A Study of Abiraterone Acetate Plus Prednisone With or Wi... | NCT03706365

ID	Type	Description
I3Y-MC-JPCM	Other Identifier	Eli Lilly and Company
2016-004276-21	EudraCT Number
2023-506777-36-00	EU Trial (CTIS) Number

Status 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
Abemaciclib	Experimental	Participants received 200 milligrams (mg) abemaciclib twice daily (BID) in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.	Drug: Abemaciclib Drug: Abiraterone acetate Drug: Prednisone
Placebo	Placebo Comparator	Participants received placebo BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.	Drug: Placebo Drug: Abiraterone acetate Drug: Prednisone

Name	Type	Description	Arm Group Labels	Other Names
Abemaciclib	Drug	Administered orally.	Abemaciclib	LY2835219

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiographic Progression Free Survival (rPFS)	The rPFS time is measured from the date of randomization to the earliest date of investigator determined radiographic disease progression (by objective radiographic disease assessment per response evaluation criteria in solid tumors (RECIST) version 1.1 for soft tissue AND/OR radionuclide bone scan using prostate cancer working group 3 -PCWG3 criteria for bone) or death from any cause, whichever occurs first.	From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)

Secondary Outcomes

Measure	Description	Time Frame
Time to Prostate-Specific Antigen (PSA) Progression	The PSA progression is defined as a greater than or equal to (>=) 25 percentage (%) increase and an absolute increase of >=2 nanogram/milliliter (ng/mL) above the nadir (or baseline value if baseline is the smallest on study), which is confirmed by a second value obtained 3 or more weeks later.	From Date of Randomization to the Date of the First Observation of PSA Progression (Up to 60 Months)

Eligibility Module

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
St. Joseph's Hospital and Medical Center		Phoenix	Arizona	85004	United States
Mayo Clinic in Arizona - Phoenix

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41167216	Derived	Smith M, Piulats J, Todenhofer T, Lee JL, Arija JA, Mazilu L, Azad A, Alonso-Gordoa T, McGovern U, Choudhury A, Horvath L, Ye D, Han W, Suzuki H, Uemura H, McKay R, Ades S, Flechon A, Pieczonka C, Fernandes MS, Hulstijn M, Lithio A, Nacerddine K, Agarwal N; CYCLONE 2 investigators. Abemaciclib plus abiraterone in patients with metastatic castration-resistant prostate cancer (CYCLONE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2025 Nov;26(11):1489-1500. doi: 10.1016/S1470-2045(25)00475-9.

Label	URL
A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Abemaciclib	Participants received 200 milligram (mg) abemaciclib twice daily (BID) in combination with standard doses of 1000 mg abiraterone acetate once daily and 5mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

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	Apr 30, 2024	Dec 10, 2024

Arm/Group Information

ID	Title	Description
BG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
BG001	Placebo	Participants received placebo BID in combination with standard doses of 1000 mg abiraterone once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
BG002	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
	BG00068.70± 8.57 BG00169.60± 8.81 BG00269.10± 8.69

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000 BG0010 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00013 BG0017 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Australia

Title	Measurements
	BG00017 BG00118 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

Radiographic Progression Free Survival (rPFS)

The rPFS time is measured from the date of randomization to the earliest date of investigator determined radiographic disease progression (by objective radiographic disease assessment per response evaluation criteria in solid tumors (RECIST) version 1.1 for soft tissue AND/OR radionuclide bone scan using prostate cancer working group 3 -PCWG3 criteria for bone) or death from any cause, whichever occurs first.

All randomized participants. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received.

Posted

Median

95% Confidence Interval

Months

From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)

ID	Title	Description
OG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
OG001	Placebo	Participants received placebo BID in combination with standard doses of 1000 mg abiraterone once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Units	Counts
Participants	OG000206 OG001187

Title

Denominators

Categories

Title	Measurements
	OG00021.96(19.33 to 27.48) OG00120.28(16.47 to 24.36)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.2123		Hazard Ratio (HR)	0.829			2-Sided	95	0.619	1.111					Other

Secondary

Time to Prostate-Specific Antigen (PSA) Progression

The PSA progression is defined as a greater than or equal to (>=) 25 percentage (%) increase and an absolute increase of >=2 nanogram/milliliter (ng/mL) above the nadir (or baseline value if baseline is the smallest on study), which is confirmed by a second value obtained 3 or more weeks later.

All randomized participants. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received.

Posted

Median

95% Confidence Interval

Months

From Date of Randomization to the Date of the First Observation of PSA Progression (Up to 60 Months)

ID	Title	Description
OG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
OG001	Placebo	Participants received placebo BID in combination with standard doses of 1000 mg abiraterone once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Secondary

Radiographic Progression Free Survival (rPFS) Determined by Blinded Independent Central Review

rPFS is defined as the time from the date of randomization to the earliest date of radiographic disease progression determined by blinded independent central review (BICR) or death from any cause, whichever occurs first.

