First-In-Human Study to Evaluate Safety, Tolerability, an... | NCT02675465

NCT02675465

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions 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
ATB200	Experimental	Sequential single ascending doses of intravenously infused ATB200 for 3 dosing periods	Drug: ATB200
ATB200 + AT2221	Experimental	ATB200 co-administered with AT2221 (Miglustat)	Drug: ATB200 Drug: AT2221

Name	Type	Description	Arm Group Labels	Other Names
ATB200	Drug		ATB200 ATB200 + AT2221	Cipaglucosidase alfa
AT2221

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Discontinuation of Study Drug	Number of subjects with TEAE, TESAE, and AE leading to discontinuation during the 2 year treatment period and extension (Stage 3 and 4 combined)	Stage 3 (2 year treatment) and Stage 4 (Extension) combined, (mean = 71 months on treatment)
Plasma Human Acid α-glucosidase (GAA) Activity Levels as Measured by Maximum Observed Plasma Concentration (Cmax).	Plasma GAA levels (Cmax) measured in Cohorts 1 and 3 following 1st and 3rd doses of cipaglucosidase alfa + miglustat	18 Weeks
Plasma GAA Activity Levels as Measured by Time to Reach the Maximum Observed Plasma Concentration (Tmax).	Plasma GAA levels (Tmax) measured in Cohorts 1 and 3 following 1st and 3rd doses of cipaglucosidase alfa + miglustat	18 Weeks
Plasma GAA Activity Levels as Measured by Area Under the Plasma Drug Concentration-time Curve (AUC).	Plasma GAA levels (AUC) measured in Cohorts 1 and 3 following 1st and 3rd doses of cipaglucosidase alfa + miglustat	18 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in 6-minute Walk Distance (6MWD)	Motor function was measured in ambulatory subjects using 6MWD (meters).	Baseline, Month 60
Change From Baseline in Pulmonary Function Tests

Eligibility Module

Eligibility Criteria

Adults with Diagnosis of Pompe disease

Cohort 1: Enzyme Replacement Therapy (ERT)-experienced subject (ambulatory):

Male and female subjects between 18 and 65 years of age, inclusive
Received ERT with alglucosidase alfa (Myozyme/Lumizyme) for the previous 2-6 years, inclusive
Was receiving alglucosidase alfa at a frequency of once every other week
Must have been able to walk 200-500 meters on the 6-Minute Walk Test (6MWT)
Had upright Forced Vial Capacity (FVC) 30-80% of predicted normal value

Cohort 2: ERT-experienced subjects (non-ambulatory):

Male and female subjects between 18 and 65 years of age, inclusive
Had been receiving ERT with alglucosidase alfa for ≥2 years at a regular or set frequency
Was wheelchair-bound

Cohort 3: ERT-naïve subjects (ambulatory):

Male and female subjects between 18 and 65 years of age, inclusive
Must have been able to walk 200-500 meters on the 6MWT
Had upright FVC 30-80% of predicted normal value

Cohort 4: ERT-experienced subject (ambulatory):

Male and female subjects between 18 and 75 years of age, inclusive
Had been receiving ERT with alglucosidase alfa for ≥7 years, inclusive
Was receiving alglucosidase alfa at a frequency of once every other week
Must have been able to walk 75-600 meters on the 6MWT
Had upright FVC 30-85% of predicted normal value

Exclusion Criteria:

Received treatment with prohibited medications within 30 days of Baseline Visit
Subject, if female, was pregnant or breastfeeding at screening
Subject, whether male or female, planned to conceive a child during the study
Had a medical or any other extenuating condition or circumstance that may, in opinion of investigator, pose an undue safety risk to the subject or compromise his/her ability to comply with protocol requirements
Had a history of allergy or sensitivity to alglucosidase alfa, miglustat or other iminosugars (Cohorts 1, 2, and 4)
Required invasive ventilatory support, or used noninvasive ventilatory support ≥ 6 hours a day while awake (Cohorts 1, 3, and 4)
Had active systemic autoimmune disease such as lupus, scleroderma, or rheumatoid arthritis; subjects with autoimmune disease must have been discussed with the Amicus Medical Monitor
Had active bronchial asthma; subjects with bronchial asthma must have been discussed with the Amicus Medical Monitor

