization/prolongs existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical event. Per protocol, the percentage of participants in RSV season 1 and RSV season 2 with SAEs were reported.

Safety analysis population which included all randomized participants who received a dose of protocol specified study treatment. For safety analysis population, participants with protocol deviation were excluded. Per protocol, a subset of participants from RSV season 1 entered RSV season 2 and SAEs were collected separately for RSV season 1 and RSV Season 2.

Posted

Number

Percentage of participants

RSV Season 1: Day 1 to Day 365, RSV Season 2: Day 366 to Day 515

ID	Title	Description
OG000	RSV Season 1: Clesrovimab 105 mg	Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
OG001	RSV Season 1: Placebo	Participants received a single IM administration of placebo on Day 1.
OG002	RSV Season 2: Clesrovimab 105 mg

Secondary

RSV Season 1: Number of Participants With RSV-Associated Hospitalization

RSV-associated hospitalization is defined as a hospital admission for respiratory illness and RSV-positive RT-PCR nasopharyngeal sample. Per protocol, the number of participants with RSV-associated hospitalization were reported for RSV season 1.

All randomized participants who received a dose of study treatment and were protocol compliant.

Posted

Count of Participants

Participants

From Day 1 (postdose) to Day 150

ID	Title	Description
OG000	RSV Season 1: Clesrovimab 105 mg	Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
OG001	RSV Season 1: Placebo	Participants received a single IM administration of placebo on Day 1.

Units	Counts
Participants	OG000

Secondary

RSV Season 1: Number of Participants With RSV-Associated MALRI

Outpatient and inpatient MALRI was defined as the presence of the following in a clinical setting: 1) cough or difficulty breathing; AND 2) 1 or more of wheezing, chest wall in-drawing/retraction, rales/crackles, hypoxemia, tachypnea, or dehydration due to respiratory symptoms; AND 3) RSV-positive RT-PCR nasopharyngeal sample. Per protocol, participants with outpatient and inpatient RSV-associated MALRI were reported together for RSV season 1 participants.

All randomized participants who received a dose of study treatment and were protocol compliant.