All randomized participants. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received.

Posted

Median

95% Confidence Interval

Months

From Date of Randomization Until Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)

ID	Title	Description
OG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
OG001	Placebo	Participants received placebo BID in combination with standard doses of 1000 mg abiraterone once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Secondary

Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)

ORR is a summary measure of best overall response (BOR) as defined by RECIST 1.1 for soft tissue per investigator assessment. BOR is derived from time point responses. All time point responses observed while on study treatment and during the short-term follow-up period (but before the initiation of post-discontinuation systemic anticancer therapy) will be included in the derivation.

Each patient's BOR will be categorized as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE). A BOR of CR or PR will require confirmation, but sensitivity analyses of response-based endpoints may be performed where confirmation of a BOR of CR or PR is not required.

All randomized participants who received at least one dose of the study drug and had CR or PR responses.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline to Radiographic Disease Progression (Up to 60 Months)

ID	Title	Description
OG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
OG001	Placebo

Secondary

Duration of Response (DOR)

The DoR time is defined only for responders (participants with a soft tissue BOR of CR or PR) in the measurable disease population. It is measured from the date of first evidence of soft tissue CR or PR to the earliest date of investigator determined radiographic disease progression or death from any cause, whichever is earlier.

All randomized participants who received at least one dose of the study drug and had CR or PR responses with objective response.

Posted

Median

95% Confidence Interval

Months

Date of First Documented CR or PR to Date of Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)

ID	Title	Description
OG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
OG001	Placebo	Participants received placebo BID in combination with standard doses of 1000 mg abiraterone once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Secondary

Overall Survival (OS)

The OS time is measured from the date of randomization to the date of death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data were censored on the last date the participant was known to be alive.

All randomized participants. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received.

Posted

Median

95% Confidence Interval

Months

From Date of Randomization to Date of Death Due to Any Cause (Up to 60 Months)

ID	Title	Description
OG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
OG001	Placebo	Participants received placebo BID in combination with standard doses of 1000 mg abiraterone once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Secondary

Time to Symptomatic Progression

Time to symptomatic progression is defined as the time from randomization to any of the following (whichever occurs earlier):

Symptomatic Skeletal Event (SSE), defined as symptomatic fracture, surgery or radiation to bone, or spinal cord compression.
Pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anti-cancer therapy.
Development of clinically significant symptoms due to loco-regional tumor progression requiring surgical intervention or radiation therapy.

All randomized participants. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received.

Posted

Median

95% Confidence Interval

Months

From Randomization to the Date of the First Documented Symptomatic Progression (Up to 60 Months)

ID	Title	Description
OG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
OG001	Placebo	Participants received placebo BID in combination with standard doses of 1000 mg abiraterone once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Secondary

Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib

PK: Mean steady state exposure of abemaciclib.

All participants who received at least one dose of study drug had evaluable PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram per milliliter (ng/mL)

Cycle (C) 1 Day (D) 1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)

ID	Title	Description
OG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Units	Counts
Participants	OG000

Secondary

PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567

PK: Mean steady state exposure of abemaciclib metabolite LSN2839567.

All participants who received at least one dose of study drug had evaluable PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)

ID	Title	Description
OG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Units	Counts
Participants	OG000

Secondary

PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726

PK: Mean steady state exposure of abemaciclib metabolite LSN3106726.

All participants who received at least one dose of study drug had evaluable PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)

ID	Title	Description
OG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Units	Counts
Participants	OG000

Secondary

PK: Mean Steady State Exposure of Abiraterone Acetate

PK: Mean Steady State Exposure of Abiraterone Acetate.

All participants who received at least one dose of study drug had evaluable PK data.

Posted

Geometric Mean

Geometric Coefficient of Variation

ng/mL

C1 D15, Post dose

ID	Title	Description
OG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
OG001	Placebo	Participants received placebo BID in combination with standard doses of 1000 mg abiraterone once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

Units	Counts
Participants

Secondary

Time to Worst Pain Progression

Time to Worst Pain Progression defined as the time from randomization to any of the following (whichever occurs earlier): For participants without opioid use at baseline (World Health Organization-Analgesic Ladder-WHO-AL ≤ 2):- Worst pain progression (an increase of 2 points from baseline on the Worst Pain Numeric Rating Scale (NRS) item on 2 consecutive evaluations), Initiation of weak or strong opioids (WHO-AL ≥ 3); For participants with weak or strong opioid use at baseline (WHO-AL ≥ 3): Worst pain progression (an increase of 2 points from baseline on the Worst Pain NRS item on 2 consecutive evaluations) without concurrent decreased opioid use (a decrease in WHO-AL of 1 or more) -Increased opioid use (an increase in WHO-AL of 1 or more).

All randomized participants. Participants were analyzed according to the treatment arm they were assigned to regardless of what actual treatment they received.

Posted

Median

95% Confidence Interval

Months

From Randomization Through Follow-up (Up to 60 months)

ID	Title	Description
OG000	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
OG001	Placebo	Participants received placebo BID in combination with standard doses of 1000 mg abiraterone once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.

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	Abemaciclib	Participants received 200 mg abemaciclib BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.	81	206	89	206	204	206
EG001	Placebo	Participants received placebo BID in combination with standard doses of 1000 mg abiraterone once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.	72	187	66	185	176	185

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0008 events6 affected206 at risk EG0013 events3 affected185 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected206 at risk EG0010 events0 affected185 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Angina pectoris	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0012 events2 affected185 at risk
Atrial flutter	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected206 at risk EG0010 events0 affected185 at risk
Cardiac arrest	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Cardiac failure	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Left ventricular failure	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Myocardial infarction	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0011 events1 affected185 at risk
Tachycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Hypothyroidism	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Amaurosis fugax	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Ascites	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Colitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0013 events3 affected185 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected206 at risk EG0011 events1 affected185 at risk
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0011 events1 affected185 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0013 events1 affected185 at risk
Chest pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Death	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Fatigue	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
General physical health deterioration	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0012 events2 affected185 at risk
Malaise	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Oedema	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Oedema peripheral	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Peripheral swelling	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Pyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0011 events1 affected185 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Abdominal sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Adenovirus infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Anal abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected206 at risk EG0010 events0 affected185 at risk
Atypical pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Bacteraemia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Bacterial infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Bronchitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Cellulitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected206 at risk EG0010 events0 affected185 at risk
Covid-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0005 events4 affected206 at risk EG0010 events0 affected185 at risk
Covid-19 pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected206 at risk EG0011 events1 affected185 at risk
Device related bacteraemia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Device related sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Gastroenteritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Influenza	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Norovirus infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Perirectal abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Pleural infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0007 events6 affected206 at risk EG0015 events5 affected185 at risk
Postoperative wound infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Pyelonephritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0012 events1 affected185 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events2 affected185 at risk
Scrotal abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0004 events2 affected206 at risk EG0011 events1 affected185 at risk
Septic shock	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Soft tissue infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Tooth infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected206 at risk EG0012 events2 affected185 at risk
Urosepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0005 events4 affected206 at risk EG0010 events0 affected185 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events1 affected185 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected206 at risk EG0011 events1 affected185 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0010 events0 affected185 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Snake bite	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Spinal cord injury cervical	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Alanine aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0010 events0 affected185 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0003 events1 affected206 at risk EG0010 events0 affected185 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0013 events3 affected185 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0013 events3 affected185 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0013 events3 affected185 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Papillary renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0010 events0 affected185 at risk
Cognitive disorder	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Colloid brain cyst	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Loss of consciousness	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Presyncope	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Seizure	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Somnolence	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events1 affected185 at risk
Spinal cord compression	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0013 events3 affected185 at risk
Syncope	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0011 events1 affected185 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Device occlusion	Product Issues	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0009 events9 affected206 at risk EG0011 events1 affected185 at risk
Bladder obstruction	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Haematuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0014 events3 affected185 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected206 at risk EG0010 events0 affected185 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Renal failure	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Renal impairment	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Urethral fistula	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Urinary fistula	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Urinary retention	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0005 events4 affected206 at risk EG0012 events2 affected185 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected206 at risk EG0010 events0 affected185 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected206 at risk EG0010 events0 affected185 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0013 events3 affected185 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Aortic dissection	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Embolism arterial	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0003 events1 affected206 at risk EG0010 events0 affected185 at risk
Hypertension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG000164 events91 affected206 at risk EG00130 events21 affected185 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Anaemia megaloblastic	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Bone marrow disorder	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Haemorrhagic diathesis	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Increased tendency to bruise	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events1 affected185 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0016 events2 affected185 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00078 events39 affected206 at risk EG0013 events3 affected185 at risk
Lymph node pain	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected206 at risk EG0010 events0 affected185 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00024 events19 affected206 at risk EG00126 events13 affected185 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG000135 events57 affected206 at risk EG0011 events1 affected185 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0010 events0 affected185 at risk
