Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT00828204
Status:
COMPLETED
Last Update Posted:
2014-06-03
First Post:
2009-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinjector in Multiple Sclerosis Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068556', 'term': 'Interferon beta-1a'}], 'ancestors': [{'id': 'D016899', 'term': 'Interferon-beta'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@biogenidec.com', 'title': 'Biogen Idec Medical Director', 'organization': 'Biogen Idec Inc.'}, '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}, 'limitationsAndCaveats': {'description': 'The Initial Subset is too small a population from which to draw conclusions.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) and serious adverse events (SAEs) treatment-emergent to the autoinjector (from Day 8) through Day 23 (end of Main Study, for the Initial Study Subset), and through Day 107 (end of Extension Period, for the Main Study Subset).', 'eventGroups': [{'id': 'EG000', 'title': 'Avonex Single-Use Autoinjector: Main Subset', 'description': 'Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.\n\nIn the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.\n\nMain Subset participants were enrolled after study suspension and could enroll in the Extension Study.', 'otherNumAtRisk': 72, 'otherNumAffected': 33, 'seriousNumAtRisk': 72, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Avonex Single-Use Autoinjector: Initial Subset', 'description': 'Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.\n\nIn the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.\n\nInitial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.', 'otherNumAtRisk': 19, 'otherNumAffected': 7, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Acute Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Lyme Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Bipolar Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Multiple Sclerosis Relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Macular Degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Ulcerative Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Upper Respiratory Tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Chondropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Injection Site Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Injection Site Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Injection Site Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Injection Site Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vessel Puncture Site Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vessel Puncture Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Body Temperature Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Muscle Strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Skin Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Rash Macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Needle Issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants in the Main Subset With Overall Success Using the Avonex Single-Use Autoinjector', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Avonex Single-Use Autoinjector: Main Subset', 'description': 'Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.\n\nIn the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.\n\nMain Subset participants were enrolled after study suspension and could enroll in the Extension Study.'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '81', 'upperLimit': '96'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22', 'description': "A trainer/observer documented the participant's ability to self-inject with the Avonex single-use autoinjector and completed an observation form. Overall success in using the device for each participant was defined as no failures occurring in any step (ie, device set-up, self-administration of injection, and capping/disposal of the device) during the participant's use of the single-use Avonex autoinjector.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Main Subset who received an injection of Avonex prefilled syringe as a manual IM injection, at least 1 injection of Avonex prefilled syringe using the autoinjector, and had a completed Observation Form were included in the analysis. Missing data were not imputed. All analyses are based on observed data.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants in the Initial Subset Who Were Satisfied With the Avonex Single-Use Autoinjector', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Avonex Single-Use Autoinjector: Initial Subset', 'description': 'Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.\n\nIn the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.\n\nInitial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 23', 'description': 'Number of participants in the Initial Subset who answered yes to the question "Were you satisfied with this single-use injector?" on the Subject Satisfaction Questionnaire.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Initial Subset who received at least 1 injection with autoinjector who had a complete Subject Satisfaction Questionnaire.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With No Erythema, Induration, or Tenderness, and Normal Temperature at the Injection Site After Injection With the Avonex Single-use Autoinjector', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avonex Single-Use Autoinjector: Main Subset', 'description': 'Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.\n\nIn the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.\n\nMain Subset participants were enrolled after study suspension and could enroll in the Extension Study.'}, {'id': 'OG001', 'title': 'Avonex Single-Use Autoinjector: Initial Subset', 'description': 'Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.\n\nIn the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.\n\nInitial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.'}], 'classes': [{'title': 'No Erythema', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}, {'title': 'No Induration', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'No Tenderness', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'Normal Temperature', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, Day 8 through 22 (highest severity reported between Days 8 and 22)', 'description': 'The clinician/investigator evaluated the injection site for erythema, induration, and tenderness as none, mild, moderate, or severe after the use of the Avonex single-use autoinjector. Temperature at the injection site was evaluated as normal, warm, or hot. Those participants having no erythema, induration, or tenderness, and normal temperature at the injection site after injection are presented.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one injection with the Avonex single-use autoinjector. Missing data were not imputed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Score for Ease of Use Grading Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avonex Single-Use Autoinjector: Main Subset', 'description': 'Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.\n\nIn the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.