BG00012 Monotherapy Safety and Efficacy Extension Study i... | NCT00835770

ID	Type	Description	Link
2008-004753-14	EudraCT Number

Label	Type	Description	Intervention Names
BG00012 plus placebo	Experimental	In the first phase, participants will receive BG00012 240 mg (two 120 mg capsules) twice a day (BID) and 2 placebo capsules once a day. In the second phase participants will receive open-label BG00012 240 mg BID, for atleast 8 years.	Drug: dimethyl fumarate Drug: Placebo
BG00012	Experimental	In the first phase participants will receive BG00012 240 mg (two 120 mg capsules) three times a day (TID). In the second phase participants will receive open-label BG00012 240 mg BID for atleast 8 years.	Drug: dimethyl fumarate

Name	Type	Description	Arm Group Labels	Other Names
dimethyl fumarate	Drug	BG00012 capsules	BG00012 BG00012 plus placebo

Measure	Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs)	An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	Day 1 up to Week 561

Measure	Description	Time Frame
Percentage of Participants Who Had Relapses	Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours.	Day 1 up to Week 384
Annualized Relapse Rate (ARR)

Name	Affiliation	Role
Medical Director	Biogen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35294	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
37061656	Derived	Amezcua L, Mao-Draayer Y, Vargas WS, Farber R, Schaefer S, Branco F, England SM, Belviso N, Lewin JB, Mendoza JP, Shankar SL; ENDORSE Study Investigators. Efficacy of Dimethyl Fumarate in Young Adults with Relapsing-Remitting Multiple Sclerosis: Analysis of the DEFINE, CONFIRM, and ENDORSE Studies. Neurol Ther. 2023 Jun;12(3):883-897. doi: 10.1007/s40120-023-00475-8. Epub 2023 Apr 15.
32426039

ID	Title	Description
FG000	BG00012 240 mg BID	Participants received BG00012 240 milligram (mg), 2 capsules (120 mg each) orally, twice a day (BID) and 2 matching placebo capsules once a day (QD) for up to 8 years.
FG001	BG00012 240 mg TID

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 12, 2018	Oct 20, 2020

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Treatment-Emergent Adverse Events (AEs)

An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Safety population included all participants who had any post-baseline safety follow-up in study NCT00835770, defined as any treatment emergent AE in study NCT00835770 or any post-baseline laboratory, vital signs, or physical exam assessment in study NCT00835770, and received at least one dose of study treatment in study NCT00835770.

Posted

Count of Participants

Participants

Day 1 up to Week 561

ID	Title	Description
OG000	BG00012 240 mg BID	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.
OG001	BG00012 240 mg TID	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.

Units	Counts
Participants	OG000868 OG001868

Title

Denominators

Categories

Title	Measurements
	OG000824 OG001814

Secondary

Percentage of Participants Who Had Relapses

Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours.

ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. Data for this outcome measure (OM) was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Posted

Number

percentage of participants

Day 1 up to Week 384

ID	Title	Description
OG000	BG00012 240 mg BID (Prior BG00012 240 mg BID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
OG001	BG00012 240 mg TID (Prior BG00012 240 mg TID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
OG002	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.

Secondary

Annualized Relapse Rate (ARR)

The annualized relapse rate is calculated as the total number of relapses occurred during the period for all participants, divided by the total number of participant-years followed in the period.

ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Posted

Number

relapses per participant-years

Day 1 up to Week 384

ID	Title	Description
OG000	BG00012 240 mg BID (Prior BG00012 240 mg BID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
OG001	BG00012 240 mg TID (Prior BG00012 240 mg TID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
OG002	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.

Secondary

Change From Baseline in the Expanded Disability Status Scale (EDSS) at Week 384

EDSS scale ranges from 0 (Normal neurological exam, no disability) to 10 (Death) in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. Sustained disability progression was defined as at least a 1.0 point increase on the EDSS from a baseline EDSS ≥1.0 that was sustained for at least 24 weeks, or a 1.5 point increase on the EDSS from a baseline EDSS =0 that was sustained for at least 24 weeks.

ITT population included participants who had entered study NCT00835770 and received at least one dose of study treatment. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Posted

Mean

Standard Deviation

score on a scale

Baseline, Week 384

ID	Title	Description
OG000	BG00012 240 mg BID (Prior BG00012 240 mg BID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
OG001	BG00012 240 mg TID (Prior BG00012 240 mg TID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.