Spontaneous haematoma	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG00056 events34 affected206 at risk EG0016 events5 affected185 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Angina pectoris	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0005 events4 affected206 at risk EG0015 events3 affected185 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0013 events3 affected185 at risk
Atrial flutter	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0010 events0 affected185 at risk
Atrioventricular block	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Bradycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Bundle branch block right	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Cardiac disorder	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Cardiac failure	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0014 events2 affected185 at risk
Cardiac septal hypertrophy	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Coronary artery disease	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Diastolic dysfunction	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Myocardial infarction	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Palpitations	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected206 at risk EG0014 events4 affected185 at risk
Pericardial effusion	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0016 events6 affected185 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0011 events1 affected185 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0012 events1 affected185 at risk
Tachycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0007 events7 affected206 at risk EG0014 events3 affected185 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events2 affected185 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0013 events3 affected185 at risk
Corneal dystrophy	Congenital, familial and genetic disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0012 events2 affected185 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0014 events3 affected185 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Cushing's syndrome	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Cushingoid	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected206 at risk EG0015 events5 affected185 at risk
Hypothyroidism	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Pituitary-dependent cushing's syndrome	Endocrine disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Asthenopia	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Cataract	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected206 at risk EG0017 events4 affected185 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Conjunctivitis allergic	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Corneal erosion	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Diplopia	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Dry eye	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected206 at risk EG0010 events0 affected185 at risk
Episcleritis	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Eye discharge	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected206 at risk EG0010 events0 affected185 at risk
Eye pruritus	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Eyelid function disorder	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Foreign body sensation in eyes	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected206 at risk EG0010 events0 affected185 at risk
Keratitis	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Lacrimation increased	Eye disorders	MedDRA 26.1	Systematic Assessment	EG00018 events14 affected206 at risk EG0010 events0 affected185 at risk
Meibomian gland dysfunction	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Ocular hyperaemia	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Uveitis	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Vision blurred	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0006 events5 affected206 at risk EG0010 events0 affected185 at risk
Visual impairment	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Vitreous floaters	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected206 at risk EG0014 events3 affected185 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00053 events39 affected206 at risk EG00130 events25 affected185 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0012 events2 affected185 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected206 at risk EG0010 events0 affected185 at risk
Ascites	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00057 events41 affected206 at risk EG00143 events35 affected185 at risk
Dental caries	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0013 events3 affected185 at risk
Dental pulp disorder	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG000414 events134 affected206 at risk EG00176 events35 affected185 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00012 events10 affected206 at risk EG0015 events5 affected185 at risk
Duodenal polyp	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Dyschezia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00027 events23 affected206 at risk EG0017 events7 affected185 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected206 at risk EG0010 events0 affected185 at risk
Faeces hard	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Faeces soft	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected206 at risk EG0010 events0 affected185 at risk
Flatulence	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0007 events6 affected206 at risk EG0014 events4 affected185 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events1 affected206 at risk EG0010 events0 affected185 at risk
Gastritis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0013 events3 affected185 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Gastrointestinal polyp	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00011 events10 affected206 at risk EG0017 events7 affected185 at risk
Gingival pain	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Gingival recession	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00012 events12 affected206 at risk EG0010 events0 affected185 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Intra-abdominal haematoma	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected206 at risk EG0011 events1 affected185 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0011 events1 affected185 at risk
Mucous stools	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG000121 events73 affected206 at risk EG00132 events27 affected185 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0005 events4 affected206 at risk EG0011 events1 affected185 at risk
Oesophageal pain	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Oral disorder	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Oral mucosa haematoma	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Oral pain	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Paraesthesia oral	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0011 events1 affected185 at risk
Peritoneal lesion	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected206 at risk EG0010 events0 affected185 at risk
Proctitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0006 events5 affected206 at risk EG0011 events1 affected185 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00012 events10 affected206 at risk EG0012 events2 affected185 at risk
Swollen tongue	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Tongue discomfort	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Tongue erythema	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Toothache	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0015 events5 affected185 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG00063 events48 affected206 at risk EG00131 events17 affected185 at risk
Axillary pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Catheter site pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Chest discomfort	General disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected206 at risk EG0010 events0 affected185 at risk
Chest pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0015 events4 affected185 at risk
Chills	General disorders	MedDRA 26.1	Systematic Assessment	EG0007 events6 affected206 at risk EG0013 events3 affected185 at risk
Crying	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Discomfort	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Face oedema	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0013 events3 affected185 at risk
Fatigue	General disorders	MedDRA 26.1	Systematic Assessment	EG000196 events107 affected206 at risk EG00174 events47 affected185 at risk
Gait disturbance	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Impaired healing	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Inflammation	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Inflammatory pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Influenza like illness	General disorders	MedDRA 26.1	Systematic Assessment	EG0008 events7 affected206 at risk EG0015 events4 affected185 at risk
