Adrabetadex to Treat Niemann-Pick Type C1 (NPC1) Disease | NCT04958642

ID	Type	Description	Link
2015-002548-15	EudraCT Number

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adrabetadex	Experimental	All participants receive their prescribed dose of adrabetadex. Dose is allowed to be adjusted down to a minimum of 400 milligrams (mg) or up to a maximum of 900 mg, at the investigator's discretion.	Drug: Adrabetadex

Name	Type	Description	Arm Group Labels	Other Names
Adrabetadex	Drug	Mallinckrodt test formulation, administered intrathecal (IT) via lumbar puncture (LP) infusion.	Adrabetadex

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A TEAE was defined as an AE with onset on or after the start of adrabetadex treatment. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.	Baseline up to 5 years

Eligibility Module

Name	Affiliation	Role
Clinical Study Lead	Mandos LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35233	United States
Children's Hospital of Orange County: CHOC Children's

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Treatment Naive	Treatment-naive participants received adrabetadex 900 milligrams (mg) administered intrathecal (IT) via lumbar puncture (LP) infusion every 2 weeks until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.
FG001

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	Jun 23, 2021	Aug 4, 2023

Arm/Group Information

ID	Title	Description
BG000	Treatment Naive	Treatment-naive participants received adrabetadex 900 milligrams (mg) administered intrathecal (IT) via lumbar puncture (LP) infusion every 2 weeks until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.
BG001	Previously Treated in Phase I	Rollover participants from Study 13-CH-0001 received adrabetadex at an amended dose and/or regimen after prior written authorization from the sponsor. The treatment was continued until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.
BG002	Previously Treated in Part A/B	Participants continuing from Part B of the study received adrabetadex 900 mg administered IT via LP infusion every 2 weeks until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00013.2± 5.07 BG00117.5± 6.16 BG00214.1± 5.60 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00010 BG0017 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0003 BG0011 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A TEAE was defined as an AE with onset on or after the start of adrabetadex treatment. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

The Open-label population included participants who received at least 1 dose of adrabetadex during Part C.

Posted

Count of Participants

Participants

Baseline up to 5 years

ID	Title	Description
OG000	Treatment Naive	Treatment-naive participants received adrabetadex 900 milligrams (mg) administered intrathecal (IT) via lumbar puncture (LP) infusion every 2 weeks until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.
OG001	Previously Treated in Phase I	Rollover participants from Study 13-CH-0001 received adrabetadex at an amended dose and/or regimen after prior written authorization from the sponsor. The treatment was continued until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.
OG002	Previously Treated in Part A/B	Participants continuing from Part B of the study received adrabetadex 900 mg administered IT via LP infusion every 2 weeks until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.

Units	Counts
Participants	OG00018 OG00113 OG00235

Title

Denominators

Categories

Any TEAEs

Title	Measurements
	OG00018 OG00113 OG00234

SAEs

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Treatment Naive	Treatment-naive participants received adrabetadex 900 milligrams (mg) administered intrathecal (IT) via lumbar puncture (LP) infusion every 2 weeks until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.	1	18	9	18	18	18
EG001	Previously Treated in Phase I	Rollover participants from Study 13-CH-0001 received adrabetadex at an amended dose and/or regimen after prior written authorization from the sponsor. The treatment was continued until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.	0	13	7	13	13	13
EG002	Previously Treated in Part A/B	Participants continuing from Part B of the study received adrabetadex 900 mg administered IT via LP infusion every 2 weeks until the investigator considered adrabetadex to no longer be beneficial to the participant, or the development program was discontinued.	1	35	20	35	34	35