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Neuromuscular Research Centre		Phoenix	Arizona	85028	United States
University of California Irvine

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41631150	Derived	Andersen H, Diaz-Manera J, Goker-Alpan O, Mozaffar T, Sitaraman Das S, Fox B, Amon F, O'Brien-Prince K, Goldman M, Holdbrook F, Jain V, Byrne BJ. Safety of home administration of cipaglucosidase alfa plus miglustat in late-onset Pompe disease: results from multiple clinical trials. Ther Adv Rare Dis. 2026 Jan 31;7:26330040261416943. doi: 10.1177/26330040261416943. eCollection 2026 Jan-Dec.
40920287

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cohort 1 (ERT Experienced; Ambulatory): SAD 5 to 20 mg/kg ATB200	ERT experienced ambulatory subjects receiving single ascending dose (SAD) of ATB200 (5 mg/kg, 10 mg/kg, and 20 mg/kg)
FG001	Cohort 1 (ERT Experienced; Ambulatory) MAD 20 mg/kg ATB200 + 130 to 260 mg AT2221

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 10, 2019	Jul 11, 2025

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Pulmonary function was measured by sitting and supine % predicted forced vital capacity (FVC)

FG00011 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Cohort 1	ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6-minute walk test (6MWT)
BG001	Cohort 2	ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment
BG002	Cohort 3	ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT
BG003	Cohort 4	ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for at least 7 years prior to enrollment and were able to walk at least 75 meters in the 6MWT
BG004	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, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002 BG0012 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Years since diagnosis with Pompe disease

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0007.7± 5.11 BG00115.9± 13.08 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

Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Discontinuation of Study Drug

Number of subjects with TEAE, TESAE, and AE leading to discontinuation during the 2 year treatment period and extension (Stage 3 and 4 combined)

Posted

Count of Participants

Participants

Stage 3 (2 year treatment) and Stage 4 (Extension) combined, (mean = 71 months on treatment)

ID	Title	Description
OG000	Cohort 1	ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
OG001	Cohort 2	ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
OG002	Cohort 3	ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
OG003	Cohort 4	ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for at least 7 years prior to enrollment and were able to walk at least 75 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.

Units	Counts
Participants	OG00011 OG0016 OG0026 OG003

Title

Denominators

Categories

Number of subjects with TEAEs

Title	Measurements
	OG00011 OG0016 OG0026 OG003

Primary

Plasma Human Acid α-glucosidase (GAA) Activity Levels as Measured by Maximum Observed Plasma Concentration (Cmax).

Plasma GAA levels (Cmax) measured in Cohorts 1 and 3 following 1st and 3rd doses of cipaglucosidase alfa + miglustat

Pharmacokinetic (PK) analysis only performed in Cohort 1 and Cohort 3. One subject each in Cohort 1 and Cohort 3 did not have PK sample available following first dose.

Posted

Geometric Mean

Geometric Coefficient of Variation

nmol/mL/hr

18 Weeks

ID	Title	Description
OG000	Cohort 1	ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study
OG001	Cohort 3	ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.

Units	Counts
Participants

Primary

Plasma GAA Activity Levels as Measured by Time to Reach the Maximum Observed Plasma Concentration (Tmax).

Plasma GAA levels (Tmax) measured in Cohorts 1 and 3 following 1st and 3rd doses of cipaglucosidase alfa + miglustat

PK analysis only performed in Cohort 1 and Cohort 3. One subject each in Cohort 1 and Cohort 3 did not have PK sample available following first dose.

Posted

Median

Full Range

18 Weeks

ID	Title	Description
OG000	Cohort 1	ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study
OG001	Cohort 3	ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.

Units	Counts
Participants	OG000

Primary

Plasma GAA Activity Levels as Measured by Area Under the Plasma Drug Concentration-time Curve (AUC).

Plasma GAA levels (AUC) measured in Cohorts 1 and 3 following 1st and 3rd doses of cipaglucosidase alfa + miglustat

PK analysis only performed in Cohort 1 and Cohort 3. One subject each in Cohort 1 and Cohort 3 did not have PK sample available following first dose.

Posted

Geometric Mean

Geometric Coefficient of Variation

nmol*hr/mL

18 Weeks

ID	Title	Description
OG000	Cohort 1	ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
OG001	Cohort 3	ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.

