Study to Evaluate the Safety & Tolerability of MRT5005 Ad... | NCT03375047

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part A - SAD Group 1: MRT5005 8 mg	Experimental	Participants received single dose of MRT5005 8 milligrams (mg) by nebulization on Day 1.	Drug: MRT5005
Part A - SAD Group 2: MRT5005 16 mg	Experimental	Participants received single dose of MRT5005 16 mg by nebulization on Day 1.	Drug: MRT5005
Part A - SAD Group 3: MRT5005 20 mg	Experimental	Participants received single dose of MRT5005 20 mg by nebulization on Day 1.	Drug: MRT5005
Part A - SAD Group 4: MRT5005 24 mg	Experimental	Participants received single dose of MRT5005 24 mg by nebulization on Day 1.	Drug: MRT5005
Part A - SAD Groups: Pooled Placebo	Placebo Comparator	Participants received single dose of placebo (normal saline) by nebulization on Day 1. Data were analyzed as a pooled population for all participants who received placebo in Part A SAD groups and reported in this arm.	Drug: Normal saline
Part B - MAD Group 1: MRT5005 8 mg

Name	Type	Description	Arm Group Labels	Other Names
MRT5005	Drug	Nebulization of MRT5005	Part A - SAD Group 1: MRT5005 8 mg Part A - SAD Group 2: MRT5005 16 mg Part A - SAD Group 3: MRT5005 20 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Parts A, B and D: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events	An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that did not necessarily had a causal relationship with the study treatment. A serious adverse event (SAE) was any untoward medical occurrence (whether considered to be related to study treatment or not) that at any dose: resulted in death; or was life-threatening; or required inpatient hospitalization or prolongation of existing hospitalization; or resulted in persistent or significant disability/incapacity; or was a congenital abnormality/birth defect; or was an important medical event. The TEAEs were defined as events that were newly reported or reported to worsen in severity after the start of study treatment up to 48 weeks (end of follow-up period) after the last dose of study treatment administration.	From the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341)

Secondary Outcomes

Measure	Description	Time Frame
Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)	Spirometry was performed according to the guidelines published by the American Thoracic Society for standardization of spirometry. The ppFEV1 was assessed during the spirometry testing. For Parts A and B, the baseline value was defined as the average of the results from testing on Day -1 and at pre-dose on Day 1. For Part D, the baseline value was defined as the result from testing pre-dose on Day 1. Here, Baseline= BL, Day= D, pre-dose= PrD, hours post dose= hPD.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35233	United States
National Jewish Health

PubMed Identifier	Type	Citation	Retractions
31215818	Derived	Miah KM, Hyde SC, Gill DR. Emerging gene therapies for cystic fibrosis. Expert Rev Respir Med. 2019 Aug;13(8):709-725. doi: 10.1080/17476348.2019.1634547. Epub 2019 Jun 27.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Part A - SAD Group 1: MRT5005 8 mg	Participants received single dose of MRT5005 8 milligrams (mg) by nebulization on Day 1.
FG001	Part A - SAD Group 2: MRT5005 16 mg	Participants received single dose of MRT5005 16 mg by nebulization on Day 1.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 30, 2020	Jan 8, 2026