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Tachycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0022 events2 affected35 at risk
Deafness	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0024 events4 affected35 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Pneumoperitoneum	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Superior mesenteric artery syndrome	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Catheter site inflammation	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0021 events1 affected35 at risk
Appendicitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Cellulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0022 events2 affected35 at risk
Herpes simplex pharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Implant site infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Infectious mononucleosis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Influenza	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Meningitis bacterial	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Meningitis staphylococcal	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0015 events2 affected13 at risk EG0021 events1 affected35 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Stoma site cellulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0022 events1 affected35 at risk
Intentional medical device removal by patient	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Food intolerance	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Myosclerosis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Chorea	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Diplegia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Encephalopathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Epilepsy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0021 events1 affected35 at risk
Lethargy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Paraesthesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Seizure	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0022 events1 affected35 at risk
Seizure cluster	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0022 events1 affected35 at risk
Somnolence	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Spinal subarachnoid haemorrhage	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Spinal subdural haematoma	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Device dislocation	Product Issues	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0022 events2 affected35 at risk
Mania	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Acute respiratory failure	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0022 events2 affected35 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0021 events1 affected35 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0022 events1 affected35 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0024 events3 affected35 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events2 affected13 at risk EG0020 events0 affected35 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0022 events1 affected35 at risk
Palpitations	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events2 affected13 at risk EG0020 events0 affected35 at risk
Tachycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0013 events3 affected13 at risk EG0023 events2 affected35 at risk
Deafness	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events1 affected13 at risk EG0023 events3 affected35 at risk
External ear inflammation	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0021 events1 affected35 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG00020 events9 affected18 at risk EG0017 events4 affected13 at risk EG00212 events9 affected35 at risk
Neurosensory hypoacusis	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Otorrhoea	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG00072 events6 affected18 at risk EG0015 events2 affected13 at risk EG0025 events5 affected35 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Conjunctivitis allergic	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0023 events2 affected35 at risk
Eye pruritus	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Eye swelling	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0022 events2 affected35 at risk
Periorbital oedema	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Vision blurred	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 events4 affected18 at risk EG0011 events1 affected13 at risk EG0022 events2 affected35 at risk
Anal incontinence	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 events2 affected18 at risk EG00110 events2 affected13 at risk EG0026 events2 affected35 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected18 at risk EG0012 events2 affected13 at risk EG00215 events9 affected35 at risk
Dental caries	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0022 events2 affected35 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00019 events9 affected18 at risk EG00114 events6 affected13 at risk EG00228 events14 affected35 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected18 at risk EG0016 events6 affected13 at risk EG00210 events6 affected35 at risk
Faeces soft	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Gastritis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Malpositioned teeth	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0006 events4 affected18 at risk EG00113 events4 affected13 at risk EG00210 events6 affected35 at risk
Oral disorder	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Retained deciduous tooth	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Retching	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Toothache	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00026 events12 affected18 at risk EG00124 events9 affected13 at risk EG00225 events16 affected35 at risk
Adverse drug reaction	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0021 events1 affected35 at risk
Application site rash	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events1 affected13 at risk EG0020 events0 affected35 at risk
Asthenia	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected18 at risk EG0010 events0 affected13 at risk EG0022 events2 affected35 at risk
Catheter site haematoma	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Catheter site swelling	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Cyst	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0021 events1 affected35 at risk
Discomfort	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Fatigue	General disorders	MedDRA 23.0	Systematic Assessment	EG000101 events8 affected18 at risk EG00111 events5 affected13 at risk EG002146 events13 affected35 at risk
Gait disturbance	General disorders	MedDRA 23.0	Systematic Assessment	EG0004 events2 affected18 at risk EG00110 events6 affected13 at risk EG00255 events10 affected35 at risk
Infusion site extravasation	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Malaise	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0013 events2 affected13 at risk EG0021 events1 affected35 at risk
Oedema peripheral	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0013 events1 affected13 at risk EG0020 events0 affected35 at risk
Pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected18 at risk EG0013 events2 affected13 at risk EG0024 events3 affected35 at risk
Peripheral swelling	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG00013 events6 affected18 at risk EG00148 events9 affected13 at risk EG00236 events17 affected35 at risk
Swelling	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected18 at risk EG0010 events0 affected13 at risk EG0024 events2 affected35 at risk
Hepatosplenomegaly	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0021 events1 affected35 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Hypersensitivity	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0023 events2 affected35 at risk
Seasonal allergy	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0028 events3 affected35 at risk
Abscess limb	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0022 events2 affected35 at risk
Bronchitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0013 events3 affected13 at risk EG0020 events0 affected35 at risk
COVID-19	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Cellulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Conjunctivitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0014 events3 affected13 at risk EG0023 events2 affected35 at risk
Cystitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Ear infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0013 events3 affected13 at risk EG0022 events2 affected35 at risk
Folliculitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Fungal skin infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Gastroenteritis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Genital infection fungal	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Gingivitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Hordeolum	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Influenza	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected18 at risk EG0015 events3 affected13 at risk EG0020 events0 affected35 at risk
Laryngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00010 events3 affected18 at risk EG0016 events3 affected13 at risk EG00213 events7 affected35 at risk
Oral herpes	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Otitis externa	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0021 events1 affected35 at risk
Otitis media	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected18 at risk EG0016 events3 affected13 at risk EG0021 events1 affected35 at risk
Otitis media acute	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Paronychia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Pharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0023 events2 affected35 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0014 events2 affected13 at risk EG0020 events0 affected35 at risk
Pilonidal cyst	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0022 events2 affected35 at risk
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 events1 affected18 at risk EG0014 events4 affected13 at risk EG0021 events1 affected35 at risk
Pneumonia mycoplasmal	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0022 events1 affected35 at risk
Rhinitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0004 events3 affected18 at risk EG0010 events0 affected13 at risk EG0027 events7 affected35 at risk
Sinusitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0014 events3 affected13 at risk EG0023 events2 affected35 at risk
Skin infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0021 events1 affected35 at risk
Tonsillitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Tooth infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00034 events11 affected18 at risk EG00127 events7 affected13 at risk EG00224 events10 affected35 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0013 events2 affected13 at risk EG0020 events0 affected35 at risk
Varicella	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Viral infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Administration related reaction	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0023 events1 affected35 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Bone contusion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG00010 events2 affected18 at risk EG00117 events7 affected13 at risk EG00229 events5 affected35 at risk
Eye contusion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0013 events1 affected13 at risk EG0022 events2 affected35 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG00037 events5 affected18 at risk EG00142 events7 affected13 at risk EG002117 events16 affected35 at risk
Foot fracture	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG00210 events5 affected35 at risk
Injection related reaction	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0022 events2 affected35 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0022 events2 affected35 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected13 at risk EG0021 events1 affected35 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected13 at risk EG0025 events5 affected35 at risk
Lip injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Nail injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Oral contusion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0003 events1 affected18 at risk EG0010 events0 affected13 at risk EG00233 events3 affected35 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG00210 events1 affected35 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0006 events3 affected18 at risk EG0011 events1 affected13 at risk EG00215 events5 affected35 at risk
Sedation complication	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0023 events2 affected35 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0009 events2 affected18 at risk EG00115 events6 affected13 at risk EG00233 events11 affected35 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected18 at risk EG0012 events2 affected13 at risk EG0027 events4 affected35 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Stoma site pain	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0021 events1 affected35 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0023 events3 affected35 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0022 events2 affected35 at risk
Body temperature increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events2 affected13 at risk EG0020 events0 affected35 at risk
Electroencephalogram abnormal	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Mean cell volume decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Oxygen saturation decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events1 affected13 at risk EG0021 events1 affected35 at risk
PO2 decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Platelet count decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0023 events3 affected35 at risk
Prothrombin time prolonged	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Respiratory rate increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
SARS-CoV-2 test positive	Investigations	MedDRA 23.0	Systematic Assessment	EG0004 events3 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Vitamin D decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Weight decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0021 events1 affected35 at risk
Weight increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0022 events2 affected35 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0022 events2 affected35 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events2 affected13 at risk EG0022 events1 affected35 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0021 events1 affected35 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Polydipsia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0004 events2 affected18 at risk EG0012 events2 affected13 at risk EG0023 events3 affected35 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00036 events8 affected18 at risk EG00174 events9 affected13 at risk EG002142 events18 affected35 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG00114 events4 affected13 at risk EG0021 events1 affected35 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0022 events2 affected35 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0025 events3 affected35 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG00116 events1 affected13 at risk EG0025 events2 affected35 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00018 events2 affected18 at risk EG00110 events3 affected13 at risk EG0021 events1 affected35 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0012 events2 affected13 at risk EG0021 events1 affected35 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0007 events6 affected18 at risk EG0017 events3 affected13 at risk EG00212 events7 affected35 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Amnesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Ataxia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00021 events9 affected18 at risk EG0017 events2 affected13 at risk EG00278 events8 affected35 at risk
Atonic seizures	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Balance disorder	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0013 events2 affected13 at risk EG00215 events8 affected35 at risk
Cataplexy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected18 at risk EG0011 events1 affected13 at risk EG0027 events5 affected35 at risk
Coordination abnormal	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0022 events2 affected35 at risk
Diplegia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Dizziness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected18 at risk EG0012 events1 affected13 at risk EG0024 events2 affected35 at risk
Dysarthria	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00018 events3 affected18 at risk EG0013 events1 affected13 at risk EG00264 events2 affected35 at risk
Dyskinesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Dystonia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected18 at risk EG0015 events4 affected13 at risk EG0023 events2 affected35 at risk