Units	Counts
Participants

Secondary

Change From Baseline in 6-minute Walk Distance (6MWD)

Motor function was measured in ambulatory subjects using 6MWD (meters).

Motor function was evaluated using the Efficacy Population (consisting of subjects who took at least 1 dose of study drug (20 mg/kg cipaglucosidase alfa + 260 mg miglustat) and had both a baseline and at least 1 post-baseline assessment for any efficacy endpoint. 6-minute walk distance (6MWD) was only performed in ambulatory subjects (Cohorts 1, 3, and 4). Baseline and Month 60 assessment available for 9 subjects in Cohort 1, 6 subjects in Cohort 3, and 4 subjects in Cohort 4.

Posted

Mean

Standard Deviation

meters

Baseline, Month 60

ID	Title	Description
OG000	Cohort 1	ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
OG001	Cohort 3	ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
OG002	Cohort 4	ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for at least 7 years prior to enrollment and were able to walk at least 75 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.

Secondary

Change From Baseline in Pulmonary Function Tests

Pulmonary function was measured by sitting and supine % predicted forced vital capacity (FVC)

Number of participants analyzed per cohort represents the number of subjects assessed at the specific visit for the parameter. Eight subjects in Cohort 1, 1 subject in Cohort 2, and 5 subjects in Cohort 4 had FVC values reported at Month 60.

Posted

Mean

Standard Deviation

percent predicted FVC

Baseline, Month 60

ID	Title	Description
OG000	Cohort 1	ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
OG001	Cohort 2	ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
OG002	Cohort 3	ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.

Secondary

Change From Baseline in Muscle Strength Tests

Muscle strength was measured by total manual muscle test (MMT) score. Total MMT score ranges from 0 to 80 based on all 16 muscle groups, which are right/left shoulder abduction, right/left shoulder adduction, right/left elbow flexion, right/left elbow extension, right/left hip flexion, right/left hip abduction, right/left knee flexion, and right/left knee extension. Higher scores indicate less disease impact on muscle functions.

Total MMT score was evaluated using the Efficacy Population consisting of all enrolled subjects who took at least 1 dose of study drug (20 mg/kg cipaglucosidase alfa + 260 mg miglustat co-administration) in Stage 3 and had both a baseline and at least 1 post-baseline assessment for any efficacy endpoint. Number of participants analyzed per cohort represents the number of subjects assessed at the specific visit for the parameter.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Month 60

ID	Title	Description
OG000	Cohort 1	ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
OG001	Cohort 2	ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.

Secondary

Change From Baseline in Fatigue Severity Score (FSS)

The Fatigue Severity Score (FSS) consists of 9 questions, each scored on a scale from 1 ("completely disagree") to 7 ("completely agree"). The total score ranges from 9 to 63, with higher values representing higher level of fatigue due to the disease condition.

The Efficacy Population consists of all enrolled subjects who took at least 1 dose of study drug (20 mg/kg cipaglucosidase alfa + 260 mg miglustat co-administration) in Stage 3 and had both a baseline and at least 1 post-baseline assessment for any efficacy endpoint. Number of participants analyzed for FSS are those in each cohort who completed the assessment at baseline and Month 60.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Month 60

ID	Title	Description
OG000	Cohort 1	ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
OG001	Cohort 2	ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
OG002	Cohort 3

Secondary

Change From Baseline in Overall Physical Wellbeing (Subject's Global Impression of Change [SGIC], Question1)

The Subject's Global Impression of Change overall physical wellbeing (question 1) is scored on a 7-point rating scale. Improved = response of 5 or higher, No change = response of 4, and Declined = response of 3 or lower.

Number of participants analyzed per cohort represents the number of subjects assessed at the specific visit for the parameter. Eight subjects in Cohort 1, 2 subjects in Cohort 2, and 5 subjects in Cohort 4 had SGIC values reported at Month 60.

Posted

Count of Participants

Participants

Baseline, Month 60

ID	Title	Description
OG000	Cohort 1	ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
OG001	Cohort 2	ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
OG002	Cohort 3	ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.

Secondary

Change From Baseline in Overall Physical Wellbeing (Physician's Global Impression of Change [PGIC])

The Physician's Global Impression of Change overall physical wellbeing is scored on a 7-point rating scale. Improved = response of 5 or higher, No change = response of 4, and Declined = response of 3 or lower.

Number of participants analyzed per cohort represents the number of subjects assessed at the specific visit for the parameter. Eight subjects in Cohort 1, 3 subjects in Cohort 2, and 5 subjects in Cohort 4 had PGIC values reported at Month 60.

Posted

Count of Participants

Participants

Baseline, Month 60

ID	Title	Description
OG000	Cohort 1	ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
OG001	Cohort 2	ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
OG002	Cohort 3	ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.

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	Cohort 1: ATB200 5 mg	ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received single dose of ATB200 5 mg/kg in Stage 1	0	11	0	11	7	11
EG001	Cohort 1: ATB 200 10 mg	ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received single dose of ATB200 10 mg/kg in Stage 1	0	11	0	11	5	11
EG002	Cohort 1: ATB200 20 mg	ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received single dose of ATB200 20 mg/kg in Stage 1	0	11	0	11	4	11
EG003	Cohort 1: ATB200 20 mg + 130/260 mg Miglustat	ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 130 or 260 mg in Stage 2	0	11	0	11	9	11
EG004	Cohort 1 ATB200 20 mg/kg + Miglustat 260 mg	ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg in Stage 3 and 4.	0	11	7	11	11	11
EG005	Cohort 2 ATB200 20 mg/kg + Miglustat 260 mg	ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment. Subjects received ATB200 20 mg/kg + miglustat 260 mg in Stage 3 and 4.	1	6	4	6	6	6
EG006	Cohort 3 ATB200 20 mg/kg + Miglustat 260 mg	ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg in Stage 3 and 4.	0	6	4	6	6	6
EG007	Cohort 4 ATB200 20 mg/kg + Miglustat 260 mg	ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for at least 7 years prior to enrollment and were able to walk at least 75 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg in Stage 3 and 4.	0	6	6	6	6	6