Infusion site extravasation	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Injection site erythema	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Injection site reaction	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0012 events2 affected185 at risk
Localised oedema	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events2 affected185 at risk
Malaise	General disorders	MedDRA 26.1	Systematic Assessment	EG0006 events5 affected206 at risk EG0014 events4 affected185 at risk
Mucosal inflammation	General disorders	MedDRA 26.1	Systematic Assessment	EG0008 events5 affected206 at risk EG0010 events0 affected185 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Non-cardiac chest pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected206 at risk EG0012 events2 affected185 at risk
Oedema	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0018 events5 affected185 at risk
Oedema peripheral	General disorders	MedDRA 26.1	Systematic Assessment	EG00061 events41 affected206 at risk EG00129 events23 affected185 at risk
Pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0007 events7 affected206 at risk EG0012 events2 affected185 at risk
Peripheral swelling	General disorders	MedDRA 26.1	Systematic Assessment	EG0006 events5 affected206 at risk EG0010 events0 affected185 at risk
Physical deconditioning	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Pyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG00033 events21 affected206 at risk EG00117 events14 affected185 at risk
Swelling	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Swelling face	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events2 affected185 at risk
Hepatic cytolysis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0012 events1 affected185 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0012 events2 affected185 at risk
Hepatobiliary disease	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0003 events1 affected206 at risk EG0010 events0 affected185 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG00010 events5 affected206 at risk EG0010 events0 affected185 at risk
Amyloidosis	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Contrast media allergy	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Seasonal allergy	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0011 events1 affected185 at risk
Abscess limb	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Acarodermatitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Adenovirus infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Anal abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Arthritis infective	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Asymptomatic bacteriuria	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Atypical pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Balanitis candida	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Body tinea	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Bronchitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0011 events1 affected185 at risk
Candida infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected206 at risk EG0010 events0 affected185 at risk
Cellulitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0006 events4 affected206 at risk EG0012 events2 affected185 at risk
Conjunctivitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0008 events5 affected206 at risk EG0013 events2 affected185 at risk
Conjunctivitis viral	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Covid-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00039 events32 affected206 at risk EG00128 events28 affected185 at risk
Covid-19 pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events2 affected185 at risk
Diverticulitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Ear infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Enterocolitis infectious	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Escherichia infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Fungal skin infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events2 affected185 at risk
Fungal tracheitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Furuncle	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Gastroenteritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0007 events7 affected206 at risk EG0014 events4 affected185 at risk
Gingivitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Herpes simplex reactivation	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Herpes zoster	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0013 events3 affected185 at risk
Hordeolum	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0012 events2 affected185 at risk
Infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Infectious mononucleosis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Influenza	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected206 at risk EG0015 events5 affected185 at risk
Intervertebral discitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Kidney infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Klebsiella infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Large intestine infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Lip infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Localised infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected206 at risk EG0010 events0 affected185 at risk
Mastoiditis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Nail infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Nasopharyngitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0008 events7 affected206 at risk EG0017 events5 affected185 at risk
Norovirus infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Oesophageal infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Onychomycosis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Oral candidiasis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Oral herpes	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0010 events0 affected185 at risk
Oral infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Osteomyelitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Otitis externa	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Paronychia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Periodontitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0012 events2 affected185 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Pharyngitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected206 at risk EG0016 events6 affected185 at risk
Pneumonia aspiration	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Prostate infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected206 at risk EG0010 events0 affected185 at risk
Pulpitis dental	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Pyelonephritis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0011 events1 affected185 at risk
Rhinitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0011 events1 affected185 at risk
Sepsis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Septic shock	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Sinusitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0013 events3 affected185 at risk
Skin infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Syphilis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Tinea cruris	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Tinea pedis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0012 events2 affected185 at risk
Tooth infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0007 events4 affected206 at risk EG0012 events2 affected185 at risk
Tuberculosis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0008 events7 affected206 at risk EG0018 events7 affected185 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00021 events15 affected206 at risk EG00133 events21 affected185 at risk
Viral infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected206 at risk EG0011 events1 affected185 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0012 events2 affected185 at risk
Wound infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0010 events0 affected185 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Animal scratch	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events1 affected185 at risk
Avulsion fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Bone contusion	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0014 events2 affected185 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG00014 events14 affected206 at risk EG00111 events10 affected185 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG00036 events26 affected206 at risk EG00124 events13 affected185 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Gastroenteritis radiation	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Heat illness	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Heat stroke	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events2 affected185 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0012 events2 affected185 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Mouth injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Ocular procedural complication	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events2 affected185 at risk