Posted

Count of Participants

Participants

From Day 1 (postdose) to Day 180

ID	Title	Description
OG000	RSV Season 1: Clesrovimab 105 mg	Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.
OG001	RSV Season 1: Placebo	Participants received a single IM administration of placebo on Day 1.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 28.1	Systematic Assessment	EG0003 events3 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG0030 events0 affected501 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0021 events1 affected1,017 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Mitral valve disease	Cardiac disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Congenital vesicoureteric reflux	Congenital, familial and genetic disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Cryptorchism	Congenital, familial and genetic disorders	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Hydrocele	Congenital, familial and genetic disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0021 events1 affected1,017 at risk EG003
Phimosis	Congenital, familial and genetic disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Retinopathy of prematurity	Eye disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Cricopharyngeal dysfunction	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Diaphragmatic hernia	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0012 events2 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0005 events5 affected2,409 at risk EG0015 events5 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0021 events1 affected1,017 at risk EG003
Death	General disorders	MedDRA 28.1	Systematic Assessment	EG0003 events3 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Drug withdrawal syndrome	General disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Pyrexia	General disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0012 events2 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Sudden infant death syndrome	General disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 28.1	Systematic Assessment	EG0004 events4 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Hyperbilirubinaemia neonatal	Hepatobiliary disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Milk allergy	Immune system disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Adenovirus infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Bacterial infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0021 events1 affected1,017 at risk EG003
Bacterial tracheitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0022 events2 affected1,017 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG00033 events32 affected2,409 at risk EG00122 events19 affected1,202 at risk EG0022 events2 affected1,017 at risk EG003
Bronchitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG00017 events16 affected2,409 at risk EG0017 events7 affected1,202 at risk EG0022 events2 affected1,017 at risk EG003
Bronchitis mycoplasmal	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Bronchitis viral	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Bullous impetigo	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0021 events1 affected1,017 at risk EG003
COVID-19	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0006 events6 affected2,409 at risk EG0017 events7 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
COVID-19 pneumonia	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0003 events3 affected2,409 at risk EG0014 events4 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Campylobacter gastroenteritis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Cellulitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0003 events3 affected2,409 at risk EG0012 events2 affected1,202 at risk EG0021 events1 affected1,017 at risk EG003
Coronavirus pneumonia	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Croup infectious	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0021 events1 affected1,017 at risk EG003
Dengue fever	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0012 events2 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Dysentery	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0003 events3 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Enterovirus infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Epididymitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Exanthema subitum	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG00020 events20 affected2,409 at risk EG0017 events7 affected1,202 at risk EG0023 events3 affected1,017 at risk EG003
Gastroenteritis adenovirus	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Gastroenteritis rotavirus	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0003 events3 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0004 events4 affected2,409 at risk EG0012 events2 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Gastrointestinal viral infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
HIV infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Hand-foot-and-mouth disease	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Herpangina	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0021 events1 affected1,017 at risk EG003
Impetigo	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Influenza	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0003 events3 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0021 events1 affected1,017 at risk EG003
Laryngitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0004 events4 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Laryngitis viral	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0012 events2 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG00015 events13 affected2,409 at risk EG0014 events4 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Lower respiratory tract infection viral	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Lymphadenitis bacterial	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Mastoiditis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0002 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Meningitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Metapneumovirus bronchiolitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0021 events1 affected1,017 at risk EG003
Metapneumovirus pneumonia	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Otitis externa bacterial	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Otitis media	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0012 events2 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Otitis media acute	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0004 events4 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Parainfluenzae viral bronchitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Parainfluenzae virus infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Parasitic gastroenteritis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Periorbital cellulitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Pneumonia	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG00046 events43 affected2,409 at risk EG00133 events30 affected1,202 at risk EG0022 events2 affected1,017 at risk EG003
Pneumonia aspiration	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0021 events1 affected1,017 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0006 events6 affected2,409 at risk EG0012 events2 affected1,202 at risk EG0021 events1 affected1,017 at risk EG003
Pneumonia escherichia	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Pneumonia influenzal	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Pneumonia klebsiella	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Pneumonia mycoplasmal	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0003 events2 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected2,409 at risk EG0018 events8 affected1,202 at risk EG0023 events2 affected1,017 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0007 events7 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0021 events1 affected1,017 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0021 events1 affected1,017 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0021 events1 affected1,017 at risk EG003
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0005 events5 affected2,409 at risk EG00113 events13 affected1,202 at risk EG0021 events1 affected1,017 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0006 events6 affected2,409 at risk EG0013 events3 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0004 events4 affected2,409 at risk EG0014 events4 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Rhinolaryngitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Rhinovirus infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0004 events3 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Salmonella bacteraemia	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Sepsis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Sinusitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Streptococcal bacteraemia	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Streptococcal sepsis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Systemic viral infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Tonsillitis bacterial	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Tracheitis	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Tracheobronchitis viral	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0009 events9 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG00014 events12 affected2,409 at risk EG0014 events4 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Varicella zoster pneumonia	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Viral infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0003 events3 affected2,409 at risk EG0012 events2 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Viral rash	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0003 events3 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0021 events1 affected1,017 at risk EG003
Accidental exposure to product	Injury, poisoning and procedural complications	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Exposure to SARS-CoV-2	Injury, poisoning and procedural complications	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Extradural haematoma	Injury, poisoning and procedural complications	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 28.1	Systematic Assessment	EG0003 events3 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Poisoning	Injury, poisoning and procedural complications	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Skull fracture	Injury, poisoning and procedural complications	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0012 events2 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Body temperature increased	Investigations	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0012 events2 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Weight decreased	Investigations	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0012 events2 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0021 events1 affected1,017 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Feeding disorder	Metabolism and nutrition disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Lactose intolerance	Metabolism and nutrition disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0012 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Weight gain poor	Metabolism and nutrition disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
B precursor type acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Brain injury	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Dyskinesia	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG0002 events2 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Febrile convulsion	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG00014 events10 affected2,409 at risk EG0013 events3 affected1,202 at risk EG0022 events2 affected1,017 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Hydrocephalus	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Motor developmental delay	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Partial seizures	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Seizure	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG0003 events3 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Status epilepticus	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Subdural effusion	Nervous system disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Autism spectrum disorder	Psychiatric disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0021 events1 affected1,017 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0005 events5 affected2,409 at risk EG0012 events2 affected1,202 at risk EG0023 events2 affected1,017 at risk EG003
Brief resolved unexplained event	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0012 events2 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Childhood asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Fibrinous bronchitis	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 28.1	Systematic Assessment	EG0000 events0 affected2,409 at risk EG0011 events1 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Cyanosis	Vascular disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003
Hypovolaemic shock	Vascular disorders	MedDRA 28.1	Systematic Assessment	EG0001 events1 affected2,409 at risk EG0010 events0 affected1,202 at risk EG0020 events0 affected1,017 at risk EG003

ID	Term
D018186	Pneumovirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections

ID	Title	Description
BG000	Clesrovimab 105 mg	Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1. An eligible subset of participants will be followed through RSV season 2.
BG001	Placebo	Participants received a single IM administration of placebo on Day 1. An eligible subset of participants will be followed through RSV season 2.
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	RSV Season 1: Clesrovimab 105 mg	Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1.	7	2,421	282	2,409	1,432	2,409
EG001	RSV Season 1: Placebo	Participants received a single IM administration of placebo on Day 1.	3	1,211	151	1,202	724	1,202
EG002	RSV Season 2: Clesrovimab 105 mg	A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single intramuscular (IM) administration of clesrovimab 105 mg on Day 1 during RSV Season 1.	0	1,017	32	1,017	0	0
EG003	RSV Season 2: Placebo	A subset of participants from RSV season 1 entered RSV Season 2 per protocol. Participants received a single IM administration of placebo on Day 1 during RSV Season 1.	0	501	20	501	0	0