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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003176-39 | EudraCT Number |
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Study terminated because of differences in the participant population under study compared with indicated Zinbryta use in most countries.
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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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The primary objective of the study is to assess the safety and tolerability of long-term treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).
Secondary objectives of this study in this study population are as follows:
To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and participant-reported impact of MS, following long-term treatment with DAC HYP To assess the long-term immunogenicity of DAC HYP administered by prefilled syringe (PFS) To assess the safety, tolerability, and efficacy of switching to DAC HYP in participants previously on long-term treatment with interferon β-1a (Avonex) in Study 205MS301(NCT01064401).
Enrollment will include up to 1600 Participants, this includes approximately 1200 Participants who completed Study 205MS301 (NCT01064401). Additionally, approximately 400 Participants from the other BIIB019 extension studies 205MS203 (NCT01051349) and 205MS302 (NCT01462318) will be eligible to enter Study 205MS303 at Week 144 of Study 205MS303 [Study 205MS301 (NCT01064401), study 205MS203 (NCT01051349) and study 205MS302 (NCT01462318) have been referred to as parent studies in the protocol]. All Participants will receive the same dose of DAC HYP as received in the parent studies; i.e., 150 mg by an SC injection every 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB019 | Experimental | BIIB019 150 mg subcutaneous (SC) every 4 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB019 (Daclizumab) | Drug | Participants will receive open-label treatment with BIIB019 150 mg subcutaneous injection every 4 weeks for up to 5 years. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. | First dose of study drug in Study 303 to within 180 days of last dose (up to approximately 5.5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Relapse Rate (ARR) in the 205MS303 Treatment Period | Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist. The unadjusted ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.25. Relapses that occurred after participants received alternative multiple sclerosis (MS) medications were excluded from the analyses. ARR was adjusted for relapse rate, IFN beta use, Expanded Disability Status Scale (EDSS) (<=2.5 vs >2.5) and age (<=35 vs >35) prior to start of study treatment in 205MS301, calculated using the negative binomial model. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
The Investigator must re review the subject's medical fitness for participation and consider any factors that would preclude treatment in this Study 205MS303.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85013 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27411694 | Derived | Gold R, Stefoski D, Selmaj K, Havrdova E, Hurst C, Holman J, Tornesi B, Akella S, McCroskery P. Pregnancy Experience: Nonclinical Studies and Pregnancy Outcomes in the Daclizumab Clinical Study Program. Neurol Ther. 2016 Dec;5(2):169-182. doi: 10.1007/s40120-016-0048-2. Epub 2016 Jul 13. |
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Participants who completed studies: 205MS301 (NCT01064401), 205MS203 (NCT01051349), 205MS302 (NCT01462318) were eligible to enroll in this long-term extension study.
Participants were enrolled in the study at 226 investigative sites in 28 countries (United States, Canada, Western European countries, Australia, Israel, Eastern European countries, Argentina, Brazil, India, and Mexico) from 15 February 2013 to 24 September 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks. |
| FG001 |
| 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 | Yes | No | No | Study Protocol | Sep 29, 2017 | Sep 24, 2019 |
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| Up to 4.6 years in the 303 study |
| ARR in the 205MS301-303 Combined Study Period and 205MS301 Treatment Period | Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist. The unadjusted ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.25. Relapses that occurred after participants received alternative MS medications were excluded from the analyses. ARR was adjusted for relapse rate, IFN beta use, EDSS (<=2.5 vs >2.5) and age (<=35 vs >35) prior to start of study treatment in 301, calculated using the negative binomial model. | Up to 5.6 years combining 303 with the initial Study 301; Up to 1 year in the 301 study |
| Number of Participants With Relapse in the 205MS303 Treatment Period | Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist. | Up to 4.6 years in the 303 study |
| Number of Participants With Relapse in the 205MS301-303 Combined Study Period | Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist. | Up to 5.6 years combining 303 with the initial Study 301 |
| Number of Participants With Sustained Disability Progression in the 205MS303 Treatment Period | Sustained disability progression is defined as at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from 303 baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from 303 baseline EDSS of 0, that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) =normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. Higher scores indicate more disability. | Up to 4.6 years in Study 303 |
| Number of Participants With Sustained Disability Progression in the 205MS301-303 Combined Study Period | Sustained disability progression is defined as at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from 303 baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from 303 baseline EDSS of 0, that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) =normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. Higher scores indicate more disability. | Up to 5.6 years combining 303 with the initial Study 301 |
| Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period | T2 Hyperintense Lesions were assessed by magnetic resonance imaging (MRI) and were analyzed by a central MRI reader. The number of participants with New or Newly Enlarging T2 Hyperintense Lesions relative to the 303 Baseline in the 303 Treatment Period is reported. | Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303 |
| Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period | T2 Hyperintense Lesions were assessed by MRI and were analyzed by a central MRI reader. The number of participants with New or Newly Enlarging T2 Hyperintense Lesions relative to the 301 Baseline in the 301 Treatment Period is reported. | Baseline 301, Weeks 24, 96, 144 in Study 301 |
| Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period | Gd+ lesions were evaluated by MRI and were analyzed by a central MRI reader. | 301-303: Baseline 303, Weeks 48, 96, 144, 192, 240; 203-303 and 302-303: Week 96 |
| Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period | Gd+ lesions were evaluated by MRI and were analyzed by a central MRI reader. | Baseline 301, Weeks 24, 96 and 144 |
| Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period | T1 hypointense lesions were evaluated by MRI and were analyzed by a central MRI reader. The number of participants with New T1 Hyperintense Lesions relative to the 303 Baseline in the 303 Treatment Period is reported. | Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303 |
| Number of Participants With New T1 Hypointense Lesions in the 205MS301 Treatment Period | T1 hypointense lesions were evaluated by MRI and were analyzed by a central MRI reader. The number of participants with New T1 Hyperintense Lesions relative to the 301 Baseline in the 301 Treatment Period is reported . | Baseline 301, Weeks 24, 96, 144 in Study 301 |
| Percent Change in Brain Volume From the 205MS303 Baseline | To assess brain atrophy, total brain volume was measured by MRI and was analyzed by a central MRI reader. A negative percent change from baseline indicates improvement. | Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303 |
| Percent Change in Brain Volume From 205MS301 Baseline | To assess brain atrophy, total brain volume was measured by MRI and was analyzed by a central MRI reader. A negative percent change from baseline indicates improvement. | Baseline 301, Weeks 48, 96, 144, 192, 240 in Study 303 |
| Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period | Volume of T2 hyperintense Lesions was evaluated by MRI and was analyzed by a central MRI reader. | Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303; 203-303 and 302-303: Week 96 |
| Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period | MSFC is a three-part, standardized, quantitative, assessment instrument consisting of (Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) and Paced Auditory Serial Addition Test (PASAT-3"). 2 timed 25-foot walk scores are averaged. 4 trials of the Peg Test (2 for each hand) are converted to the reciprocals and averaged. The number correct of the PASAT-3 is used. The composite Z-score is calculated by: Z(25-foot walk) + Z (HPT) + Z(PASAT)/3. A positive change from baseline indicates improvement. | Baseline 303, Weeks 12, 24 and 48 in Study 303 |
| Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | MSFC is a three-part, standardized, quantitative, assessment instrument consisting of (Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) and Paced Auditory Serial Addition Test (PASAT-3"). 2 timed 25-foot walk scores are averaged. 4 trials of the Peg Test (2 for each hand) are converted to the reciprocals and averaged. The number correct of the PASAT-3 is used. The composite Z-score is calculated by: Z(25-foot walk) + Z (HPT) + Z(PASAT)/3. A positive change from baseline indicates improvement. | Baseline 301, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 in the 301 study, Baseline 303, Weeks 12, 24, 48 in the 303 study |
| Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | The EDSS measures the disability status of people with multiple sclerosis as assessed by the Study Neurologist based on 8 functional systems that ranges from 0=normal neurologic exam; to 5=ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to 10=death due to MS. Higher scores indicate more disability. A negative change from Baseline indicates improvement. | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 260; 203-303 and 302-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 116 in Study 303 |
| Number of Participants Who Are Free From Disease Activity in the 205MS303 Treatment Period | Participants without clinical or radiological activity are defined as disease-free. Clinical activity includes assessment of relapses and of disease progression. Radiological activity includes assessments of Gd+ lesions and new or enlarging T2 lesions. | Up to 4.6 years in Study 303 |
| Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | The 29-item MSIS-29 is a disease specific participant-reported outcome measure that has been developed and validated to examine the physical (coordination and mobility) and psychological (mental) impact of MS from a participant's perspective; it measures 20 physical items and 9 psychological items. The results for each of the physical and psychological scores are transformed to a score of 0 to 100 (worse state of health). A negative change from Baseline indicates improvement. | Baseline 303, Weeks 12, 24, 48, 96, 120 and 144 |
| Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | The EQ-5D is a self-administered questionnaire consisting of 5 domains pertaining to specific health state profile : mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The participants recorded their level of current health for each domain where: 1=no problems, 2=some problem and 3=severe problems. The health score is derived from the individual scores for each of the 5 domains transformed to a score of 0=worst health state to 1=perfect health state. A positive change from Baseline indicates improvement. | 301-303: Baseline 303, Weeks 12, 24, 48, 96, 120, 144, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48 and 96 in Study 303 |
| Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | The participant rated their current heath state using the EQ VAS 20-centimeter horizontal line from 0 (worst imaginable health state) to 100 (best imaginable health state). A positive change from baseline indicates improvement. | 301-303: Baseline 303, Weeks 12, 24, 48, 96, 120, 44, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48 and 96 in Study 303 |
| Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Heath resource utilization was assessed by the number of hospitalizations, emergency room visits, and unscheduled neurologist visits for MS-related and non-MS-related visits. | 301-303: Baseline 303, Weeks 24, 48, 96, 144, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48, 96 in 303 |
| Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | Heath resource utilization was assessed by the number of hospitalizations, emergency room visits, and unscheduled neurologist visits for MS-related and non-MS-related visits. | Baseline 301, Weeks 24, 48, 72, 96, 120 and 144 in 301 |
| Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Participants answered the question: "How satisfied or dissatisfied are you with the ability of the medication to prevent or treat the condition?" using the following scale: Dissatisfied (Extremely dissatisfied, Very dissatisfied, Dissatisfied) or Satisfied (Somewhat satisfied, Satisfied, Very Satisfied and Extremely satisfied). The number of participants in the Dissatisfied and Satisfied categories is reported. | Baseline 303, Weeks 12, 24, 48, 72, 96, 120 in Study 303 |
| Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participant recorded their scheduled work hours. Data is reported by part time or full time employment. | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 |
| HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participant recorded whether their MS or its treatments caused them to miss work. Data is reported by part time or full time employment. | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 |
| HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participant recorded the hours they missed work due to MS or its treatments. Data is reported by part time or full time employment. | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 |
| HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participants assessed the percent impact of MS and its treatments on their work output using a VAS where 0= MS or its treatments had no impact on how much I accomplished to 100=MS or its treatments kept me from accomplishing anything. Data is reported for part time or full time employment. | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 |
| HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant recorded their planned hours for household chores. | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 |
| HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant recorded whether MS or its treatments kept them from completing household chores. | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 |
| HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant recorded the hours where they were not able to perform household chores due to MS or its treatments. | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 |
| HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant assessed the percent impact of MS and its treatments on how much they accomplished using a VAS where 0= MS or its treatments had no impact on how much I accomplished to 100=MS or its treatments kept me from accomplishing anything. | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 |
| Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Assessments in the 205MS303 Treatment Period | Clinical Laboratory assessments included tests of hematology, blood chemistry, renal function, and thyroid function. The investigator determined if the results were clinically significant. | Up to 4.6 years in 303 |
| Local Tolerability as Assessed by Participant-reported Injection Site Pain VAS | The VAS is a 10 cm-long horizontal line labeled with 2 extremes of pain at either end: 0 =no pain on the left and 100=very painful on the right. The participant rates their perceived pain of each injection by placing a vertical mark on the line to indicate the level of pain. | After the first and fourth injections in 303, approximately Week 0 and Week 12 |
| Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | The investigator assessed the injection site after the first dose and before the fourth dose for the presence of erythema (None, Mild, Moderate, Severe), pigmentation (None, Hypo, Hyper), Induration (None, Mild, Moderate, Severe), Tenderness (None, Mild, Moderate, Severe) and Temperature (Normal, Warm, Hot). The number of participants in each grade is reported. | After the first and fourth injections in 303, approximately Week 0 and Week 12 |
| Number of Participants With Anti-BIIB019 Binding Antibodies (ADAbs) in the 205MS303 Treatment Period | Blood samples were collected for ADAbs and were analyzed using a laboratory test. The number of participants ADAb positive at any post-baseline timepoint is reported. | Up to 4.6 years in the 303 Treatment Period |
| Number of Participants With Anti-BIIB019 Neutralizing Antibodies (Nabs) in the 205MS303 Treatment Period | Blood samples were collected for NAbs and were analyzed using a laboratory test. The number of participants NAb positive at any post-baseline timepoint is reported. | Up to 4.6 years in the 303 Treatment Period |
| Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period | SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best). A positive change from baseline indicates improvement. | Baseline 303, Weeks 144, 168, 192, 240 in 303 |
| Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best). A positive change from baseline indicates improvement. | Baseline 301, Weeks 24, 48, 72, 96, 120, 144 in 301; Weeks 144, 168, 192, 216, 240 in 303 |
| Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | The PASAT 3 assesses auditory information processing speed. A random series of numbers from 1 to 9, inclusive, are presented and the participant is instructed to consecutively add pairs of numbers so that each number is added to the one that immediately preceded it. In the 3- second PASAT, numbers are presented at a rate of 1 every 3 seconds. The total possible score is the number of correct responses from 0 to 60 (best). A positive change from baseline indicates improvement. | Baseline 303, Weeks 12, 24, 48, 120, 144, 168, 192, 216, 240 in 303 |
| Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | The PASAT 3 assesses auditory information processing speed. A random series of numbers from 1 to 9, inclusive, are presented and the participant is instructed to consecutively add pairs of numbers so that each number is added to the one that immediately preceded it. In the 3- second PASAT, numbers are presented at a rate of 1 every 3 seconds. The total possible score is the number of correct responses from 0 to 60 (best). A positive change from baseline indicates improvement. | Baseline 301, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 in the 301 study, Baseline 303, Weeks 12, 24, 48, 120, 144,168, 192, 216, 240 in 303 study |
| Phoenix |
| Arizona |
| 85050 |
| United States |
| Research Site | Tucson | Arizona | 85704 | United States |
| Research Site | Little Rock | Arkansas | 72205 | United States |
| Research Site | La Jolla | California | 92037 | United States |
| Research Site | Aurora | Colorado | 80045 | United States |
| Research Site | Centennial | Colorado | 80112 | United States |
| Research Site | Naples | Florida | 34102 | United States |
| Research Site | Pompano Beach | Florida | 33060 | United States |
| Research Site | Atlanta | Georgia | 30327 | United States |
| Research Site | Fort Wayne | Indiana | 46804 | United States |
| Research Site | Indianapolis | Indiana | 46202 | United States |
| Research Site | Kansas City | Kansas | 66160 | United States |
| Research Site | Lexington | Kentucky | 40503 | United States |
| Research Site | Wellesley | Massachusetts | 02481 | United States |
| Research Site | Worcester | Massachusetts | 01605 | United States |
| Research Site | Farmington Hills | Michigan | 48334 | United States |
| Research Site | Lebanon | New Hampshire | 03756 | United States |
| Research Site | Albuquerque | New Mexico | 87131 | United States |
| Research Site | Buffalo | New York | 14203 | United States |
| Research Site | Latham | New York | 12110 | United States |
| Research Site | New York | New York | 10016 | United States |
| Research Site | New York | New York | 10065 | United States |
| Research Site | Rochester | New York | 14642 | United States |
| Research Site | Charlotte | North Carolina | 28207 | United States |
| Research Site | Raleigh | North Carolina | 27607 | United States |
| Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Research Site | Dayton | Ohio | 45408 | United States |
| Research Site | Medford | Oregon | 97504 | United States |
| Research Site | Portland | Oregon | 97225 | United States |
| Research Site | Allentown | Pennsylvania | 18103 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Research Site | Cordova | Tennessee | 38018 | United States |
| Research Site | Franklin | Tennessee | 37064 | United States |
| Research Site | Knoxville | Tennessee | 37922 | United States |
| Research Site | Round Rock | Texas | 78681 | United States |
| Research Site | Henrico | Virginia | 23226 | United States |
| Research Site | Tacoma | Washington | 98405 | United States |
| Research Site | Milwaukee | Wisconsin | 53215 | United States |
| Research Site | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1015ABR | Argentina |
| Research Site | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1061ABD | Argentina |
| Research Site | Godoy Cruz | Mendoza Province | M5501 | Argentina |
| Research Site | Rosario | Santa Fe Province | S2000BZL | Argentina |
| Research Site | Auchenflower | Queensland | 4066 | Australia |
| Research Site | Heidelberg | Victoria | 3084 | Australia |
| Research Site | Belo Horizonte | Minas Gerais | 30150-221 | Brazil |
| Research Site | Recife | Pernambuco | 52010-040 | Brazil |
| Research Site | Porto Alegre | Rio Grande do Sul | 90035-001 | Brazil |
| Research Site | Campinas | São Paulo | 13083-888 | Brazil |
| Research Site | Ribeirão Preto | São Paulo | 14049-900 | Brazil |
| Research Site | Rio de Janeiro | 20270-004 | Brazil |
| Research Site | Rio de Janeiro | 21941-590 | Brazil |
| Research Site | Vancouver | British Columbia | V6T 2B5 | Canada |
| Research Site | Saint Johns | Newfoundland and Labrador | A1B 3V6 | Canada |
| Research Site | London | Ontario | N6A 5A5 | Canada |
| Research Site | Ottawa | Ontario | K1H 8L6 | Canada |
| Research Site | Gatineau | Quebec | J9J 0A5 | Canada |
| Research Site | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Research Site | Jihlava | Kray Vysocina | 586 33 | Czechia |
| Research Site | Ostrava | Moravian-Silesian Region | 708 52 | Czechia |
| Research Site | Pardubice | Pardubice Region | 532 03 | Czechia |
| Research Site | Prague | Prague | 100 34 | Czechia |
| Research Site | Prague | Prague | 128 08 | Czechia |
| Research Site | Olomouc | Severomoravsky Kraj | 775 20 | Czechia |
| Research Site | Brno | South Moravian | 625 00 | Czechia |
| Research Site | Brno | South Moravian | 656 91 | Czechia |
| Research Site | Hradec Králové | 500 03 | Czechia |
| Research Site | Prague | 150 06 | Czechia |
| Research Site | Teplice | Ústí nad Labem Region | 415 29 | Czechia |
| Research Site | Copenhagen | 2100 | Denmark |
| Research Site | Glostrup Municipality | 2600 | Denmark |
| Research Site | Odense C | 5000 | Denmark |
| Research Site | Strasbourg | Bas-Rhin | 67091 | France |
| Research Site | Marseille | Bouches-du-Rhône | 13385 | France |
| Research Site | Caen | Calvados | 14033 | France |
| Research Site | Bordeaux | Gironde | 33076 | France |
| Research Site | Toulouse | Haute-Garonne | 31059 | France |
| Research Site | Nancy | Meurthe-et-Moselle | 54000 | France |
| Research Site | Lille | Nord | 59037 | France |
| Research Site | Amiens | 80054 | France |
| Research Site | Paris | 75019 | France |
| Research Site | Bobigny | Île-de-France Region | 93009 | France |
| Research Site | Tbilisi | 0179 | Georgia |
| Research Site | Bad Mergentheim | Baden-Wurttemberg | 97980 | Germany |
| Research Site | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Research Site | Bayreuth | Bavaria | 95445 | Germany |
| Research Site | Erlangen | Bavaria | 91054 | Germany |
| Research Site | München | Bavaria | 81675 | Germany |
| Research Site | Marburg | Hesse | 35043 | Germany |
| Research Site | Rostock | Mecklenburg-Vorpommern | 18147 | Germany |
| Research Site | Dresden | Saxony | 01307 | Germany |
| Research Site | Bamberg | 96052 | Germany |
| Research Site | Athens | Attica | 11525 | Greece |
| Research Site | Thessaloniki | Macedonia | 57010 | Greece |
| Research Site | Athens | 115 21 | Greece |
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| Research Site | Miskolc | Borsod-Abauj Zemplen county | 3533 | Hungary |
| Research Site | Kecskemét | Bács-Kiskun county | 6000 | Hungary |
| Research Site | Székesfehérvár | Fejér | 8000 | Hungary |
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| Research Site | Budapest | 1125 | Hungary |
| Research Site | Budapest | 1134 | Hungary |
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| Research Site | Budapest | 1204 | Hungary |
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| Research Site | Esztergom | 2500 | Hungary |
| Research Site | Győr | 9024 | Hungary |
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| Research Site | Nyíregyháza | 4400 | Hungary |
| Research Site | Hyderabad | Andhra Pradesh | 500082 | India |
| Research Site | Bangalore | Karnataka | 560054 | India |
| Research Site | Trivandrum | Kerala | 695011 | India |
| Research Site | Mumbai | Maharashtra | 400016 | India |
| Research Site | Gurgaon | 122002 | India |
| Research Site | Dublin | DU04 | Ireland |
| Research Site | Dublin | DU09 | Ireland |
| Research Site | Ashkelon | 78278 | Israel |
| Research Site | Haifa | 31096 | Israel |
| Research Site | Petah Tikva | 49100 | Israel |
| Research Site | Safed | 13100 | Israel |
| Research Site | Genoa | Liguria | 16132 | Italy |
| Research Site | Milan | Lombardy | 20127 | Italy |
| Research Site | Padova | Veneto | 35128 | Italy |
| Research Site | Catania | 95123 | Italy |
| Research Site | Cefalù | 90015 | Italy |
| Research Site | Roma | 00133 | Italy |
| Research Site | Roma | 00189 | Italy |
| Research Site | Distrito Federal | 03310 | Mexico |
| Research Site | Distrito Federal | 06700 | Mexico |
| Research Site | Chisinau | MD 2001 | Moldova |
| Research Site | Chisinau | MD 2028 | Moldova |
| Research Site | Plewiska | Greater Poland Voivodeship | 62-064 | Poland |