Radiation proctitis	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG00010 events9 affected206 at risk EG0015 events4 affected185 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0008 events8 affected206 at risk EG0011 events1 affected185 at risk
Skin wound	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0006 events3 affected206 at risk EG0011 events1 affected185 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected206 at risk EG0010 events0 affected185 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Alanine aminotransferase decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0013 events1 affected185 at risk
Alanine aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG00068 events48 affected206 at risk EG00140 events21 affected185 at risk
Alpha 1 microglobulin increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0014 events1 affected185 at risk
Amylase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected206 at risk EG0011 events1 affected185 at risk
Apolipoprotein a-i increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Apolipoprotein b decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Aspartate aminotransferase decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events1 affected185 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG00043 events36 affected206 at risk EG00119 events15 affected185 at risk
Bile acids increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0004 events1 affected206 at risk EG0010 events0 affected185 at risk
Bleeding time prolonged	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG00016 events10 affected206 at risk EG00111 events8 affected185 at risk
Blood bilirubin decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events1 affected185 at risk
Blood bilirubin increased	Investigations	MedDRA 26.1	Systematic Assessment	EG00010 events5 affected206 at risk EG0015 events2 affected185 at risk
Blood cholesterol decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Blood creatine phosphokinase decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0013 events1 affected185 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected206 at risk EG0012 events2 affected185 at risk
Blood creatinine decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Blood creatinine increased	Investigations	MedDRA 26.1	Systematic Assessment	EG000126 events58 affected206 at risk EG0011 events1 affected185 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected206 at risk EG0017 events7 affected185 at risk
Blood urea increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0007 events7 affected206 at risk EG0016 events2 affected185 at risk
Blood uric acid increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0003 events1 affected206 at risk EG0010 events0 affected185 at risk
Bone scan abnormal	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
C-reactive protein increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events1 affected185 at risk
Cardiac ventriculogram left abnormal	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Complement factor c1 decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0013 events1 affected185 at risk
Cystatin c increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected206 at risk EG0013 events1 affected185 at risk
Ejection fraction decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Electrocardiogram abnormal	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Electrocardiogram qt prolonged	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Electrocardiogram st-t segment abnormal	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Electrocardiogram u-wave abnormality	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG00010 events5 affected206 at risk EG0010 events0 affected185 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0009 events3 affected206 at risk EG0011 events1 affected185 at risk
Glomerular filtration rate increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Glucose urine present	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Heart rate decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
International normalised ratio increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0010 events0 affected185 at risk
Lipase increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Monocyte count increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0016 events2 affected185 at risk
Muscle strength abnormal	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Neutrophil count increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0014 events2 affected185 at risk
Nitrite urine present	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Protein total decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Sars-cov-2 test positive	Investigations	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected206 at risk EG0010 events0 affected185 at risk
Serum ferritin decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Transaminases increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0004 events2 affected206 at risk EG0010 events0 affected185 at risk
Troponin increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Vitamin b12 decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0010 events0 affected185 at risk
Weight decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG00031 events23 affected206 at risk EG00111 events10 affected185 at risk
Weight increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected206 at risk EG0017 events6 affected185 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00070 events50 affected206 at risk EG00117 events15 affected185 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00010 events8 affected206 at risk EG0012 events2 affected185 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0012 events2 affected185 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0013 events3 affected185 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Folate deficiency	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Food aversion	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected206 at risk EG0010 events0 affected185 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0015 events1 affected185 at risk
Gout	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0011 events1 affected185 at risk
Hyperchloraemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00011 events10 affected206 at risk EG0016 events5 affected185 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00019 events14 affected206 at risk EG00119 events14 affected185 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected206 at risk EG0013 events3 affected185 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0018 events4 affected185 at risk
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0013 events2 affected185 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0009 events3 affected206 at risk EG0011 events1 affected185 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00024 events16 affected206 at risk EG00111 events7 affected185 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0003 events1 affected206 at risk EG0018 events2 affected185 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0008 events7 affected206 at risk EG00111 events5 affected185 at risk
Hypochloraemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0013 events1 affected185 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events2 affected185 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00037 events22 affected206 at risk EG00120 events13 affected185 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected206 at risk EG0010 events0 affected185 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00012 events12 affected206 at risk EG0017 events5 affected185 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG00017 events14 affected206 at risk EG0018 events4 affected185 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0011 events1 affected185 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Vitamin b12 deficiency	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0013 events2 affected185 at risk
Vitamin d deficiency	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00049 events38 affected206 at risk EG00145 events34 affected185 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00044 events36 affected206 at risk EG00157 events42 affected185 at risk
Bone loss	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0009 events7 affected206 at risk EG00114 events12 affected185 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0007 events7 affected206 at risk EG0017 events7 affected185 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected206 at risk EG0010 events0 affected185 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected206 at risk EG0017 events6 affected185 at risk
Inguinal mass	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0011 events1 affected185 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0013 events3 affected185 at risk
