Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-26 @ 12:20 AM
Study NCT ID:
NCT01939002
Status:
COMPLETED
Last Update Posted:
2017-01-25
First Post:
2013-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-β) Therapies to Peginterferon Beta-1a (BIIB017)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C428112', 'term': 'peginterferon beta-1a'}, {'id': 'D009288', 'term': 'Naproxen'}, {'id': 'D000894', 'term': 'Anti-Inflammatory Agents, Non-Steroidal'}], 'ancestors': [{'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D018712', 'term': 'Analgesics, Non-Narcotic'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D018501', 'term': 'Antirheumatic Agents'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@biogen.com', 'title': 'Biogen Study Medical Director', 'organization': 'Biogen'}, 'certainAgreement': {'otherDetails': "Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 to Week 52', 'eventGroups': [{'id': 'EG000', 'title': 'BIIB017 Plus Current FLS Therapy', 'description': 'BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus current FLS management regimen as determined by the clinician', 'otherNumAtRisk': 103, 'otherNumAffected': 92, 'seriousNumAtRisk': 103, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'BIIB017 Plus Naproxen', 'description': 'BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently', 'otherNumAtRisk': 98, 'otherNumAffected': 90, 'seriousNumAtRisk': 98, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Appendix cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Arteriospasm coronary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Overall Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Population', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:\n\n* current FLS management regimen as determined by the clinician; or\n* 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'pValueComment': '1-sample Chi-square test comparing to Null hypotheses at 25%.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'during the first 8 weeks of treatment', 'description': 'The total Flu-like Symptoms Score (FLS-S) is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Between FLS Management Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIIB017 Plus Current FLS Therapy', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.'}, {'id': 'OG001', 'title': 'BIIB017 Plus Naproxen', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2037', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Chi-square test between 2 treatment arms.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'during the first 8 weeks of treatment', 'description': 'The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BIIB017 Plus Current FLS Therapy', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.'}, {'id': 'OG001', 'title': 'BIIB017 Plus Naproxen', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.'}, {'id': 'OG002', 'title': 'Overall Population', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:\n\n* current FLS management regimen as determined by the clinician; or\n* 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently'}], 'classes': [{'title': '4WRI', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '91.5', 'groupId': 'OG001'}, {'value': '89.7', 'groupId': 'OG002'}]}]}, {'title': 'F8W', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '88.3', 'groupId': 'OG001'}, {'value': '89.7', 'groupId': 'OG002'}]}]}, {'title': '48W', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '94.7', 'groupId': 'OG001'}, {'value': '94.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4-week run-in period, first 8 weeks of treatment, 48 weeks of treatment', 'description': 'Any FLS is defined as an FLS-S total score \\> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in; F8W=first 8 weeks; 48W=48 weeks.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.'}, {'type': 'SECONDARY', 'title': 'Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BIIB017 Plus Current FLS Therapy', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.'}, {'id': 'OG001', 'title': 'BIIB017 Plus Naproxen', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.'}, {'id': 'OG002', 'title': 'Overall Population', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:\n\n* current FLS management regimen as determined by the clinician; or\n* 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently'}], 'classes': [{'title': 'With FLS in 4WRI / With FLS during F8W', 'categories': [{'measurements': [{'value': '85.00', 'groupId': 'OG000'}, {'value': '82.98', 'groupId': 'OG001'}, {'value': '84.02', 'groupId': 'OG002'}]}]}, {'title': 'With FLS in 4WRI / Without FLS during F8W', 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000'}, {'value': '8.51', 'groupId': 'OG001'}, {'value': '5.67', 'groupId': 'OG002'}]}]}, {'title': 'Without FLS in 4WRI / With FLS during F8W', 'categories': [{'measurements': [{'value': '6.00', 'groupId': 'OG000'}, {'value': '5.32', 'groupId': 'OG001'}, {'value': '5.67', 'groupId': 'OG002'}]}]}, {'title': 'Without FLS in 4WRI / Without FLS during F8W', 'categories': [{'measurements': [{'value': '6.00', 'groupId': 'OG000'}, {'value': '3.19', 'groupId': 'OG001'}, {'value': '4.64', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG002'], 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'McNemar tests the null hypothesis of no difference in FLS between 4WRI and F8W.', 'testedNonInferiority': False}, {'pValue': '0.5078', 'groupIds': ['OG000'], 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5811', 'groupIds': ['OG001'], 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '4-week run-in period, first 8 weeks of treatment', 'description': 'Any FLS is defined as an FLS-S total score \\> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. Pre-dose data not were used. Data up to 48-hours after dosing were used. Total score was imputed as the highest score after dose. 4WRI=4-week run-in period; F8W=first 8 weeks.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.'}, {'type': 'SECONDARY', 'title': 'Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BIIB017 Plus Current FLS Therapy', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.'}, {'id': 'OG001', 'title': 'BIIB017 Plus Naproxen', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.'}, {'id': 'OG002', 'title': 'Overall Population', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:\n\n* current FLS management regimen as determined by the clinician; or\n* 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently'}], 'classes': [{'title': 'With FLS in 4WRI / With FLS during 48W', 'categories': [{'measurements': [{'value': '86.00', 'groupId': 'OG000'}, {'value': '87.23', 'groupId': 'OG001'}, {'value': '86.60', 'groupId': 'OG002'}]}]}, {'title': 'With FLS in 4WRI / Without FLS during 48W', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000'}, {'value': '4.26', 'groupId': 'OG001'}, {'value': '3.09', 'groupId': 'OG002'}]}]}, {'title': 'Without FLS in 4WRI / With FLS during 48W', 'categories': [{'measurements': [{'value': '9.00', 'groupId': 'OG000'}, {'value': '7.45', 'groupId': 'OG001'}, {'value': '8.25', 'groupId': 'OG002'}]}]}, {'title': 'Without FLS in 4WRI / Without FLS during 48W', 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000'}, {'value': '1.06', 'groupId': 'OG001'}, {'value': '2.06', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0525', 'groupIds': ['OG002'], 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0654', 'groupIds': ['OG000'], 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5488', 'groupIds': ['OG001'], 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '4-week run-in period, 48 weeks of treatment', 'description': 'Any FLS is defined as an FLS-S total score \\> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. Pre-dose data not were used. Data up to 48-hours after dosing were used. Total score was imputed as the highest score after dose. 4WRI=4-week run-in period; 48W=48 weeks.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.'}, {'type': 'SECONDARY', 'title': 'Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BIIB017 Plus Current FLS Therapy', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.'