| Research Site | Poznan | Greater Poland Voivodeship | 60-355 | Poland |
| Research Site | Poznan | Greater Poland Voivodeship | 60-631 | Poland |
| Research Site | Poznan | Greater Poland Voivodeship | 61-853 | Poland |
| Research Site | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-681 | Poland |
| Research Site | Krakow | Lesser Poland Voivodeship | 31-505 | Poland |
| Research Site | Krakow | Lesser Poland Voivodeship | 31-637 | Poland |
| Research Site | Lublin | Lublin Voivodeship | 20-954 | Poland |
| Research Site | Lodz | Lódzkie | 90-324 | Poland |
| Research Site | Warsaw | Masovian Voivodeship | 00-901 | Poland |
| Research Site | Warsaw | Masovian Voivodeship | 02-097 | Poland |
| Research Site | Warsaw | Masovian Voivodeship | 02-507 | Poland |
| Research Site | Warsaw | Masovian Voivodeship | 02-957 | Poland |
| Research Site | Warsaw | Masovian Voivodeship | 04-749 | Poland |
| Research Site | Bialystok | Podlaskie Voivodeship | 15-276 | Poland |
| Research Site | Bialystok | Podlaskie Voivodeship | 15-402 | Poland |
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| Research Site | Gdansk | Pomeranian Voivodeship | 80-952 | Poland |
| Research Site | Katowice | Silesian Voivodeship | 40-595 | Poland |
| Research Site | Katowice | Silesian Voivodeship | 40-650 | Poland |
| Research Site | Katowice | Silesian Voivodeship | 40-752 | Poland |
| Research Site | Olsztyn | Warmian-Masurian Voivodeship | 10-443 | Poland |
| Research Site | Szczecin | West Pomeranian Voivodeship | 70-111 | Poland |
| Research Site | Szczecin | West Pomeranian Voivodeship | 71-252 | Poland |
| Research Site | Gdansk | 80-803 | Poland |
| Research Site | Grudziądz | 86-300 | Poland |
| Research Site | Katowice | 40-684 | Poland |
| Research Site | Katowice | 40-749 | Poland |
| Research Site | Olsztyn | 10-561 | Poland |
| Research Site | Kielce | Świętokrzyskie Voivodeship | 25-726 | Poland |
| Research Site | Cluj-Napoca | Cluj | 400012 | Romania |
| Research Site | Târgu Mures | Mureș County | 540136 | Romania |
| Research Site | Timișoara | Timiș County | 300736 | Romania |
| Research Site | Bucharest | 011461 | Romania |
| Research Site | Iași | 700656 | Romania |
| Research Site | Yaroslavl | Yaroslavlr | 150030 | Russia |
| Research Site | Kazan' | 420021 | Russia |
| Research Site | Kemerovo | 650066 | Russia |
| Research Site | Krasnoyarsk | 660022 | Russia |
| Research Site | Moscow | 127018 | Russia |
| Research Site | Moscow | 129128 | Russia |
| Research Site | Nizhny Novgorod | 603005 | Russia |
| Research Site | Nizhny Novgorod | 603155 | Russia |
| Research Site | Novosibirsk | 630087 | Russia |
| Research Site | Omsk | 644043 | Russia |
| Research Site | Perm | 614990 | Russia |
| Research Site | Saint Petersburg | 194044 | Russia |
| Research Site | Saint Petersburg | 194291 | Russia |
| Research Site | Saint Petersburg | 197376 | Russia |
| Research Site | Samara | 443095 | Russia |
| Research Site | Smolensk | 214018 | Russia |
| Research Site | Tyumen | 625000 | Russia |
| Research Site | Ufa | 450005 | Russia |
| Research Site | Belgrade | 11000 | Serbia |
| Research Site | Kragujevac | 34000 | Serbia |
| Research Site | Niš | 18000 | Serbia |
| Research Site | Novi Sad | 21000 | Serbia |
| Research Site | Badalona | Barcelona | 08035 | Spain |
| Research Site | Córdoba | Córdoba | 14008 | Spain |
| Research Site | Madrid | Madrid, Communidad Delaware | 28040 | Spain |
| Research Site | Girona | 17007 | Spain |
| Research Site | L'Hospitalet de Llobregat | 08907 | Spain |
| Research Site | Seville | 41071 | Spain |
| Research Site | Malmö | Skåne County | 205 02 | Sweden |
| Research Site | Stockholm | Södermanland County | 141 86 | Sweden |
| Research Site | Stockholm | Södermanland County | 182 88 | Sweden |
| Research Site | Gothenburg | Västra Götaland County | 413 45 | Sweden |
| Research Site | Stockholm | 171 76 | Sweden |
| Research Site | Basel | Basel-Stadt (de) | 4031 | Switzerland |
| Research Site | Chernivtsi | Chernivtsi Oblast | 58018 | Ukraine |
| Research Site | Dnipropetrovsk | Dnipropetrovsk Oblast | 49027 | Ukraine |
| Research Site | Donetsk | Donetsk Oblast | 83003 | Ukraine |
| Research Site | Kharkiv | Kharkiv Oblast | 61068 | Ukraine |
| Research Site | Kyiv | Kyïv | 02125 | Ukraine |
| Research Site | Kyiv | Kyïv | 03110 | Ukraine |
| Research Site | Kyiv | Kyïv | 04060 | Ukraine |
| Research Site | Odesa | Odesa Oblast | 65025 | Ukraine |
| Research Site | Poltava | Poltava Oblast | 36011 | Ukraine |
| Research Site | Vinnytsia | Vinnytsia Oblast | 21005 | Ukraine |
| Research Site | Zaporizhzhia | Zaporizhzhia Oblast | 69035 | Ukraine |
| Research Site | Zaporizhzhia | Zaporizhzhia Oblast | 69600 | Ukraine |
| Research Site | Kharkiv | 61103 | Ukraine |
| Research Site | Plymouth | Devon | PL6 8BX | United Kingdom |
| Research Site | Edinburgh | Edinburgh, City of | EH4 2XU | United Kingdom |
| Research Site | Brighton | BN2 5BE | United Kingdom |
| Research Site | London | E1 2AT | United Kingdom |
| Research Site | London | SE5 9RS | United Kingdom |
| Research Site | London | W6 8RF | United Kingdom |
| Research Site | London | WC1N 3BG | United Kingdom |
| Research Site | Nottingham | NG7 2UH | United Kingdom |
| Research Site | Sheffield | S10 2JF | United Kingdom |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) |
Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks. |
| FG002 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
| FG003 | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 94. 1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat (ITT) population included all participants who completed Study 301, 302 or 203 and received at least 1 dose of DAC HYP during Study 303.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks. |
| BG001 | DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks. |
| BG002 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
| BG003 | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 94. 1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||
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| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. | Safety Population consisted of all participants who completed Study 301, 203 or 302 and had at least 1 dose of DAC HYP during Study 303. | Posted | Count of Participants | Participants | First dose of study drug in Study 303 to within 180 days of last dose (up to approximately 5.5 years) |
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| Secondary | Annualized Relapse Rate (ARR) in the 205MS303 Treatment Period | Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist. The unadjusted ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.25. Relapses that occurred after participants received alternative multiple sclerosis (MS) medications were excluded from the analyses. ARR was adjusted for relapse rate, IFN beta use, Expanded Disability Status Scale (EDSS) (<=2.5 vs >2.5) and age (<=35 vs >35) prior to start of study treatment in 205MS301, calculated using the negative binomial model. | Intent-to-treat (ITT) Population consisted of all participants who completed Study 301, 203 or 302 and received at least 1 dose of DAC HYP during Study 303. | Posted | Mean | 95% Confidence Interval | relapses per year | Up to 4.6 years in the 303 study |
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| Secondary | ARR in the 205MS301-303 Combined Study Period and 205MS301 Treatment Period | Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist. The unadjusted ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.25. Relapses that occurred after participants received alternative MS medications were excluded from the analyses. ARR was adjusted for relapse rate, IFN beta use, EDSS (<=2.5 vs >2.5) and age (<=35 vs >35) prior to start of study treatment in 301, calculated using the negative binomial model. | 301-303 ITT Population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. | Posted | Mean | 95% Confidence Interval | relapses per year | Up to 5.6 years combining 303 with the initial Study 301; Up to 1 year in the 301 study |
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| Secondary | Number of Participants With Relapse in the 205MS303 Treatment Period | Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist. | ITT Population consisted of all participants who completed Study 301, 203 or 302 and had at least 1 dose of DAC HYP during Study 303. | Posted | Count of Participants | Participants | Up to 4.6 years in the 303 study |
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| Secondary | Number of Participants With Relapse in the 205MS301-303 Combined Study Period | Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist. | 301-303 ITT Population consisted of all participants who completed Study 301 and had at least 1 dose of DAC HYP during Study 303. | Posted | Count of Participants | Participants | Up to 5.6 years combining 303 with the initial Study 301 |