Limb asymmetry	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Muscle contracture	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Muscle fatigue	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00015 events14 affected206 at risk EG00124 events21 affected185 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events2 affected185 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00013 events10 affected206 at risk EG00110 events10 affected185 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00022 events15 affected206 at risk EG00116 events12 affected185 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0018 events7 affected185 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00015 events12 affected206 at risk EG00111 events10 affected185 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0009 events6 affected206 at risk EG0017 events7 affected185 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected206 at risk EG0015 events4 affected185 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected206 at risk EG0010 events0 affected185 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0007 events5 affected206 at risk EG0013 events3 affected185 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0012 events2 affected185 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected206 at risk EG0014 events3 affected185 at risk
Osteosclerosis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG00024 events21 affected206 at risk EG00121 events17 affected185 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0008 events7 affected206 at risk EG0011 events1 affected185 at risk
Pubic pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Sacral pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected206 at risk EG0013 events2 affected185 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Sjogren's syndrome	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0012 events2 affected185 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0014 events4 affected185 at risk
Bone neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Oral neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Akathisia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Amnesia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0013 events3 affected185 at risk
Aphasia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Balance disorder	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0010 events0 affected185 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Cognitive disorder	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Disturbance in attention	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0012 events2 affected185 at risk
Dizziness	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00035 events29 affected206 at risk EG00117 events15 affected185 at risk
Dizziness postural	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0012 events2 affected185 at risk
Dysarthria	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Dysgeusia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00029 events25 affected206 at risk EG0014 events4 affected185 at risk
Dyskinesia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Dyspraxia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Essential tremor	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00021 events16 affected206 at risk EG00122 events16 affected185 at risk
Hemiparesis	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Hyperaesthesia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Lethargy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0012 events2 affected185 at risk
Lumbosacral radiculopathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events1 affected185 at risk
Memory impairment	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0014 events3 affected185 at risk
Meralgia paraesthetica	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Monoparesis	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Muscle spasticity	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected206 at risk EG0010 events0 affected185 at risk
Nerve compression	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events2 affected185 at risk
Neuropathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00020 events18 affected206 at risk EG00114 events14 affected185 at risk
Neurotoxicity	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Occipital neuralgia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Presyncope	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Primary stabbing headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events1 affected185 at risk
Radiculopathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Restless legs syndrome	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0012 events2 affected185 at risk
Sciatica	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0012 events2 affected185 at risk
Somnolence	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0012 events2 affected185 at risk
Spinal cord compression	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Syncope	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0008 events6 affected206 at risk EG0013 events3 affected185 at risk
Taste disorder	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0008 events6 affected206 at risk EG0011 events1 affected185 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Tremor	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0007 events6 affected206 at risk EG0011 events1 affected185 at risk
Vascular parkinsonism	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Abnormal dreams	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Affect lability	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Aggression	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Agitation	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Anxiety	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected206 at risk EG0014 events4 affected185 at risk
Apathy	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Bruxism	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Claustrophobia	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Confusional state	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events2 affected185 at risk
Delirium	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected206 at risk EG0010 events0 affected185 at risk
Depression	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG00011 events10 affected206 at risk EG0013 events3 affected185 at risk
Disorientation	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events1 affected185 at risk
Dissociation	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Hallucination	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Insomnia	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG00020 events19 affected206 at risk EG00117 events15 affected185 at risk
Irritability	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Major depression	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Nightmare	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Sleep disorder	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0012 events2 affected185 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0007 events6 affected206 at risk EG0010 events0 affected185 at risk
Azotaemia	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Bladder hypertrophy	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Bladder spasm	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Chromaturia	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected206 at risk EG0010 events0 affected185 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Dysuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG00016 events13 affected206 at risk EG0018 events7 affected185 at risk
Glycosuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events2 affected185 at risk
Haematuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG00025 events21 affected206 at risk EG00128 events17 affected185 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Lower urinary tract symptoms	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0016 events2 affected185 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected206 at risk EG0012 events2 affected185 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0010 events0 affected185 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0005 events1 affected206 at risk EG0010 events0 affected185 at risk
Nocturia	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG00013 events11 affected206 at risk EG00110 events10 affected185 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0009 events9 affected206 at risk EG00115 events14 affected185 at risk
Polyuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Proteinuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG00011 events5 affected206 at risk EG0012 events2 affected185 at risk
Renal colic	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected206 at risk EG0010 events0 affected185 at risk
Renal failure	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0005 events4 affected206 at risk EG0011 events1 affected185 at risk
