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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-010788-18 | EudraCT Number | ||
| LTE12824 | Other Identifier | Sanofi |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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This open-label, rater-blinded extension study enrolled participants who had relapsing-remitting multiple sclerosis (RRMS) and who participated in one of three prior Genzyme-sponsored studies of alemtuzumab (CAMMS223 [NCT00050778], CAMMS323 [NCT00530348] also known as CARE-MS I, or CAMMS324 [NCT00548405] also known as CARE-MS II). The purposes of this study were:
Alemtuzumab treatment was on a fixed schedule of two treatment courses a year apart for participants who received Rebif® in one of the prior Genzyme-sponsored studies of alemtuzumab or on an as needed schedule (e.g. due to documented evidence of resumed Multiple Sclerosis [MS] activity) for participants who had already completed a fixed schedule of treatment with alemtuzumab in one of the prior Genzyme-sponsored studies. There was no comparison treatment in this study. All participants were required to return to their study site every 3 months for neurologic and other assessments. In addition, safety-related laboratory tests and surveys were performed at least monthly. Participation in the extension study was at least 48 months from enrollment. Study duration could be extended to allow participants to remain in the study until a follow-up study was available in their country or through month 60 (month 72 in USA), whichever occurred first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Previously treated with alemtuzumab | Experimental | Alemtuzumab 12 mg per day administered through IV, once a day for 3 consecutive days (participants might receive additional cycles of alemtuzumab upon documented evidence of resumed disease activity, but not within same 12-month period) |
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| Previously treated with interferon beta-1a (Rebif®) | Experimental | Alemtuzumab 12 mg per day administered through IV, once a day for 5 consecutive days during the first cycle and 12 mg per day administered through IV, once a day for 3 consecutive days during the second cycle, 12 months later. Participants might qualify for as-needed retreatment (12 mg per day administered through IV, once a day for 3 consecutive days) after their second fixed annual cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alemtuzumab | Biological | Alemtuzumab 12 mg/day IV infusion on 5 consecutive days if the participants had no prior alemtuzumab exposure (ie, first treatment course). All subsequent treatment courses were for 3 days only. |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Relapse Rate (ARR) | Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis (MS) that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of follow-up time of all participants involved in certain treatment groups. ARR was estimated through negative binomial regression with robust variance estimation. | Year 3, 4, 5, 6 from the Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively) |
| Annualized Relapse Rate (ARR) Before and After Receiving Alemtuzumab | Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of total follow-up time of all participants involved in certain treatment groups. ARR was estimated through repeated negative binomial regression with robust variance estimation and covariate adjustment for geographic region. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. | Baseline (Year 0 of initial studies) up to Year 4 |
| Annualized Relapse Rate (ARR) Before and After Alemtuzumab Retreatment | Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of total follow-up time of all participants involved in certain treatment groups. ARR was estimated through negative binomial regression with robust variance estimation without covariate adjustment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS at Year 6 | SRD was defined as a ≥1 point decrease in EDSS score lasting >= 6 months. SRD is only applicable to participants with a baseline EDSS score of >= 2.0. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Number of participants with SRD at Year 6 was estimated using Kaplan-Meier method and reported in this outcome measure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Genzyme Coorporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Central Neurology Associates, P.C. | Cullman | Alabama | United States | |||
| HOPE Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18946064 | Background | CAMMS223 Trial Investigators; Coles AJ, Compston DA, Selmaj KW, Lake SL, Moran S, Margolin DH, Norris K, Tandon PK. Alemtuzumab vs. interferon beta-1a in early multiple sclerosis. N Engl J Med. 2008 Oct 23;359(17):1786-801. doi: 10.1056/NEJMoa0802670. | |
| 23122652 | Background | Cohen JA, Coles AJ, Arnold DL, Confavreux C, Fox EJ, Hartung HP, Havrdova E, Selmaj KW, Weiner HL, Fisher E, Brinar VV, Giovannoni G, Stojanovic M, Ertik BI, Lake SL, Margolin DH, Panzara MA, Compston DA; CARE-MS I investigators. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet. 2012 Nov 24;380(9856):1819-28. doi: 10.1016/S0140-6736(12)61769-3. Epub 2012 Nov 1. |
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Efficacy outcome data was analyzed only on CAMMS323 and CAMMS324 participants; safety data was analyzed on all participants, as pre-specified in protocol.
This extension study enrolled participants from previous 3 studies: CAMMS223 (NCT00050778), CAMMS323 (NCT00530348), and CAMMS324 (NCT00548405). Participants were enrolled in this study only after their Month 24 visit in CAMMS323 and CAMMS324. CAMMS223 participants were enrolled within 6 months once their site received approval of extension study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alemtuzumab | Participants enrolled from any of the prior studies received long-term follow-up in this study. Participants randomized to receive interferon beta-1a (IFNB-1a) in prior studies received alemtuzumab 12 mg/day infusion intravenously (IV) once daily (QD) for 5 consecutive days in treatment Course 1, and for 3 consecutive days in treatment Course 2, 12 months later in this study. Participants who received 2 treatment courses with alemtuzumab could be treated with additional alemtuzumab courses of 12 mg/day infusion IV QD, for 3 consecutive days at least 48 weeks after the prior course if they had documented evidence of resumed disease activity (defined as >=1 protocol-defined relapse and/or >=2 new or enlarging brain or spinal lesions on magnetic resonance imaging [MRI]), unless they met safety-related retreatment disqualifying criteria. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Year 1 prior to retreatment, Year 1, 2, 3 after retreatment |
| Number of Participants With Sustained Accumulation of Disability (SAD) | SAD: defined as an increase of at least 1.5 points in Expanded Disability Status Scale (EDSS) score for participants with prior study baseline score of 0 and increase of at least 1.0 point for participants with a prior study baseline score of 1.0 or more; and the increase persisted over a 6-month consecutive period. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) and ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), higher scores indicating worse neurological function. Number of participants with SAD was estimated by Kaplan-Meier method and reported in this outcome measure. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "alemtuzumab treatment CAMMS323 extension" group and "alemtuzumab Treatment CAMMS324 Extension" group, respectively. | Baseline (Year 0) up to Year 6 |