Epilepsy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0005 events2 affected18 at risk EG0010 events0 affected13 at risk EG0023 events3 affected35 at risk
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00029 events9 affected18 at risk EG00134 events9 affected13 at risk EG00279 events12 affected35 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0024 events3 affected35 at risk
Hypotonia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0023 events2 affected35 at risk
Intracranial pressure increased	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Lethargy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected18 at risk EG0014 events1 affected13 at risk EG00211 events4 affected35 at risk
Memory impairment	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0024 events2 affected35 at risk
Migraine	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Motor dysfunction	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Movement disorder	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Muscle spasticity	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Petit mal epilepsy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0023 events2 affected35 at risk
Repetitive speech	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Seizure	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events1 affected18 at risk EG00134 events4 affected13 at risk EG00214 events8 affected35 at risk
Seizure cluster	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Somnolence	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0012 events2 affected13 at risk EG0020 events0 affected35 at risk
Tremor	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected13 at risk EG0021 events1 affected35 at risk
Visual field defect	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Device dislocation	Product Issues	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0024 events2 affected35 at risk
Device malfunction	Product Issues	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Aggression	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Agitation	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0023 events3 affected35 at risk
Anxiety	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0023 events3 affected35 at risk
Communication disorder	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Daydreaming	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0005 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Depressed mood	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Dyssomnia	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Inappropriate affect	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events1 affected13 at risk EG0020 events0 affected35 at risk
Initial insomnia	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Insomnia	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0013 events3 affected13 at risk EG0023 events2 affected35 at risk
Irritability	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0023 events3 affected35 at risk
Restlessness	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Sleep disorder	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Dysuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0023 events3 affected35 at risk
Haematuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0022 events2 affected35 at risk
Incontinence	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events2 affected13 at risk EG0020 events0 affected35 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0021 events1 affected35 at risk
Proteinuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0022 events2 affected35 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0019 events2 affected13 at risk EG0024 events2 affected35 at risk
Urinary retention	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0012 events1 affected13 at risk EG0021 events1 affected35 at risk
Urine abnormality	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events1 affected13 at risk EG0020 events0 affected35 at risk
Amenorrhoea	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Perineal rash	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Allergic respiratory symptom	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Apnoea	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events2 affected13 at risk EG0024 events2 affected35 at risk
Choking	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0023 events2 affected35 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00013 events5 affected18 at risk EG00115 events6 affected13 at risk EG00229 events15 affected35 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected18 at risk EG0014 events4 affected13 at risk EG00245 events9 affected35 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Increased upper airway secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Laryngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Laryngeal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Lower respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0006 events2 affected18 at risk EG0013 events3 affected13 at risk EG00212 events6 affected35 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected18 at risk EG0012 events2 affected13 at risk EG0022 events2 affected35 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0022 events2 affected35 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0013 events2 affected13 at risk EG0021 events1 affected35 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected13 at risk EG0022 events1 affected35 at risk
Respiratory tract oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0015 events4 affected13 at risk EG0020 events0 affected35 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0004 events2 affected18 at risk EG0011 events1 affected13 at risk EG0022 events1 affected35 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events2 affected13 at risk EG0020 events0 affected35 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0021 events1 affected35 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0013 events2 affected13 at risk EG0023 events2 affected35 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events1 affected13 at risk EG0022 events2 affected35 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0021 events1 affected35 at risk
Excessive granulation tissue	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events1 affected13 at risk EG0021 events1 affected35 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected13 at risk EG0021 events1 affected35 at risk
Ingrown hair	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Papule	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0014 events3 affected13 at risk EG0025 events3 affected35 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected13 at risk EG0021 events1 affected35 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected18 at risk EG0010 events0 affected13 at risk EG0021 events1 affected35 at risk
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Skin striae	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0020 events0 affected35 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events1 affected13 at risk EG0020 events0 affected35 at risk
Flushing	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected13 at risk EG0020 events0 affected35 at risk
Haematoma	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0023 events3 affected35 at risk
Hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected13 at risk EG0024 events3 affected35 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected13 at risk EG0022 events2 affected35 at risk

Ancestor Terms

ID	Term
D009542	Niemann-Pick Diseases
D013106	Sphingolipidoses
D020140	Lysosomal Storage Diseases, Nervous System
D020739	Brain Diseases, Metabolic, Inborn
D001928	Brain Diseases, Metabolic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D015616	Histiocytosis, Non-Langerhans-Cell
D015614	Histiocytosis
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D008064	Lipidoses
D008052	Lipid Metabolism, Inborn Errors
D016464	Lysosomal Storage Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D052439	Lipid Metabolism Disorders
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010608	Pharyngeal Diseases
D010038	Otorhinolaryngologic Diseases
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D012816	Signs and Symptoms

ID	Term
D052556	Niemann-Pick Disease, Type C
D004194	Disease
D003680	Deglutition Disorders
D060825	Cognitive Dysfunction
D051346	Mobility Limitation

ID	Term
D000073738	2-Hydroxypropyl-beta-cyclodextrin
D003505	Cyclodextrins

ID	Term
D047392	beta-Cyclodextrins
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D003912	Dextrins
D013213	Starch
D004040	Dietary Carbohydrates
D002241	Carbohydrates
D005936	Glucans
D011134	Polysaccharides