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG0030 events0 affected11 at risk EG0040 events0 affected11 at risk EG0050 events0 affected6 at risk EG0060 events0 affected6 at risk EG0071 events1 affected6 at risk
Arrhythmia	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Cardiac arrest	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Supraventricular tachycardia	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Hypothyroidism	Endocrine disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Colitis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Femoral hernia	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Chills	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Peripheral swelling	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Pyrexia	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
COVID-19	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Diverticulitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Lower respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Pneumonia	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Postoperative wound infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Septic shock	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Urinary tract infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Clavicle fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Limb injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Traumatic hematoma	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Presyncope	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Syncope	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Acute kidney injury	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Nephrolithiasis	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Pharyngeal edema	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Flushing	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Hemorrhage	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Hypotension	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Fall	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0011 events1 affected11 at risk EG0020 events0 affected11 at risk EG0032 events2 affected11 at risk EG00436 events6 affected11 at risk EG0054 events2 affected6 at risk EG00643 events6 affected6 at risk EG00727 events4 affected6 at risk
Nasopharyngitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected11 at risk EG0020 events0 affected11 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Headache	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0011 events1 affected11 at risk EG0020 events0 affected11 at risk EG003
COVID-19	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Diarrhea	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Fatigue	General disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected11 at risk EG0021 events1 affected11 at risk EG003
Urinary tract infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Contusion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Influenza	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected11 at risk EG0021 events1 affected11 at risk EG003
Sinusitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected11 at risk EG0020 events0 affected11 at risk EG003
Rash	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Abdominal pain	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Chills	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Hypertension	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Migraine	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0011 events1 affected11 at risk EG0021 events1 affected11 at risk EG003
Bronchitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Dizziness	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0021 events1 affected11 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Pyrexia	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Abdominal distension	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Constipation	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Gastroesophageal reflux disease	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Pain	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Peripheral swelling	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Vaccination complication	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Vertigo	Ear and labyrinth disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Anemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Burning sensation	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Chest discomfort	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Dyspepsia	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Dyspnea exertional	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Flatulence	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Gait disturbance	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Gastritis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Hemorrhoids	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Head injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Hypotension	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Joint injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Large intestine polyp	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Limb injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Lower respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Non-cardiac chest pain	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Rhinitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Tooth fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Tremor	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Viral infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Acne	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Alkalosis hypochloremic	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Angina pectoris	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Anxiety	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Arthropod sting	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Blood pressure increased	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Body temperature increased	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Bone contusion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Bundle branch block right	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Catheter site bruise	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Catheter site pain	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Conjunctivitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Cystitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Depression	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Dizziness postural	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Dysarthria	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Dysphagia	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Ear discomfort	Ear and labyrinth disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Folliculitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Forced expiratory volume decreased	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Forced vital capacity decreased	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Gamma-glutamyltransferase increased	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Hematuria	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Hordeolum	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Hot flush	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Hypoesthesia	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Hypothyroidism	Endocrine disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Influenza-like illness	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Infusion site extravasation	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Infusion site pain	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Infusion site swelling	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Insomnia	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Metabolic alkalosis	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Muscle fatigue	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Muscle tightness	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0021 events1 affected11 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Edema peripheral	General disorders	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Osteopenia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Palpitations	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Plantar fasciitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Pneumonia	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Presyncope	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
SARS-CoV-2 test positive	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Sciatica	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Supraventricular tachycardia	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Tinnitus	Ear and labyrinth disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Toothache	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Vaccination site pain	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Vertigo positional	Ear and labyrinth disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Abnormal dreams	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Amenorrhea	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Anal fissure	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Arterial occlusive disease	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Asthenia	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Atrial fibrillation	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Atrioventricular block first degree	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Atrophic vulvovaginitis	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Autoimmune thyroiditis	Endocrine disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Balance disorder	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Biliary dyskinesia	Hepatobiliary disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Bilirubinuria	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Blepharitis	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Blister	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Blood glucose decreased	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Blood testosterone decreased	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Blood uric acid increased	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Blood urine present	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
C-reactive protein increased	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Calculus bladder	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Cardiac flutter	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Cataract	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Cerumen impaction	Ear and labyrinth disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Chalazion	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Chest pain	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Clubbing	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Cognitive disorder	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Complication associated with device	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Culture wound positive	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Cyanosis	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Deafness unilateral	Ear and labyrinth disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Deep vein thrombosis	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Dehydration	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Diplopia	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Drug hypersensitivity	Immune system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Dry eye	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Dry mouth	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Dysstasia	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Dysuria	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Ear infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Ear pain	Ear and labyrinth disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Enteritis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Eosinophil count increased	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Eye infection bacterial	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Facial paresis	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Feeling abnormal	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Feeling hot	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Feeling jittery	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Fluid overload	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Food poisoning	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Fungal skin infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Gastritis erosive	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Gastroenteritis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Gastroenteritis viral	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
General physical health deterioration	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Glaucoma	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Gout	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Graft infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Hemiplegic migraine	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Hepatic cyst	Hepatobiliary disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Herpes zoster	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Hyperthyroidism	Endocrine disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Hypoglycemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Hypomagnesemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Increased upper airway secretion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Ingrowing nail	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Inguinal hernia	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Initial insomnia	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Iron deficiency anemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Joint hyperextension	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Joint noise	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Labyrinthitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Lacunar infarction	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Left atrial enlargement	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0011 events1 affected11 at risk EG0020 events0 affected11 at risk EG003
Lip swelling	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Lipoprotein (a) increased	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Medial tibial stress syndrome	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Migraine with aura	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Mouth ulceration	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Muscle twitching	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Mycobacterium test positive	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Neck mass	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Nodule	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Ocular discomfort	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Oral herpes	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Oral viral infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Orthostatic hypotension	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Pallor	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Paresthesia	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Paronychia	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Peripheral venous disease	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Pharyngitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Post herpetic neuralgia	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Prostatic specific antigen increased	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Protein urine	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Proteinuria	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Radial nerve palsy	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Rectal hemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Regurgitation	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0021 events1 affected11 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Seasonal allergy	Immune system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Sepsis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Sinus tachycardia	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Skin discoloration	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Skin mass	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Skin edema	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Snake bite	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Soft tissue swelling	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Swelling	General disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Swollen tongue	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Tachycardia	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Thrombocytosis	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Thyroid mass	Endocrine disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Tissue injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Tooth abscess	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Tooth infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Transaminases increased	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Vaginal hemorrhage	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Ventricular hypertrophy	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Viral pharyngitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Vision blurred	Eye disorders	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Vitamin D decreased	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
White blood cells urine positive	Investigations	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Wound	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003
Large intestine polyp	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 events1 affected11 at risk EG0010 events0 affected11 at risk EG0020 events0 affected11 at risk EG003