}, {'id': 'OG001', 'title': 'BIIB017 Plus Naproxen', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.'}, {'id': 'OG002', 'title': 'Overall Population', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:\n\n* current FLS management regimen as determined by the clinician; or\n* 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently'}], 'classes': [{'title': 'Severity of FLS in 4WRI', 'categories': [{'measurements': [{'value': '1.198', 'spread': '1.224', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '1.02', 'groupId': 'OG001'}, {'value': '1.126', 'spread': '1.129', 'groupId': 'OG002'}]}]}, {'title': 'Severity of FLS in F8W', 'categories': [{'measurements': [{'value': '1.311', 'spread': '1.185', 'groupId': 'OG000'}, {'value': '1.036', 'spread': '0.951', 'groupId': 'OG001'}, {'value': '1.178', 'spread': '1.084', 'groupId': 'OG002'}]}]}, {'title': 'Mean Change from 4WRI to F8W', 'categories': [{'measurements': [{'value': '0.113', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '-0.013', 'spread': '0.581', 'groupId': 'OG001'}, {'value': '0.052', 'spread': '0.63', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0945', 'groupIds': ['OG000'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8246', 'groupIds': ['OG001'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2533', 'groupIds': ['OG002'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1631', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': '2-sample t-test between 2 arms', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4-week run-in period, first 8 weeks of treatment', 'description': 'The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in period; F8W=first 8 weeks.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.'}, {'type': 'SECONDARY', 'title': 'Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BIIB017 Plus Current FLS Therapy', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.'}, {'id': 'OG001', 'title': 'BIIB017 Plus Naproxen', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.'}, {'id': 'OG002', 'title': 'Overall Population', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:\n\n* current FLS management regimen as determined by the clinician; or\n* 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently'}], 'classes': [{'title': 'Severity of FLS in 4WRI', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '1.02', 'groupId': 'OG001'}, {'value': '1.13', 'spread': '1.13', 'groupId': 'OG002'}]}]}, {'title': 'Severity of FLS in 48W', 'categories': [{'measurements': [{'value': '1.28', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '1.14', 'spread': '1.11', 'groupId': 'OG002'}]}]}, {'title': 'Mean Change from 4WRI to 48W', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.77', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3189', 'groupIds': ['OG000'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3582', 'groupIds': ['OG001'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8484', 'groupIds': ['OG002'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1771', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': '2-sample t-test between 2 arms', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4-week run-in period, 48 weeks of treatment', 'description': 'The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in period; 48W=48 weeks.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.'}, {'type': 'SECONDARY', 'title': 'Summary of Average Duration of FLS in the First 8 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BIIB017 Plus Current FLS Therapy', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.'}, {'id': 'OG001', 'title': 'BIIB017 Plus Naproxen', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.'}, {'id': 'OG002', 'title': 'Overall Population', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:\n\n* current FLS management regimen as determined by the clinician; or\n* 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently'}], 'classes': [{'title': 'Average duration in 4WRI; n=88, 86, 174', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '33.38'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '42.86'}, {'value': '13.75', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '42.86'}]}]}, {'title': 'Average duration in F8W; n=91, 83, 174', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '40.8'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '43.5'}, {'value': '18', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '43.5'}]}]}, {'title': 'Change from 4WRI to F8W; n=85, 78, 163', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '-16.5', 'upperLimit': '18.4'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '-10.5', 'upperLimit': '20.4'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '-16.5', 'upperLimit': '20.4'}]}]}], 'analyses': [{'pValue': '0.0009', 'groupIds': ['OG000'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3792', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': '2-sample t-test between 2 arms', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '4-week run-in period, first 8 weeks of treatment', 'description': 'Duration of FLS for a treatment was defined as the sum of hours from the time of treatment to 48 hours with an FLS-S score \\> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If an FLS is \\> 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. Average duration of FLS for the first 8 weeks was defined as the mean duration from Weeks 0, 2, 4, 6, and 8. 4WRI=4-week run-in period; F8W=first 8 weeks.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of subjects assessed at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Summary of Average Duration of FLS in the 48 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BIIB017 Plus Current FLS Therapy', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.'}, {'id': 'OG001', 'title': 'BIIB017 Plus Naproxen', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.'}, {'id': 'OG002', 'title': 'Overall Population', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:\n\n* current FLS management regimen as determined by the clinician; or\n* 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently'}], 'classes': [{'title': 'Average duration in 4WRI; n=88, 86, 174', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '33.38'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '42.86'}, {'value': '13.75', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '42.86'}]}]}, {'title': 'Average duration in 48W; n=95, 89, 184', 'categories': [{'measurements': [{'value': '16.75', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '38.09'}, {'value': '16.96', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '39'}, {'value': '16.96', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': '39'}]}]}, {'title': 'Change from 4WRI to 48W; n=86, 82, 168', 'categories': [{'measurements': [{'value': '2.82', 'groupId': 'OG000', 'lowerLimit': '-19.57', 'upperLimit': '17.83'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '-10', 'upperLimit': '14.88'}, {'value': '2.16', 'groupId': 'OG002', 'lowerLimit': '-19.57', 'upperLimit': '17.83'}]}]}], 'analyses': [{'pValue': '0.0019', 'groupIds': ['OG000'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0009', 'groupIds': ['OG001'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '4-week run-in period, 48 weeks of treatment', 'description': 'Duration of FLS for a treatment was defined as the sum of hours from the time of treatment to 48 hours with a FLS-S score \\> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If a FLS is \\> 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. Average duration of FLS for the first 8 weeks was defined as the mean duration from Weeks 0, 2, 4, 6, and 8. 4WRI=4-week run-in period; 48W=48 weeks.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of subjects assessed at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BIIB017 Plus Current FLS Therapy', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.'}, {'id': 'OG001', 'title': 'BIIB017 Plus Naproxen', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.'