Secondary

Number of Gadolinium (Gd)-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)

The Gd-enhancing lesions was evaluated using MRI technique.

MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Posted

Mean

Standard Deviation

lesions

Baseline up to Week 288

ID	Title	Description
OG000	BG00012 240 mg BID (Prior BG00012 240 mg BID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
OG001	BG00012 240 mg TID (Prior BG00012 240 mg TID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
OG002	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.

Secondary

Volume of Gd-Enhancing Lesions as Measured by Magnetic Resonance Imaging (MRI)

The Gd-enhancing lesions was evaluated using MRI technique.

MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Posted

Mean

Standard Deviation

millimeter cube (mm^3)

Baseline up to Week 288

ID	Title	Description
OG000	BG00012 240 mg BID (Prior BG00012 240 mg BID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
OG001	BG00012 240 mg TID (Prior BG00012 240 mg TID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
OG002	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.

Secondary

Number of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI)

The T2 lesions was evaluated using MRI technique.

MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Posted

Mean

Standard Deviation

lesions

Baseline up to Week 288

ID	Title	Description
OG000	BG00012 240 mg BID (Prior BG00012 240 mg BID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
OG001	BG00012 240 mg TID (Prior BG00012 240 mg TID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
OG002	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.

Secondary

Volume of New or Newly Enlarging T2 Lesions as Measured by Magnetic Resonance Imaging (MRI)

The T2 lesions was evaluated using MRI technique.

MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Posted

Mean

Standard Deviation

mm^3

Baseline up to Week 288

ID	Title	Description
OG000	BG00012 240 mg BID (Prior BG00012 240 mg BID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
OG001	BG00012 240 mg TID (Prior BG00012 240 mg TID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
OG002	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.

Secondary

Number of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI)

The T1 hypointense lesions was evaluated using MRI technique.

MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Posted

Mean

Standard Deviation

lesions

Baseline up to Week 288

ID	Title	Description
OG000	BG00012 240 mg BID (Prior BG00012 240 mg BID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
OG001	BG00012 240 mg TID (Prior BG00012 240 mg TID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
OG002	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.

Secondary

Volume of T1 Hypointense Lesions as Measured by Magnetic Resonance Imaging (MRI)

The T1 hypointense lesions was evaluated using MRI technique.

MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Posted

Mean

Standard Deviation

mm^3

Baseline up to Week 288

ID	Title	Description
OG000	BG00012 240 mg BID (Prior BG00012 240 mg BID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
OG001	BG00012 240 mg TID (Prior BG00012 240 mg TID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
OG002	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.

Secondary

Percent Change From Baseline in Brain Atrophy

Brain atrophy was measured using magnetic resonance imaging (MRI) technique.

MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Posted

Mean

Standard Deviation

percent change

Baseline up to Week 288

ID	Title	Description
OG000	BG00012 240 mg BID (Prior BG00012 240 mg BID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
OG001	BG00012 240 mg TID (Prior BG00012 240 mg TID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
OG002	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.

Secondary

Percent Change From Baseline in Magnetization Transfer Ratio (MTR)

Magnetization Transfer Ratio (MTR) was measured using MRI technique.

MRI population. 'Number Analyzed' =Number of participants analyzed at specific timepoint. Data for this OM was summarized as per treatment received in previous studies (NCT00420212 and NCT00451451).

Posted

Mean

Standard Deviation

percent change

Baseline up to Week 288

ID	Title	Description
OG000	BG00012 240 mg BID (Prior BG00012 240 mg BID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
OG001	BG00012 240 mg TID (Prior BG00012 240 mg TID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
OG002	BG00012 240 mg BID (Prior BG00012 Matched Placebo)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received placebo matched to BG00012 in the previous studies were included in this arm group.

Secondary

Change From Baseline in Short Form-36 Health Survey (SF-36®) at Week 384

The SF-36 is a brief (36-item) scale reflecting the impact of both dysfunctions and general health perception the questionnaire measures: 1.physical function (PF),2. role physical (RF),3. bodily pain (BP),4. role emotional (RE),5. social function (SF), 6. general health (GH),7. vitality (VT), 8. mental health (MH). Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. The questions related to each dimension are scored on a scale from 0 (worst score) to 100 (best score), with higher scores indicating better function.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Week 384

ID	Title	Description
OG000	BG00012 240 mg BID (Prior BG00012 240 mg BID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
OG001	BG00012 240 mg TID (Prior BG00012 240 mg TID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.

Secondary

Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - EQ-5D Index Score at Week 384

The EQ-5D is a generic health-related quality of life instrument consisting of 2 components, EQ-5D index score and EQ-VAS. The EQ-5D provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has (1) "no problems", (2) "some problems", or (3) "severe problems". A positive change from baseline indicates improvement.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Week 384

ID	Title	Description
OG000	BG00012 240 mg BID (Prior BG00012 240 mg BID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
OG001	BG00012 240 mg TID (Prior BG00012 240 mg TID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.

Secondary

Change From Baseline in EuroQol 5 Dimensions Questionnaire (EQ-5D) Health Survey - Visual Analog Scale (VAS) at Week 384

The EQ-5D is a generic health-related quality of life instrument consisting of 2 components, EQ-5D index score and EQ-VAS. In EQ-VAS participants are asked to rate their current health on a 20 centimeter (cm) scale from 0 to 100 where 0 represents "worst imaginable health state" and 100 represents "best imaginable health state". A positive change from baseline indicates improvement.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Week 384

ID	Title	Description
OG000	BG00012 240 mg BID (Prior BG00012 240 mg BID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
OG001	BG00012 240 mg TID (Prior BG00012 240 mg TID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.

Secondary

Change From Baseline in Visual Function Test Scores at Week 384

Participants were tested using the contrast level of 100%, 2.5%, and 1.25% charts, and the scores were defined as the number of letters identified correctly for each chart (the maximum score was 60). Higher scores indicate better functioning. A positive change from baseline indicates better functioning.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Week 384

ID	Title	Description
OG000	BG00012 240 mg BID (Prior BG00012 240 mg BID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years. Participants who had received BG00012 240 mg BID in the previous studies were included in this arm group.
OG001	BG00012 240 mg TID (Prior BG00012 240 mg TID)	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years. Participants who had received BG00012 240 mg TID in the previous studies were included in this arm group.
OG002