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| Secondary | Number of Participants With Sustained Disability Progression in the 205MS303 Treatment Period | Sustained disability progression is defined as at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from 303 baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from 303 baseline EDSS of 0, that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) =normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. Higher scores indicate more disability. | ITT Population consisted of all participants who completed Study 301, 203 or 302 and had at least 1 dose of DAC HYP during Study 303. | Posted | Count of Participants | Participants | Up to 4.6 years in Study 303 |
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| Secondary | Number of Participants With Sustained Disability Progression in the 205MS301-303 Combined Study Period | Sustained disability progression is defined as at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from 303 baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from 303 baseline EDSS of 0, that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) =normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. Higher scores indicate more disability. | 301-303 ITT Population consisted of all participants who completed Study 301 and had at least 1 dose of DAC HYP during Study 303. | Posted | Count of Participants | Participants | Up to 5.6 years combining 303 with the initial Study 301 |
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| Secondary | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period | T2 Hyperintense Lesions were assessed by magnetic resonance imaging (MRI) and were analyzed by a central MRI reader. The number of participants with New or Newly Enlarging T2 Hyperintense Lesions relative to the 303 Baseline in the 303 Treatment Period is reported. | 301-303 ITT population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. No data was collected for participants from the 203 and 302 studies. Number analyzed is the number of participants with data available at the given timepoint. | Posted | Count of Participants | Participants | Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303 |
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| Secondary | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period | T2 Hyperintense Lesions were assessed by MRI and were analyzed by a central MRI reader. The number of participants with New or Newly Enlarging T2 Hyperintense Lesions relative to the 301 Baseline in the 301 Treatment Period is reported. | 301-303 ITT population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. Number analyzed is the number of participants with data available at the given timepoint. | Posted | Count of Participants | Participants | Baseline 301, Weeks 24, 96, 144 in Study 301 |
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| Secondary | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period | Gd+ lesions were evaluated by MRI and were analyzed by a central MRI reader. | ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAY HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. | Posted | Count of Participants | Participants | 301-303: Baseline 303, Weeks 48, 96, 144, 192, 240; 203-303 and 302-303: Week 96 |
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| Secondary | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period | Gd+ lesions were evaluated by MRI and were analyzed by a central MRI reader. | 301-303 ITT Population consisted of all participants who completed Study 301 and received at least one dose of DAY HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. | Posted | Count of Participants | Participants | Baseline 301, Weeks 24, 96 and 144 |
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| Secondary | Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period | T1 hypointense lesions were evaluated by MRI and were analyzed by a central MRI reader. The number of participants with New T1 Hyperintense Lesions relative to the 303 Baseline in the 303 Treatment Period is reported. | 301-303 ITT Population consisted of all participants who completed Study 303 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data was collected from participants from the 203 and 302 studies. | Posted | Count of Participants | Participants | Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303 |
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| Secondary | Number of Participants With New T1 Hypointense Lesions in the 205MS301 Treatment Period | T1 hypointense lesions were evaluated by MRI and were analyzed by a central MRI reader. The number of participants with New T1 Hyperintense Lesions relative to the 301 Baseline in the 301 Treatment Period is reported . | 301-303 ITT Population consisted of all participants who completed Study 303 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. | Posted | Count of Participants | Participants | Baseline 301, Weeks 24, 96, 144 in Study 301 |
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| Secondary | Percent Change in Brain Volume From the 205MS303 Baseline | To assess brain atrophy, total brain volume was measured by MRI and was analyzed by a central MRI reader. A negative percent change from baseline indicates improvement. | 301-303 ITT Population consisted of all participants who completed Study 303 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data was collected for participants from the 203 and 302 studies. | Posted | Mean | Standard Deviation | percent change | Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303 |
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| Secondary | Percent Change in Brain Volume From 205MS301 Baseline | To assess brain atrophy, total brain volume was measured by MRI and was analyzed by a central MRI reader. A negative percent change from baseline indicates improvement. | 301-303 ITT Population consisted of all participants who completed Study 303 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. | Posted | Mean | Standard Deviation | percent change | Baseline 301, Weeks 48, 96, 144, 192, 240 in Study 303 |
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| Secondary | Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period | Volume of T2 hyperintense Lesions was evaluated by MRI and was analyzed by a central MRI reader. | ITT Population included all participants who completed Study 301, 203 or 302 and received at least 1 dose of DAC HYP in Study 303. Number Analyzed is the number of participants with data available at the given timepoint. | Posted | Mean | Standard Deviation | millimeters cubed (mm^3) | Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303; 203-303 and 302-303: Week 96 |
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| Secondary | Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period | MSFC is a three-part, standardized, quantitative, assessment instrument consisting of (Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) and Paced Auditory Serial Addition Test (PASAT-3"). 2 timed 25-foot walk scores are averaged. 4 trials of the Peg Test (2 for each hand) are converted to the reciprocals and averaged. The number correct of the PASAT-3 is used. The composite Z-score is calculated by: Z(25-foot walk) + Z (HPT) + Z(PASAT)/3. A positive change from baseline indicates improvement. | 301-303 ITT Population consisted of all participants who completed Study 301 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data was collected from participants from the 203 and 302 studies. | Posted | Median | Full Range | z-score | Baseline 303, Weeks 12, 24 and 48 in Study 303 |
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| Secondary | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | MSFC is a three-part, standardized, quantitative, assessment instrument consisting of (Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) and Paced Auditory Serial Addition Test (PASAT-3"). 2 timed 25-foot walk scores are averaged. 4 trials of the Peg Test (2 for each hand) are converted to the reciprocals and averaged. The number correct of the PASAT-3 is used. The composite Z-score is calculated by: Z(25-foot walk) + Z (HPT) + Z(PASAT)/3. A positive change from baseline indicates improvement. | 301-303 ITT Population consisted of all participants who completed Study 301 and received at least one dose of DAC HYP in Study 303. Number analyzed: Number of participants with data available at given timepoint. | Posted | Median | Full Range | z-score | Baseline 301, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 in the 301 study, Baseline 303, Weeks 12, 24, 48 in the 303 study |
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| Secondary | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | The EDSS measures the disability status of people with multiple sclerosis as assessed by the Study Neurologist based on 8 functional systems that ranges from 0=normal neurologic exam; to 5=ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to 10=death due to MS. Higher scores indicate more disability. A negative change from Baseline indicates improvement. | ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. | Posted | Mean | Standard Deviation | score on a scale | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 260; 203-303 and 302-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 116 in Study 303 |
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| Secondary | Number of Participants Who Are Free From Disease Activity in the 205MS303 Treatment Period | Participants without clinical or radiological activity are defined as disease-free. Clinical activity includes assessment of relapses and of disease progression. Radiological activity includes assessments of Gd+ lesions and new or enlarging T2 lesions. | 301-303 ITT Population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. No data was collected for participants from the 203 and 302 studies. | Posted | Count of Participants | Participants | Up to 4.6 years in Study 303 |
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| Secondary | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | The 29-item MSIS-29 is a disease specific participant-reported outcome measure that has been developed and validated to examine the physical (coordination and mobility) and psychological (mental) impact of MS from a participant's perspective; it measures 20 physical items and 9 psychological items. The results for each of the physical and psychological scores are transformed to a score of 0 to 100 (worse state of health). A negative change from Baseline indicates improvement. | 301-303 ITT Population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data was collected for participants from the 203 and 302 studies. | Posted | Mean | Standard Deviation | score on a scale | Baseline 303, Weeks 12, 24, 48, 96, 120 and 144 |
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| Secondary | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | The EQ-5D is a self-administered questionnaire consisting of 5 domains pertaining to specific health state profile : mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The participants recorded their level of current health for each domain where: 1=no problems, 2=some problem and 3=severe problems. The health score is derived from the individual scores for each of the 5 domains transformed to a score of 0=worst health state to 1=perfect health state. A positive change from Baseline indicates improvement. | ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. | Posted | Mean | Standard Deviation | score on a scale | 301-303: Baseline 303, Weeks 12, 24, 48, 96, 120, 144, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48 and 96 in Study 303 |
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| Secondary | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | The participant rated their current heath state using the EQ VAS 20-centimeter horizontal line from 0 (worst imaginable health state) to 100 (best imaginable health state). A positive change from baseline indicates improvement. | ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. | Posted | Mean | Standard Deviation | score on a scale | 301-303: Baseline 303, Weeks 12, 24, 48, 96, 120, 44, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48 and 96 in Study 303 |
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| Secondary | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Heath resource utilization was assessed by the number of hospitalizations, emergency room visits, and unscheduled neurologist visits for MS-related and non-MS-related visits. | ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. | Posted | Number | site visits | 301-303: Baseline 303, Weeks 24, 48, 96, 144, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48, 96 in 303 |
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| Secondary | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | Heath resource utilization was assessed by the number of hospitalizations, emergency room visits, and unscheduled neurologist visits for MS-related and non-MS-related visits. | 301-303 ITT Population consisted of all participants who completed Study 301 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. | Posted | Number | site visits | Baseline 301, Weeks 24, 48, 72, 96, 120 and 144 in 301 |
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| Secondary | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Participants answered the question: "How satisfied or dissatisfied are you with the ability of the medication to prevent or treat the condition?" using the following scale: Dissatisfied (Extremely dissatisfied, Very dissatisfied, Dissatisfied) or Satisfied (Somewhat satisfied, Satisfied, Very Satisfied and Extremely satisfied). The number of participants in the Dissatisfied and Satisfied categories is reported. | 301-303 ITT Population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data was collected for participants from the 203 and 302 studies. | Posted | Count of Participants | Participants | Baseline 303, Weeks 12, 24, 48, 72, 96, 120 in Study 303 |
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| Secondary | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participant recorded their scheduled work hours. Data is reported by part time or full time employment. | ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. | Posted | Mean | Standard Deviation | hours | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 |
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| Secondary | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participant recorded whether their MS or its treatments caused them to miss work. Data is reported by part time or full time employment. | ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. | Posted | Count of Participants | Participants | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 |
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| Secondary | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participant recorded the hours they missed work due to MS or its treatments. Data is reported by part time or full time employment. | ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants who missed work with data available at the given timepoint. | Posted | Mean | Standard Deviation | hours | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 |
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| Secondary | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participants assessed the percent impact of MS and its treatments on their work output using a VAS where 0= MS or its treatments had no impact on how much I accomplished to 100=MS or its treatments kept me from accomplishing anything. Data is reported for part time or full time employment. | ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. | Posted | Mean | Standard Deviation | percent impact | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 |
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| Secondary | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant recorded their planned hours for household chores. | ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. | Posted | Mean | Standard Deviation | hours | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 |
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| Secondary | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant recorded whether MS or its treatments kept them from completing household chores. | ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. | Posted | Count of Participants | Participants | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 |
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| Secondary | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant recorded the hours where they were not able to perform household chores due to MS or its treatments. | ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants unable to complete chores with data available at the given timepoint. | Posted | Mean | Standard Deviation | hours | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 |
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| Secondary | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant assessed the percent impact of MS and its treatments on how much they accomplished using a VAS where 0= MS or its treatments had no impact on how much I accomplished to 100=MS or its treatments kept me from accomplishing anything. | ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. | Posted | Mean | Standard Deviation | percent impact | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 |
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| Secondary | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Assessments in the 205MS303 Treatment Period | Clinical Laboratory assessments included tests of hematology, blood chemistry, renal function, and thyroid function. The investigator determined if the results were clinically significant. | Safety Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. | Posted | Count of Participants | Participants | Up to 4.6 years in 303 |
