Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-04-23 @ 5:27 PM
Study NCT ID:
NCT02255656
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2014-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '6#', 'organization': 'Sanofi'}, 'certainAgreement': {'otherDetails': 'The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years).', 'description': "Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).", 'eventGroups': [{'id': 'EG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).", 'otherNumAtRisk': 241, 'deathsNumAtRisk': 241, 'otherNumAffected': 150, 'seriousNumAtRisk': 241, 'deathsNumAffected': 0, 'seriousNumAffected': 55}, {'id': 'EG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).", 'otherNumAtRisk': 598, 'deathsNumAtRisk': 598, 'otherNumAffected': 338, 'seriousNumAtRisk': 598, 'deathsNumAffected': 10, 'seriousNumAffected': 133}, {'id': 'EG002', 'title': 'Alemtuzumab', 'description': "All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \\[NCT00050778\\], CAMMS323 \\[NCT00530348\\], or CAMMS324 \\[NCT00548405\\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).", 'otherNumAtRisk': 1062, 'deathsNumAtRisk': 1062, 'otherNumAffected': 601, 'seriousNumAtRisk': 1062, 'deathsNumAffected': 11, 'seriousNumAffected': 237}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 37, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 45, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 54, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 81, 'numAffected': 67}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 35, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 57, 'numAffected': 50}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 55, 'numAffected': 48}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 60, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 112, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 204, 'numAffected': 129}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 45, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 71, 'numAffected': 57}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 29, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 73, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 123, 'numAffected': 96}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 56, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 143, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 271, 'numAffected': 151}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 34, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 74, 'numAffected': 54}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 27, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 45, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 86, 'numAffected': 69}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 34, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 68, 'numAffected': 62}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 52, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 87, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 164, 'numAffected': 125}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 23, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 46, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 86, 'numAffected': 63}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 45, 'numAffected': 43}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 32, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 62, 'numAffected': 57}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 34, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 64, 'numAffected': 51}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Immune Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute Left Ventricular Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Atrioventricular Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bundle Branch Block Left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Left Ventricular Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Mitral Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sinus Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ventricular Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Atrial Septal Defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Congenital Cystic Kidney Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Congenital Nail Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Foetal Chromosome Abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Trisomy 21', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haematotympanum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Autoimmune Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Autoimmune Thyroid Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Autoimmune Thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': "Basedow's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 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'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Skin Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Peripheral Artery Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 598, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1062, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '598', 'groupId': 'OG001'}, {'value': '1062', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG002', 'title': 'Alemtuzumab', 'description': "All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \\[NCT00050778\\], CAMMS323 \\[NCT00530348\\], or CAMMS324 \\[NCT00548405\\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}, {'value': '879', 'groupId': 'OG002'}]}]}, {'title': 'Any TESAE', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}]}]}, {'title': 'Any TEAE leading to death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Any TEAE leading to permanent treatment discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline until the end of the study (up to a maximum duration of 5.6 years)', 'description': "An Adverse Event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed/worsened during the 'treatment period (time from Baseline until the end of the study LPS13649 \\[i.e. up to a maximum of 5.6 years\\]). Serious adverse events (SAEs) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety analysis set that included all participants who signed the informed consent form (ICF). As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Infusion-Associated Reactions (IAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '294', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG002', 'title': 'Alemtuzumab', 'description': "All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \\[NCT00050778\\], CAMMS323 \\[NCT00530348\\], or CAMMS324 \\[NCT00548405\\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 24 hours of any alemtuzumab infusion', 'description': 'Infusion-associated reactions (IAR) was defined as any adverse event occurring during and within 24 hours of alemtuzumab infusion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on re-treated population that included all participants who had signed the ICF and who had received study drug in the current study LPS13649. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT)."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events of Special Interest (AESI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '598', 'groupId': 'OG001'}, {'value': '1062', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG002', 'title': 'Alemtuzumab', 'description': "All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \\[NCT00050778\\], CAMMS323 \\[NCT00530348\\], and CAMMS324 \\[NCT00548405\\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'title': 'Hypersensitivity or anaphylaxis', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}, {'title': 'Pregnancy of a woman entered in the study', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}]}, {'title': 'Symptomatic overdose (serious or non-serious) with IMP', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Increase in ALT', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Autoimmune mediated conditions', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}, {'title': 'Hemophagocytic lymphohistiocytosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Progressive multifocal leukoencephalopathy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Temporally associated AEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Serious infections', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}, {'title': 'Malignancy', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Pneumonitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline until the end of the study (up to a maximum duration of 5.6 years)', 'description': 'Adverse events of special interest included the following: hypersensitivity or anaphylaxis; pregnancy of a woman entered in the study; symptomatic overdose (serious or non-serious) with investigational medicinal Product (IMP); increase in alanine transaminase (ALT); autoimmune mediated conditions; hemophagocytic lymphohistiocytosis; progressive multifocal leukoencephalopathy; temporally associated AEs; serious infections; malignancy; and pneumonitis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on safety population. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Potentially Clinically Significant Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '619', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG002', 'title': 'Alemtuzumab (Overall)', 'description': "All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \\[NCT00050778\\], CAMMS323 \\[NCT00530348\\], or CAMMS324 \\[NCT00548405\\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'title': 'Hb:<=115 g/L, <=95 g/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '619', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}, {'title': 'Hb: >=185 g/L, >=165 g/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '619', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Hb: DFB >=20 g/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '580', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}]}, {'title': 'Hematocrit: <= 0.37 v/v; <=0.32 v/v', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '617', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}]}, {'title': 'Hematocrit: >=0.55 v/v; >=0.5 v/v', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '617', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'RBCs: >=6 *10^12/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}, {'value': '618', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Platelets: <100 *10^9/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '615', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Platelets: >=700 *10^9/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}, {'value': '615', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline until the end of the study (up to a maximum duration of 5.6 years)', 'description': 'Criteria for potentially clinically significant laboratory abnormalities included:\n\n* Hemoglobin (Hb): less than or equal to (\\<=)115 grams per liter (g/L)(Male \\[M\\]), \\<= 95 g/L (Female\\[ F\\]); greater than or equal to (\\>=)185 g/L (M), \\>= 165 g/L (F); Decrease From Baseline (DFB) \\>= 20 g/L.\n* Hematocrit: \\<= 0.37 volume/volume (v/v) (M); \\<= 0.32 v/v (F); \\>= 0.55 v/v (M); \\>= 0.5 v/v (F).\n* Red Blood Cells (RBCs): \\>=6 \\*10\\^12/L.\n* Platelets: \\<100 \\*10\\^9/L; \\>=700 \\*10\\^9/L. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on all participants who had signed the ICF; and received study drug in the TOPAZ study; or in studies CAMMS223,CAMMS323,CAMMS324 or CAMMS03409, and did not complete 48 months of follow-up at the screening visit in the TOPAZ study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Annualized Relapse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '598', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'categories': [{'measurements': [{'value': '0.1994', 'groupId': 'OG000', 'lowerLimit': '0.1710', 'upperLimit': '0.2325'}, {'value': '0.1608', 'groupId': 'OG001', 'lowerLimit': '0.1418', 'upperLimit': '0.1823'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum duration of 5.6 years', 'description': 'Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. Annualized relapse rate was obtained from the total number of confirmed relapses that occurred during the treatment follow up time of all participants divided by the total years of follow-up for all participants. The annualized relapse rate was estimated using a negative binomial model with robust variance estimation.', 'unitOfMeasure': 'relapses per participant per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on efficacy population which included all enrolled participants who had received study drug in studies CAMMS223, CAMMS323, CAMMS324 or CAMMS03409. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Who Were Relapse Free', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '598', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'categories': [{'measurements': [{'value': '29.59', 'groupId': 'OG000', 'lowerLimit': '23.73', 'upperLimit': '35.65'}, {'value': '36.86', 'groupId': 'OG001', 'lowerLimit': '32.96', 'upperLimit': '40.76'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum duration of 5.6 years', 'description': 'Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. The proportion of participants who were relapse free (without event) were estimated using the Kaplan-Meier method.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '598', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '583', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.092', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.065', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '580', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.093', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.065', 'groupId': 'OG001'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '562', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.096', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.067', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '559', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.102', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.070', 'groupId': 'OG001'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '547', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.102', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.071', 'groupId': 'OG001'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '545', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.103', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.071', 'groupId': 'OG001'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '515', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.103', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '0.071', 'groupId': 'OG001'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '468', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.104', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.072', 'groupId': 'OG001'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '346', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.106', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.074', 'groupId': 'OG001'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.129', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.088', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60', 'description': 'EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It consists of 8 ordinal rating scales assessing seven functional systems (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other). EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicated worst outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT)."}, {'type': 'SECONDARY', 'title': 'Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) Lesions Per MRI Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '598', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'categories': [{'measurements': [{'value': '1.307', 'groupId': 'OG000', 'lowerLimit': '0.880', 'upperLimit': '1.941'}, {'value': '1.558', 'groupId': 'OG001', 'lowerLimit': '1.153', 'upperLimit': '2.105'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum duration of 5.6 years', 'description': 'Number of Gd-enhancing lesions per scan was defined as the total number of Gd-enhancing lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with generalized estimating equation (GEE) adjusted for analysis groups and geographic region as covariates.', 'unitOfMeasure': 'lesions per scan', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).'}, {'type': 'SECONDARY', 'title': 'Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '598', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'categories': [{'measurements': [{'value': '8.033', 'groupId': 'OG000', 'lowerLimit': '6.001', 'upperLimit': '10.753'}, {'value': '9.564', 'groupId': 'OG001', 'lowerLimit': '7.656', 'upperLimit': '11.946'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum duration of 5.6 years', 'description': 'Number of new or enlarged T2 lesions per scan was defined as the total number of new or enlarged T2 lesion that occurred during treatment period divided by the total number of scans performed during treatment period. The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with GEE adjusted for analysis groups and geographic region as covariates.', 'unitOfMeasure': 'lesions per scan', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).'}, {'type': 'SECONDARY', 'title': 'Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New T1 (and New Hypointense T1) Lesions Per MRI Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '598', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'categories': [{'measurements': [{'value': '1.719', 'groupId': 'OG000', 'lowerLimit': '1.141', 'upperLimit': '2.589'}, {'value': '1.908', 'groupId': 'OG001', 'lowerLimit': '1.386', 'upperLimit': '2.628'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum duration of 5.6 years', 'description': 'Number of new T1 lesions per scan was defined as the total number of new T1 lesion (and New Hypointense T1) that occurred during treatment period divided by the total number of scans performed during treatment period.The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with GEE adjusted for analysis groups and geographic region as covariates.', 'unitOfMeasure': 'lesions per scan', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).'}, {'type': 'SECONDARY', 'title': 'Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T1 Lesions at Months 12, 24, 36, 48, and 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '598', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '501', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '141.71', 'spread': '449.79', 'groupId': 'OG000'}, {'value': '64.73', 'spread': '241.92', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '489', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '130.73', 'spread': '398.65', 'groupId': 'OG000'}, {'value': '67.48', 'spread': '262.64', 'groupId': 'OG001'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '478', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '145.57', 'spread': '404.35', 'groupId': 'OG000'}, {'value': '104.41', 'spread': '524.62', 'groupId': 'OG001'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '421', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '163.30', 'spread': '461.38', 'groupId': 'OG000'}, {'value': '76.90', 'spread': '312.05', 'groupId': 'OG001'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '202.47', 'spread': '499.46', 'groupId': 'OG000'}, {'value': '93.61', 'spread': '260.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'The total lesion volume (T1 lesions) was measured by MRI scan.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was preformed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT)."}, {'type': 'SECONDARY', 'title': 'Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T2 Lesions at Months 12, 24, 36, 48, and 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '598', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '558', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.44', 'spread': '132.04', 'groupId': 'OG000'}, {'value': '9.09', 'spread': '62.52', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '542', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.53', 'spread': '76.73', 'groupId': 'OG000'}, {'value': '13.89', 'spread': '62.45', 'groupId': 'OG001'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '529', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.24', 'spread': '94.85', 'groupId': 'OG000'}, {'value': '22.02', 'spread': '111.95', 'groupId': 'OG001'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.98', 'spread': '80.06', 'groupId': 'OG000'}, {'value': '19.46', 'spread': '70.72', 'groupId': 'OG001'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.03', 'spread': '136.68', 'groupId': 'OG000'}, {'value': '17.95', 'spread': '75.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'The total lesion volume (T2 lesions) was measured by MRI scan.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT)."}, {'type': 'SECONDARY', 'title': 'Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Brain Parenchymal Fraction (BPF) at Month 12, 24, 36, 48, and 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '598', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '549', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.65', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '-1.49', 'spread': '1.55', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.77', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '-1.68', 'spread': '1.64', 'groupId': 'OG001'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '524', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.92', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '-1.84', 'spread': '1.71', 'groupId': 'OG001'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '459', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.02', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '-2.07', 'spread': '1.78', 'groupId': 'OG001'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.11', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '-2.37', 'spread': '1.