| Number of Participants With Sustained Accumulation of Disability (SAD) Before and After Alemtuzumab Treatment: 2 Year Comparison | SAD: defined as an increase of at least 1.5 points in EDSS score for participants with prior study baseline score of 0 and increase of at least 1.0 point for participants with a prior study baseline score of 1.0 or more; and the increase persisted over a 6-month consecutive period. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) and ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), higher scores indicating worse neurological function. Number of participants with SAD over 2 years before and 2 years after alemtuzumab treatment were estimated by Kaplan-Meier method and reported in this outcome measure. The IFNB-1a/Alemtuzumab switch pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. | Baseline (Year 0 of initial studies) up to Year 4 |
| Baseline (Year 0) up to Year 6 |
| Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS (After Alemtuzumab Treatment) at Year 2 of the Extension Study | SRD was defined as a >=1 point decrease in EDSS score lasting >=6 months. SRD is only applicable to participants with a baseline EDSS score of ≥2.0. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Number of participants with SRD at Year 2 of CAMMS03409 was estimated using Kaplan-Meier method and reported in this outcome measure. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. | Extension study (CAMMS03409) baseline up to Extension Year 2 |
| Change From Initial Study Baseline in EDSS Score at Year 3, 4, 5 and 6 | EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Change was calculated by subtracting baseline (Month 0 of the study CAMMS323 [NCT00530348] or CAMMS324 [NCT00548405]) value from EDSS scores at specified time points. | Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5, 6 |
| Change From Initial Study Baseline in EDSS Score Before and After Alemtuzumab Treatment: 2 Year Comparison | EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Change was calculated by subtracting baseline (Month 0 of the study CAMMS323 or CAMMS324 for pre alemtuzumab period or CAMMS03409 baseline for post alemtuzumab period) value, from EDSS scores at specified time points. The IFNB-1a/Alemtuzumab switch pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting groups. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "CAMMS323 participants" and "CAMMS324 participants" respectively. | Baseline (Year 0 of initial studies) up to Year 4 |
| Change From Retreatment Baseline in EDSS Score After Alemtuzumab Retreatment | EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Change was calculated by subtracting retreatment baseline (annual visit prior to the retreatment start date) value from EDSS scores at specified time points. | Retreatment baseline, Year 1, 2 and 3 after retreatment baseline |
| Percentage of Participants Without New or Enlarging Magnetic Resonance Imaging (MRI)-T2-Hypertense Lesion Activity | Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually. | Year 3, 4, 5 and 6 |
| Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Treatment | Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. | Baseline (Year 0 of initial studies) up to Year 4 |
| Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Retreatment | Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually. Retreatment baseline was the annual visit prior to the retreatment start date. | Retreatment Baseline, Year 1, 2 and 3 after retreatment |
| Percentage Change From Baseline in MRI-T2-Hypertense Lesion Volumes at Year 3, 4, 5, 6 | Lesion volume was quantitatively assessed by hyperintensity on T2-weighted MRI scans. | Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5, 6 |
| Percentage of Participants Without New Gadolinium-enhancing MRI Lesion Activity | Analysis of new gadolinium-enhancing lesions that appear on MRI scans performed annually. Baseline was the prior annual visit. | Year 3, 4, 5 and 6 |
| Percent Change From Baseline in Brain Parenchymal Fractions (BPF) at Year 3, 4, 5 and 6 | Brain parenchymal fraction (calculated as the ratio of brain parenchymal volume to total intradural volume), is a sensitive indicator of brain atrophy. | Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5 and 6 |
| Percentage of Relapse Free Participants | Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. | Year 3, 4, 5 and 6 |
| Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey at Year 3, 4, 5 and 6 | SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of first four health aspects (1 - 4) were aggregated to derive the PCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. | Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "alemtuzumab treatment CAMMS323 extension group", "alemtuzumab Treatment CAMMS324 Extension" group, respectively),Year 3, 4, 5 and 6 |
| Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey Before and After Alemtuzumab Treatment: 2 Year Comparison | SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of first four health aspects (1 - 4) were aggregated to derive the PCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "CAMMS323" and "CAMMS324" participants, respectively. | Baseline (Year 0 of initial studies) up to Year 4 |
| Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) at Year 3, 4, 5, and 6 | SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of last four health aspects (5 - 8) were aggregated to derive the MCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. | Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5 and 6 |
| Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) Before and After Alemtuzumab Treatment: 2 Year Comparison | SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of last four health aspects (5 - 8) were aggregated to derive the MCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "CAMMS323" and "CAMMS324" participants, respectively. | Baseline (Year 0 of initial studies) up to Year 4 |
| Change From Baseline in Self-reported Quality of Life as Assessed by Functional Assessment of Multiple Sclerosis (FAMS) Score at Year 3, 4, 5 and 6 | FAMS is a widely accepted, MS-specific, quality of life questionnaire. It comprised of 58 items on 7 subscales: mobility (7 items); symptoms (7 items); emotional well-being (7 items); general contentment (7 items); thinking and fatigue (9 items); family/social well-being (7 items); and additional concerns (14 items, these are not scored). Participants provided their response based on the recall of past week. Each item was rated on a 5-point scale ranges from 0 (poor) to 4 (best), where higher scores indicated higher/better quality of life. Scores from 44 calculable items were summed to provide FAMS total score. FAMS total score ranges from 0 (poor) to 176 (best), where higher scores indicated higher/better quality of life. | Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5, 6 |
| Change From Baseline in Self-reported Quality of Life as Assessed by Functional Assessment of Multiple Sclerosis (FAMS) Score Before and After Alemtuzumab Treatment: 2 Year Comparison | FAMS is a widely accepted, MS-specific, quality of life questionnaire. It comprised of 58 items on 7 subscales: mobility (7 items); symptoms (7 items); emotional well-being (7 items); general contentment (7 items); thinking and fatigue (9 items); family/social well-being (7 items); and additional concerns (14 items, these are not scored). Participants provided their response based on the recall of past week. Each item was rated on a 5-point scale ranges from 0 (poor) to 4 (best), where higher scores indicated higher/better quality of life. Scores from 44 calculable items were summed to provide FAMS total score. FAMS total score ranges from 0 (poor) to 176 (best), where higher scores indicated higher/better quality of life. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. | Baseline (Year 0 of initial studies) up to Year 4 |
| Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score at Year 3, 4, 5 and 6 | EQ-5D is a standardized instrument for measuring health status consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). The EQ-5D VAS range is from 0-100, higher scores indicate a better health state and a positive change indicates improvement. | Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5 and 6 |
| Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score Before and After Alemtuzumab Treatment: 2 Year Comparison | EQ-5D is a standardized instrument for measuring health status consisting of EQ-5D descriptive system and VAS. The EQ-5D VAS range is from 0-100, higher scores indicate a better health state and a positive change indicates improvement. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. | Baseline (Year 0 of initial studies) up to Year 4 |
| Phoenix |
| Arizona |
| United States |
| St. Joseph's Hospital and Medical Center Barrow Neurology Clinics - Barrow Neurological Institute | Phoenix | Arizona | United States |
| Mayo Clinic Arizona (Scottsdale) | Scottsdale | Arizona | United States |
| Northwest NeuroSpecialists, PLLC | Tucson | Arizona | United States |
| East Bay Physicians Medical Group/ Sutter East Bay Medical Foundation | Berkeley | California | United States |
| Neurology Center North Orange County | La Habra | California | United States |
| University of Southern California Keck School of Medicine/University of Southern California LAC & USC Medical Center | Los Angeles | California | United States |
| Neuro-Therapeutics, Inc. | Pasadena | California | United States |
| Stanford University Medical Center | Stanford | California | United States |
| University of Colorado Health Science Center - Aurora | Aurora | Colorado | United States |
| Advanced Neurology of Colorado | Fort Collins | Colorado | United States |
| Yale MS Research Center | New Haven | Connecticut | United States |
| The George Washington University Medical Faculty Associates | Washington D.C. | District of Columbia | United States |
| University of Florida Neuroscience Institute | Jacksonville | Florida | United States |
| Neurology Associates, P.A. | Maitland | Florida | United States |
| Neurological Associates | Pompano Beach | Florida | United States |
| Negroski, Stein, Sutherland and Hanes Neurology | Sarasota | Florida | United States |
| Axiom Clinical Research of Florida | Tampa | Florida | United States |
| University of South Florida College of Medicine | Tampa | Florida | United States |
| Emory University Department of Neurology | Atlanta | Georgia | United States |
| Shepherd Center Multiple Sclerosis Institute | Atlanta | Georgia | United States |
| University of Chicago Medical Center | Chicago | Illinois | United States |
| Consultants in Neurology, LTD | Northbrook | Illinois | United States |
| Fort Wayne Neurological Center | Fort Wayne | Indiana | United States |
| Indiana University Multiple Sclerosis Center | Indianapolis | Indiana | United States |
| Iowa Health Physicians | Des Moines | Iowa | United States |
| Ruan Neurology Clinic and Clinical Research Center, Mercy Medical Center | Des Moines | Iowa | United States |
| University of Kansas Medical Center, Department of Neurology | Kansas City | Kansas | United States |
| MidAmerica Neuroscience Institute | Lenexa | Kansas | United States |
| Associates in Neurology, P.S.C. | Lexington | Kentucky | United States |
| Kentucky Neuroscience Research | Louisville | Kentucky | United States |
| University of Maryland, Maryland Center for MS | Baltimore | Maryland | United States |
| The MS Center at St. Elizabeth's | Boston | Massachusetts | United States |
| UMass Memorial Medical Center | Worcester | Massachusetts | United States |
| University of Michigan Medical School | Ann Arbor | Michigan | United States |
| Michigan Neurology Association | Clinton | Michigan | United States |
| Wayne State University, The School of Medicine, Department of Neurology | Detroit | Michigan | United States |
| Spectrum Health Medical Group, Neurology/Michigan Medical P.C., West Michigan MS Clinic | Grand Rapids | Michigan | United States |
| Northern Michigan Neurology | Traverse City | Michigan | United States |
| Saint Luke's Brain & Stroke Institute | Kansas City | Missouri | United States |
| Renown Institute for Neurosciences | Reno | Nevada | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States |
| MS Center at Holy Name Hospital | Teaneck | New Jersey | United States |
| University of New Mexico, Dept. of Neurology | Albuquerque | New Mexico | United States |
| Empire Neurology P.C. | Latham | New York | United States |
| Winthrop University Hospital Multiple Sclerosis Treatment Center | Mineola | New York | United States |
| MS Care Center at NYUMC and HJD | New York | New York | United States |
| The Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai | New York | New York | United States |
| South Shore Neurologic Associates, P.C. | Patchogue | New York | United States |
| Rochester Multiple Sclerosis Center | Rochester | New York | United States |
| SUNY Upstate Medical University, Department of Neurology | Syracuse | New York | United States |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States |
| Wake Forest University Health Science Department of Neurology | Winston-Salem | North Carolina | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | United States |
| Oak Clinic for Multiple Sclerosis | Uniontown | Ohio | United States |
| OMRF Multiple Sclerosis Center of Excellence | Oklahoma City | Oklahoma | United States |
| Lehigh Valley Hospital Neurosciences and Pain Research | Allentown | Pennsylvania | United States |
| Rhode Island Hospital MS Center - The Neurology Foundation, Inc | Providence | Rhode Island | United States |
| Neurology Clinic PC | Cordova | Tennessee | United States |
| Advanced Neurosciences Institute | Franklin | Tennessee | United States |
| Hope Neurology | Knoxville | Tennessee | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | United States |
| Baylor College of Medicine, Maxine Mesinger MS Clinic | Houston | Texas | United States |
| Central Texas Neurology Consultants | Round Rock | Texas | United States |
| Integra Clinical Research | San Antonio | Texas | United States |
| Neurology Center of San Antonio | San Antonio | Texas | United States |
| MS Center of Greater Washington | Vienna | Virginia | United States |
| Swedish Medical MS Center | Seattle | Washington | United States |
| DIABAID | Buenos Aires | Argentina |
| Concord Repatriation General Hospital | Concord | New South Wales | Australia |
| Southern Neurology | Kogarah | New South Wales | Australia |
| Liverpool Hospital | Liverpool | New South Wales | Australia |
| Westmead Hospital | Westmead | New South Wales | Australia |
| Gold Coast Hospital | Southport | Queensland | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | Australia |
| St. Vincent's Hospital | Fitzroy | Victoria | Australia |
| Austin Health | Heidelberg | Victoria | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | Australia |
| The Wesley Research Institute | Auchenflower QLD | Australia |
| The Queen Elizabeth Hospital | Woodville, SA | Australia |
| AKH Wien-Universitätskliniken für Neurologie | Vienna | Austria |
| Cliniques Universitaires Saint-luc | Brussels | Belgium |
| CHU Ourthe Amblève | Esneux | Belgium |
| University Hospital Leuven, Campus Gasthuisberg | Leuven | Belgium |
| Hospital Mae de Deus | Porto Alegre | Brazil |
| Hospital da Restauração, Neurology department | Recife, PE | Brazil |
| Irmandade da Santa Casa de Misericórdio de São Paulo, Neurology department | São Paulo, SP | Brazil |
| Hospital das Clínicas da Faculdade de Medicina da USP, Neurology department | São Paulo,SP | Brazil |
| University of Calgary, Department of Neurology | Calgary | Alberta | Canada |
| Kingston General Hospital MS Clinic | Kingston | Ontario | Canada |
| Clinique Neuro-Outaouais | Gatineau | Quebec | Canada |
| Recherche Sepmus, Inc. | Greenfield Park | Quebec | Canada |
| Hopital Maisonneuve-Rosemont | Montreal | Quebec | Canada |
| London Health Sciences Centre - University Hospital | London, on | Canada |
| The Ottawa Hospital - MS Research | Ottawa, Ontario | Canada |
| University of British Columbia | Vancouver, BC | Canada |
| Clinical Hospital Osijek | Osijek | Croatia |
| Clinical Hospital Centre Rijeka | Rijeka | Croatia |
| General Hospital Varazdin, Department for Neurology | Varaždin | Croatia |
| Clinical Hospital Centre "Sestre Milosrdnice" | Zagreb | Croatia |
| Clinical Hospital Centre Zagreb | Zagreb | Croatia |
| Clinical Hospital Sveti Duh | Zagreb | Croatia |
| St. Anne's University Hospital Brno | Brno | Czechia |
| University Hospital Hradec Králové | Hradec Králové | Czechia |
| General Hospital, 128 21 Praha 2 | Prague | Czechia |
| Hospital Teplice, Neurology Department, MS centrum | Teplice | Czechia |
| Aarhus Sygehus | Århus C | Denmark |
| Rigshospitalet Department of Neurology | Copenhagen | Denmark |
| Hôpital Général | Dijon | France |
| Groupe Hospitalier Pitié-Salpêtrière, Fédération de Maladies du System Nerveux Central | Paris | France |
| CHU Pontchaillou | Rennes | France |
| Hôpital Civil | Strasbourg | France |
| CHU de Toulouse, Hôpital Purpan | Toulouse | France |
| Klinik und Poliklinik für Neurologie, Universitätsklinikum Bonn | Bonn | DE | Germany |
| Universitätsklinik Carl Gustav Carus Dresden | Dresden | Germany |
| Klinikum der JW Goethe Universität | Frankfurt am Main | Germany |
| Asklepios Klinik Barmbek | Hamburg | Germany |
| Medizinische Hochschule Hannover | Hanover | Germany |
| Oberhavel Klinicum GmbH - Krankenhaus Hennigsdorf | Hennigsdorf | Germany |
| Klinikum Ingolstadt | Ingolstadt | Germany |
| Jüdisches Krankenhaus Berlin | Mitte | Germany |
| Klinikum rechts der Isar | München | Germany |
| Medizinische Fakultät der Universität Rostock,Zentrum für Nervenheilkunde | Rostock | Germany |
| Universitätsklinikum Ulm, Klinik für Neurologie im RKU | Ulm | Germany |
| Fachkrankenhaus Hubertusburg GmbH, Klinik für Neurologie und Neurologische Intensivmedizin | Wermsdorf | Germany |
| Hadassah Medical Center Ein Karem | Ein Karem, Jerusalem | Israel |
| Sheba Medical Center | Ramat Gan | Israel |
| Sourasky Tel Aviv Medical Center | Tel Aviv | Israel |
| Università di Cagliari | Cagliari | Italy |
| Ospedale S. Antonio Abate di Gallarate | Gallarate (Varese) | Italy |
| Ospedale S. Luigi Gonzaga | Orbassano (TO) | Italy |
| Universita Degli Studi di Roma "La Sapienza" | Roma | Italy |
| Unidad de Investigación en Salud | Chihuahua, CHH | Mexico |
| Medica Sur | Mexico City, DFE | Mexico |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | Netherlands |
| Orbis Medisch Concern | Sittard-Geleen | Netherlands |
| Centrum Neurologii Klinicznej Sp. Zo.o. | Krakow | Poland |
| Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Kliniczny Nr1 im. Norberta Barlickiego | Lodz | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie | Lublin | Poland |
| Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Med. im. Karola Marcinkowskiego w Poznaniu | Poznan | Poland |
| Institute of Psychiatry and Neurology/Instytut Psychiatrii i Neurologii | Warsaw | Poland |
| Research Medical Complex "Your Health" Ltd | Kazan' | Russia |
| Moscow State Public Medical Institution Clinical Hospital #11, Neurology Department | Moscow | Russia |
| Neurology Research Center under the Russian Academy of Medical Sciences | Moscow | Russia |
| Russian State Medical University, Department of Neurology and Neurosurgery | Moscow | Russia |
| Municipal Treatment and Prevention Institution, City Hospital #33 | Nizhny Novgorod | Russia |
| Federal State Public Medical Institution: Siberian District Medical Center under the Federal Agency | Novosibirsk | Russia |
| Municipal Public Medical Institution: City Hospital #2 of Pyatigorsk, Neurology Department | Pyatigorsk | Russia |
| Institute of Human Brain RAS, Laboratory of Neuroimmunology | Saint Petersburg | Russia |
| St Petersburg State Pavlov Medical University, Dept of Neurology and Neurosurgery with a Hospital | Saint Petersburg | Russia |
| St. Petersburg General Hospital #2, Neurology Department #2 | Saint Petersburg | Russia |
| St. Petersburg State Public Medical Institution: Nikolayevskaya Hospital | Saint Petersburg | Russia |
| Samara Regional Clinical Hospital n.a. Kalinin | Samara | Russia |
| State Public Medical Institution: Republican Clinical Hospital n.a. G.G. Kuvatov | Ufa | Russia |
| Clinical Centre Serbia, Institute of Neurology,Dr.Subotica 6,Belgrade | Belgrade | Serbia |
| Military Medical Academy, Institute of Neurology | Belgrade | Serbia |
| Clinical Centre Kragujevac, Clinic of Neurology | Kragujevac | Serbia |
| Clinical Centre Nis, Clinic of Neurology | Niš | Serbia |
| Clinical Centre Vojvodina | Novi Sad | Serbia |
| Hospital Universitario Vall d' Hebron | Barcelona | Spain |
| Hospital Clínico Universitario San Carlos | Madrid | Spain |
| Hospital Carlos Haya, Neurology Service | Málaga | Spain |
| Hospital Virgen Macarena | Seville | Spain |
| SU/Östra sjukhuset | Gothenburg | Sweden |
| Norrlands Universitets sjukhus | Umeå | Sweden |
| Institute of Neurology, Psychiatry and Narcology under the AMS of Ukraine, Dep of Neuroinfection& MS | Kharkiv | Ukraine |
| Kiev Municipal Clinical Hospital #4, Department of Demyelinating Diseases of the Nervous System | Kiev | Ukraine |
| Hospital of Directorate of the Medical Corps within the Ukrainian Security Service, Neurology Dept. | Kiev-21 | Ukraine |
| Lviv National Medical University n.a. Danylo Galytsky, Department of Neurology | Lviv | Ukraine |
| Frenchay Hospital | Bristol | United Kingdom |
| Addenbrookes Hospital | Cambridge | United Kingdom |
| University Hospital of Wales, Dept of Neurology | Cardiff | United Kingdom |
| Royal London Hospital | London | United Kingdom |
| Salford Royal NHS Foundation Trust | Salford | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | United Kingdom |
| 23122650 | Background | Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, Hartung HP, Havrdova E, Selmaj KW, Weiner HL, Miller T, Fisher E, Sandbrink R, Lake SL, Margolin DH, Oyuela P, Panzara MA, Compston DA; CARE-MS II investigators. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet. 2012 Nov 24;380(9856):1829-39. doi: 10.1016/S0140-6736(12)61768-1. Epub 2012 Nov 1. |
| 39935588 | Derived | Ziemssen T, Bass AD, Van Wijmeersch B, Eichau S, Richter S, Hoffmann F, Armstrong NM, Chirieac M, Cunha-Santos J, Singer BA. Long-term efficacy and safety of alemtuzumab in participants with highly active MS: TOPAZ clinical trial and interim analysis of TREAT-MS real-world study. Ther Adv Neurol Disord. 2025 Feb 10;18:17562864241306575. doi: 10.1177/17562864241306575. eCollection 2025. |
| 37745914 | Derived | Coles AJ, Achiron A, Traboulsee A, Singer BA, Pozzilli C, Oreja-Guevara C, Giovannoni G, Comi G, Freedman MS, Ziemssen T, Shiota D, Rawlings AM, Wong AT, Chirieac M, Montalban X. Safety and efficacy with alemtuzumab over 13 years in relapsing-remitting multiple sclerosis: final results from the open-label TOPAZ study. Ther Adv Neurol Disord. 2023 Sep 21;16:17562864231194823. doi: 10.1177/17562864231194823. eCollection 2023. |
| 36619856 | Derived | Dayan CM, Lecumberri B, Muller I, Ganesananthan S, Hunter SF, Selmaj KW, Hartung HP, Havrdova EK, LaGanke CC, Ziemssen T, Van Wijmeersch B, Meuth SG, Margolin DH, Poole EM, Baker DP, Senior PA. Endocrine and multiple sclerosis outcomes in patients with autoimmune thyroid events in the alemtuzumab CARE-MS studies. Mult Scler J Exp Transl Clin. 2023 Jan 3;9(1):20552173221142741. doi: 10.1177/20552173221142741. eCollection 2023 Jan-Mar. |
| 34882037 | Derived | Coles AJ, Jones JL, Vermersch P, Traboulsee A, Bass AD, Boster A, Chan A, Comi G, Fernandez O, Giovannoni G, Kubala Havrdova E, LaGanke C, Montalban X, Oreja-Guevara C, Piehl F, Wiendl H, Ziemssen T. Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data. Mult Scler. 2022 Apr;28(5):842-846. doi: 10.1177/13524585211061335. Epub 2021 Dec 9. |
| 34378446 | Derived | Kuhle J, Daizadeh N, Benkert P, Maceski A, Barro C, Michalak Z, Sormani MP, Godin J, Shankara S, Samad TA, Jacobs A, Chung L, Rӧsch N, Kaiser C, Mitchell CP, Leppert D, Havari E, Kappos L. Sustained reduction of serum neurofilament light chain over 7 years by alemtuzumab in early relapsing-remitting MS. Mult Scler. 2022 Apr;28(4):573-582. doi: 10.1177/13524585211032348. Epub 2021 Aug 11. |
| 34035833 | Derived | Coles AJ, Arnold DL, Bass AD, Boster AL, Compston DAS, Fernandez O, Havrdova EK, Nakamura K, Traboulsee A, Ziemssen T, Jacobs A, Margolin DH, Huang X, Daizadeh N, Chirieac MC, Selmaj KW. Efficacy and safety of alemtuzumab over 6 years: final results of the 4-year CARE-MS extension trial. Ther Adv Neurol Disord. 2021 Apr 23;14:1756286420982134. doi: 10.1177/1756286420982134. eCollection 2021. |
| 33476880 | Derived | Bass AD, Arroyo R, Boster AL, Boyko AN, Eichau S, Ionete C, Limmroth V, Navas C, Pelletier D, Pozzilli C, Ravenscroft J, Sousa L, Tintore M, Uitdehaag BMJ, Baker DP, Daizadeh N, Choudhry Z, Rog D; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators. Alemtuzumab outcomes by age: Post hoc analysis from the randomized CARE-MS studies over 8 years. Mult Scler Relat Disord. 2021 Apr;49:102717. doi: 10.1016/j.msard.2020.102717. Epub 2020 Dec 24. |
| 33414927 | Derived | Horakova D, Boster A, Bertolotto A, Freedman MS, Firmino I, Cavalier SJ, Jacobs AK, Thangavelu K, Daizadeh N, Poole EM, Baker DP, Margolin DH, Ziemssen T; CARE-MS I, CARE-MS II, and CAMMS03409 Investigators. Proportion of alemtuzumab-treated patients converting from relapsing-remitting multiple sclerosis to secondary progressive multiple sclerosis over 6 years. Mult Scler J Exp Transl Clin. 2020 Dec 18;6(4):2055217320972137. doi: 10.1177/2055217320972137. eCollection 2020 Oct-Dec. |
| 32710396 | Derived | Ziemssen T, Bass AD, Berkovich R, Comi G, Eichau S, Hobart J, Hunter SF, LaGanke C, Limmroth V, Pelletier D, Pozzilli C, Schippling S, Sousa L, Traboulsee A, Uitdehaag BMJ, Van Wijmeersch B, Choudhry Z, Daizadeh N, Singer BA; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators. Efficacy and Safety of Alemtuzumab Through 9 Years of Follow-up in Patients with Highly Active Disease: Post Hoc Analysis of CARE-MS I and II Patients in the TOPAZ Extension Study. CNS Drugs. 2020 Sep;34(9):973-988. doi: 10.1007/s40263-020-00749-x. |
| 32539719 | Derived | Gilmore W, Lund BT, Li P, Levy AM, Kelland EE, Akbari O, Groshen S, Cen SY, Pelletier D, Weiner LP, Javed A, Dunn JE, Traboulsee AL. Repopulation of T, B, and NK cells following alemtuzumab treatment in relapsing-remitting multiple sclerosis. J Neuroinflammation. 2020 Jun 15;17(1):189. doi: 10.1186/s12974-020-01847-9. |
| 31762387 | Derived | Comi G, Alroughani R, Boster AL, Bass AD, Berkovich R, Fernandez O, Kim HJ, Limmroth V, Lycke J, Macdonell RA, Sharrack B, Singer BA, Vermersch P, Wiendl H, Ziemssen T, Jacobs A, Daizadeh N, Rodriguez CE, Traboulsee A; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy of alemtuzumab in relapsing-remitting MS patients who received additional courses after the initial two courses: Pooled analysis of the CARE-MS, extension, and TOPAZ studies. Mult Scler. 2020 Dec;26(14):1866-1876. doi: 10.1177/1352458519888610. Epub 2019 Nov 25. |
| 31675266 | Derived | Van Wijmeersch B, Singer BA, Boster A, Broadley S, Fernandez O, Freedman MS, Izquierdo G, Lycke J, Pozzilli C, Sharrack B, Steingo B, Wiendl H, Wray S, Ziemssen T, Chung L, Margolin DH, Thangavelu K, Vermersch P. Efficacy of alemtuzumab over 6 years in relapsing-remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies. Mult Scler. 2020 Nov;26(13):1719-1728. doi: 10.1177/1352458519881759. Epub 2019 Nov 1. |
| 31654272 | Derived | Okai AF, Amezcua L, Berkovich RR, Chinea AR, Edwards KR, Steingo B, Walker A, Jacobs AK, Daizadeh N, Williams MJ; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy and Safety of Alemtuzumab in Patients of African Descent with Relapsing-Remitting Multiple Sclerosis: 8-Year Follow-up of CARE-MS I and II (TOPAZ Study). Neurol Ther. 2019 Dec;8(2):367-381. doi: 10.1007/s40120-019-00159-2. Epub 2019 Oct 25. |
| 31144568 | Derived | Arroyo R, Bury DP, Guo JD, Margolin DH, Melanson M, Daizadeh N, Cella D. Impact of alemtuzumab on health-related quality of life over 6 years in CARE-MS II trial extension patients with relapsing-remitting multiple sclerosis. Mult Scler. 2020 Jul;26(8):955-963. doi: 10.1177/1352458519849796. Epub 2019 May 30. |
| 28835401 | Derived | Havrdova E, Arnold DL, Cohen JA, Hartung HP, Fox EJ, Giovannoni G, Schippling S, Selmaj KW, Traboulsee A, Compston DAS, Margolin DH, Thangavelu K, Rodriguez CE, Jody D, Hogan RJ, Xenopoulos P, Panzara MA, Coles AJ; CARE-MS I and CAMMS03409 Investigators. Alemtuzumab CARE-MS I 5-year follow-up: Durable efficacy in the absence of continuous MS therapy. Neurology. 2017 Sep 12;89(11):1107-1116. doi: 10.1212/WNL.0000000000004313. Epub 2017 Aug 23. |
| Participants Entered From CAMMS223 |
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| Participants Entered From CAMMS323 |
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| Participants Entered From CAMMS324 |
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Alemtuzumab | Participants enrolled from any of the previous studies received long-term follow-up in this study. Participants randomized to receive IFNB-1a in any of the previous studies received alemtuzumab 12 mg/day infusion IV, QD for 5 consecutive days in treatment Course 1, and for 3 consecutive days in treatment Course 2, 12 months later in this study. Participants who received 2 treatment courses with alemtuzumab could be treated with additional alemtuzumab courses of 12 mg/day infusion IV QD, for 3 consecutive days at least 48 weeks after the prior course if they had documented evidence of resumed disease activity (defined as >=1 protocol-defined relapse and/or >=2 new or enlarging brain or spinal lesions on MRI), unless they met safety-related retreatment disqualifying criteria. |
| 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, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Annualized Relapse Rate (ARR) | Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis (MS) that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of follow-up time of all participants involved in certain treatment groups. ARR was estimated through negative binomial regression with robust variance estimation. | Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure. | Posted | Number | relapses per participant per year | Year 3, 4, 5, 6 from the Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively) |
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| Primary | Annualized Relapse Rate (ARR) Before and After Receiving Alemtuzumab | Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of total follow-up time of all participants involved in certain treatment groups. ARR was estimated through repeated negative binomial regression with robust variance estimation and covariate adjustment for geographic region. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. | Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409. | Posted | Number | 95% Confidence Interval | relapses per participant per year | Baseline (Year 0 of initial studies) up to Year 4 |
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| Primary | Annualized Relapse Rate (ARR) Before and After Alemtuzumab Retreatment | Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. ARR was obtained from the total number of confirmed relapses that occurred during the treatment follow-up time of all participants divided by the sum of total follow-up time of all participants involved in certain treatment groups. ARR was estimated through negative binomial regression with robust variance estimation without covariate adjustment. | Subset of FAS included participants who had received alemtuzumab in CAMMS323 or CAMMS324 and received an additional course of alemtuzumab in this extension study. | Posted | Number | 95% Confidence Interval | relapses per participant per year | Year 1 prior to retreatment, Year 1, 2, 3 after retreatment |
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| Primary | Number of Participants With Sustained Accumulation of Disability (SAD) | SAD: defined as an increase of at least 1.5 points in Expanded Disability Status Scale (EDSS) score for participants with prior study baseline score of 0 and increase of at least 1.0 point for participants with a prior study baseline score of 1.0 or more; and the increase persisted over a 6-month consecutive period. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) and ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), higher scores indicating worse neurological function. Number of participants with SAD was estimated by Kaplan-Meier method and reported in this outcome measure. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "alemtuzumab treatment CAMMS323 extension" group and "alemtuzumab Treatment CAMMS324 Extension" group, respectively. | Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. | Posted | Count of Participants | Participants | No | Baseline (Year 0) up to Year 6 |
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| Primary | Number of Participants With Sustained Accumulation of Disability (SAD) Before and After Alemtuzumab Treatment: 2 Year Comparison | SAD: defined as an increase of at least 1.5 points in EDSS score for participants with prior study baseline score of 0 and increase of at least 1.0 point for participants with a prior study baseline score of 1.0 or more; and the increase persisted over a 6-month consecutive period. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) and ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), higher scores indicating worse neurological function. Number of participants with SAD over 2 years before and 2 years after alemtuzumab treatment were estimated by Kaplan-Meier method and reported in this outcome measure. The IFNB-1a/Alemtuzumab switch pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. | Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409. | Posted | Count of Participants | Participants | No | Baseline (Year 0 of initial studies) up to Year 4 |
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| Secondary | Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS at Year 6 | SRD was defined as a ≥1 point decrease in EDSS score lasting >= 6 months. SRD is only applicable to participants with a baseline EDSS score of >= 2.0. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Number of participants with SRD at Year 6 was estimated using Kaplan-Meier method and reported in this outcome measure. | Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure. | Posted | Count of Participants | Participants | No | Baseline (Year 0) up to Year 6 |
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| Secondary | Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS (After Alemtuzumab Treatment) at Year 2 of the Extension Study | SRD was defined as a >=1 point decrease in EDSS score lasting >=6 months. SRD is only applicable to participants with a baseline EDSS score of ≥2.0. EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Number of participants with SRD at Year 2 of CAMMS03409 was estimated using Kaplan-Meier method and reported in this outcome measure. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. | Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409. Number of participants analyzed = participants with available data for this outcome measure. | Posted | Count of Participants | Participants | No | Extension study (CAMMS03409) baseline up to Extension Year 2 |
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| Secondary | Change From Initial Study Baseline in EDSS Score at Year 3, 4, 5 and 6 | EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Change was calculated by subtracting baseline (Month 0 of the study CAMMS323 [NCT00530348] or CAMMS324 [NCT00548405]) value from EDSS scores at specified time points. | Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5, 6 |
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| Secondary | Change From Initial Study Baseline in EDSS Score Before and After Alemtuzumab Treatment: 2 Year Comparison | EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Change was calculated by subtracting baseline (Month 0 of the study CAMMS323 or CAMMS324 for pre alemtuzumab period or CAMMS03409 baseline for post alemtuzumab period) value, from EDSS scores at specified time points. The IFNB-1a/Alemtuzumab switch pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting groups. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "CAMMS323 participants" and "CAMMS324 participants" respectively. | Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (Year 0 of initial studies) up to Year 4 |
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| Secondary | Change From Retreatment Baseline in EDSS Score After Alemtuzumab Retreatment | EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicate worse neurological function. Change was calculated by subtracting retreatment baseline (annual visit prior to the retreatment start date) value from EDSS scores at specified time points. | Subset of FAS included participants who had received alemtuzumab in CAMMS323 or CAMMS324 and received an additional course of alemtuzumab in this extension study. | Posted | Mean | Standard Deviation | units on a scale | Retreatment baseline, Year 1, 2 and 3 after retreatment baseline |
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| Secondary | Percentage of Participants Without New or Enlarging Magnetic Resonance Imaging (MRI)-T2-Hypertense Lesion Activity | Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually. | Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure. | Posted | Number | percentage of participants | Year 3, 4, 5 and 6 |
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| Secondary | Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Treatment | Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. | Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409. | Posted | Number | percentage of participants | Baseline (Year 0 of initial studies) up to Year 4 |
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| Secondary | Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Retreatment | Analysis of new or enlarging lesions that appear hyperintense on T2-weighted MRI scans performed annually. Retreatment baseline was the annual visit prior to the retreatment start date. | Subset of FAS included participants who had received alemtuzumab in CAMMS323 or CAMMS324 and received an additional course of alemtuzumab in this extension study. | Posted | Number | percentage of participants | Retreatment Baseline, Year 1, 2 and 3 after retreatment |
|
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| Secondary | Percentage Change From Baseline in MRI-T2-Hypertense Lesion Volumes at Year 3, 4, 5, 6 | Lesion volume was quantitatively assessed by hyperintensity on T2-weighted MRI scans. | Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | percent change | Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5, 6 |
|
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| Secondary | Percentage of Participants Without New Gadolinium-enhancing MRI Lesion Activity | Analysis of new gadolinium-enhancing lesions that appear on MRI scans performed annually. Baseline was the prior annual visit. | Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure. | Posted | Number | percentage of participants | Year 3, 4, 5 and 6 |
|
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| Secondary | Percent Change From Baseline in Brain Parenchymal Fractions (BPF) at Year 3, 4, 5 and 6 | Brain parenchymal fraction (calculated as the ratio of brain parenchymal volume to total intradural volume), is a sensitive indicator of brain atrophy. | Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | percent change | Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5 and 6 |
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| Secondary | Percentage of Relapse Free Participants | Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to MS that last for at least 48 hours, present at normal body temperature, and that were preceded by at least 30 days of clinical stability. | Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure. | Posted | Number | percentage of participants | Year 3, 4, 5 and 6 |
|
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| Secondary | Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey at Year 3, 4, 5 and 6 | SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of first four health aspects (1 - 4) were aggregated to derive the PCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. | Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "alemtuzumab treatment CAMMS323 extension group", "alemtuzumab Treatment CAMMS324 Extension" group, respectively),Year 3, 4, 5 and 6 |
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| Secondary | Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey Before and After Alemtuzumab Treatment: 2 Year Comparison | SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of first four health aspects (1 - 4) were aggregated to derive the PCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "CAMMS323" and "CAMMS324" participants, respectively. | Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (Year 0 of initial studies) up to Year 4 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) at Year 3, 4, 5, and 6 | SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of last four health aspects (5 - 8) were aggregated to derive the MCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. | Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5 and 6 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) Before and After Alemtuzumab Treatment: 2 Year Comparison | SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: 1) physical functioning, 2) role physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role emotional and 8) mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of last four health aspects (5 - 8) were aggregated to derive the MCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. Baseline was defined as Year 0 of CAMMS323 and Year 0 of CAMMS324 for "CAMMS323" and "CAMMS324" participants, respectively. | Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (Year 0 of initial studies) up to Year 4 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Self-reported Quality of Life as Assessed by Functional Assessment of Multiple Sclerosis (FAMS) Score at Year 3, 4, 5 and 6 | FAMS is a widely accepted, MS-specific, quality of life questionnaire. It comprised of 58 items on 7 subscales: mobility (7 items); symptoms (7 items); emotional well-being (7 items); general contentment (7 items); thinking and fatigue (9 items); family/social well-being (7 items); and additional concerns (14 items, these are not scored). Participants provided their response based on the recall of past week. Each item was rated on a 5-point scale ranges from 0 (poor) to 4 (best), where higher scores indicated higher/better quality of life. Scores from 44 calculable items were summed to provide FAMS total score. FAMS total score ranges from 0 (poor) to 176 (best), where higher scores indicated higher/better quality of life. | Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5, 6 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Self-reported Quality of Life as Assessed by Functional Assessment of Multiple Sclerosis (FAMS) Score Before and After Alemtuzumab Treatment: 2 Year Comparison | FAMS is a widely accepted, MS-specific, quality of life questionnaire. It comprised of 58 items on 7 subscales: mobility (7 items); symptoms (7 items); emotional well-being (7 items); general contentment (7 items); thinking and fatigue (9 items); family/social well-being (7 items); and additional concerns (14 items, these are not scored). Participants provided their response based on the recall of past week. Each item was rated on a 5-point scale ranges from 0 (poor) to 4 (best), where higher scores indicated higher/better quality of life. Scores from 44 calculable items were summed to provide FAMS total score. FAMS total score ranges from 0 (poor) to 176 (best), where higher scores indicated higher/better quality of life. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. | Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (Year 0 of initial studies) up to Year 4 |
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| Secondary | Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score at Year 3, 4, 5 and 6 | EQ-5D is a standardized instrument for measuring health status consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). The EQ-5D VAS range is from 0-100, higher scores indicate a better health state and a positive change indicates improvement. | Subset of full analysis set (FAS - defined as all participants randomized in CAMMS223, CAMMS323, and CAMMS324 and who received at least 1 dose of study drug) included participants who had received at least 1 dose of alemtuzumab in CAMMS323 and CAMMS324. Number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5 and 6 |
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| Secondary | Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score Before and After Alemtuzumab Treatment: 2 Year Comparison | EQ-5D is a standardized instrument for measuring health status consisting of EQ-5D descriptive system and VAS. The EQ-5D VAS range is from 0-100, higher scores indicate a better health state and a positive change indicates improvement. The IFNB-1a/Alemtuzumab switch from CAMMS323 or CAMMS324 to CAMMS03409 pre alemtuzumab reporting group consisted of the same participants as those in the corresponding post alemtuzumab reporting group. | Subset of FAS who received IFNB-1a in CAMMS323 or CAMMS324 and who were treated with alemtuzumab in CAMMS03409. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (Year 0 of initial studies) up to Year 4 |
|
All Adverse Events (AE) were collected from signature of the informed consent form in the extension study up to the end of extension study visit (up to Year 6) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events (TEAEs), AEs that developed/worsened during or at any time after first alemtuzumab treatment. Alemtuzumab TEAEs were defined as AEs with start dates and start times on or after the date and time of the first alemtuzumab treatment in CAMMS03409 or in prior studies (CAMMS223, CAMMS323, or CAMMS324).
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 | Alemtuzumab | Participants enrolled in any of the previous studies who had received alemtuzumab. Participants enrolled in any of the previous studies who had received IFNB-1a, who received alemtuzumab 12 mg/day infusion in this study. | 376 | 1,314 | 1,225 | 1,314 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acquired haemophilia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Autoimmune pancytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bradycardia foetal | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bradycardia neonatal | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bundle branch block right | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Foetal cystic hygroma | Congenital, familial and genetic disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Autoimmune hypothyroidism | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Basedow's disease | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Endocrine ophthalmopathy | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Optic atrophy | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pancreatic fistula | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pancreatic pseudocyst | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Perforated ulcer | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Biliary dyskinesia | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sphincter of Oddi dysfunction | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anaphylactoid reaction | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abscess bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Bone abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Chronic hepatitis C | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Endometritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| HIV infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Infectious colitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Infective myositis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pancreas infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Scrotal abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Staphylococcal abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Tubo-ovarian abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Varicella zoster virus infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Gastrostomy failure | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Incision site oedema | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Pancreatic injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Post procedural fistula | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Skull fractured base | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Spinal column injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Urine ketone body present | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Back disorder | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Joint instability | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| SAPHO syndrome | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Benign hydatidiform mole | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Castleman's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Cervix carcinoma stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Insulinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Meningioma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Pancreatic neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Pituitary tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Vulval cancer stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Basal ganglia haemorrhage | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Complex partial seizures | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Intraventricular haemorrhage | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Uhthoff's phenomenon | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Foetal cardiac disorder | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Foetal-maternal haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| HELLP syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Low birth weight baby | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Peripartum cardiomyopathy | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Placental insufficiency | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Premature separation of placenta | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Adjustment disorder | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Affective disorder | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bipolar II disorder | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypomania | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Post-traumatic amnestic disorder | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Psychogenic pain disorder | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Psychogenic tremor | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Schizoaffective disorder bipolar type | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Self injurious behaviour | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Automatic bladder | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Glomerulonephritis membranous | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Renal mass | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Adnexa uteri mass | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Menometrorrhagia | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ovarian haemorrhage | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Parovarian cyst | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pelvic adhesions | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vulvar dysplasia | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Apnoea neonatal | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Eosinophilic pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Polymorphic eruption of pregnancy | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Thyroidectomy | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Basedow's disease | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-US@sanofi.com |
| 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 |
|---|---|
| D000074323 | Alemtuzumab |
| 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
| Year 5 |
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| Year 6 |
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Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
| OG002 | IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab) | Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period |
| OG003 | IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab) | Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period |
|
|
|
| Alemtuzumab Treatment CAMMS324 Extension |
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in this extension study. |
|
|
|
Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period |
| OG002 | IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab) | Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period |
| OG003 | IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab) | Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period |
|
|
|
|
|
|
Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period |
|
|
|
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
|
|
Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
| OG002 | IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab) | Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period |
| OG003 | IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab) | Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period |
|
|
|
|
| OG003 | IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab) | Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period |
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| Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Alemtuzumab Treatment CAMMS324 Extension |
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409. |
|
|
| IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab) |
Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period |
| OG002 | IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab) | Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period |
| OG003 | IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab) | Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period |
|
|
| Alemtuzumab Treatment CAMMS324 Extension |
Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409. |
|
|
Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period |
| OG002 | IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab) | Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period |
| OG003 | IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab) | Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period |
|
|
| OG001 | Alemtuzumab Treatment CAMMS324 Extension | Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409. |
|
|
Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period |
| OG002 | IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab) | Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period |
| OG003 | IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab) | Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period |
| OG003 | IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab) | Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period |
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| Title | Measurements |
|---|---|
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