}, {'id': 'OG002', 'title': 'Overall Population', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:\n\n* current FLS management regimen as determined by the clinician; or\n* 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently'}], 'classes': [{'title': 'Effectiveness in 4WRI; n=91, 86, 177', 'categories': [{'measurements': [{'value': '64.5', 'spread': '27.952', 'groupId': 'OG000'}, {'value': '66.398', 'spread': '28.855', 'groupId': 'OG001'}, {'value': '65.422', 'spread': '28.329', 'groupId': 'OG002'}]}]}, {'title': 'Effectiveness in F8W; n=96, 91, 187', 'categories': [{'measurements': [{'value': '69.695', 'spread': '22.423', 'groupId': 'OG000'}, {'value': '74.253', 'spread': '23.85', 'groupId': 'OG001'}, {'value': '71.913', 'spread': '23.179', 'groupId': 'OG002'}]}]}, {'title': 'Change from 4WRI to F8W; n=87, 83, 170', 'categories': [{'measurements': [{'value': '6.525', 'spread': '23.271', 'groupId': 'OG000'}, {'value': '5.694', 'spread': '29.151', 'groupId': 'OG001'}, {'value': '6.119', 'spread': '26.231', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0105', 'groupIds': ['OG000'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0789', 'groupIds': ['OG001'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0027', 'groupIds': ['OG002'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8380', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': '2-sample t-test between 2 arms', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4-week run-in period, first 8 weeks of treatment', 'description': 'Participants reported the effectiveness of their FLS management regimen on a 100-mm VAS between not effective (0) and very effective (100). 4WRI=4-week run-in period; F8W=first 8 weeks.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BIIB017 Plus Current FLS Therapy', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.'}, {'id': 'OG001', 'title': 'BIIB017 Plus Naproxen', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.'}, {'id': 'OG002', 'title': 'Overall Population', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:\n\n* current FLS management regimen as determined by the clinician; or\n* 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently'}], 'classes': [{'title': 'Satisfaction in 4WRI; n=91, 86, 177', 'categories': [{'measurements': [{'value': '68.654', 'spread': '26.574', 'groupId': 'OG000'}, {'value': '72.778', 'spread': '23.817', 'groupId': 'OG001'}, {'value': '70.658', 'spread': '25.285', 'groupId': 'OG002'}]}]}, {'title': 'Satisfaction in F8W; n=96, 91, 187', 'categories': [{'measurements': [{'value': '71.153', 'spread': '21.884', 'groupId': 'OG000'}, {'value': '74.684', 'spread': '23.671', 'groupId': 'OG001'}, {'value': '72.871', 'spread': '22.778', 'groupId': 'OG002'}]}]}, {'title': 'Change from 4WRI to F8W; n=87, 83, 170', 'categories': [{'measurements': [{'value': '3.715', 'spread': '23.307', 'groupId': 'OG000'}, {'value': '0.759', 'spread': '24.729', 'groupId': 'OG001'}, {'value': '2.272', 'spread': '23.986', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1407', 'groupIds': ['OG000'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7805', 'groupIds': ['OG001'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2186', 'groupIds': ['OG002'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4234', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': '2-sample t-test between 2 arms', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4-week run-in period, first 8 weeks of treatment', 'description': 'Participants reported their satisfaction with the effectiveness of their FLS management regimen on a 100-mm VAS between not satisfied (0) and very satisfied (100). 4WRI=4-week run-in period; F8W=first 8 weeks.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BIIB017 Plus Current FLS Therapy', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.'}, {'id': 'OG001', 'title': 'BIIB017 Plus Naproxen', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.'}, {'id': 'OG002', 'title': 'Overall Population', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:\n\n* current FLS management regimen as determined by the clinician; or\n* 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently'}], 'classes': [{'title': 'Effectiveness in 4WRI; n=91, 86, 177', 'categories': [{'measurements': [{'value': '64.5', 'spread': '27.952', 'groupId': 'OG000'}, {'value': '66.398', 'spread': '28.855', 'groupId': 'OG001'}, {'value': '65.422', 'spread': '28.329', 'groupId': 'OG002'}]}]}, {'title': 'Effectiveness in 48W; n=99, 94, 193', 'categories': [{'measurements': [{'value': '70.547', 'spread': '21.657', 'groupId': 'OG000'}, {'value': '75.416', 'spread': '21.28', 'groupId': 'OG001'}, {'value': '72.918', 'spread': '21.557', 'groupId': 'OG002'}]}]}, {'title': 'Change from 4WRI to 48W; n=90, 86, 176', 'categories': [{'measurements': [{'value': '6.803', 'spread': '24.182', 'groupId': 'OG000'}, {'value': '8.042', 'spread': '27.206', 'groupId': 'OG001'}, {'value': '7.408', 'spread': '25.638', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0090', 'groupIds': ['OG000'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0075', 'groupIds': ['OG001'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG002'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7497', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': '2-sample t-test between 2 arms', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4-week run-in period, 48 weeks of treatment', 'description': 'Participants reported the effectiveness of their FLS management regimen on a 100-mm VAS between not effective (0) and very effective (100). 4WRI=4-week run-in period; 48W=48 weeks.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BIIB017 Plus Current FLS Therapy', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.'}, {'id': 'OG001', 'title': 'BIIB017 Plus Naproxen', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.'}, {'id': 'OG002', 'title': 'Overall Population', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:\n\n* current FLS management regimen as determined by the clinician; or\n* 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently'}], 'classes': [{'title': 'Satisfaction in 4WRI; n=91, 86, 177', 'categories': [{'measurements': [{'value': '68.654', 'spread': '26.574', 'groupId': 'OG000'}, {'value': '72.778', 'spread': '23.817', 'groupId': 'OG001'}, {'value': '70.658', 'spread': '25.285', 'groupId': 'OG002'}]}]}, {'title': 'Satisfaction in 48W; n=99, 94, 193', 'categories': [{'measurements': [{'value': '72.192', 'spread': '21.053', 'groupId': 'OG000'}, {'value': '76.061', 'spread': '21.075', 'groupId': 'OG001'}, {'value': '74.076', 'spread': '21.098', 'groupId': 'OG002'}]}]}, {'title': 'Change from 4WRI to 48W; n=90, 86, 176', 'categories': [{'measurements': [{'value': '4.607', 'spread': '22.43', 'groupId': 'OG000'}, {'value': '2.274', 'spread': '21.874', 'groupId': 'OG001'}, {'value': '3.467', 'spread': '22.128', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0545', 'groupIds': ['OG000'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3377', 'groupIds': ['OG001'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0391', 'groupIds': ['OG002'], 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4861', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': '2-sample t-test between 2 arms', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4-week run-in period, 48 weeks of treatment', 'description': 'Participants reported their satisfaction with the effectiveness of their FLS management regimen on a 100-mm VAS between not satisfied (0) and very satisfied (100). 4WRI=4-week run-in period; 48W=48 weeks.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIIB017 Plus Current FLS Therapy', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.'}, {'id': 'OG001', 'title': 'BIIB017 Plus Naproxen', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.'}], 'classes': [{'title': 'Used additional regimen, first 8 weeks; n=78, 85', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}, {'value': '15.3', 'groupId': 'OG001'}]}]}, {'title': 'No additional regimen, first 8 weeks; n=78, 85', 'categories': [{'measurements': [{'value': '93.6', 'groupId': 'OG000'}, {'value': '84.7', 'groupId': 'OG001'}]}]}, {'title': 'Used additional regimen, Weeks 0-2; n=57, 73', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'No additional regimen, Weeks 0-2; n=57, 73', 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'Used additional regimen, Weeks 3-4; n=61, 77', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '5.2', 'groupId': 'OG001'}]}]}, {'title': 'No additional regimen, Weeks 3-4; n=61, 77', 'categories': [{'measurements': [{'value': '93.4', 'groupId': 'OG000'}, {'value': '94.8', 'groupId': 'OG001'}]}]}, {'title': 'Used additional regimen, Weeks 5-6; n=63, 76', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'No additional regimen, Weeks 5-6; n=63, 76', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '97.4', 'groupId': 'OG001'}]}]}, {'title': 'Used additional regimen, Weeks 7-8; n=52, 74', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '4.1', 'groupId': 'OG001'}]}]}, {'title': 'No additional regimen, Weeks 7-8; n=52, 74', 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000'}, {'value': '95.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0834', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'first 8 weeks', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0767', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Weeks 0-2', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7320', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Weeks 3-4', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5008', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Weeks 5-6', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6422', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Weeks 7-8', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'during the first 8 weeks of treatment', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of subjects assessed at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Mean Change From 4-Week Run-In Period at Each Visit for Treatment Satisfaction Questionnaire for Medication (TSQM), Effectiveness Scale Factor: Overall Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Population', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:\n\n* current FLS management regimen as determined by the clinician; or\n* 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently'}], 'classes': [{'title': 'Effectiveness at 4WRI; 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Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for effectiveness (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Side Effects Scale Factor: Between FLS Management Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIIB017 Plus Current FLS Therapy', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.'}, {'id': 'OG001', 'title': 'BIIB017 Plus Naproxen', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.'}], 'classes': [{'title': 'Side Effects at 4WRI; n=100, 94', 'categories': [{'measurements': [{'value': '83.78', 'spread': '20.074', 'groupId': 'OG000'}, {'value': '86.649', 'spread': '15.789', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4; n=95, 90', 'categories': [{'measurements': [{'value': '8.579', 'spread': '23.576', 'groupId': 'OG000'}, {'value': '3.411', 'spread': '18.222', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000'], 'groupDescription': 'change at Week 4', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0792', 'groupIds': ['OG001'], 'groupDescription': 'change at Week 4', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0961', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'change at Week 4', 'statisticalMethod': '2-sample t-test between 2 arms', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4-week run-in period, Week 4', 'description': "The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for side effects (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Convenience Scale Factor: Between FLS Management Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIIB017 Plus Current FLS Therapy', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.'}, {'id': 'OG001', 'title': 'BIIB017 Plus Naproxen', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.'}], 'classes': [{'title': 'Convenience at 4WRI; n=100, 94', 'categories': [{'measurements': [{'value': '65.94', 'spread': '15.878', 'groupId': 'OG000'}, {'value': '67.436', 'spread': '17.365', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4; n=95, 90', 'categories': [{'measurements': [{'value': '19.768', 'spread': '22.403', 'groupId': 'OG000'}, {'value': '17.578', 'spread': '21.347', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'change at Week 4', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'groupDescription': 'change at Week 4', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4973', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'change at Week 4', 'statisticalMethod': '2-sample t-test between 2 arms', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4-week run-in period, Week 4', 'description': "The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for convenience (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Global Satisfaction Scale Factor: Between FLS Management Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIIB017 Plus Current FLS Therapy', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.'}, {'id': 'OG001', 'title': 'BIIB017 Plus Naproxen', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.'}], 'classes': [{'title': 'Global Satisfaction at 4WRI; n=100, 94', 'categories': [{'measurements': [{'value': '75.86', 'spread': '14.001', 'groupId': 'OG000'}, {'value': '76.117', 'spread': '16.334', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4; n=95, 90', 'categories': [{'measurements': [{'value': '8.663', 'spread': '16.633', 'groupId': 'OG000'}, {'value': '4.811', 'spread': '22.596', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'change at Week 4', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0464', 'groupIds': ['OG001'], 'groupDescription': 'change at Week 4', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1905', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'change at Week 4', 'statisticalMethod': '2-sample t-test between 2 arms', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4-week run-in period, Week 4', 'description': "The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for global satisfaction (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Usual Work Days Per Week: Overall Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Population', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:\n\n* current FLS management regimen as determined by the clinician; or\n* 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently'}], 'classes': [{'title': 'Days in 4WRI; n=123', 'categories': [{'measurements': [{'value': '4.691', 'spread': '1.033', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 12; n=106', 'categories': [{'measurements': [{'value': '-0.019', 'spread': '0.436', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 24; n=99', 'categories': [{'measurements': [{'value': '-0.081', 'spread': '0.566', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 36; n=96', 'categories': [{'measurements': [{'value': '-0.052', 'spread': '0.773', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 48; n=95', 'categories': [{'measurements': [{'value': '0.032', 'spread': '0.573', 'groupId': 'OG000'}]}]}, {'title': 'Change at Early Termination; n=15', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.862', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.6569', 'groupIds': ['OG000'], 'groupDescription': 'change at Week 12', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1584', 'groupIds': ['OG000'], 'groupDescription': 'change at Week 24', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5106', 'groupIds': ['OG000'], 'groupDescription': 'change at Week 36', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5927', 'groupIds': ['OG000'], 'groupDescription': 'change at Week 48', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3840', 'groupIds': ['OG000'], 'groupDescription': 'change at Early Termination', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4182', 'groupIds': ['OG000'], 'pValueComment': 'p-value on slope is based on general linear model with repeat measures over all visits.', 'statisticalMethod': 'general linear model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination', 'description': 'Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from multiple sclerosis (MS) symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and were employed; n=number of participants assessed at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Symptoms: Overall Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Population', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:\n\n* current FLS management regimen as determined by the clinician; or\n* 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently'}], 'classes': [{'title': 'Days in 4WRI; n=123', 'categories': [{'measurements': [{'value': '0.016', 'spread': '0.127', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 12; n=106', 'categories': [{'measurements': [{'value': '0.057', 'spread': '0.513', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 24; n=99', 'categories': [{'measurements': [{'value': '0.061', 'spread': '0.373', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 36; n=96', 'categories': [{'measurements': [{'value': '0', 'spread': '0.205', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 48; n =95', 'categories': [{'measurements': [{'value': '0.137', 'spread': '1.078', 'groupId': 'OG000'}]}]}, {'title': 'Change at Early Termination; n=15', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.2588', 'groupIds': ['OG000'], 'groupDescription': 'change at Week 12', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1092', 'groupIds': ['OG000'], 'groupDescription': 'change at Week 24', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.0000', 'groupIds': ['OG000'], 'groupDescription': 'change at Week 36', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2190', 'groupIds': ['OG000'], 'groupDescription': 'change at Week 48', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6402', 'groupIds': ['OG000'], 'pValueComment': 'p-value on slope is based on general linear model with repeat measures over all visits.', 'statisticalMethod': 'general linear model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination', 'description': 'Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from MS symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and were employed; n=number of participants assessed at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Treatment: Overall Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Population', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:\n\n* current FLS management regimen as determined by the clinician; or\n* 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently'}], 'classes': [{'title': 'Days in 4WRI; n=123', 'categories': [{'measurements': [{'value': '0.016', 'spread': '0.127', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 12; n=106', 'categories': [{'measurements': [{'value': '0.019', 'spread': '0.275', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 24; n=99', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.319', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 36; n=96', 'categories': [{'measurements': [{'value': '-0.021', 'spread': '0.144', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 48; n =95', 'categories': [{'measurements': [{'value': '0.126', 'spread': '1.074', 'groupId': 'OG000'}]}]}, {'title': 'Change at Early Termination; n=15', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.414', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.4821', 'groupIds': ['OG000'], 'groupDescription': 'change at Week 12', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5298', 'groupIds': ['OG000'], 'groupDescription': 'change at Week 24', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1584', 'groupIds': ['OG000'], 'groupDescription': 'change at Week 36', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2547', 'groupIds': ['OG000'], 'groupDescription': 'change at Week 48', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0824', 'groupIds': ['OG000'], 'groupDescription': 'change at Early Termination', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3148', 'groupIds': ['OG000'], 'pValueComment': 'p-value on slope is based GLM with repeat measures over all visits.', 'statisticalMethod': 'general linear model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination', 'description': 'Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from MS symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and were employed; n=number of participants assessed at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Visit (Day 1) to Week 48 in Walking Disability Status as Measured by Patient Determined Disease Steps (PDDS): Overall Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Population', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:\n\n* current FLS management regimen as determined by the clinician; or\n* 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently'}], 'classes': [{'title': 'Baseline; n=194', 'categories': [{'measurements': [{'value': '0.83', 'spread': '1.258', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 12; n=174', 'categories': [{'measurements': [{'value': '0.029', 'spread': '0.836', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 48; n=153', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.857', 'groupId': 'OG000'}]}]}, {'title': 'Change Early Termination; n=26', 'categories': [{'measurements': [{'value': '0.346', 'spread': '1.093', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.6508', 'groupIds': ['OG000'], 'groupDescription': 'change at Week 12', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0315', 'groupIds': ['OG000'], 'groupDescription': 'change at Week 48', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1190', 'groupIds': ['OG000'], 'groupDescription': 'change at Early Termination', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1520', 'groupIds': ['OG000'], 'pValueComment': 'p-value on slope is based GLM with repeat measures over all visits.', 'statisticalMethod': 'general linear model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Baseline, pre-dose), Week 12, Week 48, Early Termination', 'description': 'Subjects rated their perceived walking disability on a scale of 0 to 8 using the PDDS, with higher scores indicating more severe disability. This secondary endpoint was targeted to analyze the Overall Population only.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIIB017 Plus Current FLS Therapy', 'description': 'BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus current FLS management regimen as determined by the clinician'}, {'id': 'OG001', 'title': 'BIIB017 Plus Naproxen', 'description': 'BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently'}], 'classes': [{'title': 'Any event', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'Moderate or severe event', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Severe event', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Related event', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Serious event', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Discontinuations due to AEs', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Treatment discontinuation due to FLS event', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Treatment discontinuation due to ISR events', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Study discontinuation due to an event', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Week 52', 'description': 'An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could jeopardize the subject or could require intervention to prevent one of the other outcomes listed in the definition above. ISR=injection site reactions.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 injection of study treatment.'}, {'type': 'SECONDARY', 'title': 'Summary of Average Duration of FLS Within the Last 4 Weeks of the BIIB017 Treatment Period Compared With the Duration of FLS in the 4-Week Run-In Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BIIB017 Plus Current FLS Therapy', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.'}, {'id': 'OG001', 'title': 'BIIB017 Plus Naproxen', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.'}, {'id': 'OG002', 'title': 'Overall Population', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:\n\n* current FLS management regimen as determined by the clinician; or\n* 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently'}], 'classes': [{'title': 'Average duration in 4WRI; n=88, 86, 174', 'categories': [{'measurements': [{'value': '16.067', 'spread': '8.277', 'groupId': 'OG000'}, {'value': '14.915', 'spread': '7.637', 'groupId': 'OG001'}, {'value': '15.497', 'spread': '7.965', 'groupId': 'OG002'}]}]}, {'title': 'Average duration in L4W; n=87, 83, 170', 'categories': [{'measurements': [{'value': '18.057', 'spread': '9.06', 'groupId': 'OG000'}, {'value': '15.892', 'spread': '8.073', 'groupId': 'OG001'}, {'value': '17', 'spread': '8.635', 'groupId': 'OG002'}]}]}, {'title': 'Change from 4WRI to L4W; n=80, 77, 157', 'categories': [{'measurements': [{'value': '2.612', 'spread': '8.067', 'groupId': 'OG000'}, {'value': '0.943', 'spread': '6.738', 'groupId': 'OG001'}, {'value': '1.793', 'spread': '7.468', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0049', 'groupIds': ['OG000'], 'groupDescription': 'Change from 4WRI to L4W', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2230', 'groupIds': ['OG001'], 'groupDescription': 'Change from 4WRI to L4W', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0031', 'groupIds': ['OG002'], 'groupDescription': 'Change from 4WRI to L4W', 'statisticalMethod': 'paired t-test within 1 arm', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1624', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change from 4WRI to L4W', 'statisticalMethod': '2-sample t-test between 2 arms', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Weeks -4 to -1 (Screening), Weeks 45-48 (last 4 weeks of study)', 'description': 'Average duration of FLS for the last 4 weeks (L4W) is defined as the mean duration of last 4 weeks. Duration of FLS for a treatment is defined as the sum of hours from the treatment to 48 hours with a FLS-S score \\> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If a FLS is \\> 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. 4WRI=4-week run-in.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and had FLS; n=number of participants assessed at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Antibody Data in the Overall Population: IFN β-1a Antibody Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Population', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:\n\n* current FLS management regimen as determined by the clinician; or\n* 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently'}], 'classes': [{'title': 'Baseline: Positive; n=199', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Negative; n=199', 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}]}]}, {'title': 'Any post-baseline visit: Positive; n=198', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Any post-baseline visit: Negative; n=198', 'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Positive; n=183', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Negative; n=183', 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Positive; n=171', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Negative; n=171', 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Positive; n=167', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Negative; n=167', 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}]}]}, {'title': 'Week 48/EW: Positive; n=193', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Week 48/EW: Negative; n=193', 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}]}]}, {'title': 'Negative at BL with ≥ 1 positive post-BL; n=174', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)', 'description': "The number of participants who tested positive for IFN β-1a binding antibodies (BAbs). Value was coded as 'positive' if observed value \\> 0 or coded as 'negative' if observed value \\< 0. This secondary endpoint was targeted to analyze the Overall Population only.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: participants who received at least 1 injection of study treatment and had an assessment; n=number of participants with an assessment at given timepoint.'}, {'type': 'SECONDARY', 'title': 'Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Population', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:\n\n* current FLS management regimen as determined by the clinician; or\n* 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently'}], 'classes': [{'title': 'Baseline: Positive; n=201', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Negative; n=201', 'categories': [{'measurements': [{'value': '194', 'groupId': 'OG000'}]}]}, {'title': 'Any post-baseline visit: Positive; n=198', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Any post-baseline visit: Negative; n=198', 'categories': [{'measurements': [{'value': '196', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Positive; n=182', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Negative; n=182', 'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Positive; n=173', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Negative; n=173', 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Positive; n=168', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Negative; n=168', 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}]}]}, {'title': 'Week 48/EW: Positive; n=193', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 48/EW: Negative; n=193', 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}]}]}, {'title': 'Negative at BL with ≥ 1 positive post-BL; n=192', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)', 'description': "The number of participants who tested positive or negative for IFN β-1a anti-PEG antibodies. Value was coded as 'positive' if observed value \\> 0 or coded as 'negative' if observed value \\< 0. This secondary endpoint was targeted to analyze the Overall Population only.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: participants who received at least 1 injection of study treatment and had an assessment; n=number of participants with an assessment at given timepoint.'}, {'type': 'SECONDARY', 'title': 'Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Population', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:\n\n* current FLS management regimen as determined by the clinician; or\n* 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently'}], 'classes': [{'title': 'Baseline: Positive; n=22', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Negative; n=22', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Any post-baseline visit: Positive; n=35', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Any post-baseline visit: Negative; n=35', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Positive; n=26', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Negative; n=26', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Positive; n=22', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Negative; n=22', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Positive; n=18', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Week 36: Negative; n=18', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Week 48/EW: Positive; n=25', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Week 48/EW: Negative; n=25', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Negative at BL with ≥ 1 positive post-BL; n=7', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)', 'description': "The number of participants who tested positive for IFN β-1a Nabs. Value was coded as 'positive' if observed value \\> 0 or coded as 'negative' if observed value \\< 0. This secondary endpoint was targeted to analyze the Overall Population only.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: participants who received at least 1 injection of study treatment and had an assessment; n=number of participants with an assessment at given timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BIIB017 Plus Current FLS Therapy', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.'}, {'id': 'FG001', 'title': 'BIIB017 Plus Naproxen', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Of the 251 participants who entered into the run-in period of non-pegylated interferon (IFN) therapy, a total of 201 were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BIIB017 Plus Current FLS Therapy', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.'}, {'id': 'BG001', 'title': 'BIIB017 Plus Naproxen', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.76', 'spread': '10.32', 'groupId': 'BG000'}, {'value': '49.88', 'spread': '9.45', 'groupId': 'BG001'}, {'value': '49.82', 'spread': '9.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 251}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-30', 'studyFirstSubmitDate': '2013-08-23', 'resultsFirstSubmitDate': '2016-10-06', 'studyFirstSubmitQcDate': '2013-09-05', 'lastUpdatePostDateStruct': {'date': '2017-01-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-30', 'studyFirstPostDateStruct': {'date': '2013-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Overall Population', 'timeFrame': 'during the first 8 weeks of treatment', 'description': 'The total Flu-like Symptoms Score (FLS-S) is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Between FLS Management Arms', 'timeFrame': 'during the first 8 weeks of treatment', 'description': 'The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose.'}, {'measure': 'Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment', 'timeFrame': '4-week run-in period, first 8 weeks of treatment, 48 weeks of treatment', 'description': 'Any FLS is defined as an FLS-S total score \\> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in; F8W=first 8 weeks; 48W=48 weeks.'}, {'measure': 'Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks', 'timeFrame': '4-week run-in period, first 8 weeks of treatment', 'description': 'Any FLS is defined as an FLS-S total score \\> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. Pre-dose data not were used. Data up to 48-hours after dosing were used. Total score was imputed as the highest score after dose. 4WRI=4-week run-in period; F8W=first 8 weeks.'}, {'measure': 'Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks', 'timeFrame': '4-week run-in period, 48 weeks of treatment', 'description': 'Any FLS is defined as an FLS-S total score \\> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. Pre-dose data not were used. Data up to 48-hours after dosing were used. Total score was imputed as the highest score after dose. 4WRI=4-week run-in period; 48W=48 weeks.'}, {'measure': 'Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms', 'timeFrame': '4-week run-in period, first 8 weeks of treatment', 'description': 'The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in period; F8W=first 8 weeks.'}, {'measure': 'Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms', 'timeFrame': '4-week run-in period, 48 weeks of treatment', 'description': 'The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in period; 48W=48 weeks.'}, {'measure': 'Summary of Average Duration of FLS in the First 8 Weeks of Treatment', 'timeFrame': '4-week run-in period, first 8 weeks of treatment', 'description': 'Duration of FLS for a treatment was defined as the sum of hours from the time of treatment to 48 hours with an FLS-S score \\> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If an FLS is \\> 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. Average duration of FLS for the first 8 weeks was defined as the mean duration from Weeks 0, 2, 4, 6, and 8. 4WRI=4-week run-in period; F8W=first 8 weeks.'}, {'measure': 'Summary of Average Duration of FLS in the 48 Weeks of Treatment', 'timeFrame': '4-week run-in period, 48 weeks of treatment', 'description': 'Duration of FLS for a treatment was defined as the sum of hours from the time of treatment to 48 hours with a FLS-S score \\> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If a FLS is \\> 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. Average duration of FLS for the first 8 weeks was defined as the mean duration from Weeks 0, 2, 4, 6, and 8. 4WRI=4-week run-in period; 48W=48 weeks.'}, {'measure': 'Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment', 'timeFrame': '4-week run-in period, first 8 weeks of treatment', 'description': 'Participants reported the effectiveness of their FLS management regimen on a 100-mm VAS between not effective (0) and very effective (100). 4WRI=4-week run-in period; F8W=first 8 weeks.'}, {'measure': 'Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment', 'timeFrame': '4-week run-in period, first 8 weeks of treatment', 'description': 'Participants reported their satisfaction with the effectiveness of their FLS management regimen on a 100-mm VAS between not satisfied (0) and very satisfied (100). 4WRI=4-week run-in period; F8W=first 8 weeks.'}, {'measure': 'Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment', 'timeFrame': '4-week run-in period, 48 weeks of treatment', 'description': 'Participants reported the effectiveness of their FLS management regimen on a 100-mm VAS between not effective (0) and very effective (100). 4WRI=4-week run-in period; 48W=48 weeks.'}, {'measure': 'Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment', 'timeFrame': '4-week run-in period, 48 weeks of treatment', 'description': 'Participants reported their satisfaction with the effectiveness of their FLS management regimen on a 100-mm VAS between not satisfied (0) and very satisfied (100). 4WRI=4-week run-in period; 48W=48 weeks.'}, {'measure': 'Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS', 'timeFrame': 'during the first 8 weeks of treatment'}, {'measure': 'Mean Change From 4-Week Run-In Period at Each Visit for Treatment Satisfaction Questionnaire for Medication (TSQM), Effectiveness Scale Factor: Overall Population', 'timeFrame': '4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)', 'description': "The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for effectiveness (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in."}, {'measure': 'Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Side-Effects Scale Factor: Overall Population', 'timeFrame': '4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)', 'description': "The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for side effects (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in."}, {'measure': 'Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Convenience Scale Factor: Overall Population', 'timeFrame': '4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)', 'description': "The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for convenience (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in."}, {'measure': 'Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Global Satisfaction Scale Factor: Overall Population', 'timeFrame': '4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)', 'description': "The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for global satisfaction (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in."}, {'measure': 'Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Effectiveness Scale Factor: Between FLS Management Arms', 'timeFrame': '4-week run-in period, Week 4', 'description': "The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for effectiveness (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in."}, {'measure': 'Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Side Effects Scale Factor: Between FLS Management Arms', 'timeFrame': '4-week run-in period, Week 4', 'description': "The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for side effects (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in."}, {'measure': 'Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Convenience Scale Factor: Between FLS Management Arms', 'timeFrame': '4-week run-in period, Week 4', 'description': "The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for convenience (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in."}, {'measure': 'Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Global Satisfaction Scale Factor: Between FLS Management Arms', 'timeFrame': '4-week run-in period, Week 4', 'description': "The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for global satisfaction (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in."}, {'measure': 'Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Usual Work Days Per Week: Overall Population', 'timeFrame': 'Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination', 'description': 'Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from multiple sclerosis (MS) symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.'}, {'measure': 'Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Symptoms: Overall Population', 'timeFrame': 'Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination', 'description': 'Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from MS symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.'}, {'measure': 'Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Treatment: Overall Population', 'timeFrame': 'Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination', 'description': 'Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from MS symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.'}, {'measure': 'Change From Baseline Visit (Day 1) to Week 48 in Walking Disability Status as Measured by Patient Determined Disease Steps (PDDS): Overall Population', 'timeFrame': 'Day 1 (Baseline, pre-dose), Week 12, Week 48, Early Termination', 'description': 'Subjects rated their perceived walking disability on a scale of 0 to 8 using the PDDS, with higher scores indicating more severe disability. This secondary endpoint was targeted to analyze the Overall Population only.'}, {'measure': 'Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs', 'timeFrame': 'Day 1 to Week 52', 'description': 'An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could jeopardize the subject or could require intervention to prevent one of the other outcomes listed in the definition above. ISR=injection site reactions.'}, {'measure': 'Summary of Average Duration of FLS Within the Last 4 Weeks of the BIIB017 Treatment Period Compared With the Duration of FLS in the 4-Week Run-In Period', 'timeFrame': 'Weeks -4 to -1 (Screening), Weeks 45-48 (last 4 weeks of study)', 'description': 'Average duration of FLS for the last 4 weeks (L4W) is defined as the mean duration of last 4 weeks. Duration of FLS for a treatment is defined as the sum of hours from the treatment to 48 hours with a FLS-S score \\> 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If a FLS is \\> 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. 4WRI=4-week run-in.'}, {'measure': 'Antibody Data in the Overall Population: IFN β-1a Antibody Screening', 'timeFrame': 'Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)', 'description': "The number of participants who tested positive for IFN β-1a binding antibodies (BAbs). Value was coded as 'positive' if observed value \\> 0 or coded as 'negative' if observed value \\< 0. This secondary endpoint was targeted to analyze the Overall Population only."}, {'measure': 'Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing', 'timeFrame': 'Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)', 'description': "The number of participants who tested positive or negative for IFN β-1a anti-PEG antibodies. Value was coded as 'positive' if observed value \\> 0 or coded as 'negative' if observed value \\< 0. This secondary endpoint was targeted to analyze the Overall Population only."}, {'measure': 'Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing', 'timeFrame': 'Baseline (Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)', 'description': "The number of participants who tested positive for IFN β-1a Nabs. Value was coded as 'positive' if observed value \\> 0 or coded as 'negative' if observed value \\< 0. This secondary endpoint was targeted to analyze the Overall Population only."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['flu-like symptoms'], 'conditions': ['Relapsing Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the proportion of participants with relapsing multiple sclerosis who experience new and/or increased flu-like symptoms (FLS) after transitioning from nonpegylated IFN-β therapies to peginterferon beta-1a (BIIB017).\n\nSecondary objectives are: to determine the severity and frequency (measured by flu-like symptom score \\[FLS-S\\]) of FLS in these participants; to determine the duration (measured in number of hours) of FLS in these participants; to determine the effect of BIIB017 on other participant-reported outcomes, including treatment satisfaction (measured with the Treatment Satisfaction Questionnaire for Medication \\[TSQM\\]) and disability status (measured with the Patient Determined Disease Steps \\[PDDS\\]) over a 56-week period; to determine whether interferon-related FLS result in missed days of work/daily activities (e.g., absenteeism); to assess the use of additional medications (in addition to current medications used to treat FLS) to relieve BIIB017-related FLS; to determine the incidence of adverse events throughout the study period; to characterize the immunogenicity profiles of participants switching from prior IFN-β therapy to BIIB017.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Must have a confirmed diagnosis of relapsing forms of multiple sclerosis (MS), as defined by McDonald criteria #1-4 \\[Polman 2005\\]\n* Must have neurological findings consistent with an Expanded Disability Status Scale (EDSS) score of 0.0 - 5.0\n* Must be treated with IFN-β and must be receiving a stable dose of IFN-β for at least 4 months immediately prior to screening\n* All male patients and female patients of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment.\n\nKey Exclusion Criteria:\n\n* Primary progressive, secondary progressive, or progressive relapsing MS \\[Lublin and Reingold 1996\\]. These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Patients with these conditions may also have superimposed relapse but are distinguished from patients with relapsing MS by the lack of clinically stable periods or clinical improvement\n* History of severe allergic or anaphylactic reactions or known hypersensitivity to medication which might suggest potential for a reaction to IFN β-1a or polyethylene glycol\n* History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured)\n* History of seizure disorder or unexplained blackouts OR history of a seizure within 3 months prior to Baseline\n* Known allergy to any component of the BIIB017 formulation\n* An MS relapse that has occurred within the 50 days prior to Baseline (Day 1) and/or lack of stabilization from a previous relapse prior to Baseline.\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01939002', 'acronym': 'ALLOW', 'briefTitle': 'Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-β) Therapies to Peginterferon Beta-1a (BIIB017)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'An Open-Label, Two-Arm Randomized Study to Characterize Flu-Like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Current Interferon Beta Therapies to BIIB017', 'orgStudyIdInfo': {'id': '105MS303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIIB017 plus current FLS therapy', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administer non-pegylated IFN therapy, participants receive BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.', 'interventionNames': ['Drug: BIIB017']}, {'type': 'EXPERIMENTAL', 'label': 'BIIB017 plus naproxen', 'description': 'Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administer non-pegylated IFN therapy, participants receive BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.', 'interventionNames': ['Drug: BIIB017', 'Drug: naproxen']}], 'interventions': [{'name': 'BIIB017', 'type': 'DRUG', 'otherNames': ['Plegridy', 'peginterferon beta-1a', 'PEGylated interferon beta-1a', 'PEG IFN β-1a'], 'armGroupLabels': ['BIIB017 plus current FLS therapy', 'BIIB017 plus naproxen']}, {'name': 'naproxen', 'type': 'DRUG', 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