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0010 affected868 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0011 affected868 at risk
Cardiac arrest	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0012 affected868 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Coronary artery disease	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0010 affected868 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Mitral valve prolapse	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Myocardial infarction	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0015 affected868 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Wolff-parkinson-white syndrome	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Cytogenetic abnormality	Congenital, familial and genetic disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Limb malformation	Congenital, familial and genetic disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Autoimmune thyroiditis	Endocrine disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Basedow's disease	Endocrine disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0010 affected868 at risk
Goitre	Endocrine disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Cataract	Eye disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Glaucoma	Eye disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Retinal ischaemia	Eye disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Ulcerative keratitis	Eye disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Vision blurred	Eye disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Colitis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Gastritis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0013 affected868 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Gastrointestinal mucosal disorder	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0013 affected868 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Subileus	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0010 affected868 at risk
Volvulus	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Capsular contracture associated with breast implant	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Chest pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Gait disturbance	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Impaired healing	General disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Non-cardiac chest pain	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0013 affected868 at risk
Oedema peripheral	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Pyrexia	General disorders	MedDRA 13.1	Systematic Assessment	EG0003 affected868 at risk EG0011 affected868 at risk
Serositis	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Treatment failure	General disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0012 affected868 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0003 affected868 at risk EG0011 affected868 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0012 affected868 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0017 affected868 at risk
Chronic hepatitis	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Appendicitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0014 affected868 at risk
Bacterial infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Bacteriuria	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Bronchitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Bronchopneumonia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0012 affected868 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Cellulitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0012 affected868 at risk
Chronic sinusitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0012 affected868 at risk
Chronic tonsillitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Dengue fever	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0010 affected868 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Diverticulitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Endometritis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Escherichia infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Gastroenteritis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0011 affected868 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Gastrointestinal bacterial infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Genital herpes	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Haematoma infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Herpes simplex	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Herpes zoster	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0013 affected868 at risk
Infected skin ulcer	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Meningitis viral	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Nasopharyngitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Oral candidiasis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Osteomyelitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Papilloma viral infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Pelvic abscess	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Peritonsillitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Pneumonia	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0006 affected868 at risk EG0011 affected868 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Post procedural infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Progressive multifocal leukoencephalopathy (PML)	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Pulmonary tuberculoma	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Pyothorax	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Rectal abscess	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Respiratory tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Scrub typhus	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Septic shock	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Sinusitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0010 affected868 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Tooth abscess	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00010 affected868 at risk EG0014 affected868 at risk
Urosepsis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Vaginal infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Vestibular neuronitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Viral infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Accident	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Accident at work	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0012 affected868 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0012 affected868 at risk
Avulsion fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0003 affected868 at risk EG0011 affected868 at risk
Drug toxicity	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG00013 affected868 at risk EG00118 affected868 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0003 affected868 at risk EG0014 affected868 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0003 affected868 at risk EG0010 affected868 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0013 affected868 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0010 affected868 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0014 affected868 at risk
Incision site haematoma	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Ligament injury	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0010 affected868 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0013 affected868 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0012 affected868 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0010 affected868 at risk
Postoperative hernia	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0003 affected868 at risk EG0010 affected868 at risk
Respiratory fume inhalation disorder	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0012 affected868 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0004 affected868 at risk EG0015 affected868 at risk
Skeletal injury	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0012 affected868 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0015 affected868 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Investigation	Investigations	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Lymphocyte count decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0011 affected868 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0004 affected868 at risk EG0010 affected868 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Chondropathy	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0012 affected868 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0005 affected868 at risk EG0011 affected868 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0005 affected868 at risk EG0014 affected868 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0013 affected868 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0010 affected868 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0010 affected868 at risk
Spinal deformity	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Adenolymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Anal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0010 affected868 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0003 affected868 at risk EG0012 affected868 at risk
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Bowenoid papulosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0004 affected868 at risk EG0018 affected868 at risk
Breast cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Breast cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Carcinoid tumour of the pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Cervix neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Glioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Lung adenocarcinoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Lung squamous cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0012 affected868 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Mesothelioma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Pharyngeal neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0003 affected868 at risk EG0010 affected868 at risk
Salivary gland cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Squamous cell carcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Squamous endometrial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0011 affected868 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0006 affected868 at risk EG0013 affected868 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Complex partial seizures	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Convulsion	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0003 affected868 at risk EG0012 affected868 at risk
Dementia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Disturbance in attention	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Dysarthria	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Epilepsy	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Headache	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Hemiparesis	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0012 affected868 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Migraine	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Multiple sclerosis	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0004 affected868 at risk EG0012 affected868 at risk
Multiple sclerosis relapse	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG000116 affected868 at risk EG001122 affected868 at risk
Muscle spasticity	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Neuralgia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0012 affected868 at risk
Optic neuritis	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0012 affected868 at risk
Paraesthesia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Paraparesis	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0010 affected868 at risk
Parkinson's disease	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Quadriparesis	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Radiculitis	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Relapsing-remitting multiple sclerosis	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0011 affected868 at risk
Sciatica	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Syncope	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0011 affected868 at risk
Transient global amnesia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0012 affected868 at risk
Uhthoff's phenomenon	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Abortion missed	Pregnancy, puerperium and perinatal conditions	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Complication of pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Acute psychosis	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Alcoholism	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Anorexia nervosa	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Burnout syndrome	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Catatonia	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Completed suicide	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0012 affected868 at risk
Delirium	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Depression	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0013 affected868 at risk
Drug abuse	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0010 affected868 at risk
Hallucination	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Major depression	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0012 affected868 at risk
Mood disorder due to a general medical condition	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Morbid thoughts	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Neurosis	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Psychiatric decompensation	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Psychotic behaviour	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Psychotic disorder due to a general medical condition	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Stress	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Suicide attempt	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Haematuria	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0012 affected868 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Neurogenic bladder	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Breast necrosis	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0012 affected868 at risk
Cystocele	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Dysfunctional uterine bleeding	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0013 affected868 at risk
Fibrocystic breast disease	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0012 affected868 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0013 affected868 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0011 affected868 at risk
Ovarian cyst ruptured	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Pelvic adhesions	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Choking	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0011 affected868 at risk
Paranasal cyst	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0002 affected868 at risk EG0011 affected868 at risk
Pulmonary sarcoidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Abdominoplasty	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Aortic valve replacement	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Appendicectomy	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Bladder neck suspension	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Bunion operation	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Caesarean section	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Carpal tunnel decompression	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Cochlea implant	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Cystocele repair	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Female sterilisation	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Hysterectomy	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Mammoplasty	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Medical device change	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Medical device removal	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Ovarian cystectomy	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Postoperative care	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Surgery	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Thyroidectomy	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Umbilical hernia repair	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Varicose vein operation	Surgical and medical procedures	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Circulatory collapse	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0011 affected868 at risk
Hypertension	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Hypertensive crisis	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk
Venous thrombosis	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0001 affected868 at risk EG0010 affected868 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 affected868 at risk EG0011 affected868 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphopenia	Blood and lymphatic system disorders	MedDRA 13.1	Systematic Assessment	EG00052 affected868 at risk EG00142 affected868 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00050 affected868 at risk EG00155 affected868 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00069 affected868 at risk EG00176 affected868 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG000111 affected868 at risk EG001118 affected868 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00056 affected868 at risk EG00161 affected868 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG00042 affected868 at risk EG00145 affected868 at risk
Fatigue	General disorders	MedDRA 13.1	Systematic Assessment	EG000100 affected868 at risk EG001102 affected868 at risk
Pyrexia	General disorders	MedDRA 13.1	Systematic Assessment	EG00047 affected868 at risk EG00143 affected868 at risk
Bronchitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00082 affected868 at risk EG00198 affected868 at risk
Gastroenteritis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00052 affected868 at risk EG00133 affected868 at risk
Herpes zoster	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00047 affected868 at risk EG00138 affected868 at risk
Influenza	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00087 affected868 at risk EG00167 affected868 at risk
Nasopharyngitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG000220 affected868 at risk EG001226 affected868 at risk
Pharyngitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00044 affected868 at risk EG00150 affected868 at risk
Sinusitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG00065 affected868 at risk EG00163 affected868 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG000143 affected868 at risk EG001136 affected868 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG000196 affected868 at risk EG001164 affected868 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG00060 affected868 at risk EG00163 affected868 at risk
Alanine aminotransferase increased	Investigations	MedDRA 13.1	Systematic Assessment	EG00053 affected868 at risk EG00159 affected868 at risk
Albumin urine present	Investigations	MedDRA 13.1	Systematic Assessment	EG00066 affected868 at risk EG00162 affected868 at risk
Lymphocyte count decreased	Investigations	MedDRA 13.1	Systematic Assessment	EG00056 affected868 at risk EG00142 affected868 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG00097 affected868 at risk EG001115 affected868 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG000125 affected868 at risk EG001125 affected868 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG00038 affected868 at risk EG00149 affected868 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG00035 affected868 at risk EG00149 affected868 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG000102 affected868 at risk EG00192 affected868 at risk
Dizziness	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG00060 affected868 at risk EG00145 affected868 at risk
Headache	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG000145 affected868 at risk EG001131 affected868 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG00064 affected868 at risk EG00149 affected868 at risk
Multiple sclerosis relapse	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG000324 affected868 at risk EG001335 affected868 at risk
Paraesthesia	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG00057 affected868 at risk EG00159 affected868 at risk
Anxiety	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG00031 affected868 at risk EG00146 affected868 at risk
Depression	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG000102 affected868 at risk EG00187 affected868 at risk
Insomnia	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG00052 affected868 at risk EG00151 affected868 at risk
Haematuria	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG00049 affected868 at risk EG00161 affected868 at risk
Microalbuminuria	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG00055 affected868 at risk EG00161 affected868 at risk
Proteinuria	Renal and urinary disorders	MedDRA 13.1	Systematic Assessment	EG00076 affected868 at risk EG00181 affected868 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Systematic Assessment	EG00054 affected868 at risk EG00166 affected868 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG00047 affected868 at risk EG00132 affected868 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG00050 affected868 at risk EG00138 affected868 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment	EG00045 affected868 at risk EG00140 affected868 at risk
Flushing	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG000170 affected868 at risk EG001165 affected868 at risk
Hot flush	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG00044 affected868 at risk EG00153 affected868 at risk
Hypertension	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG00051 affected868 at risk EG00143 affected868 at risk

ID	Term
D020529	Multiple Sclerosis, Relapsing-Remitting
D012008	Recurrence
D009103	Multiple Sclerosis

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D005650	Fumarates
D003998	Dicarboxylic Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

ID	Title	Description
BG000	BG00012 240 mg BID	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.
BG001	BG00012 240 mg TID	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	BG00012 240 mg BID	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, BID and 2 matching placebo capsules QD for up to 8 years.	5	868	279	868	779	868
EG001	BG00012 240 mg TID	Participants received BG00012 240 mg, 2 capsules (120 mg each) orally, TID for up to 8 years.	6	868	272	868	767	868