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| Secondary | Local Tolerability as Assessed by Participant-reported Injection Site Pain VAS | The VAS is a 10 cm-long horizontal line labeled with 2 extremes of pain at either end: 0 =no pain on the left and 100=very painful on the right. The participant rates their perceived pain of each injection by placing a vertical mark on the line to indicate the level of pain. | Safety Population consisted of all participants who completed Study 301,203 or 302 and received at least one dose of DAC HYP in Study 303. Local tolerability of the DAC HYP injection was assessed for all participants who received DAC HYP in Study 303 with data available at the given timepoint and is independent of the treatment previously received. | Posted | Mean | Standard Deviation | score on scale | After the first and fourth injections in 303, approximately Week 0 and Week 12 |
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| Secondary | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | The investigator assessed the injection site after the first dose and before the fourth dose for the presence of erythema (None, Mild, Moderate, Severe), pigmentation (None, Hypo, Hyper), Induration (None, Mild, Moderate, Severe), Tenderness (None, Mild, Moderate, Severe) and Temperature (Normal, Warm, Hot). The number of participants in each grade is reported. | Safety Population included all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Local tolerability of the DAC HYP injection was assessed for all participants who received DAC HYP in Study 303 with data available at the given timepoint and is independent of the treatment previously received. | Posted | Count of Participants | Participants | After the first and fourth injections in 303, approximately Week 0 and Week 12 |
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| Secondary | Number of Participants With Anti-BIIB019 Binding Antibodies (ADAbs) in the 205MS303 Treatment Period | Blood samples were collected for ADAbs and were analyzed using a laboratory test. The number of participants ADAb positive at any post-baseline timepoint is reported. | Safety Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number of participants analyzed is the number of participants with evaluable data for this outcome measure. | Posted | Count of Participants | Participants | Up to 4.6 years in the 303 Treatment Period |
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| Secondary | Number of Participants With Anti-BIIB019 Neutralizing Antibodies (Nabs) in the 205MS303 Treatment Period | Blood samples were collected for NAbs and were analyzed using a laboratory test. The number of participants NAb positive at any post-baseline timepoint is reported. | Safety Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number of participants analyzed is the number of participants with evaluable data for this outcome measure. | Posted | Count of Participants | Participants | Up to 4.6 years in the 303 Treatment Period |
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| Secondary | Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period | SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best). A positive change from baseline indicates improvement. | ITT Population: All participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data is collected for participants from 203 and 302 studies. | Posted | Mean | Standard Deviation | score on a scale | Baseline 303, Weeks 144, 168, 192, 240 in 303 |
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| Secondary | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best). A positive change from baseline indicates improvement. | 301-303 ITT Population consisted of all participants who completed Study 301 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline 301, Weeks 24, 48, 72, 96, 120, 144 in 301; Weeks 144, 168, 192, 216, 240 in 303 |
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| Secondary | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | The PASAT 3 assesses auditory information processing speed. A random series of numbers from 1 to 9, inclusive, are presented and the participant is instructed to consecutively add pairs of numbers so that each number is added to the one that immediately preceded it. In the 3- second PASAT, numbers are presented at a rate of 1 every 3 seconds. The total possible score is the number of correct responses from 0 to 60 (best). A positive change from baseline indicates improvement. | 301-303 ITT Population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data was collected for participants from the 203 and 302 studies. | Posted | Median | Full Range | score on a scale | Baseline 303, Weeks 12, 24, 48, 120, 144, 168, 192, 216, 240 in 303 |
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| Secondary | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | The PASAT 3 assesses auditory information processing speed. A random series of numbers from 1 to 9, inclusive, are presented and the participant is instructed to consecutively add pairs of numbers so that each number is added to the one that immediately preceded it. In the 3- second PASAT, numbers are presented at a rate of 1 every 3 seconds. The total possible score is the number of correct responses from 0 to 60 (best). A positive change from baseline indicates improvement. | 301-303 ITT Population consisted of all participants who completed study 301 and had at least 1 dose of DAC HYP during study 303. Number analyzed is the number of participants with data available at the given timepoint. | Posted | Median | Full Range | score on a scale | Baseline 301, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 in the 301 study, Baseline 303, Weeks 12, 24, 48, 120, 144,168, 192, 216, 240 in 303 study |
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First dose of study drug in study 205MS303 to within 180 days of last dose (up to approximately 5.5 years)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received IFN β-1a 30 µg IM injection once weekly in study 301 every 4 weeks for up to 144 weeks. | 2 | 597 | 157 | 597 | 463 | 597 |
| EG001 | DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks. | 4 | 606 | 190 | 606 | 476 | 606 |
| EG002 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. | 0 | 70 | 15 | 70 | 42 | 70 |
| EG003 | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 94. 1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. | 0 | 227 | 38 | 227 | 116 | 227 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
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| Granulocytopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
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| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
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| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
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| Lymphoid tissue hyperplasia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
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| Pernicious anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
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| Pseudolymphoma | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Cardiomyopathy | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Left ventricular hypertrophy | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Acute vestibular syndrome | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 16.1 | Systematic Assessment |
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| Hyperparathyroidism primary | Endocrine disorders | MedDRA 16.1 | Systematic Assessment |
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| Eye haemorrhage | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| Iritis | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Anorectal disorder | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Coeliac disease | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Colitis ulcerative | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Crohn's disease | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Diverticulum | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Duodenal ulcer | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Gingivitis ulcerative | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Large intestine perforation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Peptic ulcer haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Stomatitis necrotising | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Tongue necrosis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Umbilical hernia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Device dislocation | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Inflammation | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Multi-organ disorder | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Multi-organ failure | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
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| Chronic hepatitis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
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| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
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| Hepatic necrosis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
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| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
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| Hepatitis toxic | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
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| Jaundice | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
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| Liver injury | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
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| Sarcoidosis | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
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| Serum sickness | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Atypical pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Bartholin's abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Brucellosis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Chlamydial infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Chronic hepatitis c | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Chronic sinusitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Cytomegalovirus infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Genitourinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Hepatitis e | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Intervertebral discitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Lobar pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Lyme disease | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Meningitis aseptic | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Myelitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Parotitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Pulmonary tuberculosis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Reiter's syndrome | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Salmonellosis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Accident | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Ligament injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Snake bite | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Diagnostic procedure | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hyperamylasaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Juvenile idiopathic arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ligament laxity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Seronegative arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Still's disease adult onset | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Systemic sclerosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Anorectal human papilloma virus infection | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Metaplastic breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Ovarian fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Testicular neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Uterine leiomyosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Brain compression | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cerebellar syndrome | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cerebral venous thrombosis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Encephalitis autoimmune | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Guillain-barre syndrome | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Muscle spasticity | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Neurological symptom | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 16.1 | Systematic Assessment |
| |
| Blighted ovum | Pregnancy, puerperium and perinatal conditions | MedDRA 16.1 | Systematic Assessment |
| |
| Foetal growth restriction | Pregnancy, puerperium and perinatal conditions | MedDRA 16.1 | Systematic Assessment |
| |
| Premature delivery | Pregnancy, puerperium and perinatal conditions | MedDRA 16.1 | Systematic Assessment |
| |
| Acute stress disorder | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bipolar i disorder | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Personality disorder | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Somatoform disorder | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypertonic bladder | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Urogenital fistula | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vesicoureteric reflux | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Adnexal torsion | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ovarian adhesion | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pelvic prolapse | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pharyngeal necrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary sarcoidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Tracheal fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Alopecia scarring | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Drug reaction with eosinophilia and systemic symptoms | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Henoch-schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pemphigoid | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Perivascular dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Stevens-johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominoplasty | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Female sterilisation | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Hospitalisation | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Immunosuppressant drug therapy | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Mastectomy | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
| |
| Granulomatosis with polyangiitis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Kawasaki's disease | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Biogen Study Medical Director | Biogen | 866-633-4636 | clinicaltrials@biogen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 8, 2018 | Sep 24, 2019 | SAP_001.pdf |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077561 | Daclizumab |
| C000598527 | daclizumab HYP |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| Other |
|
| Not Reported |
|
| Participants with SAEs |
|
Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.
| OG002 | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. |
| OG003 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
|
|
Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.
|
|
DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks.
| OG003 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| OG002 | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. |
| OG003 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. |
| OG003 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. |
| OG003 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
|
|
|
|
|
|
|
|
| OG002 | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. |
| OG003 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks.
| OG002 | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. |
| OG003 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
|
|
| OG002 | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. |
| OG003 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
|
|
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) |
DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. |
| OG003 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
| OG002 | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. |
| OG003 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
|
|
| OG002 | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. |
| OG003 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
|
|
| OG002 | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. |
| OG003 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
|
|
| OG002 | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. |
| OG003 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
|
|
| OG002 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) |
DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. |
| OG003 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
|
|
| OG002 | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. |
| OG003 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
|
|
| OG002 | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. |
| OG003 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
|
|
| OG002 | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. |
| OG003 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
|
|
DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. |
| OG003 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
|
|
|
|
DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. |
| OG003 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
|
|
DAC HYP 150 mg SC injection every 4 weeks for up to 94.1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. |
| OG003 | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. |
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