ID	Term
D006009	Glycogen Storage Disease Type II

Ancestor Terms

ID	Term
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
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D006008	Glycogen Storage Disease
D002239	Carbohydrate Metabolism, Inborn Errors
D016464	Lysosomal Storage Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
C059896	miglustat

EG0040 events0 affected11 at risk

EG0050 events0 affected6 at risk

EG0061 events1 affected6 at risk

EG0070 events0 affected6 at risk

EG0040 events0 affected11 at risk

EG0051 events1 affected6 at risk

EG0060 events0 affected6 at risk

EG0070 events0 affected6 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected6 at risk

EG0064 events2 affected6 at risk

EG0070 events0 affected6 at risk

EG0041 events1 affected11 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected6 at risk

EG0070 events0 affected6 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected6 at risk

EG0071 events1 affected6 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected6 at risk

EG0061 events1 affected6 at risk

EG0070 events0 affected6 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected6 at risk

EG0071 events1 affected6 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected6 at risk

EG0061 events1 affected6 at risk

EG0070 events0 affected6 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected6 at risk

EG0061 events1 affected6 at risk

EG0070 events0 affected6 at risk

EG0041 events1 affected11 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected6 at risk

EG0070 events0 affected6 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected6 at risk

EG0062 events1 affected6 at risk

EG0070 events0 affected6 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected6 at risk

EG0061 events1 affected6 at risk

EG0070 events0 affected6 at risk

EG0040 events0 affected11 at risk

EG0051 events1 affected6 at risk

EG0060 events0 affected6 at risk

EG0071 events1 affected6 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected6 at risk

EG0061 events1 affected6 at risk

EG0070 events0 affected6 at risk

EG0040 events0 affected11 at risk

EG0051 events1 affected6 at risk

EG0060 events0 affected6 at risk

EG0070 events0 affected6 at risk

EG0040 events0 affected11 at risk

EG0051 events1 affected6 at risk

EG0061 events1 affected6 at risk

EG0070 events0 affected6 at risk

EG0041 events1 affected11 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected6 at risk

EG0070 events0 affected6 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected6 at risk

EG0071 events1 affected6 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected6 at risk

EG0071 events1 affected6 at risk

EG0040 events0 affected11 at risk

EG0051 events1 affected6 at risk

EG0060 events0 affected6 at risk

EG0070 events0 affected6 at risk

EG0041 events1 affected11 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected6 at risk

EG0070 events0 affected6 at risk

EG0041 events1 affected11 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected6 at risk

EG0070 events0 affected6 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected6 at risk

EG0061 events1 affected6 at risk

EG0070 events0 affected6 at risk

EG0041 events1 affected11 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected6 at risk

EG0070 events0 affected6 at risk

EG0041 events1 affected11 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected6 at risk

EG0070 events0 affected6 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected6 at risk

EG0071 events1 affected6 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected6 at risk

EG0071 events1 affected6 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected6 at risk

EG0072 events1 affected6 at risk

EG0040 events0 affected11 at risk

EG0051 events1 affected6 at risk

EG0060 events0 affected6 at risk

EG0070 events0 affected6 at risk

EG0041 events1 affected11 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected6 at risk

EG0070 events0 affected6 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected6 at risk

EG0072 events1 affected6 at risk

EG0040 events0 affected11 at risk

EG0052 events1 affected6 at risk

EG0060 events0 affected6 at risk

EG0071 events1 affected6 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected6 at risk

EG0071 events1 affected6 at risk

EG0040 events0 affected11 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected6 at risk

EG0071 events1 affected6 at risk

EG0041 events1 affected11 at risk

EG0050 events0 affected6 at risk

EG0060 events0 affected6 at risk

EG0070 events0 affected6 at risk

EG00419 events9 affected11 at risk

EG0054 events3 affected6 at risk

EG0065 events4 affected6 at risk

EG0073 events2 affected6 at risk

EG00411 events6 affected11 at risk

EG0051 events1 affected6 at risk

EG00610 events3 affected6 at risk

EG0078 events5 affected6 at risk