Efficacy, Safety, and Tolerability of Plovamer Acetate (P... | NCT01963611

NCT01963611

ID	Type	Description	Link
2013-002283-25	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Plovamer acetate 0.5 milligram (mg)	Experimental	Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.	Drug: Plovamer acetate 0.5 milligram (mg)
Plovamer acetate 3 mg	Experimental	Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.	Drug: Plovamer acetate 3 mg
Plovamer acetate 10 mg	Experimental	Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.	Drug: Plovamer acetate 10 mg
Plovamer acetate 20 mg	Experimental	Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.	Drug: Plovamer acetate 20 mg
Copaxone 20 mg	Active Comparator	Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plovamer acetate 0.5 milligram (mg)	Drug	Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.	Plovamer acetate 0.5 milligram (mg)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan	Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions per Subject and Scan was calculated using 5 serial magnetic resonance imaging (MRI) scans.	Baseline , Week 12, 24, 28, 32, 36, 40

Secondary Outcomes

Measure	Description	Time Frame
Mean Annualized Relapse Rate (ARR)	Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Annualized Relapse Rate was calculated as = 365.25 x (Number of relapses during Treatment Period) per (Number of days on treatment during Treatment Period).

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Medical Responsible	EMD Serono, Inc., Billerica MA, a subsidiary of Merck KGaA, Darmstadt, Germany	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research site		Redding	California	96001	United States
Research site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Plovamer Acetate 0.5 Milligram (mg)	Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
FG001	Plovamer Acetate 3 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Plovamer Acetate 0.5 Milligram (mg)	Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
BG001	Plovamer Acetate 3 mg	Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
BG002	Plovamer Acetate 10 mg	Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
BG003	Plovamer Acetate 20 mg	Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
BG004	Copaxone 20 mg	Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
BG005	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Baseline (n=44,45,42,41,44)

Title	Measurements
	OG0001.5± 2.93 OG0011.6± 4.12 OG0021.0± 2.43 OG003

Secondary

Mean Annualized Relapse Rate (ARR)

Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Annualized Relapse Rate was calculated as = 365.25 x (Number of relapses during Treatment Period) per (Number of days on treatment during Treatment Period).

Safety Analysis Set (SAF) includes all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP).

Posted

Mean

Standard Deviation

percent relapse

Baseline up to Week 40

ID	Title	Description
OG000	Plovamer Acetate 0.5 Milligram (mg)	Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG001	Plovamer Acetate 3 mg	Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.

Secondary

Percentage of Subjects Remaining Relapse-Free

Safety Analysis Set (SAF) includes all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP).

Posted

Number

percent subjects

Baseline up to Week 40

ID	Title	Description
OG000	Plovamer Acetate 0.5 Milligram (mg)	Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG001	Plovamer Acetate 3 mg	Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG002	Plovamer Acetate 10 mg

Secondary

Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan

T1 Gd-enhancing lesions per subject and scan was measured using 5 serial MRI scans.

ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here "n" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.

Posted

Mean

Standard Deviation

lesions/subject/scan

Weeks 12, 24, 28, 32, 36, 40

ID	Title	Description
OG000	Plovamer Acetate 0.5 Milligram (mg)	Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG001	Plovamer Acetate 3 mg	Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG002	Plovamer Acetate 10 mg	Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG003	Plovamer Acetate 20 mg

Secondary

Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan

New or enlarging Time Constant 2 (T2) lesions per subject and scan was calculated using 5 serial MRI scans.

ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.

Posted

Mean

Standard Deviation

lesions/subject/scan

Weeks 12, 24, 28, 32, 36,40

ID	Title	Description
OG000	Plovamer Acetate 0.5 Milligram (mg)	Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG001	Plovamer Acetate 3 mg	Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG002	Plovamer Acetate 10 mg	Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG003	Plovamer Acetate 20 mg

Secondary

Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan

New, unenhancing T1 lesions (Black Holes) per subject and scan was calculated using 5 Serial MRIs.

Posted

Mean

Standard Deviation

lesions/subject/scan

Weeks 12, 24, 28, 32, 36, 40

ID	Title	Description
OG000	Plovamer Acetate 0.5 Milligram (mg)	Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG001	Plovamer Acetate 3 mg	Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG002	Plovamer Acetate 10 mg	Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG003	Plovamer Acetate 20 mg

Secondary

Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan

Change from baseline in volume of T1 Gd-enhancing lesions per subject was calculated using 5 Serial MRI Scans.

Posted

Mean

Standard Deviation

cubic millimeter (mm^3)

Baseline, Weeks 12, 24, 28, 32, 36, 40

ID	Title	Description
OG000	Plovamer Acetate 0.5 Milligram (mg)	Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG001	Plovamer Acetate 3 mg	Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG002	Plovamer Acetate 10 mg	Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG003

Secondary

Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan

Change from baseline per subjects in volume of T2 Gd-enhancing lesions was calculated using 5 series MRI scan.

Posted

Mean

Standard Deviation

cubic millimeter (mm^3)

Baseline, Weeks 12, 24, 28, 32, 36, 40

ID	Title	Description
OG000	Plovamer Acetate 0.5 Milligram (mg)	Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG001	Plovamer Acetate 3 mg	Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG002	Plovamer Acetate 10 mg	Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG003

Secondary

Time to First Relapse

The Outcome Measure was not derived due to early termination of the study.

Posted

Baseline up to Week 40

ID	Title	Description
OG000	Plovamer Acetate 0.5 Milligram (mg)	Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG001	Plovamer Acetate 3 mg	Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG002	Plovamer Acetate 10 mg	Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.

Secondary

Mean Change From Baseline in Brain Volume Per Subject

Change from baseline in brain volume per subject was calculated using 5 series MRI scan.

The Outcome Measure was not derived due to early termination of the study.

Posted

Baseline, Weeks 24, 28, 32, 36, 40

ID	Title	Description
OG000	Plovamer Acetate 0.5 Milligram (mg)	Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG001	Plovamer Acetate 3 mg	Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG002	Plovamer Acetate 10 mg	Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
OG003	Plovamer Acetate 20 mg	Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Plovamer Acetate 0.5 Milligram (mg)	Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for a minimum of 40 weeks.	2	51	28	51
EG001	Plovamer Acetate 3 mg	Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for a minimum of 40 weeks.	0	49	34	49
EG002	Plovamer Acetate 10 mg	Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for a minimum of 40 weeks.	2	52	38	52
EG003	Plovamer Acetate 20 mg	Plovamer acetate was administered at a dose of 20 mg as weekly subcutaneous injection for a minimum of 40 weeks.	3	52	41	52
EG004	Copaxone 20 mg	Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for a minimum of 40 weeks.	0	50	42	50

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cellulitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG0030 affected52 at risk EG0040 affected50 at risk
Pyelonephritis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Major depression	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Venous thrombosis	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Influenza like illness	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG0036 affected52 at risk EG0040 affected50 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0002 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Bronchitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0011 affected49 at risk EG0021 affected52 at risk EG003
Cystitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0022 affected52 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0012 affected49 at risk EG0021 affected52 at risk EG003
Tonsillitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0022 affected52 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0021 affected52 at risk EG003
Erythema migrans	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Herpes simplex	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0021 affected52 at risk EG003
Chronic tonsillitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Ear infection	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Influenza	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Laryngitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Pneumonia	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Tracheitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Urethritis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Sinusitis	Infections and infestations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Fibroadenoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Increased tendency to bruise	Blood and lymphatic system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Depression	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0011 affected49 at risk EG0022 affected52 at risk EG003
Depressive symptom	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0012 affected49 at risk EG0021 affected52 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Panic attack	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0012 affected49 at risk EG0020 affected52 at risk EG003
Adjustment disorder	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Affective disorder	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Emotional disorder	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Mood altered	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Nightmare	Psychiatric disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Headache	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0004 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Dizziness	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0021 affected52 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Essential tremor	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Muscle spasticity	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Radicular pain	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Restless legs syndrome	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Perineurial cyst	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Eyelid skin dryness	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Iritis	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Vision blurred	Eye disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Hypertensive heart disease	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Palpitations	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Hypertension	Vascular disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0002 affected51 at risk EG0010 affected49 at risk EG0022 affected52 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0012 affected49 at risk EG0020 affected52 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Melanosis coli	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Abdominal rigidity	Gastrointestinal disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Hepatomegaly	Hepatobiliary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Myokymia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Urinary hesitation	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Epididymal cyst	Reproductive system and breast disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Injection site pain	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0008 affected51 at risk EG00120 affected49 at risk EG00226 affected52 at risk EG003
Injection site erythema	General disorders	MedDRA 18.0	Non-systematic Assessment	EG00010 affected51 at risk EG00116 affected49 at risk EG00214 affected52 at risk EG003
Injection site pruritus	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected51 at risk EG0016 affected49 at risk EG00210 affected52 at risk EG003
Injection site induration	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0012 affected49 at risk EG0025 affected52 at risk EG003
Injection site oedema	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0011 affected49 at risk EG0022 affected52 at risk EG003
Injection site bruising	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0003 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Influenza like illness	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0011 affected49 at risk EG0021 affected52 at risk EG003
Injection site haematoma	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Injection site laceration	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0021 affected52 at risk EG003
Injection site nodule	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0022 affected52 at risk EG003
Injection site rash	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Pyrexia	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Asthenia	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0021 affected52 at risk EG003
Chest discomfort	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Chills	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0021 affected52 at risk EG003
Fatigue	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Injection site haemorrhage	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Injection site paraesthesia	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Injection site swelling	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Oedema peripheral	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Chest pain	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Inflammation	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Injection site cyst	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Injection site mass	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Peripheral swelling	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Cyst	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Hyperthermia	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Injection site discolouration	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Injection site granuloma	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Pain	General disorders	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Electrocardiogram PR shortened	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Liver function test abnormal	Investigations	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0001 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Sunburn	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0011 affected49 at risk EG0020 affected52 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0021 affected52 at risk EG003
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 18.0	Non-systematic Assessment	EG0000 affected51 at risk EG0010 affected49 at risk EG0020 affected52 at risk EG003

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
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins