Study to Evaluate the Long-Term Safety, Tolerability and... | NCT02422940

NCT02422940

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
dalfampridine-ER 7.5 mg	Active Comparator	Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.	Drug: dalfampridine-ER 7.5 mg
dalfampridine-ER 10 mg	Active Comparator	Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study.	Drug: dalfampridine-ER 10 mg

Name	Type	Description	Arm Group Labels	Other Names
dalfampridine-ER 7.5 mg	Drug		dalfampridine-ER 7.5 mg
dalfampridine-ER 10 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Primary Objective Was to Evaluate Serious and Non-serious Adverse Events for Study Participants as a Measure of Safety and Tolerability of Dalfampridine ER (Extended Release) for at Least 12-months.	This extension study was designed to evaluate long-term safety, tolerability, and efficacy of dalfampridine-ER (extended release) in adult subjects with chronic post-ischemic stroke walking deficits. Subjects who had completed the placebo-controlled DALF-PS-1016 core study were eligible to enroll regardless of whether they had received active drug or placebo in the core study.	up to 12 months

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline on the Two-Minute Walk Test (2MinWT)	2 Minute Walk Test (2MinWT) and Change from Baseline by Visit	Day 1, up to 12 months
Change From Baseline on the 10 Meter Walk Test (10MWT)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Holly Roberts, MD	Acorda Therapeutics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Acorda Site #117		Gilbert	Arizona	85234	United States
Acorda Site #109

References Module

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No data is available for this block.

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	Dalfampridine-ER 7.5 mg	Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. dalfampridine-ER 7.5 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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No data is available for this block.

Document Section

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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

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

10 Meter Walk Test (10MWT) and Change from Baseline by Visit

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Dalfampridine-ER 7.5 mg	Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. dalfampridine-ER 7.5 mg
BG001	Dalfampridine-ER 10 mg	Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. dalfampridine-ER 10 mg
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
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00062.1± 10.87 BG00164.6± 10.32 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00054 BG00150 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Canada

Title	Measurements
	BG0008 BG0019 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

The Primary Objective Was to Evaluate Serious and Non-serious Adverse Events for Study Participants as a Measure of Safety and Tolerability of Dalfampridine ER (Extended Release) for at Least 12-months.

This extension study was designed to evaluate long-term safety, tolerability, and efficacy of dalfampridine-ER (extended release) in adult subjects with chronic post-ischemic stroke walking deficits. Subjects who had completed the placebo-controlled DALF-PS-1016 core study were eligible to enroll regardless of whether they had received active drug or placebo in the core study.

The Safety Population of 293 subjects included all subjects who received at least one dose of study treatment.

*One subject was randomized but discontinued the study prior to receiving double-blind study treatment

Posted

Count of Participants

Participants

up to 12 months

ID	Title	Description
OG000	Dalfampridine-ER 7.5 mg	Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. dalfampridine-ER 7.5 mg
OG001	Dalfampridine-ER 10 mg	Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. dalfampridine-ER 10 mg

Units	Counts
Participants	OG000151 OG001142

Title

Denominators

Categories

Subjects with at Least One TEAE

Title	Measurements
	OG000102 OG00199

Subjects with at Least One Serious TEAE

Title	Measurements
	OG000

Secondary

Change From Baseline on the Two-Minute Walk Test (2MinWT)

2 Minute Walk Test (2MinWT) and Change from Baseline by Visit

The study was conducted in patients with chronic walking deficits from an ischemic stroke.

Posted

Mean

Standard Deviation

Feet

Day 1, up to 12 months

ID	Title	Description
OG000	Dalfampridine-ER 7.5 mg	Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. dalfampridine-ER 7.5 mg
OG001	Dalfampridine-ER 10 mg	Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. dalfampridine-ER 10 mg

Secondary

Change From Baseline on the 10 Meter Walk Test (10MWT)

10 Meter Walk Test (10MWT) and Change from Baseline by Visit

The study was conducted in patients with chronic walking deficits from an ischemic stroke.

Posted

Mean

Standard Deviation

Meter /second

Day 1, up to 12 months

ID	Title	Description
OG000	Dalfampridine-ER 7.5 mg	Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. dalfampridine-ER 7.5 mg
OG001	Dalfampridine-ER 10 mg	Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. dalfampridine-ER 10 mg

Secondary

Change From Baseline on the Timed up and Go (TUG) Test

The TUG measures mobility and balance and can predict the risk of falls. This test, which was initially called the Get-up and Go test, is considered a measure of dynamic balance. The subject is asked to stand up from a chair, walk 10 feet at a comfortable pace, turn around and be seated. The Timed Up and Go (TUG) is measured in seconds. There will be one practice test and then the timed test. Only the timed test will be analyzed at each visit time point. Reciprocal transformation may be performed if the time values are markedly skewed.

The study was conducted in patients with chronic walking deficits from an ischemic stroke.

Posted

Mean

Standard Deviation

Seconds

Day 1, up to 12 months

ID	Title	Description
OG000	Dalfampridine-ER 7.5 mg	Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. dalfampridine-ER 7.5 mg
OG001	Dalfampridine-ER 10 mg	Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. dalfampridine-ER 10 mg

Secondary

Change From Baseline on the Walking Impact Scale (Walk-12)

The Walk-12 is a 12-question questionnaire that asks subjects to rate limitations of their mobility during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). For each visit, the Walk-12 score will be calculated by summing the 12 components and transforming into a scale with a range of 0 to 100. A higher score indicates a greater degree of limitation in walking. A negative change indicates an improvement in walking. 0 = no limitation in mobility to 100 extreme limitation in mobility. Walk-12 Score = 100 * [(Mean of the 12 items) - 1]/(5-1)

The study was conducted in patients with chronic walking deficits from an ischemic stroke.

Posted

Mean

Standard Deviation

units on a scale

Day 1, up to 12 months

ID	Title	Description
OG000	Dalfampridine-ER 7.5 mg	Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. dalfampridine-ER 7.5 mg
OG001	Dalfampridine-ER 10 mg	Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. dalfampridine-ER 10 mg

Secondary

Change From Baseline on the Stroke Impact Scale (SIS)

The SIS consists of 59 items grouped in 8 domains: strength, hand function, activities of daily living (ADL) / instrumental activities of daily living (IADL), mobility, communication, emotion, memory and thinking, and participation/role function. The subject is asked to rate the level of difficulty in performing each item in the preceding week. Each item is scored on a 5-point scale ranging from 1 (inability to complete the item) to 5 (no difficulty experienced at all). For each domain, the SIS score will be calculated by summing all the items within the domain and transforming into a scale with a range of 0 to 100 as follows: SIS Score = 100 * [(Actual raw score - Lowest possible raw score)/ (Highest possible raw score-Lowest possible raw score)].

The study was conducted in patients with chronic walking deficits from an ischemic stroke.

Posted

Mean

Standard Deviation

score on a scale

Day 1, up to 12 months

ID	Title	Description
OG000	Dalfampridine-ER 7.5 mg	Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. dalfampridine-ER 7.5 mg
OG001	Dalfampridine-ER 10 mg

Secondary

Subject Global Impression (SGI)

The Subject Global Impression (SGI) is single item measure of treatment response that asks the subject to rate the effects of the investigational drug on his or her overall walking ability using a 7 point scale ranging from 1 = "Terrible" to 7 = "Delighted."

The study was conducted in patients with chronic walking deficits from an ischemic stroke. These were the only participants to finish the SGI study due to study termination.

Posted

Count of Participants

Participants

Visit 8 (Month 12)

ID	Title	Description
OG000	Dalfampridine-ER 7.5 mg	Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. dalfampridine-ER 7.5 mg
OG001	Dalfampridine-ER 10 mg	Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. dalfampridine-ER 10 mg

Secondary

Change From Baseline on the 12-item Health Survey (SF-12)

The SF-12 v2 (4-week recall) is a general health-related quality-of-life profile measure consisting of 12 items. The SF-12 Physical Component Summary (PCS) and the Mental Component Summary (MCS) scores will be derived and normed to a general United States population for score algorithm. The normalized PCS and MCS scores will be calculated at baseline, Month 12, and subsequent visits.

SF-12 is a Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

The study was conducted in patients with chronic walking deficits from an ischemic stroke.

Posted

Mean

Standard Deviation

score on a scale

Day 1, up to 12 months

ID	Title	Description
OG000	Dalfampridine-ER 7.5 mg	Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. dalfampridine-ER 7.5 mg
OG001	Dalfampridine-ER 10 mg	Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. dalfampridine-ER 10 mg

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	Dalfampridine-ER 7.5 mg	Dalfampridine-ER 7.5 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. dalfampridine-ER 7.5 mg	1	151	14	151	102	151
EG001	Dalfampridine-ER 10 mg	Dalfampridine-ER 10 mg tablets taken orally twice daily, approximately 12 hours apart. Subjects who received active treatment in the antecedent core study will retain the dose assignment to which they were initially randomized (7.5 mg or 10 mg dalfampridine-ER tablets). Subjects who received placebo in the core study will be randomly assigned to receive 7.5 mg or 10 mg dalfampridine-ER tablets in this extension study. dalfampridine-ER 10 mg	0	142	8	142	99	142