Renal impairment	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected206 at risk EG0010 events0 affected185 at risk
Renal pain	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0012 events2 affected185 at risk
Sterile pyuria	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Ureteral disorder	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Urinary hesitation	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0017 events7 affected185 at risk
Urinary retention	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0017 events5 affected185 at risk
Urinary tract disorder	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Urinary tract pain	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Urine flow decreased	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Urine odour abnormal	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0006 events5 affected206 at risk EG0017 events6 affected185 at risk
Perineal pain	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Prostatic disorder	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Prostatic pain	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0012 events2 affected185 at risk
Pruritus genital	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Retracted nipple	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Scrotal pain	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Testicular pain	Reproductive system and breast disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Aphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00059 events45 affected206 at risk EG00122 events20 affected185 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected206 at risk EG0010 events0 affected185 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00031 events22 affected206 at risk EG00116 events15 affected185 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0007 events6 affected206 at risk EG0010 events0 affected185 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events2 affected185 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0005 events4 affected206 at risk EG0012 events2 affected185 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Hyperactive pharyngeal reflex	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Increased bronchial secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Increased viscosity of bronchial secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0010 events0 affected185 at risk
Lung opacity	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0005 events4 affected206 at risk EG0013 events3 affected185 at risk
Nasal discharge discolouration	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Nasal septum perforation	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Obstructive sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0007 events6 affected206 at risk EG0015 events5 affected185 at risk
Painful respiration	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Pleural disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected206 at risk EG0012 events1 affected185 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected206 at risk EG0013 events2 affected185 at risk
Pulmonary artery dilatation	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected206 at risk EG0011 events1 affected185 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Respiration abnormal	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0012 events2 affected185 at risk
Rhinitis hypertrophic	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG00018 events9 affected206 at risk EG0014 events4 affected185 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Sputum increased	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events1 affected185 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0009 events8 affected206 at risk EG0013 events3 affected185 at risk
Angiodermatitis	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00011 events11 affected206 at risk EG0011 events1 affected185 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0005 events4 affected206 at risk EG0011 events1 affected185 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected206 at risk EG0012 events2 affected185 at risk
Eczema asteatotic	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Eczema nummular	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0009 events6 affected206 at risk EG0012 events2 affected185 at risk
Haemorrhage subcutaneous	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0003 events1 affected206 at risk EG0010 events0 affected185 at risk
Hair growth abnormal	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected206 at risk EG0014 events4 affected185 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Koilonychia	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Madarosis	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Nail bed bleeding	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00013 events13 affected206 at risk EG0010 events0 affected185 at risk
Nail dystrophy	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0006 events6 affected206 at risk EG0010 events0 affected185 at risk
Nail ridging	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0010 events0 affected185 at risk
Nail toxicity	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0010 events0 affected185 at risk
Onycholysis	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Precancerous skin lesion	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00012 events10 affected206 at risk EG0012 events2 affected185 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0014 events3 affected185 at risk
Pustular psoriasis	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected206 at risk EG0010 events0 affected185 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG00028 events21 affected206 at risk EG00111 events11 affected185 at risk
Sebaceous gland disorder	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Sebaceous hyperplasia	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Sensitive skin	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected206 at risk EG0010 events0 affected185 at risk
Skin atrophy	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0015 events3 affected185 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Skin dystrophy	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0003 events1 affected206 at risk EG0010 events0 affected185 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected206 at risk EG0010 events0 affected185 at risk
Skin fragility	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0011 events1 affected185 at risk
Skin hypopigmentation	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0008 events7 affected206 at risk EG0014 events4 affected185 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected206 at risk EG0011 events1 affected185 at risk
Symmetrical drug-related intertriginous and flexural exanthema	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0012 events2 affected185 at risk
Tooth extraction	Surgical and medical procedures	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Aortic aneurysm	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Aortic arteriosclerosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Arteriosclerosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Capillary fragility	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected206 at risk EG0012 events2 affected185 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0006 events5 affected206 at risk EG0011 events1 affected185 at risk
Haematoma	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0005 events5 affected206 at risk EG0013 events3 affected185 at risk
Hot flush	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG00027 events25 affected206 at risk EG00127 events24 affected185 at risk
Hypertension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG00036 events24 affected206 at risk EG00163 events34 affected185 at risk
Hypertensive crisis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Hypotension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0009 events9 affected206 at risk EG0013 events3 affected185 at risk
Iliac artery stenosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Intermittent claudication	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Lymphoedema	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Peripheral coldness	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0011 events1 affected185 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Peripheral venous disease	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected206 at risk EG0010 events0 affected185 at risk
Phlebitis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Raynaud's phenomenon	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Superficial vein thrombosis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected185 at risk
Thrombophlebitis	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk
Vascular fragility	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected185 at risk

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases

ID	Term
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes

ID	Term
C000590451	abemaciclib
D000069501	Abiraterone Acetate
D011241	Prednisone