Arm/Group Information

ID	Title	Description
BG000	Part A - SAD Group 1: MRT5005 8 mg	Participants received single dose of MRT5005 8 mg by nebulization on Day 1.
BG001	Part A - SAD Group 2: MRT5005 16 mg	Participants received single dose of MRT5005 16 mg by nebulization on Day 1.
BG002	Part A - SAD Group 3: MRT5005 20 mg	Participants received single dose of MRT5005 20 mg by nebulization on Day 1.
BG003	Part A - SAD Group 4: MRT5005 24 mg	Participants received single dose of MRT5005 24 mg by nebulization on Day 1.
BG004	Part A - SAD Groups: Pooled Placebo	Participants received single dose of placebo (normal saline) by nebulization on Day 1. Data were analyzed as a pooled population for all participants who received placebo in Part A SAD groups and reported in this arm.
BG005	Part B - MAD Group 1: MRT5005 8 mg	Participants received MRT5005 8 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).
BG006	Part B - MAD Group 2: MRT5005 12 mg	Participants received MRT5005 12 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).
BG007	Part B - MAD Group 3: MRT5005 16 mg	Participants received MRT5005 16 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).
BG008	Part B - MAD Group 4: MRT5005 20 mg	Participants received MRT5005 20 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).
BG009	Part B - MAD Groups: Pooled Placebo	Participants received placebo (normal saline) once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29). Data were analyzed as a pooled population for all participants who received placebo in Part B MAD groups and reported in this arm.
BG010	Part D: MRT5005 4 mg	Participants received MRT5005 4 mg once daily by nebulization from Day 1 to Day 5.
BG011	Part D: Placebo	Participants received placebo (normal saline) once daily by nebulization from Day 1 to Day 5.
BG012	Total	Total of all reporting groups

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

Parts A, B and D: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that did not necessarily had a causal relationship with the study treatment. A serious adverse event (SAE) was any untoward medical occurrence (whether considered to be related to study treatment or not) that at any dose: resulted in death; or was life-threatening; or required inpatient hospitalization or prolongation of existing hospitalization; or resulted in persistent or significant disability/incapacity; or was a congenital abnormality/birth defect; or was an important medical event. The TEAEs were defined as events that were newly reported or reported to worsen in severity after the start of study treatment up to 48 weeks (end of follow-up period) after the last dose of study treatment administration.

The Safety analysis set included all randomized participants who received study treatment.

Posted

Count of Participants

Participants

From the first dose of study treatment administration (Day 1) up to 48 weeks (end of the follow-up period) after the last dose of study treatment administration (Part A: Day 337, Part B: Day 365 and Part D: Day 341)

ID	Title	Description
OG000	Part A - SAD Group 1: MRT5005 8 mg	Participants received single dose of MRT5005 8 mg by nebulization on Day 1.
OG001	Part A - SAD Group 2: MRT5005 16 mg	Participants received single dose of MRT5005 16 mg by nebulization on Day 1.
OG002	Part A - SAD Group 3: MRT5005 20 mg	Participants received single dose of MRT5005 20 mg by nebulization on Day 1.
OG003	Part A - SAD Group 4: MRT5005 24 mg	Participants received single dose of MRT5005 24 mg by nebulization on Day 1.
OG004	Part A - SAD Groups: Pooled Placebo	Participants received single dose of placebo (normal saline) by nebulization on Day 1. Data were analyzed as a pooled population for all participants who received placebo in Part A SAD groups and reported in this arm.
OG005	Part B - MAD Group 1: MRT5005 8 mg	Participants received MRT5005 8 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).
OG006	Part B - MAD Group 2: MRT5005 12 mg	Participants received MRT5005 12 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).
OG007

Units	Counts
Participants	OG0003 OG0013 OG0023 OG003

Title

Denominators

Categories

Any TEAE

Title	Measurements
	OG0003 OG0013 OG0023 OG003

Secondary

Parts A, B and D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)

Spirometry was performed according to the guidelines published by the American Thoracic Society for standardization of spirometry. The ppFEV1 was assessed during the spirometry testing. For Parts A and B, the baseline value was defined as the average of the results from testing on Day -1 and at pre-dose on Day 1. For Part D, the baseline value was defined as the result from testing pre-dose on Day 1. Here, Baseline= BL, Day= D, pre-dose= PrD, hours post dose= hPD.

The Safety analysis set included all randomized participants who received study treatment. Only those participants with data collected at specified timepoints are reported. '0' in the number analyzed field denotes that the specific time point category is not applicable to the respective reporting arm.