\n\nMain Subset participants were enrolled after study suspension and could enroll in the Extension Study.'}, {'id': 'OG001', 'title': 'Avonex Single-Use Autoinjector: Initial Subset', 'description': 'Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.\n\nIn the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.\n\nInitial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.'}], 'classes': [{'title': 'Day 1 (Manual Injection) n=72, 19', 'categories': [{'measurements': [{'value': '8.1', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '2.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 8 (Autoinjector) n= 72, 18', 'categories': [{'measurements': [{'value': '8.9', 'spread': '1.96', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '6.8', 'spread': '3.39', 'groupId': 'OG001'}]}]}, {'title': 'Day 15 (Autoinjector) n=71, 16', 'categories': [{'measurements': [{'value': '8.7', 'spread': '2.47', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '6.7', 'spread': '3.07', 'groupId': 'OG001'}]}]}, {'title': 'Day 22 (Autoinjector) n=70, 7', 'categories': [{'measurements': [{'value': '9.3', 'spread': '1.87', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '5.9', 'spread': '3.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 8, Day 15, Day 22', 'description': 'Participants scored the ease of use of the Avonex manual injector (Day 1) and single-use autoinjector (Days 8, 15, 22) using a scale that ranged from 0 (extremely difficult) to 10 (extremely easy).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one injection with the Avonex Single-use Autoinjector. Missing data were not imputed. n=number of participants who received an injection and had an assessment at the given timepoint.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Who Rated the Avonex Single-use Autoinjector Printed and DVD Training Materials as Very Effective', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Avonex Single-Use Autoinjector: Main Subset', 'description': 'Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.\n\nIn the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.\n\nMain Subset participants were enrolled after study suspension and could enroll in the Extension Study.'}], 'classes': [{'title': 'Printed instructions, Day 8; n=68', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'DVD, Day 8; n=69', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'Printed instructions, Day 15; n=42', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'DVD, Day 15; n=10', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Printed instructions, Day 22; n=24', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': 'DVD, Day 22; n=9', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 8, Day 15, Day 22', 'description': 'Participants evaluated how effective the printed and DVD instructions were in educating how to use the Avonex single-use autoinjector. Participants could choose one of the following descriptive answers: not effective at all, somewhat ineffective, neutral, somewhat effective, or very effective.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Main Subset who received at least one injection with the Avonex Single-use Autoinjector and submitted an assessment form. n=the number of subjects completing the assessment form at the given timepoint. Missing data were not imputed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Score for Initial Subset on Autoinjector Instructions Grading Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Avonex Single-Use Autoinjector: Initial Subset', 'description': 'Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.\n\nIn the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.\n\nInitial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'spread': '0.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8', 'description': 'Participants in the Initial Subset were asked to answer the question "How satisfied are you with the presentation of the autoinjector instructions?" on a rating scale of 0 (extremely dissatisfied) to 10 (extremely satisfied).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Initial Subset who received at least one injection with the Avonex single-use autoinjector and completed the grading scale.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Who Indicated No Difficulty With the Injection Procedure of the Manual Injection or the Avonex Single-use Autoinjector', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Avonex Single-Use Autoinjector: Main Subset', 'description': 'Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.\n\nIn the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.\n\nMain Subset participants were enrolled after study suspension and could enroll in the Extension Study.'}], 'classes': [{'title': 'Day 1 (Manual Injection); n=70', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': 'Day 8 (Autoinjector); n=71', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Day 15 (Autoinjector); n=71', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Day 22 (Autoinjector); n=71', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, Day 8, Day 15, Day 22', 'description': 'Participants assessed whether they had experienced any difficulty with the procedure in preparing, injecting, removing, and disposing process after each injection with the Avonex single-use autoinjector by answering yes or no to the following question: "Did you have any difficulty with your injection?" The percentage of participants answering no to this question for both the manual injection on Day 1 and the autoinjector on Days 8. 15 and 22 are presented.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Main Subset who received at least one injection with the Avonex single-use autoinjector and submitted an assessment of injection procedure form. Missing data were not imputed. n=number of participants with assessment at the given timepoint.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Who Indicated a Preference for the Avonex Single-use Autoinjector Over the Manual Avonex Prefilled Syringe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avonex Single-Use Autoinjector: Main Subset', 'description': 'Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.\n\nIn the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.\n\nMain Subset participants were enrolled after study suspension and could enroll in the Extension Study.'}, {'id': 'OG001', 'title': 'Avonex Single-Use Autoinjector: Initial Subset', 'description': 'Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.\n\nIn the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.\n\nInitial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 23', 'description': 'Participants were asked whether they preferred using the Avonex single-use autoinjector over the manual Avonex prefilled syringe. Preference was defined as participants answering yes to the following question: Do you prefer this single-use autoinjector over the manual injection?', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 injection with autoinjector and had a complete questionnaire. Missing data were not imputed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Pain Score After Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Avonex Single-Use Autoinjector: Main Subset', 'description': 'Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.