Supplementation of VigantOL® Oil Versus Placebo as Add-on... | NCT01285401

ID	Type	Description	Link
2010-020328-23	EudraCT Number

Label	Type	Description	Intervention Names
VigantOL® oil	Experimental	VigantOL oil plus Rebif in subjects with 25-hydroxy-vitamin D plasma levels below 150 nmol/L	Drug: VigantOL oil plus interferon beta-1a (Rebif)
Placebo	Placebo Comparator	Placebo daily plus Rebif in subjects with 25-hydroxy-vitamin D plasma levels below 150 nmol/L	Drug: Placebo plus interferon beta-1a (Rebif)
Rebif	Experimental	Rebif alone in subjects with 25-hydroxy-vitamin D plasma levels equal or higher than 150 nmol/L	Biological: Interferon beta-1a (Rebif®) alone

Name	Type	Description	Arm Group Labels	Other Names
VigantOL oil plus interferon beta-1a (Rebif)	Drug	VigantOL oil 6,670 International Units per day (IU/d) (167 microgram per day [mcg/day]), was administered orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) administered orally for 44 weeks on top of Rebif 44mcg three times per week (tiw) administered subcutaneously.

Measure	Description	Time Frame
Percentage of Subjects With Disease Activity Free Status up to Week 48	Disease activity free status was defined as absence of any of the clinical and imaging parameters related to the assessment of disease activity; no relapses, no expanded disability status scale (EDSS) progression and no new gadolinium (Gd)-enhancing or relaxation time 2 (T2) magnetic resonance imaging (MRI) lesions.	Up to Week 48

Measure	Description	Time Frame
Percentage of Relapse-free Subjects at Week 48	A relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.	Week 48
Percentage of Subjects Free From Any Expanded Disability Status Scale (EDSS) Progression at Week 48

Name	Affiliation	Role
Manolo Beelke, MD, PhD	WCT Worldwide Clinical Trials GER GmbH Germany	Study Director
Prof. Dr. Raymond Hupperts, MD	Dept of Neurology, Orbis Medical Center Sittard, Maastricht University, The Netherlands	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Vienna			Austria
Research Site

PubMed Identifier	Type	Citation	Retractions
31594857	Derived	Hupperts R, Smolders J, Vieth R, Holmoy T, Marhardt K, Schluep M, Killestein J, Barkhof F, Beelke M, Grimaldi LME; SOLAR Study Group. Randomized trial of daily high-dose vitamin D3 in patients with RRMS receiving subcutaneous interferon beta-1a. Neurology. 2019 Nov 12;93(20):e1906-e1916. doi: 10.1212/WNL.0000000000008445. Epub 2019 Oct 8.

ID	Title	Description
FG000	VigantOL Oil Interferon Beta-1a (Rebif)	Subjects with 25-hydroxyvitamin D [25(OH)D3] serum levels below 150 nano mol per liter (nmol/L) received Vigantol oil 6,670 international unit per day (IU/d) [167 microgram per day (mcg/d)] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous three times a week (tiw).

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

Percentage of Subjects With Disease Activity Free Status up to Week 48

Disease activity free status was defined as absence of any of the clinical and imaging parameters related to the assessment of disease activity; no relapses, no expanded disability status scale (EDSS) progression and no new gadolinium (Gd)-enhancing or relaxation time 2 (T2) magnetic resonance imaging (MRI) lesions.

ITT set included all randomized subjects who received at least 1 dose of the IMP.

Posted

Number

percentage of subjects

Up to Week 48

ID	Title	Description
OG000	VigantOL Oil Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
OG001	Placebo Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.

Units	Counts
Participants	OG000113 OG001116

Title

Denominators

Categories

Title	Measurements
	OG00037.2 OG00135.3

Secondary

Percentage of Relapse-free Subjects at Week 48

A relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.

ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.

Posted

Number

percentage of subjects

Week 48

ID	Title	Description
OG000	VigantOL Oil Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
OG001	Placebo Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.

Units	Counts
Participants

Secondary

Percentage of Subjects Free From Any Expanded Disability Status Scale (EDSS) Progression at Week 48

EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. An EDSS progression was defined as an increase of the EDSS score of at least 1.0 point compared to baseline (SD1) for subjects with a baseline EDSS ≤ 4.0. For subjects with an EDSS score of 0 at baseline (SD1), EDSS progression was defined as an increase of at least 1.5 points. A confirmed EDSS progression was defined as an EDSS progression confirmed after 24 weeks.

ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.

Posted

Number

percentage of subjects

Week 48

ID	Title	Description
OG000	VigantOL Oil Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
OG001	Placebo Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.

Secondary

Number od Subjects With Confirmed EDSS Progression

ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.

Posted

Number

subjects

Baseline upto 48 Weeks

ID	Title	Description
OG000	VigantOL Oil Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
OG001	Placebo Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.

Secondary

Cumulative Number of Relaxation Time 1 (T1) Gadolinium Enhancing Lesions at Week 48

ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP. Here "N" signifies number of subject analyzed for respective outcome measure.

Posted

Mean

Standard Deviation

lesions per subject per scan

48 Weeks

ID	Title	Description
OG000	VigantOL Oil Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
OG001	Placebo Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.

Units	Counts
Participants	OG000

Secondary

Mean Number of Combined Unique Active (CUA) Lesions Per Subject Per Scan at Week 48

CUA lesions was defined as new T1 (Gd enhancing) lesions, new Relaxation time 2 (T2) lesions, or enlarging T2 lesions.

ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.

Posted

Mean

Standard Deviation

lesions per subject per scan

48 Weeks

ID	Title	Description
OG000	VigantOL Oil Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
OG001	Placebo Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.

Units	Counts
Participants	OG000

Secondary

Cumulative Number of New Combined Unique Active (CUA) Lesions at Week 48

CUA lesions was defined as new T1 (Gd enhancing) lesions, new T2 lesions, or enlarging T2 lesions.

ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.

Posted

Mean

Standard Deviation

lesions per subject per scan

48 Weeks

ID	Title	Description
OG000	VigantOL Oil Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
OG001	Placebo Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline in the Total Volume of T2 Lesions at Week 48 (T2 Burden of Disease)

ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP. Here "N" signifies number of subjects analyzed for respective outcome measure.

Posted

Mean

Standard Deviation

millimeter^3 (mm^3)

Baseline, 48 Weeks

ID	Title	Description
OG000	VigantOL Oil Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
OG001	Placebo Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects Free From T1 Gadolinium Enhancing Lesions at Week 48

ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.

Posted

Number

percentage of subjects

48 Weeks

ID	Title	Description
OG000	VigantOL Oil Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
OG001	Placebo Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects Free From New T1 Hypointense Lesions (Black Holes) at Week 48

ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.

Posted

Number

percentage of subjects

48 Weeks

ID	Title	Description
OG000	VigantOL Oil Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
OG001	Placebo Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.

Units	Counts
Participants	OG000

Secondary

Percentage of New T1 Hypointense Lesions (Black Holes) at Week 48 Within the Subgroup of New or Enlarging Non-enhancing T2 Lesions

ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP. Here "N" signifies number of subjects analyzed for respective outcome measure (here in the subgroup of subjects having new or enlarging T2 lesions).

Posted

Mean

Standard Deviation

percentage of new T1 hypointense lesions

48 Weeks

ID	Title	Description
OG000	VigantOL Oil Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
OG001	Placebo Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Relapse

Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject's reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.

ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.

Posted

Number

subjects

Baseline upto 48 weeks

ID	Title	Description
OG000	VigantOL Oil Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
OG001	Placebo Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.

Secondary

Annualized Relapse Rate at Week 48

ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.

Posted

Mean

Standard Deviation

relapse per year

48 weeks

ID	Title	Description
OG000	VigantOL Oil Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
OG001	Placebo Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.

Secondary

Total Number of Reported Relapses at All Time Points up to 48 Weeks

ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.

Posted

Mean

Standard Deviation

number of relapse per subject

48 weeks

ID	Title	Description
OG000	VigantOL Oil Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
OG001	Placebo Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.

Secondary

Percentage of Subjects Treated With Glucocorticoids Due to Relapses

ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.

Posted

Number

percentage of subjects

Baseline upto 48 weeks

ID	Title	Description
OG000	VigantOL Oil Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
OG001	Placebo Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.

Secondary

Mean Change From Baseline in the Total Volume of T1 Hypo Intense Lesions at Week 48

ITT analysis set consisted of all randomized subjects who received at least 1 dose of the IMP.

Posted

Mean

Standard Deviation

millimeter^3 (mm^3)

Baseline, 48 Weeks

ID	Title	Description
OG000	VigantOL Oil Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
OG001	Placebo Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.

Units	Counts
Participants	OG000

Post-Hoc

Percentage of Subjects With Disease Activity Free Status (Alternate Definition) at Week 48

Disease activity free (DAF) status was defined as absence of any of the clinical and imaging parameters related to the assessment of disease activity; no relapses, no confirmed expanded disability status scale (EDSS) progression and no new gadolinium (Gd)-enhancing or relaxation time 2 (T2) magnetic resonance imaging (MRI) lesions. Confirmed EDSS progression was defined as an EDSS progression confirmed after 24 weeks.

ITT set included all randomized subjects who received at least 1 dose of the IMP.

Posted

Number

percentage of subjects

Week 48

ID	Title	Description
OG000	VigantOL Oil Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
OG001	Placebo Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.

Units	Counts

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 13.1	Non-systematic Assessment	EG0003 affected113 at risk EG0010 affected116 at risk
Haematotoxicity	Blood and lymphatic system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0010 affected116 at risk
Lymph node pain	Blood and lymphatic system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0010 affected116 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Angina pectoris	Cardiac disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0011 affected116 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Palpitations	Cardiac disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Tachycardia	Cardiac disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0011 affected116 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0012 affected116 at risk
Hyperparathyroidism secondary	Endocrine disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Hypothyroidism	Endocrine disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0013 affected116 at risk
Thyroid disorder	Endocrine disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Conjunctivitis	Eye disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0012 affected116 at risk
Diplopia	Eye disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Dry eye	Eye disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0010 affected116 at risk
Eye irritation	Eye disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Eye pain	Eye disorders	MedDRA 13.1	Non-systematic Assessment	EG0003 affected113 at risk EG0013 affected116 at risk
Glaucoma	Eye disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Oscillopsia	Eye disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Ulcerative keratitis	Eye disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Vision blurred	Eye disorders	MedDRA 13.1	Non-systematic Assessment	EG0003 affected113 at risk EG0013 affected116 at risk
Visual impairment	Eye disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0013 affected116 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0014 affected116 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0009 affected113 at risk EG0013 affected116 at risk
Abdominal tenderness	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Constipation	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0006 affected113 at risk EG0012 affected116 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG00010 affected113 at risk EG0017 affected116 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0011 affected116 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Flatulence	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Gastritis	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Gastrointestinal sounds abnormal	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Gingivitis	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Lip swelling	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Nausea	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0003 affected113 at risk EG0014 affected116 at risk
Oral discomfort	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Paraesthesia oral	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Tooth impacted	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Toothache	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0003 affected113 at risk EG0012 affected116 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0003 affected113 at risk EG0014 affected116 at risk
Vomiting in pregnancy	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Asthenia	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0011 affected116 at risk
Chest discomfort	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Chest pain	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0014 affected116 at risk
Chills	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Fatigue	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0008 affected113 at risk EG00113 affected116 at risk
Feeling cold	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0010 affected116 at risk
Gait disturbance	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0003 affected113 at risk EG0012 affected116 at risk
Inflammation	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Influenza like illness	General disorders	MedDRA 13.1	Non-systematic Assessment	EG00012 affected113 at risk EG00113 affected116 at risk
Injection site erythema	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0004 affected113 at risk EG0010 affected116 at risk
Injection site induration	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Injection site inflammation	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Injection site irritation	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Injection site pain	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0012 affected116 at risk
Injection site pruritus	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Injection site reaction	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0005 affected113 at risk EG0013 affected116 at risk
Injection site swelling	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Injection site urticaria	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0013 affected116 at risk
Irritability	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Malaise	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Oedema peripheral	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0011 affected116 at risk
Pain	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Pyrexia	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0007 affected113 at risk EG00112 affected116 at risk
Sensation of foreign body	General disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Multiple allergies	Immune system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Acute tonsillitis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Bacterial infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Bronchitis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0004 affected113 at risk EG0012 affected116 at risk
Cystitis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0003 affected113 at risk EG0017 affected116 at risk
Ear infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0011 affected116 at risk