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'The brain parenchymal fraction was measured by MRI scan.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT)."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Self-reported Quality of Life (QoL) as Assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Month 12, 24, 36, 48, and 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '598', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'title': 'PCS: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '559', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.54', 'spread': '9.38', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '8.72', 'groupId': 'OG001'}]}]}, {'title': 'PCS: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '545', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.20', 'spread': '9.25', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '9.10', 'groupId': 'OG001'}]}]}, {'title': 'PCS: Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.08', 'spread': '9.88', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '9.18', 'groupId': 'OG001'}]}]}, {'title': 'PCS: Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.52', 'spread': '10.15', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '9.57', 'groupId': 'OG001'}]}]}, {'title': 'PCS: Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.23', 'spread': '8.85', 'groupId': 'OG000'}, {'value': '1.28', 'spread': '8.88', 'groupId': 'OG001'}]}]}, {'title': 'MCS: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '559', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.21', 'spread': '12.29', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '11.24', 'groupId': 'OG001'}]}]}, {'title': 'MCS: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '545', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.21', 'spread': '12.23', 'groupId': 'OG000'}, {'value': '1.11', 'spread': '11.93', 'groupId': 'OG001'}]}]}, {'title': 'MCS: Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.55', 'spread': '12.23', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '11.88', 'groupId': 'OG001'}]}]}, {'title': 'MCS: Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.14', 'spread': '12.93', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '12.38', 'groupId': 'OG001'}]}]}, {'title': 'MCS: Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.94', 'spread': '14.01', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '11.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': "The MOS SF-36 is an extensively validated and widely used measure of QoL that assesses participants' perceptions of health status and its impact on their lives. It consisted of 36 items organized into 8 scales (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health). Two summary measures of physical and mental health, the PCS and MCS, respectively, were derived from scale aggregates, and were reported in this outcome measure. The score range for each of these 2 summary scores was from 0 (worst) to 100 (best), higher scores indicated better QoL.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT)."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Functional Assessment of Multiple Sclerosis (FAMS) Score at Month 12, 24, 36, 48, and 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '598', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '573', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.05', 'spread': '29.68', 'groupId': 'OG000'}, {'value': '2.83', 'spread': '27.07', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '551', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.45', 'spread': '30.30', 'groupId': 'OG000'}, {'value': '2.73', 'spread': '28.62', 'groupId': 'OG001'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.82', 'spread': '30.52', 'groupId': 'OG000'}, {'value': '2.70', 'spread': '28.94', 'groupId': 'OG001'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '472', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.73', 'spread': '31.46', 'groupId': 'OG000'}, {'value': '1.16', 'spread': '29.38', 'groupId': 'OG001'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.36', 'spread': '31.25', 'groupId': 'OG000'}, {'value': '2.74', 'spread': '26.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'The FAMS is a self-reported multidimensional index comprising a total 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). Each item (except those for "additional concerns") was rated on a 5-point scale of 0 (lower quality of life) to 4 (higher quality of life). Total FAMS score was the sum of 44 scored items, which ranged from 0 (poor) to 176 (best), with higher numbers reflecting a higher quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT)."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Score: Utility Scores at Month 12, 24, 36, 48, and 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '598', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '571', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '550', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '530', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'The EQ-5D is a generic, standardized instrument that provides a simple, descriptive profile and a single index value for health status used in the clinical and economic evaluation of health care as well as in population health surveys. The EQ-5D comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: some, moderate, and extreme problems. The 5 dimensional 3-level systems was converted into single index utility score ranges from 0 to 100, where 100=best health state; and 0=worst health state; higher scores indicated better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT)."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Scores at Month 12, 24, 36, 48, and 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '598', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '560', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.09', 'spread': '25.11', 'groupId': 'OG000'}, {'value': '-1.05', 'spread': '24.57', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '545', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.57', 'spread': '26.69', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '21.44', 'groupId': 'OG001'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '527', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.10', 'spread': '22.61', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '20.64', 'groupId': 'OG001'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.08', 'spread': '23.66', 'groupId': 'OG000'}, {'value': '-0.85', 'spread': '23.94', 'groupId': 'OG001'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.26', 'spread': '27.04', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '26.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': "EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0 to 100), where 0=worst imaginable health state to 100=best imaginable health state, and higher score indicated better outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT)."}, {'type': 'SECONDARY', 'title': 'Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '573', 'groupId': 'OG001'}, {'value': '1020', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG002', 'title': 'Alemtuzumab', 'description': "All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \\[NCT00050778\\], CAMMS323 \\[NCT00530348\\], or CAMMS324 \\[NCT00548405\\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'title': 'Employment situation change: Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '381', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Employment situation change: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '573', 'groupId': 'OG001'}, {'value': '1014', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}, {'title': 'Employment situation change: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '537', 'groupId': 'OG001'}, {'value': '960', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'Employment situation change: Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}, {'value': '929', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}, {'title': 'Employment situation change: Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}, {'value': '850', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Employment situation change: Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Had sick leaves: Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '265', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Had sick leaves: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}, {'value': '642', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}]}, {'title': 'Had sick leaves: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}, {'value': '645', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}]}, {'title': 'Had sick leaves: Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}, {'value': '584', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}]}, {'title': 'Had sick leaves: Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}, {'value': '565', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}, {'title': 'Had sick leaves: Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '266', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Had hospital admission: Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '337', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Had hospital admission: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '570', 'groupId': 'OG001'}, {'value': '1018', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}]}, {'title': 'Had hospital admission: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '544', 'groupId': 'OG001'}, {'value': '974', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG002'}]}]}, {'title': 'Had hospital admission: Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '522', 'groupId': 'OG001'}, {'value': '938', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}]}, {'title': 'Had hospital admission: Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '471', 'groupId': 'OG001'}, {'value': '859', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}]}, {'title': 'Had hospital admission: Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '374', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'Had spent time in rehabilitation center: Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}, {'value': '334', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Had spent time in rehabilitation center: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '573', 'groupId': 'OG001'}, {'value': '1020', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}, {'title': 'Had spent time in rehabilitation center: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '540', 'groupId': 'OG001'}, {'value': '968', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}, {'title': 'Had spent time in rehabilitation center: Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '532', 'groupId': 'OG001'}, {'value': '946', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': 'Had spent time in rehabilitation center: Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '474', 'groupId': 'OG001'}, {'value': '864', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}, {'title': 'Had spent time in rehabilitation center: Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '374', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Had spent time in a nursing home: Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '332', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Had spent time in a nursing home: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '572', 'groupId': 'OG001'}, {'value': '1019', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Had spent time in a nursing home: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '545', 'groupId': 'OG001'}, {'value': '972', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Had spent time in a nursing home: Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '523', 'groupId': 'OG001'}, {'value': '938', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Had spent time in a nursing home: Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '472', 'groupId': 'OG001'}, {'value': '860', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Had spent time in a nursing home: Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '369', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRUQ) designed to evaluate the economic impact of MS. Questionnaire addresses the following content areas: employment situation and changes in employment situation due to MS;sick leaves,admissions and stays in hospital, rehabilitation centers, or nursing homes; typical MS-related investments (eg, stair and bed lift, ramps,rails) and devices (eg,walking aids,wheelchairs); assistance by community or social services (e.g. home nurse, transportation), or help from family or friends. Each question requires a binary answer (yes/no). Number of participants who reported "Yes" as an answer to "employment situation change; had sick leaves; had hospital admission; had spent time in rehabilitation center and had spent time in a nursing home or a similar institution" questions were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT)."}, {'type': 'SECONDARY', 'title': 'Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '573', 'groupId': 'OG001'}, {'value': '1020', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG002', 'title': 'Alemtuzumab', 'description': "All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \\[NCT00050778\\], CAMMS323 \\[NCT00530348\\], or CAMMS324 \\[NCT00548405\\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'title': 'Had made changes to your house, apartment, car: Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '339', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Had made changes to your house, apartment, car: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '571', 'groupId': 'OG001'}, {'value': '1020', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Had made changes to your house, apartment, car: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '544', 'groupId': 'OG001'}, {'value': '972', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'Had made changes to your house, apartment, car: Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '527', 'groupId': 'OG001'}, {'value': '944', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}, {'title': 'Had made changes to your house, apartment, car: Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '472', 'groupId': 'OG001'}, {'value': '859', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Had made changes to your house, apartment, car: Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '372', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Had required assistance: Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '335', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Had required assistance: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '573', 'groupId': 'OG001'}, {'value': '1015', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}]}, {'title': 'Had required assistance: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}, {'value': '962', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}]}, {'title': 'Had required assistance: Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '522', 'groupId': 'OG001'}, {'value': '937', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}]}, {'title': 'Had required assistance: Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '466', 'groupId': 'OG001'}, {'value': '852', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}]}, {'title': 'Had required assistance: Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '369', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Had required other assistance: Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '335', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}]}, {'title': 'Had required other assistance: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '572', 'groupId': 'OG001'}, {'value': '1011', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '252', 'groupId': 'OG002'}]}]}, {'title': 'Had required other assistance: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '530', 'groupId': 'OG001'}, {'value': '958', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '241', 'groupId': 'OG002'}]}]}, {'title': 'Had required other assistance: Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '523', 'groupId': 'OG001'}, {'value': '936', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}]}]}, {'title': 'Had required other assistance: Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}, {'value': '848', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}]}, {'title': 'Had required other assistance: Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRUQ) designed to evaluate the economic impact of MS.Questionnaire addresses following content areas: employment situation and changes in employment situation due to MS; admissions and stays in hospital, rehabilitation centers, or nursing homes; typical MS-related investments(e.g.stair and bed lift,ramps,rails) and devices(e.g.walking aids,wheelchairs);assistance by community or social services(e.g.home nurse, transportation), or help from family or friends. Each question requires a binary answer (yes/no). Number of participants who reported other changes/changes in lifestyle due to MS, i.e."Yes" as an answer to "had made changes to your house, apartment, car or did you require any special equipment or aids; assistance required; other assistance required" questions were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT)."}, {'type': 'SECONDARY', 'title': 'Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '575', 'groupId': 'OG001'}, {'value': '1025', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG002', 'title': 'Alemtuzumab', 'description': "All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \\[NCT00050778\\], CAMMS323 \\[NCT00530348\\], or CAMMS324 \\[NCT00548405\\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'title': 'Full time: Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '575', 'groupId': 'OG001'}, {'value': '1025', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}, {'value': '528', 'groupId': 'OG002'}]}]}, {'title': 'Part time: Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '575', 'groupId': 'OG001'}, {'value': '1025', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}]}, {'title': 'Not employed: Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '575', 'groupId': 'OG001'}, {'value': '1025', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '399', 'groupId': 'OG002'}]}]}, {'title': 'Full time: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '569', 'groupId': 'OG001'}, {'value': '1013', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}, {'value': '511', 'groupId': 'OG002'}]}]}, {'title': 'Part time: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '569', 'groupId': 'OG001'}, {'value': '1013', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}]}, {'title': 'Not employed: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '569', 'groupId': 'OG001'}, {'value': '1013', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}, {'value': '398', 'groupId': 'OG002'}]}]}, {'title': 'Full time: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '549', 'groupId': 'OG001'}, {'value': '980', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '488', 'groupId': 'OG002'}]}]}, {'title': 'Part time: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '549', 'groupId': 'OG001'}, {'value': '980', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}]}, {'title': 'Not employed: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '549', 'groupId': 'OG001'}, {'value': '980', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '375', 'groupId': 'OG002'}]}]}, {'title': 'Full time: Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '530', 'groupId': 'OG001'}, {'value': '943', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '478', 'groupId': 'OG002'}]}]}, {'title': 'Part time: Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '530', 'groupId': 'OG001'}, {'value': '943', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}]}, {'title': 'Not employed: Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '530', 'groupId': 'OG001'}, {'value': '943', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}, {'value': '357', 'groupId': 'OG002'}]}]}, {'title': 'Full time: Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}, {'value': '860', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}, {'value': '424', 'groupId': 'OG002'}]}]}, {'title': 'Part time: Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}, {'value': '860', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}]}]}, {'title': 'Not employed: Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}, {'value': '860', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}, {'value': '333', 'groupId': 'OG002'}]}]}, {'title': 'Full time: Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '374', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}]}]}, {'title': 'Part time: Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '374', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}, {'title': 'Not employed: Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}, {'value': '374', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Current employment status of participants (i.e. Part Time/Full Time/Not Employed) was reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT)."}, {'type': 'SECONDARY', 'title': 'HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}, {'value': '675', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG002', 'title': 'Alemtuzumab', 'description': "All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \\[NCT00050778\\], CAMMS323 \\[NCT00530348\\], or CAMMS324 \\[NCT00548405\\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'title': 'Total scheduled working hours: Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '374', 'groupId': 'OG001'}, {'value': '660', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.0', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '32.2', 'spread': '16.1', 'groupId': 'OG001'}, {'value': '32.9', 'spread': '16.1', 'groupId': 'OG002'}]}]}, {'title': 'Total scheduled working hours: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}, {'value': '675', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.6', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '32.3', 'spread': '16.6', 'groupId': 'OG001'}, {'value': '32.5', 'spread': '16.6', 'groupId': 'OG002'}]}]}, {'title': 'Total scheduled working hours: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}, {'value': '647', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.2', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '30.8', 'spread': '16.1', 'groupId': 'OG001'}, {'value': '31.6', 'spread': '16.1', 'groupId': 'OG002'}]}]}, {'title': 'Total scheduled working hours: Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}, {'value': '615', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.6', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '33.1', 'spread': '15.1', 'groupId': 'OG001'}, {'value': '33.3', 'spread': '15.3', 'groupId': 'OG002'}]}]}, {'title': 'Total scheduled working hours: Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}, {'value': '559', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.4', 'spread': '19.7', 'groupId': 'OG000'}, {'value': '31.3', 'spread': '16.3', 'groupId': 'OG001'}, {'value': '32.9', 'spread': '17.0', 'groupId': 'OG002'}]}]}, {'title': 'Total scheduled working hours: Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.3', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '31.1', 'spread': '15.8', 'groupId': 'OG001'}, {'value': '31.1', 'spread': '16.6', 'groupId': 'OG002'}]}]}, {'title': 'Number of hours missed from work: Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.8', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '15.0', 'groupId': 'OG001'}, {'value': '11.7', 'spread': '12.8', 'groupId': 'OG002'}]}]}, {'title': 'Number of hours missed from work: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '12.2', 'groupId': 'OG001'}, {'value': '9.0', 'spread': '10.2', 'groupId': 'OG002'}]}]}, {'title': 'Number of hours missed from work: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '11.3', 'groupId': 'OG001'}, {'value': '10.4', 'spread': '10.9', 'groupId': 'OG002'}]}]}, {'title': 'Number of hours missed from work: Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.3', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '24.7', 'spread': '65.4', 'groupId': 'OG001'}, {'value': '18.7', 'spread': '50.8', 'groupId': 'OG002'}]}]}, {'title': 'Number of hours missed from work: Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.5', 'spread': '23.1', 'groupId': 'OG000'}, {'value': '37.7', 'spread': '107.6', 'groupId': 'OG001'}, {'value': '28.0', 'spread': '77.1', 'groupId': 'OG002'}]}]}, {'title': 'Number of hours missed from work: Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.5', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '13.4', 'spread': '13.4', 'groupId': 'OG001'}, {'value': '13.9', 'spread': '13.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Data for "total scheduled working hours of participants; number of hours missed from work by participants due to MS" were reported in this outcome measure.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT)."}, {'type': 'SECONDARY', 'title': 'HRPQ: Percentage Impact on Work Output Due to Multiple Sclerosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '622', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG002', 'title': 'Alemtuzumab (Overall)', 'description': "All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \\[NCT00050778\\], CAMMS323 \\[NCT00530348\\], or CAMMS324 \\[NCT00548405\\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'title': 'Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}, {'value': '622', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.2', 'spread': '14.4', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '22.3', 'groupId': 'OG001'}, {'value': '8.5', 'spread': '19.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}, {'value': '622', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.7', 'spread': '18.0', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '21.5', 'groupId': 'OG001'}, {'value': '9.0', 'spread': '20.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}, {'value': '596', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.9', 'spread': '20.4', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '21.2', 'groupId': 'OG001'}, {'value': '9.8', 'spread': '21.3', 'groupId': 'OG002'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '571', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '20.0', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '21.3', 'groupId': 'OG001'}, {'value': '9.4', 'spread': '19.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}, {'value': '525', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.2', 'spread': '25.4', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '21.7', 'groupId': 'OG001'}, {'value': '9.7', 'spread': '22.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.7', 'spread': '22.3', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '18.9', 'groupId': 'OG001'}, {'value': '9.2', 'spread': '19.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Percentage impact on work output due to MS were reported in this outcome measure.', 'unitOfMeasure': 'percentage impact on work output', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT)."}, {'type': 'SECONDARY', 'title': 'HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '562', 'groupId': 'OG001'}, {'value': '1004', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG002', 'title': 'Alemtuzumab', 'description': "All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \\[NCT00050778\\], CAMMS323 \\[NCT00530348\\], or CAMMS324 \\[NCT00548405\\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'title': 'Total scheduled household chores hours: Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '558', 'groupId': 'OG001'}, {'value': '993', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.8', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '11.0', 'groupId': 'OG001'}, {'value': '10.8', 'spread': '10.6', 'groupId': 'OG002'}]}]}, {'title': 'Total scheduled household chores hours: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '562', 'groupId': 'OG001'}, {'value': '1004', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.3', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '11.1', 'spread': '11.7', 'groupId': 'OG001'}, {'value': '10.9', 'spread': '11.5', 'groupId': 'OG002'}]}]}, {'title': 'Total scheduled household chores hours: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '538', 'groupId': 'OG001'}, {'value': '954', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.2', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '10.9', 'spread': '11.4', 'groupId': 'OG001'}, {'value': '10.6', 'spread': '11.4', 'groupId': 'OG002'}]}]}, {'title': 'Total scheduled household chores hours: Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '505', 'groupId': 'OG001'}, {'value': '899', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.7', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '13.1', 'groupId': 'OG001'}, {'value': '11.0', 'spread': '12.1', 'groupId': 'OG002'}]}]}, {'title': 'Total scheduled household chores hours: Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '452', 'groupId': 'OG001'}, {'value': '825', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.9', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '10.6', 'groupId': 'OG001'}, {'value': '10.3', 'spread': '10.3', 'groupId': 'OG002'}]}]}, {'title': 'Total scheduled household chores hours: Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '363', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.4', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '11.1', 'groupId': 'OG001'}, {'value': '11.5', 'spread': '12.6', 'groupId': 'OG002'}]}]}, {'title': 'Number of hours missed from household chores: Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '6.9', 'groupId': 'OG001'}, {'value': '6.0', 'spread': '5.9', 'groupId': 'OG002'}]}]}, {'title': 'Number of hours missed from household chores: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '173', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '7.7', 'groupId': 'OG001'}, {'value': '6.2', 'spread': '6.6', 'groupId': 'OG002'}]}]}, {'title': 'Number of hours missed from household chores: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '10.6', 'groupId': 'OG001'}, {'value': '6.6', 'spread': '9.3', 'groupId': 'OG002'}]}]}, {'title': 'Number of hours missed from household chores: Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.1', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '14.2', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '11.7', 'groupId': 'OG002'}]}]}, {'title': 'Number of hours missed from household chores: Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '10.6', 'groupId': 'OG001'}, {'value': '5.7', 'spread': '8.4', 'groupId': 'OG002'}]}]}, {'title': 'Number of hours missed from household chores: Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '5.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Data for "total scheduled household chores hours; number of hours missed from planned household chores by participants due to MS" were reported in this outcome measure.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on efficacy population.Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT)."}, {'type': 'SECONDARY', 'title': 'HRPQ: Percentage Impact on Work Output for Household Chores Due to Multiple Sclerosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '531', 'groupId': 'OG001'}, {'value': '947', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG002', 'title': 'Alemtuzumab', 'description': "All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \\[NCT00050778\\], CAMMS323 \\[NCT00530348\\], or CAMMS324 \\[NCT00548405\\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'title': 'Month 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '531', 'groupId': 'OG001'}, {'value': '947', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16.0', 'spread': '23.8', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '26.0', 'groupId': 'OG001'}, {'value': '16.8', 'spread': '25.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '524', 'groupId': 'OG001'}, {'value': '931', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.3', 'spread': '27.3', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '26.6', 'groupId': 'OG001'}, {'value': '17.7', 'spread': '27.5', 'groupId': 'OG002'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '501', 'groupId': 'OG001'}, {'value': '886', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.3', 'spread': '28.5', 'groupId': 'OG000'}, {'value': '18.5', 'spread': '27.4', 'groupId': 'OG001'}, {'value': '19.4', 'spread': '28.1', 'groupId': 'OG002'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}, {'value': '813', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17.5', 'spread': '25.9', 'groupId': 'OG000'}, {'value': '16.5', 'spread': '26.2', 'groupId': 'OG001'}, {'value': '17.6', 'spread': '26.6', 'groupId': 'OG002'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}, {'value': '769', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.8', 'spread': '28.8', 'groupId': 'OG000'}, {'value': '17.0', 'spread': '26.8', 'groupId': 'OG001'}, {'value': '18.6', 'spread': '27.7', 'groupId': 'OG002'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '344', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.8', 'spread': '28.3', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '22.9', 'groupId': 'OG001'}, {'value': '14.8', 'spread': '25.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Percentage impact on work output for household chores due to MS were reported in this outcome measure.', 'unitOfMeasure': 'percentage impact on work output', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT)."}, {'type': 'SECONDARY', 'title': 'HRPQ: Duration of Disease (in Months) Since Development of Multiple Sclerosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '559', 'groupId': 'OG001'}, {'value': '997', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG002', 'title': 'Alemtuzumab', 'description': "All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \\[NCT00050778\\], CAMMS323 \\[NCT00530348\\], or CAMMS324 \\[NCT00548405\\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '5.0', 'groupId': 'OG001'}, {'value': '10.5', 'spread': '4.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to end of the study (up to a maximum duration of 5.6 years)', 'description': 'Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Mean and standard deviation data for duration of MS disease (in months) since the start of MS development in participants was reported in this outcome measure.', 'unitOfMeasure': 'months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT)."}, {'type': 'SECONDARY', 'title': 'HRPQ: Number of Participants Who Reported Impact on Work Due to Multiple Sclerosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '709', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Alemtuzumab Treatment (DAT)', 'description': "Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG001', 'title': 'Initial Alemtuzumab Treatment (IAT)', 'description': "Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}, {'id': 'OG002', 'title': 'Alemtuzumab', 'description': "All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \\[NCT00050778\\], CAMMS323 \\[NCT00530348\\], or CAMMS324 \\[NCT00548405\\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'classes': [{'title': 'My MS or treatments forced me to work part-time when I wanted to work full-time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}]}, {'title': 'My MS or treatments kept me from having a job when I wanted to work full-time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}]}, {'title': 'My MS or treatments kept me from having a job when I wanted to work part-time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}]}, {'title': 'None of the above', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '709', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}, {'value': '709', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of the study (up to a maximum duration of 5.6 years)', 'description': 'Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Number of participants who reported "Yes" as an answer to questions related to impact on work: "forced me to work part-time when I wanted to work full-time; kept me from having a job when I wanted to work full-time; kept me from having a job when I wanted to work part-time; none of the above" questions were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT)."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alemtuzumab', 'description': "All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \\[NCT00050778\\], CAMMS323 \\[NCT00530348\\], or CAMMS324 \\[NCT00548405\\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 milligram per day (mg/day) for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1062'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '592'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '470'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Poor compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'Due to Coronavirus Disease (Covid-19)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '300'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '126'}]}]}], 'recruitmentDetails': 'The study was conducted at 142 study centers in 21 countries. A total of 1062 participants were screened between 7 January 2015 and 28 June 2016 and were enrolled in this current study (LPS13649 \\[TOPAZ\\]).', 'preAssignmentDetails': 'Subgroup analysis (\\[Delayed Alemtuzumab Treatment\\[DAT\\] \\& Immediate Alemtuzumab Treatment\\[IAT\\]subgroup) was performed only for outcome measures and safety analysis. Participants who rolled over from CAMMS223(NCT00050778) to CAMMS03409 (NCT00930553),then subsequently enrolled and took 24 mg alemtuzumab in CAMMS324 (NCT00548405) study, were not considered as part of DAT or IAT subgroup \\& included in overall group only. Participant flow and Baseline analysis was performed on overall population only.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1062', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Alemtuzumab', 'description': "All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \\[NCT00050778\\], CAMMS323 \\[NCT00530348\\], or CAMMS324 \\[NCT00548405\\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649)."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.2', 'spread': '8.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '686', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '376', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '988', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'American Indian or Alaska native', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on all enrolled participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-28', 'size': 868010, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-30T04:53', 'hasProtocol': True}, {'date': '2020-03-09', 'size': 612376, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-30T04:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1062}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-21', 'studyFirstSubmitDate': '2014-09-30', 'resultsFirstSubmitDate': '2021-06-30', 'studyFirstSubmitQcDate': '2014-09-30', 'lastUpdatePostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-30', 'studyFirstPostDateStruct': {'date': '2014-10-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From Baseline until the end of the study (up to a maximum duration of 5.6 years)', 'description': "An Adverse Event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed/worsened during the 'treatment period (time from Baseline until the end of the study LPS13649 \\[i.e. up to a maximum of 5.6 years\\]). Serious adverse events (SAEs) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event."}, {'measure': 'Number of Participants With Infusion-Associated Reactions (IAR)', 'timeFrame': 'Within 24 hours of any alemtuzumab infusion', 'description': 'Infusion-associated reactions (IAR) was defined as any adverse event occurring during and within 24 hours of alemtuzumab infusion.'}, {'measure': 'Number of Participants With Adverse Events of Special Interest (AESI)', 'timeFrame': 'From Baseline until the end of the study (up to a maximum duration of 5.6 years)', 'description': 'Adverse events of special interest included the following: hypersensitivity or anaphylaxis; pregnancy of a woman entered in the study; symptomatic overdose (serious or non-serious) with investigational medicinal Product (IMP); increase in alanine transaminase (ALT); autoimmune mediated conditions; hemophagocytic lymphohistiocytosis; progressive multifocal leukoencephalopathy; temporally associated AEs; serious infections; malignancy; and pneumonitis.'}, {'measure': 'Number of Participants With Potentially Clinically Significant Laboratory Abnormalities', 'timeFrame': 'From Baseline until the end of the study (up to a maximum duration of 5.6 years)', 'description': 'Criteria for potentially clinically significant laboratory abnormalities included:\n\n* Hemoglobin (Hb): less than or equal to (\\<=)115 grams per liter (g/L)(Male \\[M\\]), \\<= 95 g/L (Female\\[ F\\]); greater than or equal to (\\>=)185 g/L (M), \\>= 165 g/L (F); Decrease From Baseline (DFB) \\>= 20 g/L.\n* Hematocrit: \\<= 0.37 volume/volume (v/v) (M); \\<= 0.32 v/v (F); \\>= 0.55 v/v (M); \\>= 0.5 v/v (F).\n* Red Blood Cells (RBCs): \\>=6 \\*10\\^12/L.\n* Platelets: \\<100 \\*10\\^9/L; \\>=700 \\*10\\^9/L. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).'}], 'secondaryOutcomes': [{'measure': 'Annualized Relapse Rate', 'timeFrame': 'Up to a maximum duration of 5.6 years', 'description': 'Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. Annualized relapse rate was obtained from the total number of confirmed relapses that occurred during the treatment follow up time of all participants divided by the total years of follow-up for all participants. The annualized relapse rate was estimated using a negative binomial model with robust variance estimation.'}, {'measure': 'Proportion of Participants Who Were Relapse Free', 'timeFrame': 'Up to a maximum duration of 5.6 years', 'description': 'Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. The proportion of participants who were relapse free (without event) were estimated using the Kaplan-Meier method.'}, {'measure': 'Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60', 'description': 'EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It consists of 8 ordinal rating scales assessing seven functional systems (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other). EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicated worst outcomes.'}, {'measure': 'Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) Lesions Per MRI Scan', 'timeFrame': 'Up to a maximum duration of 5.6 years', 'description': 'Number of Gd-enhancing lesions per scan was defined as the total number of Gd-enhancing lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with generalized estimating equation (GEE) adjusted for analysis groups and geographic region as covariates.'}, {'measure': 'Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan', 'timeFrame': 'Up to a maximum duration of 5.6 years', 'description': 'Number of new or enlarged T2 lesions per scan was defined as the total number of new or enlarged T2 lesion that occurred during treatment period divided by the total number of scans performed during treatment period. The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with GEE adjusted for analysis groups and geographic region as covariates.'}, {'measure': 'Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New T1 (and New Hypointense T1) Lesions Per MRI Scan', 'timeFrame': 'Up to a maximum duration of 5.6 years', 'description': 'Number of new T1 lesions per scan was defined as the total number of new T1 lesion (and New Hypointense T1) that occurred during treatment period divided by the total number of scans performed during treatment period.The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with GEE adjusted for analysis groups and geographic region as covariates.'}, {'measure': 'Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T1 Lesions at Months 12, 24, 36, 48, and 60', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'The total lesion volume (T1 lesions) was measured by MRI scan.'}, {'measure': 'Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T2 Lesions at Months 12, 24, 36, 48, and 60', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'The total lesion volume (T2 lesions) was measured by MRI scan.'}, {'measure': 'Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Brain Parenchymal Fraction (BPF) at Month 12, 24, 36, 48, and 60', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'The brain parenchymal fraction was measured by MRI scan.'}, {'measure': 'Change From Baseline in Self-reported Quality of Life (QoL) as Assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Month 12, 24, 36, 48, and 60', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': "The MOS SF-36 is an extensively validated and widely used measure of QoL that assesses participants' perceptions of health status and its impact on their lives. It consisted of 36 items organized into 8 scales (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health). Two summary measures of physical and mental health, the PCS and MCS, respectively, were derived from scale aggregates, and were reported in this outcome measure. The score range for each of these 2 summary scores was from 0 (worst) to 100 (best), higher scores indicated better QoL."}, {'measure': 'Change From Baseline in Functional Assessment of Multiple Sclerosis (FAMS) Score at Month 12, 24, 36, 48, and 60', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'The FAMS is a self-reported multidimensional index comprising a total 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). Each item (except those for "additional concerns") was rated on a 5-point scale of 0 (lower quality of life) to 4 (higher quality of life). Total FAMS score was the sum of 44 scored items, which ranged from 0 (poor) to 176 (best), with higher numbers reflecting a higher quality of life.'}, {'measure': 'Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Score: Utility Scores at Month 12, 24, 36, 48, and 60', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'The EQ-5D is a generic, standardized instrument that provides a simple, descriptive profile and a single index value for health status used in the clinical and economic evaluation of health care as well as in population health surveys. The EQ-5D comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: some, moderate, and extreme problems. The 5 dimensional 3-level systems was converted into single index utility score ranges from 0 to 100, where 100=best health state; and 0=worst health state; higher scores indicated better outcome.'}, {'measure': 'Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Scores at Month 12, 24, 36, 48, and 60', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': "EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0 to 100), where 0=worst imaginable health state to 100=best imaginable health state, and higher score indicated better outcome."}, {'measure': 'Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRUQ) designed to evaluate the economic impact of MS. Questionnaire addresses the following content areas: employment situation and changes in employment situation due to MS;sick leaves,admissions and stays in hospital, rehabilitation centers, or nursing homes; typical MS-related investments (eg, stair and bed lift, ramps,rails) and devices (eg,walking aids,wheelchairs); assistance by community or social services (e.g. home nurse, transportation), or help from family or friends. Each question requires a binary answer (yes/no). Number of participants who reported "Yes" as an answer to "employment situation change; had sick leaves; had hospital admission; had spent time in rehabilitation center and had spent time in a nursing home or a similar institution" questions were reported in this outcome measure.'}, {'measure': 'Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRUQ) designed to evaluate the economic impact of MS.Questionnaire addresses following content areas: employment situation and changes in employment situation due to MS; admissions and stays in hospital, rehabilitation centers, or nursing homes; typical MS-related investments(e.g.stair and bed lift,ramps,rails) and devices(e.g.walking aids,wheelchairs);assistance by community or social services(e.g.home nurse, transportation), or help from family or friends. Each question requires a binary answer (yes/no). Number of participants who reported other changes/changes in lifestyle due to MS, i.e."Yes" as an answer to "had made changes to your house, apartment, car or did you require any special equipment or aids; assistance required; other assistance required" questions were reported in this outcome measure.'}, {'measure': 'Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Current employment status of participants (i.e. Part Time/Full Time/Not Employed) was reported in this outcome measure.'}, {'measure': 'HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Data for "total scheduled working hours of participants; number of hours missed from work by participants due to MS" were reported in this outcome measure.'}, {'measure': 'HRPQ: Percentage Impact on Work Output Due to Multiple Sclerosis', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Percentage impact on work output due to MS were reported in this outcome measure.'}, {'measure': 'HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Data for "total scheduled household chores hours; number of hours missed from planned household chores by participants due to MS" were reported in this outcome measure.'}, {'measure': 'HRPQ: Percentage Impact on Work Output for Household Chores Due to Multiple Sclerosis', 'timeFrame': 'Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60', 'description': 'Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Percentage impact on work output for household chores due to MS were reported in this outcome measure.'}, {'measure': 'HRPQ: Duration of Disease (in Months) Since Development of Multiple Sclerosis', 'timeFrame': 'Baseline up to end of the study (up to a maximum duration of 5.6 years)', 'description': 'Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Mean and standard deviation data for duration of MS disease (in months) since the start of MS development in participants was reported in this outcome measure.'}, {'measure': 'HRPQ: Number of Participants Who Reported Impact on Work Due to Multiple Sclerosis', 'timeFrame': 'Baseline up to end of the study (up to a maximum duration of 5.6 years)', 'description': 'Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Number of participants who reported "Yes" as an answer to questions related to impact on work: "forced me to work part-time when I wanted to work full-time; kept me from having a job when I wanted to work full-time; kept me from having a job when I wanted to work part-time; none of the above" questions were reported in this outcome measure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsing Remitting Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '39935588', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '37745914', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34882037', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34378446', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '33476880', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '32710396', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '32583052', 'type': 'DERIVED', 'citation': 'Steingo B, Al Malik Y, Bass AD, Berkovich R, Carraro M, Fernandez O, Ionete C, Massacesi L, Meuth SG, Mitsikostas DD, Pardo G, Simm RF, Traboulsee A, Choudhry Z, Daizadeh N, Compston DAS; CAMMS223, CAMMS03409, and TOPAZ Investigators. Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223. J Neurol. 2020 Nov;267(11):3343-3353. doi: 10.1007/s00415-020-09983-1. Epub 2020 Jun 24.'}, {'pmid': '31762387', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '31654272', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo evaluate long-term safety of alemtuzumab.\n\nSecondary Objectives:\n\n* To evaluate long term efficacy of alemtuzumab.\n* To evaluate the safety profile of participants who received other Disease Modifying Treatment (DMT) following alemtuzumab treatment.\n* To evaluate participant-reported Quality of Life (QoL) outcomes and health resource utilization of participant who received alemtuzumab.\n* To evaluate as needed re-treatment with alemtuzumab and other DMTs.', 'detailedDescription': "The total duration per participants was up to 5.6 years.\n\nAs per Study Investigator discretion, participants can be treated with additional courses of alemtuzumab or any commercialized DMTs.\n\nAll participants who completed CAMMS03409 were allowed into the study, which might include specific vulnerable populations. If the investigator decided to treat a participant with a course of alemtuzumab, appropriate cautionary measures were applied as indicated in the approved labelling, or, in ex-European Union countries where Lemtrada was not approved, according to the investigator's brochure."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\nParticipant had completed at least 48 months of the Extension Study CAMMS03409. Signed written informed consent form.\n\nExclusion criteria:\n\nParticipant participating in another investigational interventional study.\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT02255656', 'acronym': 'TOPAZ', 'briefTitle': 'Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)', 'orgStudyIdInfo': {'id': 'LPS13649'}, 'secondaryIdInfos': [{'id': '2013-003884-71'}, {'id': 'U1111-1148-2987', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alemtuzumab', 'description': "All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \\[NCT00050778\\], CAMMS323 \\[NCT00530348\\], or CAMMS324 \\[NCT00548405\\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 milligram per day (mg/day) for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).", 'interventionNames': ['Drug: alemtuzumab GZ402673']}], 'interventions': [{'name': 'alemtuzumab GZ402673', 'type': 'DRUG', 'description': 'Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous', 'armGroupLabels': ['Alemtuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00000', 'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site Number 1086', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 1031', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 1171', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 1090', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 1040', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 1152', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 1093', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 1027', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 1078', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 1059', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 1173', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33351', 'city': 'Sunrise', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 1034', 'geoPoint': {'lat': 26.13397, 'lon': -80.1131}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 1005', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 1049', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60062', 'city': 'Northbrook', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 1008', 'geoPoint': {'lat': 42.12753, 'lon': -87.82895}}, {'zip': '46845', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigational Site Number 1001', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigational Site Number 1024', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Investigational Site Number 1017', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Investigational Site Number 1022', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '66214', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'Investigational Site Number 1083', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '40513', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Investigational Site Number 1039', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Investigational Site Number 1021', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02481', 'city': 'Wellesley', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Investigational Site Number 1061', 'geoPoint': {'lat': 42.29649, 'lon': -71.29256}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Investigational Site Number 1028', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48105-2945', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 1025', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 1020', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49684', 'city': 'Traverse City', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 1054', 'geoPoint': {'lat': 44.76306, 'lon': -85.62063}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site Number 1084', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site Number 1092', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Investigational Site Number 1073', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Investigational Site Number 1014', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 1081', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 1026', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11772', 'city': 'Patchogue', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 1160', 'geoPoint': {'lat': 40.76565, 'lon': -73.01511}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 1015', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '13202', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 1053', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 1095', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 1082', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site Number 1035', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44685', 'city': 'Uniontown', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site Number 1058', 'geoPoint': {'lat': 40.97506, 'lon': -81.40817}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Investigational Site Number 1067', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigational Site Number 1097', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Investigational Site Number 1057', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '38018', 'city': 'Cordova', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site Number 1163', 'geoPoint': {'lat': 35.15565, 'lon': -89.7762}}, {'zip': '37064', 'city': 'Franklin', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site Number 1055', 'geoPoint': {'lat': 35.92506, 'lon': -86.86889}}, {'zip': '37922', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site Number 1009', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site Number 1042', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 1018', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78681', 'city': 'Round Rock', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 1002', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigational Site Number 1046', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22182', 'city': 'Vienna', 'state': 'Virginia', 'country': 'United States', 'facility': 'Investigational Site Number 1037', 'geoPoint': {'lat': 38.90122, 'lon': 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{'lat': 50.53596, 'lon': 5.56775}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Investigational Site Number 5001', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '90110000', 'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Investigational Site Number 3006', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '52010-040', 'city': 'Recife', 'country': 'Brazil', 'facility': 'Investigational Site Number 3002', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'zip': '01221-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Investigational Site Number 3001', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05403-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Investigational Site Number 3003', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'T2N 2T9', 'city': 'Calgary', 'country': 'Canada', 'facility': 'Investigational Site Number 1102', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'J8Y1W2', 'city': 'Gatineau', 'country': 'Canada', 'facility': 'Investigational Site Number 1105', 'geoPoint': {'lat': 45.47723, 'lon': -75.70164}}, {'zip': 'J4V2J2', 'city': 'Greenfield Park', 'country': 'Canada', 'facility': 'Investigational Site Number 1104', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'K7L2V7', 'city': 'Kingston', 'country': 'Canada', 'facility': 'Investigational Site Number 1109', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'N6A5A5', 'city': 'London', 'country': 'Canada', 'facility': 'Investigational Site Number 1110', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1H8L6', 'city': 'Ottawa', 'country': 'Canada', 'facility': 'Investigational Site Number 1101', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'V6T1Z3', 'city': 'Vancouver', 'country': 'Canada', 'facility': 'Investigational Site Number 1106', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': '65691', 'city': 'Brno', 'country': 'Czechia', 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{'lat': 52.52437, 'lon': 13.41053}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Investigational Site Number 4607', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Investigational Site Number 4634', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '22307', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Investigational Site Number 4622', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Investigational Site Number 4605', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '16761', 'city': 'Hennigsdorf', 'country': 'Germany', 'facility': 'Investigational Site Number 4609', 'geoPoint': {'lat': 52.63598, 'lon': 13.20419}}, {'zip': '81675', 'city': 'München', 'country': 'Germany', 'facility': 'Investigational Site Number 4608', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '18147', 'city': 'Rostock', 'country': 'Germany', 'facility': 'Investigational Site Number 4610', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': '04779', 'city': 'Wermsdorf', 'country': 'Germany', 'facility': 'Investigational Site Number 4613', 'geoPoint': {'lat': 51.28333, 'lon': 12.95}}, {'zip': '52621', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Investigational Site Number 5501', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Investigational Site Number 5505', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '09126', 'city': 'Cagliari', 'country': 'Italy', 'facility': 'Investigational Site Number 4112', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'zip': '21013', 'city': 'Gallarate (VA)', 'country': 'Italy', 'facility': 'Investigational Site Number 4102', 'geoPoint': {'lat': 45.66019, 'lon': 8.79164}}, {'zip': '10043', 'city': 'Orbassano (TO)', 'country': 'Italy', 'facility': 'Investigational Site 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'Investigational Site Number 6102', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'city': 'Kiev', 'country': 'Ukraine', 'facility': 'Investigational Site Number 6104', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Lviv', 'country': 'Ukraine', 'facility': 'Investigational Site Number 6103', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}, {'zip': 'BS105NB', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Investigational Site Number 4004', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CB50QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Investigational Site Number 4001', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'CF44XN', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Investigational Site Number 4005', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'E12AT', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Investigational Site Number 4006', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M68HD', 'city': 'Salford', 'country': 'United Kingdom', 'facility': 'Investigational Site Number 4008', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}, {'zip': 'S102JF', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Investigational Site Number 4007', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. 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