Evaluate the Safe and Effective Use of the Avonex® Single... | NCT00828204

NCT00828204

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Avonex Single-Use Autoinjector	Experimental	Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes. In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.	Device: single-use autoinjector with a prefilled liquid Avonex syringe Device: Avonex prefilled syringe via manual IM injection Drug: BG9418 (interferon beta-1a)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
single-use autoinjector with a prefilled liquid Avonex syringe	Device		Avonex Single-Use Autoinjector
Avonex prefilled syringe via manual IM injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants in the Main Subset With Overall Success Using the Avonex Single-Use Autoinjector	A trainer/observer documented the participant's ability to self-inject with the Avonex single-use autoinjector and completed an observation form. Overall success in using the device for each participant was defined as no failures occurring in any step (ie, device set-up, self-administration of injection, and capping/disposal of the device) during the participant's use of the single-use Avonex autoinjector.	Day 22

Other Outcomes

Measure	Description	Time Frame
Number of Participants in the Initial Subset Who Were Satisfied With the Avonex Single-Use Autoinjector	Number of participants in the Initial Subset who answered yes to the question "Were you satisfied with this single-use injector?" on the Subject Satisfaction Questionnaire.	Day 23
Percentage of Participants With No Erythema, Induration, or Tenderness, and Normal Temperature at the Injection Site After Injection With the Avonex Single-use Autoinjector

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Medical Director	Biogen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Gilbert	Arizona	85234	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21999176	Derived	Phillips JT, Fox E, Grainger W, Tuccillo D, Liu S, Deykin A. An open-label, multicenter study to evaluate the safe and effective use of the single-use autoinjector with an Avonex(R) prefilled syringe in multiple sclerosis subjects. BMC Neurol. 2011 Oct 14;11:126. doi: 10.1186/1471-2377-11-126.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Avonex Single-Use Autoinjector: Initial Subset	Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes. In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks. Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

FG00021 subjects
FG0010 subjectsMain Subset was not enrolled until after study suspension (period 2, below).

This table presents the baseline characteristics for both the Initial Subset and Main Subset populations. As represented in the Participant Flow module, these 2 groups participated prior to and after study suspension, respectively; therefore the total column should not be interpreted as cumulative.

Arm/Group Information

ID	Title	Description
BG000	Avonex Single-Use Autoinjector: Main Subset	Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes. In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks. Main Subset participants were enrolled after study suspension and could enroll in the Extension Study.
BG001	Avonex Single-Use Autoinjector: Initial Subset	Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes. In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks. Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	OG00089(81 to 96)

Other Pre-specified

Number of Participants in the Initial Subset Who Were Satisfied With the Avonex Single-Use Autoinjector

Number of participants in the Initial Subset who answered yes to the question "Were you satisfied with this single-use injector?" on the Subject Satisfaction Questionnaire.

Participants in the Initial Subset who received at least 1 injection with autoinjector who had a complete Subject Satisfaction Questionnaire.

Posted

Number

participants

Day 23

ID	Title	Description
OG000	Avonex Single-Use Autoinjector: Initial Subset	Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes. In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks. Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.

Units	Counts
Participants

Other Pre-specified

Percentage of Participants With No Erythema, Induration, or Tenderness, and Normal Temperature at the Injection Site After Injection With the Avonex Single-use Autoinjector

The clinician/investigator evaluated the injection site for erythema, induration, and tenderness as none, mild, moderate, or severe after the use of the Avonex single-use autoinjector. Temperature at the injection site was evaluated as normal, warm, or hot. Those participants having no erythema, induration, or tenderness, and normal temperature at the injection site after injection are presented.

Participants who received at least one injection with the Avonex single-use autoinjector. Missing data were not imputed.

Posted

Number

percentage of participants

Day 1, Day 8 through 22 (highest severity reported between Days 8 and 22)

ID	Title	Description
OG000	Avonex Single-Use Autoinjector: Main Subset	Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes. In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks. Main Subset participants were enrolled after study suspension and could enroll in the Extension Study.
OG001	Avonex Single-Use Autoinjector: Initial Subset

Other Pre-specified

Mean Score for Ease of Use Grading Scale

Participants scored the ease of use of the Avonex manual injector (Day 1) and single-use autoinjector (Days 8, 15, 22) using a scale that ranged from 0 (extremely difficult) to 10 (extremely easy).

Participants who received at least one injection with the Avonex Single-use Autoinjector. Missing data were not imputed. n=number of participants who received an injection and had an assessment at the given timepoint.

Posted

Mean

Standard Deviation

scores on a scale

Day 1, Day 8, Day 15, Day 22

ID	Title	Description
OG000	Avonex Single-Use Autoinjector: Main Subset	Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes. In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks. Main Subset participants were enrolled after study suspension and could enroll in the Extension Study.
OG001	Avonex Single-Use Autoinjector: Initial Subset	Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes. In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks. Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.

Other Pre-specified

Percentage of Participants Who Rated the Avonex Single-use Autoinjector Printed and DVD Training Materials as Very Effective

Participants evaluated how effective the printed and DVD instructions were in educating how to use the Avonex single-use autoinjector. Participants could choose one of the following descriptive answers: not effective at all, somewhat ineffective, neutral, somewhat effective, or very effective.

Participants in the Main Subset who received at least one injection with the Avonex Single-use Autoinjector and submitted an assessment form. n=the number of subjects completing the assessment form at the given timepoint. Missing data were not imputed.

Posted

Number

percentage of participants

Day 8, Day 15, Day 22

ID	Title	Description
OG000	Avonex Single-Use Autoinjector: Main Subset	Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes. In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks. Main Subset participants were enrolled after study suspension and could enroll in the Extension Study.

Units

Other Pre-specified

Mean Score for Initial Subset on Autoinjector Instructions Grading Scale

Participants in the Initial Subset were asked to answer the question "How satisfied are you with the presentation of the autoinjector instructions?" on a rating scale of 0 (extremely dissatisfied) to 10 (extremely satisfied).

Participants in the Initial Subset who received at least one injection with the Avonex single-use autoinjector and completed the grading scale.

Posted

Mean

Standard Deviation

scores on a scale

Day 8

ID	Title	Description
OG000	Avonex Single-Use Autoinjector: Initial Subset	Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes. In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks. Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.

Units	Counts
Participants

Other Pre-specified

Percentage of Participants Who Indicated No Difficulty With the Injection Procedure of the Manual Injection or the Avonex Single-use Autoinjector

Participants assessed whether they had experienced any difficulty with the procedure in preparing, injecting, removing, and disposing process after each injection with the Avonex single-use autoinjector by answering yes or no to the following question: "Did you have any difficulty with your injection?" The percentage of participants answering no to this question for both the manual injection on Day 1 and the autoinjector on Days 8. 15 and 22 are presented.

Participants in the Main Subset who received at least one injection with the Avonex single-use autoinjector and submitted an assessment of injection procedure form. Missing data were not imputed. n=number of participants with assessment at the given timepoint.

Posted

Number

percentage of participants

Day 1, Day 8, Day 15, Day 22

ID	Title	Description
OG000	Avonex Single-Use Autoinjector: Main Subset	Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes. In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks. Main Subset participants were enrolled after study suspension and could enroll in the Extension Study.

Other Pre-specified

Percentage of Participants Who Indicated a Preference for the Avonex Single-use Autoinjector Over the Manual Avonex Prefilled Syringe

Participants were asked whether they preferred using the Avonex single-use autoinjector over the manual Avonex prefilled syringe. Preference was defined as participants answering yes to the following question: Do you prefer this single-use autoinjector over the manual injection?

Participants who received at least 1 injection with autoinjector and had a complete questionnaire. Missing data were not imputed.

Posted

Number

percentage of participants

Day 23

ID	Title	Description
OG000	Avonex Single-Use Autoinjector: Main Subset	Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes. In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks. Main Subset participants were enrolled after study suspension and could enroll in the Extension Study.
OG001	Avonex Single-Use Autoinjector: Initial Subset	Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes. In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks. Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.

Other Pre-specified

Mean Pain Score After Injection

Participants scored their pain level after the use of the manual prefilled syringe on Day 1 and the Avonex single-use autoinjector on Days 8, 15, and 22 on a scale ranging from 0 (no pain) to 10 (extremely painful).

Participants in the Main and Initial Subsets who received at least 1 dose of Avonex injection using the Avonex single-use autoinjector. Missing data were not imputed.

Posted

Mean

Standard Deviation

scores on a scale

Day 1, Day 8, Day 15, Day 22

ID	Title	Description
OG000	Avonex Single-Use Autoinjector: Main Subset	Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes. In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks. Main Subset participants were enrolled after study suspension and could enroll in the Extension Study.
OG001	Avonex Single-Use Autoinjector: Initial Subset	Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes. In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks. Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Avonex Single-Use Autoinjector: Main Subset	Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes. In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks. Main Subset participants were enrolled after study suspension and could enroll in the Extension Study.			0	72	33	72
EG001	Avonex Single-Use Autoinjector: Initial Subset	Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes. In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks. Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.			0	19	7	19

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute Sinusitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Cystitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Ear Infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Lyme Disease	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Nasopharyngitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Sinusitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Viral Infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Anxiety	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected72 at risk EG0010 affected19 at risk
Bipolar Disorder	Psychiatric disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected72 at risk EG0011 affected19 at risk
Headache	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0011 affected19 at risk
Multiple Sclerosis Relapse	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Macular Degeneration	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Ulcerative Keratitis	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Flushing	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Hypertension	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected72 at risk EG0011 affected19 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Upper Respiratory Tract	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0011 affected19 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Chondropathy	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Protrusion	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0011 affected19 at risk
Injection Site Pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0007 affected72 at risk EG0014 affected19 at risk
Injection Site Haematoma	General disorders	MedDRA 12.1	Systematic Assessment	EG0006 affected72 at risk EG0011 affected19 at risk
Influenza Like Illness	General disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected72 at risk EG0011 affected19 at risk
Injection Site Erythema	General disorders	MedDRA 12.1	Systematic Assessment	EG0003 affected72 at risk EG0011 affected19 at risk
Injection Site Haemorrhage	General disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected72 at risk EG0010 affected19 at risk
Injection Site Induration	General disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected72 at risk EG0010 affected19 at risk
Injection Site Pruritus	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Oedema Peripheral	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Vessel Puncture Site Haematoma	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Vessel Puncture Site Pain	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Body Temperature Increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0003 affected72 at risk EG0010 affected19 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0002 affected72 at risk EG0010 affected19 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Muscle Strain	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Skin Laceration	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected72 at risk EG0010 affected19 at risk
Pruritis	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected19 at risk
Rash Macular	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected19 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected19 at risk
Needle Issue	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected72 at risk EG0011 affected19 at risk

The Initial Subset is too small a population from which to draw conclusions.

Certain Agreements

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

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
D000068556	Interferon beta-1a

Ancestor Terms

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