Eye infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Eyelid infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Folliculitis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Fungal infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Furuncle	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Gastric infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Gastroenteritis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0015 affected116 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0010 affected116 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Groin abscess	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Herpes simplex	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Herpes virus infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Herpes zoster	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Impetigo	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Infected cyst	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Influenza	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG00013 affected113 at risk EG00119 affected116 at risk
Injection site abscess	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0010 affected116 at risk
Laryngitis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0003 affected113 at risk EG0012 affected116 at risk
Localised infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Nasopharyngitis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG00018 affected113 at risk EG00117 affected116 at risk
Oral herpes	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0010 affected116 at risk
Otitis media	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0011 affected116 at risk
Pharyngitis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0012 affected116 at risk
Pneumonia	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Pneumonia mycoplasmal	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Pseudofolliculitis barbae	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Respiratory tract infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0004 affected113 at risk EG0012 affected116 at risk
Rhinitis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0005 affected113 at risk EG0011 affected116 at risk
Sinusitis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0005 affected113 at risk EG0014 affected116 at risk
Skin infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Tinea pedis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Tonsillitis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Tooth abscess	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Tooth infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0011 affected116 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0003 affected113 at risk EG0014 affected116 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG00012 affected113 at risk EG0016 affected116 at risk
Vaginal infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0010 affected116 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 13.1	Non-systematic Assessment	EG0003 affected113 at risk EG0010 affected116 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Procedural headache	Injury, poisoning and procedural complications	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Tooth injury	Injury, poisoning and procedural complications	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Traumatic brain injury	Injury, poisoning and procedural complications	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Whiplash injury	Injury, poisoning and procedural complications	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0012 affected116 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Alanine aminotransferase increased	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Anti-thyroid antibody positive	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Antibody test positive	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0012 affected116 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0003 affected113 at risk EG0011 affected116 at risk
Blood creatinine decreased	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Blood folate decreased	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0011 affected116 at risk
Blood glucose increased	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0010 affected116 at risk
Blood iron decreased	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Blood parathyroid hormone increased	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Blood thyroid stimulating hormone abnormal	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Creatine urine abnormal	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Creatinine urine increased	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Drug specific antibody present	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Electrocardiogram abnormal	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Hepatic enzyme increased	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0010 affected116 at risk
Liver function test abnormal	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Lymphocyte count decreased	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0012 affected116 at risk
Platelet count decreased	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Thyroid function test abnormal	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Urine calcium	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Urine calcium/creatinine ratio increased	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Vitamin B12 decreased	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0011 affected116 at risk
Weight decreased	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Weight increased	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
White blood cell count increased	Investigations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0010 affected116 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0004 affected113 at risk EG0015 affected116 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG00010 affected113 at risk EG0017 affected116 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Growing pains	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0010 affected116 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0007 affected113 at risk EG0011 affected116 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0003 affected113 at risk EG0011 affected116 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0012 affected116 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0010 affected116 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0011 affected116 at risk
Myokymia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0005 affected113 at risk EG0013 affected116 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0015 affected116 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG00013 affected113 at risk EG0016 affected116 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Rheumatic fever	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0012 affected116 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Lipofibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Morton's neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Mycosis fungoides	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Balance disorder	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Burning sensation	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Coordination abnormal	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0012 affected116 at risk
Dizziness	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0005 affected113 at risk EG0014 affected116 at risk
Dystonia	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Facial neuralgia	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Headache	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG00020 affected113 at risk EG00121 affected116 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0012 affected116 at risk
Memory impairment	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0010 affected116 at risk
Meralgia paraesthetica	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Migraine	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0006 affected113 at risk EG0015 affected116 at risk
Migraine with aura	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Motor dysfunction	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Multiple sclerosis relapse	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0012 affected116 at risk
Neuralgia	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Paraesthesia	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0005 affected113 at risk EG0014 affected116 at risk
Presyncope	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Restless legs syndrome	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0013 affected116 at risk
Sciatica	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Sensory disturbance	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0004 affected113 at risk EG0013 affected116 at risk
Syncope	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0010 affected116 at risk
Tremor	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0012 affected116 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0010 affected116 at risk
Affective disorder	Psychiatric disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0012 affected116 at risk
Alcohol abuse	Psychiatric disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Anxiety	Psychiatric disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0015 affected116 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Attention deficit/hyperactivity disorder	Psychiatric disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Delusional perception	Psychiatric disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Depression	Psychiatric disorders	MedDRA 13.1	Non-systematic Assessment	EG0004 affected113 at risk EG0012 affected116 at risk
Fear of needles	Psychiatric disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Insomnia	Psychiatric disorders	MedDRA 13.1	Non-systematic Assessment	EG0004 affected113 at risk EG0014 affected116 at risk
Loss of libido	Psychiatric disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Mood swings	Psychiatric disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0010 affected116 at risk
Panic attack	Psychiatric disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0013 affected116 at risk
Restlessness	Psychiatric disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Sleep disorder	Psychiatric disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0014 affected116 at risk
Stress	Psychiatric disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0010 affected116 at risk
Bladder dysfunction	Renal and urinary disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Dysuria	Renal and urinary disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0014 affected116 at risk
Incontinence	Renal and urinary disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0010 affected116 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0010 affected116 at risk
Urinary retention	Renal and urinary disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Urinary tract pain	Renal and urinary disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0011 affected116 at risk
Menopausal symptoms	Reproductive system and breast disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Menstruation irregular	Reproductive system and breast disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Premenstrual syndrome	Reproductive system and breast disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Sexual dysfunction	Reproductive system and breast disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Uterine enlargement	Reproductive system and breast disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0007 affected113 at risk EG0016 affected116 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0011 affected116 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0007 affected113 at risk EG0015 affected116 at risk
Paranasal sinus mucosal hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Pulmonary hilum mass	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0011 affected116 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Dermatitis psoriasiform	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0011 affected116 at risk
Erythema nodosum	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Pityriasis rosea	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Skin reaction	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0002 affected113 at risk EG0014 affected116 at risk
Endodontic procedure	Surgical and medical procedures	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Hospitalisation	Surgical and medical procedures	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Mammoplasty	Surgical and medical procedures	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Parotidectomy	Surgical and medical procedures	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Shoulder operation	Surgical and medical procedures	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Tooth extraction	Surgical and medical procedures	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Wisdom teeth removal	Surgical and medical procedures	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Circulatory collapse	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Haematoma	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Haemorrhage	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Hypertension	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0006 affected113 at risk EG0014 affected116 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk

ID	Term
D020529	Multiple Sclerosis, Relapsing-Remitting
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

ID	Term
D016899	Interferon-beta
D007370	Interferon Type I
D007372	Interferons
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors
D017533	Marital Status
D005191	Family Characteristics
D003710	Demography
D011154	Population Characteristics
D012959	Socioeconomic Factors

ID	Title	Description
BG000	VigantOL Oil Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
BG001	Placebo Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
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	VigantOL Oil Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.			18	113	99	113
EG001	Placebo Interferon Beta-1a (Rebif)	Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.			8	116	93	116

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abscess limb	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Appendicitis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Cellulitis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Eye infection	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Pneumonia	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Pyelonephritis	Infections and infestations	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Depression	Psychiatric disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Headache	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Syncope	Nervous system disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Cardiac failure	Cardiac disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Hypertension	Vascular disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 13.1	Non-systematic Assessment	EG0000 affected113 at risk EG0011 affected116 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 13.1	Non-systematic Assessment	EG0001 affected113 at risk EG0010 affected116 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 13.1	Non-systematic Assessment	EG0008 affected113 at risk EG0016 affected116 at risk