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute Myocardial Infarction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0010 affected142 at risk
Angina Unstable	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0010 affected142 at risk
Antrial Fibrillation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected151 at risk EG0011 affected142 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0010 affected142 at risk
Myocardial Infarction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0010 affected142 at risk
Asthenia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0010 affected142 at risk
Cellutiis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0011 affected142 at risk
Escherichia Urinary Tract Infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0000 affected151 at risk EG0011 affected142 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0010 affected142 at risk
Post Procedural Complication	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0010 affected142 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0010 affected142 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected151 at risk EG0011 affected142 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected151 at risk EG0011 affected142 at risk
Thyroid Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected151 at risk EG0011 affected142 at risk
Convulsion	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected151 at risk EG0011 affected142 at risk
Complex Partial Seizures	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0010 affected142 at risk
Ischaemic Stroke	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0010 affected142 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0010 affected142 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected151 at risk EG0011 affected142 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0010 affected142 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected151 at risk EG0011 affected142 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ear And Labyrinth Disorders	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected151 at risk EG0013 affected142 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected151 at risk EG0011 affected142 at risk
Eye Disorders	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected151 at risk EG0012 affected142 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected151 at risk EG0019 affected142 at risk
Diarrhea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected151 at risk EG0014 affected142 at risk
Abdominal Discomfort	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0012 affected142 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected151 at risk EG0011 affected142 at risk
Gastro esophageal Reflux Disease	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected151 at risk EG0011 affected142 at risk
Large Intestine Polyp	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected151 at risk EG0013 affected142 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0012 affected142 at risk
Fatigue	General disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected151 at risk EG0018 affected142 at risk
Gait Disturbance	General disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected151 at risk EG0012 affected142 at risk
Malaise	General disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected151 at risk EG0011 affected142 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0003 affected151 at risk EG00111 affected142 at risk
Nasopharyngitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0006 affected151 at risk EG0015 affected142 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0004 affected151 at risk EG0013 affected142 at risk
Cellulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0003 affected151 at risk EG0011 affected142 at risk
Bronchitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0012 affected142 at risk
Rhinitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0012 affected142 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG00013 affected151 at risk EG00119 affected142 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0003 affected151 at risk EG0013 affected142 at risk
Ligament Sprain	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0004 affected151 at risk EG0012 affected142 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0013 affected142 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0000 affected151 at risk EG0013 affected142 at risk
Blood Creatinine Phosphokinase Increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0004 affected151 at risk EG0011 affected142 at risk
Blood Creatinine Increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0002 affected151 at risk EG0011 affected142 at risk
Gout	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected151 at risk EG0010 affected142 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0009 affected151 at risk EG0017 affected142 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected151 at risk EG00111 affected142 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected151 at risk EG0017 affected142 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected151 at risk EG0015 affected142 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected151 at risk EG0013 affected142 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0013 affected142 at risk
Musculoskeletal Stiffness	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected151 at risk EG0012 affected142 at risk
Flank Pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected151 at risk EG0010 affected142 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0012 affected142 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected151 at risk EG0010 affected142 at risk
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0002 affected151 at risk EG0013 affected142 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0012 affected142 at risk
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected151 at risk EG0017 affected142 at risk
Dizziness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected151 at risk EG0017 affected142 at risk
Balance Disorder	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0014 affected142 at risk
Hypoesthesia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected151 at risk EG0014 affected142 at risk
Syncope	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected151 at risk EG0011 affected142 at risk
Amnesia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0012 affected142 at risk
Convulsion	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected151 at risk EG0011 affected142 at risk
Paresthesia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected151 at risk EG0010 affected142 at risk
Tremor	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected151 at risk EG0010 affected142 at risk
Insomnia	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected151 at risk EG0017 affected142 at risk
Anxiety	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0013 affected142 at risk
Hematuria	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0013 affected142 at risk
Renal Cyst	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected151 at risk EG0011 affected142 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected151 at risk EG0018 affected142 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected151 at risk EG0012 affected142 at risk
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected151 at risk EG0011 affected142 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected151 at risk EG0011 affected142 at risk
Hypertension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected151 at risk EG0015 affected142 at risk
Hematoma	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0012 affected142 at risk
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected151 at risk EG0016 affected142 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0011 affected142 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected151 at risk EG0011 affected142 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected151 at risk EG0011 affected142 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0011 affected142 at risk
Sinus Bradycardia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0011 affected142 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0010 affected142 at risk
Angina Unstable	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0010 affected142 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected151 at risk EG0011 affected142 at risk
Diastolic Dysfunction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected151 at risk EG0011 affected142 at risk
Dilatation Ventricular	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected151 at risk EG0011 affected142 at risk
Myocardial Infarction	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected151 at risk EG0010 affected142 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected151 at risk EG0011 affected142 at risk
Pericardial Effusion	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected151 at risk EG0011 affected142 at risk
Tachycardia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected151 at risk EG0011 affected142 at risk
Tricuspid Valve Incompetence	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected151 at risk EG0011 affected142 at risk

ID	Term
D015761	4-Aminopyridine

ID	Term
D000631	Aminopyridines
D000588	Amines
D009930	Organic Chemicals
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds