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This study assessed the long-term safety and tolerability of ADS-5102 in subjects with MS and walking impairment who had completed the double-blind, placebo-controlled study of ADS-5102 in subjects with MS (ADS-AMT-301).
This was a multicenter, open-label study of ADS-5102 (amantadine) extended-release capsules in subjects with MS and walking impairment who completed study drug treatment for 16 weeks and completed a Week 16 visit in Study ADS-AMT-MS301.
All enrolled subjects were to receive ADS-5102 at 137 mg for the first week, 205.5 mg for the second week, and 274 mg for the remainder of the 52-week open-label treatment period.
Subjects returned to the clinic for safety and efficacy assessments at Weeks 4, 24, and 52. In addition, a telephone visit for safety assessments was conducted at Week 2 and Week 38. Subjects who withdrew from the study prior to completion of the Week 52 visit had an early termination (ET) visit that included safety and efficacy assessments. Subjects who completed 52 weeks of open-label treatment had a final visit for post-treatment safety follow-up and efficacy assessment at Week 54.
All study visits and efficacy assessments were to be scheduled to occur at approximately the same time of day for each individual subject. Each subject's efficacy assessment was to be performed by the same clinical rater, if possible.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADS-5102, 274 mg | Experimental | 274 mg ADS-5102, administered once daily at bedtime for up to 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADS-5102, 274 mg | Drug | Oral capsules |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events | The incidence of treatment-emergent adverse events was used as the measure for long-term safety and tolerability of ADS-5102. | Through study completion, an average of 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Timed 25-Foot Walk (Feet/Second) (Baseline Value) | The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials Chief Medical Officer, MD | Adamas Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adamas Clinical Site | Cullman | Alabama | 35058 | United States | ||
| Adamas Clinical Site |
Not provided
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/274 mg ADS-5102 | Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303) |
| FG001 | 137 mg ADS-5102/274 mg ADS-5102 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2018 |
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| Baseline |
| Timed 25-Foot Walk (Feet/Second) (Week 24 Value) | The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed. | 24 weeks |
| Timed 25-Foot Walk (Feet/Second) (Week 52 Value) | The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed. | 52 weeks |
| Timed up and go (Baseline Value) | The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores. | Baseline |
| Timed up and go (Week 24 Value) | The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores. | 24 weeks |
| Timed up and go (Week 52 Value) | The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores. | 52 weeks |
| 2-Minute Walk Test (Baseline Value) | The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores. | Baseline |
| 2-Minute Walk Test (Week 24 Value) | The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores. | 24 weeks |
| 2-Minute Walk Test (Week 52 Value) | The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores. | 52 weeks |
| Phoenix |
| Arizona |
| 85018 |
| United States |
| Adamas Clinical Site | Phoenix | Arizona | 85032 | United States |
| Adamas Clinical Site | Tucson | Arizona | 85704 | United States |
| Adamas Clinical Site | Carlsbad | California | 92011 | United States |
| Adamas Clinical Site | Fresno | California | 93710 | United States |
| Adamas Clinical Site | Fullerton | California | 92835 | United States |
| Adamas Clinical Site | Long Beach | California | 90806 | United States |
| Adamas Clinical Site | Newport Beach | California | 92663 | United States |
| Adamas Clinical Site | Sacramento | California | 95817 | United States |
| Adamas Clinical Site | Aurora | Colorado | 80045 | United States |
| Adamas Clinical Site | Colorado Springs | Colorado | 80907 | United States |
| Adamas Clinical Site | Denver | Colorado | 800209 | United States |
| Adamas Clinical Site | Fort Collins | Colorado | 80528 | United States |
| Adamas Clinical Site | Fairfield | Connecticut | 06824 | United States |
| Adamas Clinical Site | New London | Connecticut | 06320 | United States |
| Adamas Clinical Site | Washington D.C. | District of Columbia | 20007 | United States |
| Adamas Clinical Site | Maitland | Florida | 32751 | United States |
| Adamas Clinical Site | Miami | Florida | 33136 | United States |
| Adamas Clinical Site | Miami | Florida | 33176 | United States |
| Adamas Clinical Site | Naples | Florida | 34105 | United States |
| Adamas Clinical Site | Orlando | Florida | 32806 | United States |
| Adamas Clinical Site | Ormond Beach | Florida | 32174 | United States |
| Adamas Clinical Site | Palm Coast | Florida | 32164 | United States |
| Adamas Clinical Site | Port Charlotte | Florida | 33952 | United States |
| Adamas Clinical Site | Sarasota | Florida | 34233 | United States |
| Adamas Clinical Site | St. Petersburg | Florida | 33713 | United States |
| Adamas Clinical Site | Tampa | Florida | 33609 | United States |
| Adamas Clinical Site | Vero Beach | Florida | 32960 | United States |
| Adamas Clinical Site | Atlanta | Georgia | 30309 | United States |
| Adamas Clinical Site | Savannah | Georgia | 31406 | United States |
| Adamas Clinical Site | Northbrook | Illinois | 60062 | United States |
| Adamas Clinical Site | Indianapolis | Indiana | 46256 | United States |
| Adamas Clinical Site | Kansas City | Kansas | 66103 | United States |
| Adamas Clinical Site | Lenexa | Kansas | 66214 | United States |
| Adamas Clinical Site | Overland Park | Kansas | 66212 | United States |
| Adamas Clinical Site | Burlington | Massachusetts | 01805 | United States |
| Adamas Clinical Site | Foxborough | Massachusetts | 02035 | United States |
| Adamas Clinical Site | Worcester | Massachusetts | 01655 | United States |
| Adamas Clinical Site | Detroit | Michigan | 42801 | United States |
| Adamas Clinical Site | Farmington Hills | Michigan | 48334 | United States |
| Adamas Clinical Site | Golden Valley | Minnesota | 55422 | United States |
| Adamas Clinical Site | Kansas City | Missouri | 64111 | United States |
| Adamas Clinical Site | St Louis | Missouri | 63110 | United States |
| Adamas Clinical Site | Great Falls | Montana | 59405 | United States |
| Adamas Clinical Site | Lincoln | Nebraska | 68506 | United States |
| Adamas Clinical Site | Omaha | Nebraska | 68105 | United States |
| Adamas Clinical Site | Las Vegas | Nevada | 89106 | United States |
| Adamas Clinical Site | Albuquerque | New Mexico | 87106 | United States |
| Adamas Clinical Site | Amherst | New York | 14226 | United States |
| Adamas Clinical Site | Lake Success | New York | 11042 | United States |
| Adamas Clinical Site | New York | New York | 10029 | United States |
| Adamas Clinical Site | Patchogue | New York | 11772 | United States |
| Adamas Clinical Site | Plainview | New York | 11803 | United States |
| Adamas Clinical Site | Rochester | New York | 14642 | United States |
| Adamas Clinical Site | Staten Island | New York | 10306 | United States |
| Adamas Clinical Site | Charlotte | North Carolina | 28204 | United States |
| Adamas Clinical Site | Raleigh | North Carolina | 27607 | United States |
| Adamas Clinical Site | Centerville | Ohio | 45459 | United States |
| Adamas Clinical Site | Cleveland | Ohio | 44195 | United States |
| Adamas Clinical Site | Columbus | Ohio | 43214 | United States |
| Adamas Clinical Site | Oklahoma City | Oklahoma | 73104 | United States |
| Adamas Clinical Site | Portland | Oregon | 97213 | United States |
| Adamas Clinical Site | Philadelphia | Pennsylvania | 19140 | United States |
| Adamas Clinical Site | Charleston | South Carolina | 29406 | United States |
| Adamas Clinical Site | Greer | South Carolina | 29650 | United States |
| Adamas Clinical Site | Rock Hill | South Carolina | 29732 | United States |
| Adamas Clinical Site | Spartanburg | South Carolina | 29307 | United States |
| Adamas Clinical Site | Cordova | Tennessee | 38018 | United States |
| Adamas Clinical Site | Franklin | Tennessee | 37064 | United States |
| Adamas Clinical Site | Johnson City | Tennessee | 37604 | United States |
| Adamas Clinical Site | Houston | Texas | 77030 | United States |
| Adamas Clinical Site | Houston | Texas | 77074 | United States |
| Adamas Clinical Site | Lubbock | Texas | 79410 | United States |
| Adamas Clinical Site | Round Rock | Texas | 78681 | United States |
| Adamas Clinical Site | Salt Lake City | Utah | 84103 | United States |
| Adamas Clinical Site | Newport News | Virginia | 23601 | United States |
| Adamas Clinical Site | Norfolk | Virginia | 23502 | United States |
| Adamas Clinical Site | Kirkland | Washington | 98034 | United States |
| Adamas Clinical Site | Seattle | Washington | 98122 | United States |
| Adamas Clinical Site | Seattle | Washington | 98191 | United States |
| Adamas Clinical Site | Milwaukee | Wisconsin | 53215 | United States |
| Adamas Clinical Site | Edmonton | Alberta | T6G 2G3 | Canada |
| Adamas Clinical Site | Lethbridge | Alberta | T1J 0N9 | Canada |
| Adamas Clinical Site | Burnaby | Brithis Columbia | V5G 2X6 | Canada |
| Adamas Clinical Site | Vancouver | British Columbia | V6T 2B5 | Canada |
| Adamas Clinical Site | Hamilton | Ontario | L8L 2X2 | Canada |
| Adamas Clinical Site | London | Ontario | N6A 5A5 | Canada |
| Adamas Clinical Site | Ottawa | Ontario | K1H 8L6 | Canada |
| Adamas Clinical Site | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Adamas Clinical Site | Montreal | Quebec | H3A 2B4 | Canada |
| Adamas Clinical Site | Québec | Quebec | G1J 1Z4 | Canada |
Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303)
| FG002 | 274 mg ADS-5102/274 mg ADS-5102 | Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/274 mg ADS-5102 | Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303) |
| BG001 | 137 mg ADS-5102/274 mg ADS-5102 | Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303) |
| BG002 | 274 mg ADS-5102/274 mg ADS-5102 | Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Baseline T25FW | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Adverse Events | The incidence of treatment-emergent adverse events was used as the measure for long-term safety and tolerability of ADS-5102. | Posted | Count of Participants | Participants | Through study completion, an average of 1 year. |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Timed 25-Foot Walk (Feet/Second) (Baseline Value) | The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed. | Modified intent-to-treat: subjects with available data | Posted | Mean | Standard Deviation | feet/second | Baseline |
| |||||||||||||||||||||||||||||||||
| Secondary | Timed 25-Foot Walk (Feet/Second) (Week 24 Value) | The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed. | Modified intent-to-treat: subjects with available data | Posted | Mean | Standard Deviation | feet/second | 24 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Timed 25-Foot Walk (Feet/Second) (Week 52 Value) | The timed 25-foot walk is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. The result is reported as speed (feet per second). Improvement is indicated by an increase in speed. | Modified intent-to-treat: subjects with available data | Posted | Mean | Standard Deviation | feet/second | 52 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Timed up and go (Baseline Value) | The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores. | Modified intent-to-treat population: subjects with available data | Posted | Mean | Standard Deviation | seconds | Baseline |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Timed up and go (Week 24 Value) | The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores. | Modified intent-to-treat population: subjects with available data | Posted | Mean | Standard Deviation | seconds | 24 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Timed up and go (Week 52 Value) | The "timed up and go" is a measure of lower extremity strength, balance, and coordination. The subject stands up from a chair, walks 3 meters then turns around and walks back to the chair to sit down. The result is reported in seconds. Improvement is indicated by negative change scores. | Modified intent-to-treat population: subjects with available data | Posted | Mean | Standard Deviation | seconds | 52 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | 2-Minute Walk Test (Baseline Value) | The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores. | Modified intent-to-treat: subjects with available data | Posted | Mean | Standard Deviation | meters | Baseline |
|
| ||||||||||||||||||||||||||||||||
| Secondary | 2-Minute Walk Test (Week 24 Value) | The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores. | Modified intent-to-treat: subjects with available data | Posted | Mean | Standard Deviation | meters | 24 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | 2-Minute Walk Test (Week 52 Value) | The 2-Minute Walk test is a measure of lower extremity function. The subject is instructed to walk as far as possible in 2 minutes, and the distance is measured in meters. Improvement is indicated by positive change scores. | Modified intent-to-treat: subjects with available data | Posted | Mean | Standard Deviation | meters | 52 weeks |
|
|
Approximately 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo/274 mg ADS-5102 | Consists of subjects who received placebo in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303) | 1 | 159 | 20 | 159 | 122 | 159 |
| EG001 | 137 mg ADS-5102/274 mg ADS-5102 | Consists of subjects who received 137 mg ADS-5102 in Study ADS-AMT-MS301 and 274 mg ADS-5102 in the current study (ADS-AMT-MS303) | 0 | 151 | 20 | 151 | 116 | 151 |
| EG002 | 274 mg ADS-5102/274 mg ADS-5102 | Consists of subjects who 274 mg ADS-5102 in both Studies ADS-AMT-MS301 and ADS-AMT-MS303 | 0 | 114 | 7 | 114 | 86 | 114 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multiple sclerosis relapse | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Uhthoff's phenomenon | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Generalized tonic-clonic seizure | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Bursitis infective staphylococcal | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Pharyngeal abscess | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Viral sepsis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Catatonia | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
| |
| Squamous cell carcinoma of the tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multiple sclerosis relapse | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Livedo reticularis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head, Regulatory Affairs | Adamas Pharmaceuticals, Inc. | +1 (510) 450-3500 | drugsafety@adamaspharma.com |
| Nov 5, 2021 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided
| Male |
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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| >Median of enrolled population (9.4 seconds) |
|
| Missing |
|
| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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| Participants |
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| Participants |
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