Posted

Mean

Standard Deviation

percent predicted FEV1

Part A:BL, D1(8hPD), D2(24hPD), D3, D8, D15 and D29; Part B:BL, D1(6hPD), D2, D8(PrD and 6hPD), D9, D15(PrD and 6hPD), D16, D22(PrD and 6hPD), D23, D29(PrD and 6hPD), D30, D36, D43 and D57; Part D:BL, D1(2hPD), PrD on D2, D3, D4 and D5, D11, D18 and D32

ID	Title	Description
OG000	Part A - SAD Group 1: MRT5005 8 mg	Participants received single dose of MRT5005 8 mg by nebulization on Day 1.
OG001	Part A - SAD Group 2: MRT5005 16 mg	Participants received single dose of MRT5005 16 mg by nebulization on Day 1.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part A - SAD Group1: MRT5005 8 mg	Participants received single dose of MRT5005 8 mg by nebulization on Day1.	3	0	3	3	3
EG001	Part A - SAD Group 2: MRT5005 16 mg	Participants received single dose of MRT5005 16 mg by nebulization on Day1.	3	0	3	3	3
EG002	Part A - SAD Group 3: MRT5005 20 mg	Participants received single dose of MRT5005 20 mg by nebulization on Day1.	3	1	3	3	3
EG003	Part A - SAD Group 4: MRT5005 24 mg	Participants received single dose of MRT5005 24 mg by nebulization on Day1.	3	1	3	3	3
EG004	Part A - SAD Groups: Pooled Placebo	Participants received single dose of placebo (normal saline) by nebulization on Day 1. Data were analyzed as a pooled population for all participants who received placebo in Part A SAD groups and reported in this arm.	4	3	4	4	4
EG005	Part B - MAD Group 1: MRT5005 8 mg	Participants received MRT5005 8 mg once weekly by nebulization for 5weeks (i.e., on Day1, Day 8, Day 15, Day 22 and Day 29).	3	1	3	3	3
EG006	Part B - MAD Group 2: MRT5005 12 mg	Participants received MRT5005 12 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	3	1	3	3	3
EG007	Part B - MAD Group 3: MRT5005 16 mg	Participants received MRT5005 16 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	4	0	4	4	4
EG008	Part B - MAD Group 3: MRT5005 20 mg	Participants received MRT5005 20 mg once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29).	3	2	3	3	3
EG009	Part B - MAD Groups: Pooled Placebo	Participants received placebo (normal saline) once weekly by nebulization for 5 weeks (i.e., on Day 1, Day 8, Day 15, Day 22 and Day 29). Data were analyzed as a pooled population for all participants who received placebo in Part B MAD groups and reported in this arm.	5	2	5	5	5
EG010	Part D: MRT5005 4 mg	Participants received MRT5005 4 mg once daily by nebulization from Day 1 to Day 5.	6	1	6	6	6
EG011	Part D: Placebo	Participants received placebo (normal saline) once daily by nebulization from Day 1 to Day 5.	2	1	2	2	2

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Infective Pulmonary Exacerbation Of Cystic Fibrosis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG0034 events1 affected3 at risk EG004
Anaphylactic Reaction	Immune system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Calculus Urinary	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute Sinusitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG0031 events1 affected3 at risk EG0040 events0 affected4 at risk EG0050 events0 affected3 at risk EG0060 events0 affected3 at risk EG0070 events0 affected4 at risk EG0080 events0 affected3 at risk EG0090 events0 affected5 at risk EG0100 events0 affected6 at risk EG0110 events0 affected2 at risk
Covid-19	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Candida Infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Chronic Sinusitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Gastroenteritis Viral	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Infective Pulmonary Exacerbation Of Cystic Fibrosis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0004 events3 affected3 at risk EG0012 events2 affected3 at risk EG0024 events3 affected3 at risk EG003
Influenza	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Mycobacterial Infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Oropharyngeal Candidiasis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Otitis Media	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Pharyngitis Streptococcal	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Respiratory Tract Infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Rhinovirus Infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Sialoadenitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Sinusitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events2 affected3 at risk EG0021 events1 affected3 at risk EG003
Systemic Candida	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected3 at risk EG0021 events1 affected3 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Viral Infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0022 events1 affected3 at risk EG003
Viral Rash	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Vulvovaginal Mycotic Infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Allergy To Vaccine	Immune system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Drug Hypersensitivity	Immune system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Increased Appetite	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Attention Deficit Hyperactivity Disorder	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Depression	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Sleep Disorder	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Suicidal Ideation	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Ageusia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Anosmia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Aphasia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Disturbance In Attention	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Dizziness	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Headache	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected3 at risk EG0014 events3 affected3 at risk EG0021 events1 affected3 at risk EG003
Hyperaesthesia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Mental Impairment	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Migraine	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Neuropathy Peripheral	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Presyncope	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Sinus Headache	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Sleep Paralysis	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Syncope	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Tremor	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Eye Pain	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Photophobia	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Vision Blurred	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Deafness	Ear and labyrinth disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Ear Pain	Ear and labyrinth disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Palpitations	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Deep Vein Thrombosis	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Hyperaemia	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG00011 events3 affected3 at risk EG0014 events2 affected3 at risk EG0021 events1 affected3 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0003 events1 affected3 at risk EG0010 events0 affected3 at risk EG0023 events2 affected3 at risk EG003
Increased Bronchial Secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Increased Upper Airway Secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Lower Respiratory Tract Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0021 events1 affected3 at risk EG003
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0012 events2 affected3 at risk EG0021 events1 affected3 at risk EG003
Paranasal Sinus Discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Paranasal Sinus Hypersecretion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Pulmonary Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Respiration Abnormal	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0013 events2 affected3 at risk EG0020 events0 affected3 at risk EG003
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Sinus Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Sinus Polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Sputum Discoloured	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Sputum Increased	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0004 events2 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Throat Irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Upper Respiratory Tract Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Upper-Airway Cough Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Abdominal Discomfort	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Abdominal Distension	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Dental Caries	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0022 events2 affected3 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0012 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Epigastric Discomfort	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Gastric Polyps	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Gastrointestinal Motility Disorder	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Gingival Swelling	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Hypertrophy Of Tongue Papillae	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Proctitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Tooth Deposit	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Dermatitis Contact	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Ingrowing Nail	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Nail Pigmentation	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Night Sweats	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Skin Exfoliation	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Skin Lesion	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Flank Pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Trigger Finger	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Acute Kidney Injury	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Glycosuria	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Polyuria	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Morning Sickness	Pregnancy, puerperium and perinatal conditions	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Breast Pain	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Dyspareunia	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Uterine Pain	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Vaginal Discharge	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Asthenia	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Chest Discomfort	General disorders	MedDRA 23.1	Systematic Assessment	EG0003 events1 affected3 at risk EG0012 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Chest Pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Chills	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Crepitations	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Fatigue	General disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected3 at risk EG0010 events0 affected3 at risk EG0021 events1 affected3 at risk EG003
Feeling Abnormal	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Injection Site Pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Malaise	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0022 events1 affected3 at risk EG003
Pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Pyrexia	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0013 events2 affected3 at risk EG0020 events0 affected3 at risk EG003
Reactogenicity Event	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Vaccination Site Pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Alanine Aminotransferase Increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Aspartate Aminotransferase Increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Blood Creatinine Increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Blood Uric Acid Increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Body Temperature Increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Breath Sounds Abnormal	Investigations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
C-Reactive Protein Increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Forced Expiratory Volume Decreased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Fungal Test Positive	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Heart Rate Irregular	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Hepatic Enzyme Increased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Herpes Simplex Test Positive	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Liver Function Test Abnormal	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Mycobacterium Test Positive	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Pulmonary Function Test Decreased	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Sputum Abnormal	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Streptococcus Test Positive	Investigations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Weight Decreased	Investigations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Burns First Degree	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0013 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Ligament Sprain	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Limb Injury	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Procedural Pain	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Rib Fracture	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Skin Abrasion	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0011 events1 affected3 at risk EG0020 events0 affected3 at risk EG003
Skin Laceration	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003
Sunburn	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected3 at risk EG0010 events0 affected3 at risk EG0020 events0 affected3 at risk EG003

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007232	Infant, Newborn, Diseases

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations