Viewing Study NCT00624468

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Ignite Creation Date: 2025-12-24 @ 5:52 PM
Ignite Modification Date: 2026-01-02 @ 12:46 AM
Study NCT ID: NCT00624468
Status: TERMINATED
Last Update Posted: 2016-02-17
First Post: 2008-02-15
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Atacicept in Subjects With Optic Neuritis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009902', 'term': 'Optic Neuritis'}, {'id': 'D009443', 'term': 'Neuritis'}], 'ancestors': [{'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C524618', 'term': 'TACI receptor-IgG Fc fragment fusion protein'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'service@merckgroup.com', 'phone': '+49-6151-72-5200', 'title': 'Merck KGaA Communication Center', 'organization': 'Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany'}, 'certainAgreement': {'otherDetails': 'Prior to publishing results, Institution and Principal Investigator (PI) must first provide Sponsor with a copy of proposed publication for review at least 30 days prior to submission. If Institution and PI do not agree to modification, they shall so notify Sponsor and postpone submission for additional 60 days to allow Sponsor to seek legal remedies or file patent applications. There is a need for coordinated approach to any publication of results from sites for any multi-site study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The Sponsor voluntarily terminated this trial after observing increased Multiple Sclerosis (MS) disease activity in trial 28063 (ATAMS).'}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Week 48', 'description': 'ITT population of the double-blind period included all randomized subjects according to their randomized treatment. SFU period population included all randomized participants of double-blind period who participated in the 60-week SFU (N=13,14 for Placebo and Atacicept arms respectively).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo: Double-blind Period', 'description': 'Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.', 'otherNumAtRisk': 17, 'otherNumAffected': 14, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Atacicept: Double-blind Period', 'description': 'Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.', 'otherNumAtRisk': 17, 'otherNumAffected': 16, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo: SFU Period', 'description': 'Participants who received placebo matched to atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.', 'otherNumAtRisk': 13, 'otherNumAffected': 6, 'seriousNumAtRisk': 13, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Atacicept: SFU Period', 'description': 'Participants who received atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.', 'otherNumAtRisk': 14, 'otherNumAffected': 10, 'seriousNumAtRisk': 14, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Muscle contractions involuntary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Optic neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Tongue disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Aerophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Faecal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vomiting in pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 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'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Stress urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'seriousEvents': [{'term': 'Bacterial pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Multiple sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Myelitis transverse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Myelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo: Double-blind Period', 'description': 'Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.'}, {'id': 'OG001', 'title': 'Atacicept: Double-blind Period', 'description': 'Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.'}], 'classes': [{'title': 'Baseline (n = 17, 17)', 'categories': [{'measurements': [{'value': '103.893', 'spread': '17.271', 'groupId': 'OG000'}, {'value': '104.170', 'spread': '8.832', 'groupId': 'OG001'}]}]}, {'title': 'Change at LOV (n = 16, 15)', 'categories': [{'measurements': [{'value': '-17.317', 'spread': '15.158', 'groupId': 'OG000'}, {'value': '-8.636', 'spread': '10.056', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, LOV (Week 48)', 'description': 'The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and were then averaged over 12 sectors. The change in RNFL thickness at LOV visit was calculated as RNFL thickness at LOV minus RNFL thickness at baseline.', 'unitOfMeasure': 'micrometer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Here, "n" signifies those participants who were evaluable for the specified category.'}, {'type': 'SECONDARY', 'title': 'Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo: Double-blind Period', 'description': 'Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.'}, {'id': 'OG001', 'title': 'Atacicept: Double-blind Period', 'description': 'Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.'}], 'classes': [{'title': 'Change at Week 12 (n = 13, 13)', 'categories': [{'measurements': [{'value': '-14', 'spread': '4', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24 (n = 4, 5)', 'categories': [{'measurements': [{'value': '-7', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '-10.6', 'spread': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36 (n = 3, 4)', 'categories': [{'measurements': [{'value': '-7.5', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '-9.4', 'spread': '6.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 12, 24 and 36', 'description': 'The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and was then averaged over 12 sectors. Difference was calculated as RNFL thickness in affected eye minus RNFL thickness in fellow eye.', 'unitOfMeasure': 'micrometer', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and "n" signifies those participants who were evaluable for the specified category.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Weeks 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo: Double-blind Period', 'description': 'Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.'}, {'id': 'OG001', 'title': 'Atacicept: Double-blind Period', 'description': 'Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.'}], 'classes': [{'title': 'Baseline (n=17, 17)', 'categories': [{'measurements': [{'value': '103.893', 'spread': '17.271', 'groupId': 'OG000'}, {'value': '104.170', 'spread': '8.832', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n = 13, 13)', 'categories': [{'measurements': [{'value': '-17.036', 'spread': '13.919', 'groupId': 'OG000'}, {'value': '-9.356', 'spread': '9.532', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24 (n = 4, 5)', 'categories': [{'measurements': [{'value': '-17.815', 'spread': '16.505', 'groupId': 'OG000'}, {'value': '-11.234', 'spread': '14.230', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12 and 24', 'description': 'The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by OCT measurements and was then averaged over 12 sectors. The change in RNFL thickness at Weeks 12 and 24 was calculated as RNFL thickness at Weeks 12 and 24 minus RNFL thickness at baseline, respectively.', 'unitOfMeasure': 'micrometer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and "n" signifies those participants who were evaluable for the specified category.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Macular Thickness at 3 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo: Double-blind Period', 'description': 'Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.'}, {'id': 'OG001', 'title': 'Atacicept: Double-blind Period', 'description': 'Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.'}], 'classes': [{'title': 'Baseline (n = 17, 17)', 'categories': [{'measurements': [{'value': '1054.4', 'spread': '76.5', 'groupId': 'OG000'}, {'value': '1070.6', 'spread': '72.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n = 13, 13)', 'categories': [{'measurements': [{'value': '-29.3', 'spread': '34.4', 'groupId': 'OG000'}, {'value': '-34.0', 'spread': '21.8', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24 (n = 4, 5)', 'categories': [{'measurements': [{'value': '-72.5', 'spread': '47.0', 'groupId': 'OG000'}, {'value': '-50.4', 'spread': '47.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36 (n = 3, 4)', 'categories': [{'measurements': [{'value': '-32.7', 'spread': '30.7', 'groupId': 'OG000'}, {'value': '-40.0', 'spread': '51.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, 24 and 36', 'description': 'The change in macular thickness at 3 mm around fovea in the affected eye at Weeks 12, 24 and 36 was calculated as macular thickness at 3 mm in the affected eye at Weeks 12, 24 and 36 minus macular thickness at 3 mm in the affected eye at baseline, respectively.', 'unitOfMeasure': 'micrometer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Here, "n" signifies those participants who were evaluable for the specified category.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Macular Thickness at 6 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo: Double-blind Period', 'description': 'Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.'}, {'id': 'OG001', 'title': 'Atacicept: Double-blind Period', 'description': 'Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.'}], 'classes': [{'title': 'Baseline (n = 17, 17)', 'categories': [{'measurements': [{'value': '954.4', 'spread': '57.4', 'groupId': 'OG000'}, {'value': '947.5', 'spread': '61.3', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n = 13, 13)', 'categories': [{'measurements': [{'value': '-36.1', 'spread': '28.4', 'groupId': 'OG000'}, {'value': '-32.8', 'spread': '25.2', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24 (n = 4, 5)', 'categories': [{'measurements': [{'value': '-63.8', 'spread': '32.7', 'groupId': 'OG000'}, {'value': '-46.2', 'spread': '36.5', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36 (n = 3, 4)', 'categories': [{'measurements': [{'value': '-33.3', 'spread': '33.7', 'groupId': 'OG000'}, {'value': '-34.8', 'spread': '46.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, 24 and 36', 'description': 'The change in macular thickness at 6 mm around fovea in the affected eye at Weeks 12, 24 and 36 was calculated as macular thickness at 6 mm in the affected eye at Weeks 12, 24 and 36 minus macular thickness at 6 mm in the affected eye at baseline, respectively.', 'unitOfMeasure': 'micrometer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Here, "n" signifies those participants who were evaluable for the specified category.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Macular Volume in the Affected Eye at Weeks 12, 24 and 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo: Double-blind Period', 'description': 'Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.'}, {'id': 'OG001', 'title': 'Atacicept: Double-blind Period', 'description': 'Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.'}], 'classes': [{'title': 'Baseline (n = 17, 17)', 'categories': [{'measurements': [{'value': '6.8865', 'spread': '0.4199', 'groupId': 'OG000'}, {'value': '6.8794', 'spread': '0.4372', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n = 13, 13)', 'categories': [{'measurements': [{'value': '-0.2389', 'spread': '0.1991', 'groupId': 'OG000'}, {'value': '-0.2301', 'spread': '0.1612', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24 (n = 4, 5)', 'categories': [{'measurements': [{'value': '-0.4630', 'spread': '0.2466', 'groupId': 'OG000'}, {'value': '-0.3292', 'spread': '0.2674', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 36 (n = 3, 4)', 'categories': [{'measurements': [{'value': '-0.2353', 'spread': '0.2253', 'groupId': 'OG000'}, {'value': '-0.2533', 'spread': '0.3205', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, 24 and 36', 'description': 'The change in macular volume in the affected eye at Weeks 12, 24 and 36 was calculated as macular volume in the affected eye at Weeks 12, 24 and 36 minus macular volume in the affected eye at baseline, respectively.', 'unitOfMeasure': 'cubic micrometer', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Here, "n" signifies those participants who were evaluable for the specified category.'}, {'type': 'SECONDARY', 'title': 'Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo: Double-blind Period', 'description': 'Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.'}, {'id': 'OG001', 'title': 'Atacicept: Double-blind Period', 'description': 'Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.'}], 'classes': [{'title': 'Sloan chart 1.25%, affected eye: Week 12 (n=15,14)', 'categories': [{'measurements': [{'value': '14.7', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '15.7', 'spread': '19.0', 'groupId': 'OG001'}]}]}, {'title': 'Sloan chart 1.25%, affected eye: Week 24 (n = 5,5)', 'categories': [{'measurements': [{'value': '16.2', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '13.4', 'spread': '18.4', 'groupId': 'OG001'}]}]}, {'title': 'Sloan chart 1.25%, affected eye: Week 36 (n = 3,4)', 'categories': [{'measurements': [{'value': '24.7', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '18.8', 'groupId': 'OG001'}]}]}, {'title': 'Sloan chart 2.5%, affected eye: Week 12 (n=15, 14)', 'categories': [{'measurements': [{'value': '25.6', 'spread': '16.7', 'groupId': 'OG000'}, {'value': '22.1', 'spread': '19.5', 'groupId': 'OG001'}]}]}, {'title': 'Sloan chart 2.5%, affected eye: Week 24 (n = 5, 5)', 'categories': [{'measurements': [{'value': '26.8', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '21.4', 'spread': '19.3', 'groupId': 'OG001'}]}]}, {'title': 'Sloan chart 2.5%, affected eye: Week 36 (n = 3, 4)', 'categories': [{'measurements': [{'value': '38.7', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '20.3', 'spread': '18.7', 'groupId': 'OG001'}]}]}, {'title': 'Sloan chart 1.25%, fellow eye: Week 12 (n=15,14)', 'categories': [{'measurements': [{'value': '25.7', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '25.9', 'spread': '16.5', 'groupId': 'OG001'}]}]}, {'title': 'Sloan chart 1.25%, fellow eye: Week 24 (n = 5,5)', 'categories': [{'measurements': [{'value': '22.2', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '24.6', 'spread': '18.4', 'groupId': 'OG001'}]}]}, {'title': 'Sloan chart 1.25%, fellow eye: Week 36 (n = 3,4)', 'categories': [{'measurements': [{'value': '35.3', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '19.8', 'spread': '20.6', 'groupId': 'OG001'}]}]}, {'title': 'Sloan chart 2.5%, fellow eye: Week 12 (n=15, 14)', 'categories': [{'measurements': [{'value': '35.3', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '36.4', 'spread': '12.7', 'groupId': 'OG001'}]}]}, {'title': 'Sloan chart 2.5%, fellow eye: Week 24 (n = 5, 5)', 'categories': [{'measurements': [{'value': '33.6', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '35.8', 'spread': '15.4', 'groupId': 'OG001'}]}]}, {'title': 'Sloan chart 2.5%, fellow eye: Week 36 (n = 3, 4)', 'categories': [{'measurements': [{'value': '45.7', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '32.5', 'spread': '19.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 12, 24 and 36', 'description': 'Low-contrast letter acuity was measured by using the Sloan Charts at 1.25 fraction (%) and 2.5%. Sloan letters are a set of optotypes used to test visual acuity. Total number of letters correctly identified in the affected and fellow eye were reported. The possible Sloan Chart range is 0 to 70. More the number of letters identified, better is the visual acuity.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and "n" signifies those participants who were evaluable for the specified category.'}, {'type': 'SECONDARY', 'title': 'Contrast Sensitivity: Total Number of Letters Correctly Identified', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo: Double-blind Period', 'description': 'Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.'}, {'id': 'OG001', 'title': 'Atacicept: Double-blind Period', 'description': 'Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.'}], 'classes': [{'title': 'Affected eye: Week 12 (n = 15, 14)', 'categories': [{'measurements': [{'value': '35.4', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '32.4', 'spread': '8.8', 'groupId': 'OG001'}]}]}, {'title': 'Affected eye: Week 24 (n = 5, 5)', 'categories': [{'measurements': [{'value': '34.2', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '33.0', 'spread': '4.7', 'groupId': 'OG001'}]}]}, {'title': 'Affected eye: Week 36 (n = 3, 3)', 'categories': [{'measurements': [{'value': '37.0', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '34.7', 'spread': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Fellow eye: Week 12 (n = 15, 14)', 'categories': [{'measurements': [{'value': '38.3', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '37.6', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'Fellow eye: Week 24 (n = 5, 5)', 'categories': [{'measurements': [{'value': '36.2', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '37.4', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Fellow eye: Week 36 (n = 3, 3)', 'categories': [{'measurements': [{'value': '39.7', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '40.0', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 12, 24 and 36', 'description': 'Contrast Sensitivity was measured using the Pelli-Robson Charts. Pelli-Robson chart is used for clinical measurement of contrast sensitivity and determines the contrast required to read large letters of a fixed size. Total number of letters correctly identified in the affected and fellow eye were reported. The total possible range is 0 to 48. More the number of letters identified, better is the contrast sensitivity.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and "n" signifies those participants who were evaluable for the specified category.'}, {'type': 'SECONDARY', 'title': 'Contrast Sensitivity: Score Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo: Double-blind Period', 'description': 'Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.'}, {'id': 'OG001', 'title': 'Atacicept: Double-blind Period', 'description': 'Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.'}], 'classes': [{'title': 'Affected eye: Week 12 (n = 15, 14)', 'categories': [{'measurements': [{'value': '12.1', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '10.9', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Affected eye: Week 24 (n = 5, 5)', 'categories': [{'measurements': [{'value': '11.4', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Affected eye: Week 36 (n = 3, 3)', 'categories': [{'measurements': [{'value': '12.3', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Fellow eye: Week 12 (n = 15, 14)', 'categories': [{'measurements': [{'value': '12.9', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Fellow eye: Week 24 (n = 5, 5)', 'categories': [{'measurements': [{'value': '11.8', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Fellow eye: Week 36 (n = 3, 3)', 'categories': [{'measurements': [{'value': '13.3', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 12, 24 and 36', 'description': 'Contrast sensitivity was measured using the Pelli-Robson charts with letters arranged in groups of 3. Pelli-Robson chart is used for clinical measurement of contrast sensitivity and determines the contrast required to read large letters of a fixed size. The possible score line range is 0 (visual disability) to 16 (normal contrast sensitivity).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and "n" signifies those participants who were evaluable for the specified category.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Converting to Clinically Definite Multiple Sclerosis (CDMS) Second Clinical Attack', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo: Double-blind Period', 'description': 'Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.'}, {'id': 'OG001', 'title': 'Atacicept: Double-blind Period', 'description': 'Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}, {'value': '35.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline (Study Day 1) up to Week 36', 'description': "Conversion to CDMS was defined as experiencing a second clinical attack meeting all of the following criteria: (a) Neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both (i) Neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and (ii) Neurological abnormality lasting for at least 24 hours; (b) Absence of fever or known infection (fever with temperature \\[axillary, orally or intraauricularly\\] greater than 37.5 degree Celsius/99.5 degree Fahrenheit); (c) Objective neurological impairment, correlating with the participant's reported symptoms, defined as either (i) Increase in at least 1 of the functional systems of the Expanded Disability Status Score (EDSS), or (ii) Increase of the total EDSS score. EDSS assesses disability in 8 functional systems and total score ranges from 0 (normal) to 10 (death due to MS). Percentage of participants converting to CDMS (second clinical attack) was reported.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo: Double-blind Period', 'description': 'Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.'}, {'id': 'FG001', 'title': 'Atacicept: Double-blind Period', 'description': 'Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.'}, {'id': 'FG002', 'title': 'Placebo: SFU Period', 'description': 'Subjects who received placebo matched to atacicept in double-blind period were included in safety follow-up (SFU) period (60 weeks) following premature termination of the trial.'}, {'id': 'FG003', 'title': 'Atacicept: SFU Period', 'description': 'Subjects who received atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.'}], 'periods': [{'title': 'Double-blind Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Early Termination Initiated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrew Prematurely', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Safety Follow-up (SFU) Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo: Double-blind Period', 'description': 'Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.'}, {'id': 'BG001', 'title': 'Atacicept: Double-blind Period', 'description': 'Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.3', 'spread': '7.1', 'groupId': 'BG000'}, {'value': '30.6', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '31.4', 'spread': '8.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population included all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'whyStopped': 'EMD Serono voluntarily decided to terminate this trial after observing increased MS disease activity in trial 28063 ATAMS \\[Please refer to ATAMS\\]', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-19', 'studyFirstSubmitDate': '2008-02-15', 'resultsFirstSubmitDate': '2016-01-19', 'studyFirstSubmitQcDate': '2008-02-25', 'lastUpdatePostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-19', 'studyFirstPostDateStruct': {'date': '2008-02-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV)', 'timeFrame': 'Baseline, LOV (Week 48)', 'description': 'The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and were then averaged over 12 sectors. The change in RNFL thickness at LOV visit was calculated as RNFL thickness at LOV minus RNFL thickness at baseline.'}], 'secondaryOutcomes': [{'measure': 'Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye', 'timeFrame': 'Weeks 12, 24 and 36', 'description': 'The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and was then averaged over 12 sectors. Difference was calculated as RNFL thickness in affected eye minus RNFL thickness in fellow eye.'}, {'measure': 'Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Weeks 12 and 24', 'timeFrame': 'Baseline, Weeks 12 and 24', 'description': 'The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by OCT measurements and was then averaged over 12 sectors. The change in RNFL thickness at Weeks 12 and 24 was calculated as RNFL thickness at Weeks 12 and 24 minus RNFL thickness at baseline, respectively.'}, {'measure': 'Change From Baseline in Macular Thickness at 3 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36', 'timeFrame': 'Baseline, Weeks 12, 24 and 36', 'description': 'The change in macular thickness at 3 mm around fovea in the affected eye at Weeks 12, 24 and 36 was calculated as macular thickness at 3 mm in the affected eye at Weeks 12, 24 and 36 minus macular thickness at 3 mm in the affected eye at baseline, respectively.'}, {'measure': 'Change From Baseline in Macular Thickness at 6 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36', 'timeFrame': 'Baseline, Weeks 12, 24 and 36', 'description': 'The change in macular thickness at 6 mm around fovea in the affected eye at Weeks 12, 24 and 36 was calculated as macular thickness at 6 mm in the affected eye at Weeks 12, 24 and 36 minus macular thickness at 6 mm in the affected eye at baseline, respectively.'}, {'measure': 'Change From Baseline in Macular Volume in the Affected Eye at Weeks 12, 24 and 36', 'timeFrame': 'Baseline, Weeks 12, 24 and 36', 'description': 'The change in macular volume in the affected eye at Weeks 12, 24 and 36 was calculated as macular volume in the affected eye at Weeks 12, 24 and 36 minus macular volume in the affected eye at baseline, respectively.'}, {'measure': 'Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified', 'timeFrame': 'Weeks 12, 24 and 36', 'description': 'Low-contrast letter acuity was measured by using the Sloan Charts at 1.25 fraction (%) and 2.5%. Sloan letters are a set of optotypes used to test visual acuity. Total number of letters correctly identified in the affected and fellow eye were reported. The possible Sloan Chart range is 0 to 70. More the number of letters identified, better is the visual acuity.'}, {'measure': 'Contrast Sensitivity: Total Number of Letters Correctly Identified', 'timeFrame': 'Weeks 12, 24 and 36', 'description': 'Contrast Sensitivity was measured using the Pelli-Robson Charts. Pelli-Robson chart is used for clinical measurement of contrast sensitivity and determines the contrast required to read large letters of a fixed size. Total number of letters correctly identified in the affected and fellow eye were reported. The total possible range is 0 to 48. More the number of letters identified, better is the contrast sensitivity.'}, {'measure': 'Contrast Sensitivity: Score Line', 'timeFrame': 'Weeks 12, 24 and 36', 'description': 'Contrast sensitivity was measured using the Pelli-Robson charts with letters arranged in groups of 3. Pelli-Robson chart is used for clinical measurement of contrast sensitivity and determines the contrast required to read large letters of a fixed size. The possible score line range is 0 (visual disability) to 16 (normal contrast sensitivity).'}, {'measure': 'Percentage of Participants Converting to Clinically Definite Multiple Sclerosis (CDMS) Second Clinical Attack', 'timeFrame': 'From baseline (Study Day 1) up to Week 36', 'description': "Conversion to CDMS was defined as experiencing a second clinical attack meeting all of the following criteria: (a) Neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both (i) Neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and (ii) Neurological abnormality lasting for at least 24 hours; (b) Absence of fever or known infection (fever with temperature \\[axillary, orally or intraauricularly\\] greater than 37.5 degree Celsius/99.5 degree Fahrenheit); (c) Objective neurological impairment, correlating with the participant's reported symptoms, defined as either (i) Increase in at least 1 of the functional systems of the Expanded Disability Status Score (EDSS), or (ii) Increase of the total EDSS score. EDSS assesses disability in 8 functional systems and total score ranges from 0 (normal) to 10 (death due to MS). Percentage of participants converting to CDMS (second clinical attack) was reported."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['atacicept', 'neuritis'], 'conditions': ['Optic Neuritis']}, 'descriptionModule': {'briefSummary': 'This study was intended to evaluate the efficacy, safety and tolerability of atacicept compared to placebo and to explore the neuroprotective effect of atacicept as assessed by OCT in subjects with ON as CIS. The study was randomized. Study medication was administered via subcutaneous (under the skin) injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of unilateral symptomatic optic neuritis as first clinical manifestation within 28 days between onset of symptoms and study Day 1\n* Other protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n* Pre treatment with immunosuppressants and immunomodulating drugs\n* Relevant cardiac, hepatic and renal diseases\n* Clinical significant abnormalities in blood cell counts and immunoglobulin levels\n* Clinical significant acute or chronic infections\n* Other protocol defined exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT00624468', 'briefTitle': 'Atacicept in Subjects With Optic Neuritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMD Serono'}, 'officialTitle': 'A Two-arm, Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Evaluate Safety and Tolerability and to Explore the Neuroprotective Effect of Atacicept as Assessed by Optical Coherence Tomography (OCT) in Subjects With Optic Neuritis (ON) as Clinically Isolated Syndrome (CIS) Over a 36-week Treatment Course', 'orgStudyIdInfo': {'id': '28156'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atacicept', 'interventionNames': ['Drug: Atacicept']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo matched to atacicept']}], 'interventions': [{'name': 'Atacicept', 'type': 'DRUG', 'description': 'Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.', 'armGroupLabels': ['Atacicept']}, {'name': 'Placebo matched to atacicept', 'type': 'DRUG', 'description': 'Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Fairfield', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.14121, 'lon': -73.26373}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'East Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}, {'city': 'Philadelphia', 'state': 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