\n\nIn the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.\n\nMain Subset participants were enrolled after study suspension and could enroll in the Extension Study.'}, {'id': 'OG001', 'title': 'Avonex Single-Use Autoinjector: Initial Subset', 'description': 'Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.\n\nIn the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.\n\nInitial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.'}], 'classes': [{'title': 'Day 1 (Manual Injection) n=72, 19', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '2.87', 'groupId': 'OG001'}]}]}, {'title': 'Day 8 (Autoinjector) n= 72, 18', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.46', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '1.9', 'spread': '2.19', 'groupId': 'OG001'}]}]}, {'title': 'Day 15 (Autoinjector) n=71, 16', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.64', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '2.1', 'spread': '1.95', 'groupId': 'OG001'}]}]}, {'title': 'Day 22 (Autoinjector) n=70, 7', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.13', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '2.4', 'spread': '2.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Day 8, Day 15, Day 22', 'description': 'Participants scored their pain level after the use of the manual prefilled syringe on Day 1 and the Avonex single-use autoinjector on Days 8, 15, and 22 on a scale ranging from 0 (no pain) to 10 (extremely painful).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Main and Initial Subsets who received at least 1 dose of Avonex injection using the Avonex single-use autoinjector. Missing data were not imputed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Avonex Single-Use Autoinjector: Initial Subset', 'description': 'Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.\n\nIn the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.\n\nInitial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.'}, {'id': 'FG001', 'title': 'Avonex Single-Use Autoinjector: Main Subset', 'description': 'Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.\n\nIn the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.\n\nMain Subset participants were enrolled after study suspension and could enroll in the Extension Study.'}], 'periods': [{'title': 'Main Study: Prior to Study Suspension', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'comment': 'Main Subset was not enrolled until after study suspension (period 2, below).', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Completed Manual Injection', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Continued With Autoinjector Injections', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Subject Was Withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Study Suspension', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Main Study: After Study Restart', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Initial Subset participants did not continue after the study was suspended.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'After a protocol amendment, the Main Subset participants were enrolled.', 'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'Completed Manual Injection', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'Continued With Autoinjector Injections', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Extension Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participation in the Extension Study was not offered to Initial Subset after completing Main Study.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Participation in Extension Study was optional for Main Subset participants completing Main Study.', 'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Recruitment occurred in the following stages: Main Study (Initial Subset and Main Subset enrolled), and Extension Study. Initial subset participants were withdrawn when the study was suspended. After a protocol amendment, the Main Subset participants were enrolled. Only those in the Main Subset had the option to participate in the Extension Study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Avonex Single-Use Autoinjector: Main Subset', 'description': 'Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.\n\nIn the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.\n\nMain Subset participants were enrolled after study suspension and could enroll in the Extension Study.'}, {'id': 'BG001', 'title': 'Avonex Single-Use Autoinjector: Initial Subset', 'description': 'Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.\n\nIn the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.\n\nInitial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This table presents the baseline characteristics for both the Initial Subset and Main Subset populations. As represented in the Participant Flow module, these 2 groups participated prior to and after study suspension, respectively; therefore the total column should not be interpreted as cumulative.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-08', 'studyFirstSubmitDate': '2009-01-20', 'resultsFirstSubmitDate': '2011-07-13', 'studyFirstSubmitQcDate': '2009-01-21', 'lastUpdatePostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-13', 'studyFirstPostDateStruct': {'date': '2009-01-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants in the Initial Subset Who Were Satisfied With the Avonex Single-Use Autoinjector', 'timeFrame': 'Day 23', 'description': 'Number of participants in the Initial Subset who answered yes to the question "Were you satisfied with this single-use injector?" on the Subject Satisfaction Questionnaire.'}, {'measure': 'Percentage of Participants With No Erythema, Induration, or Tenderness, and Normal Temperature at the Injection Site After Injection With the Avonex Single-use Autoinjector', 'timeFrame': 'Day 1, Day 8 through 22 (highest severity reported between Days 8 and 22)', 'description': 'The clinician/investigator evaluated the injection site for erythema, induration, and tenderness as none, mild, moderate, or severe after the use of the Avonex single-use autoinjector. Temperature at the injection site was evaluated as normal, warm, or hot. Those participants having no erythema, induration, or tenderness, and normal temperature at the injection site after injection are presented.'}, {'measure': 'Mean Score for Ease of Use Grading Scale', 'timeFrame': 'Day 1, Day 8, Day 15, Day 22', 'description': 'Participants scored the ease of use of the Avonex manual injector (Day 1) and single-use autoinjector (Days 8, 15, 22) using a scale that ranged from 0 (extremely difficult) to 10 (extremely easy).'}, {'measure': 'Percentage of Participants Who Rated the Avonex Single-use Autoinjector Printed and DVD Training Materials as Very Effective', 'timeFrame': 'Day 8, Day 15, Day 22', 'description': 'Participants evaluated how effective the printed and DVD instructions were in educating how to use the Avonex single-use autoinjector. Participants could choose one of the following descriptive answers: not effective at all, somewhat ineffective, neutral, somewhat effective, or very effective.'}, {'measure': 'Mean Score for Initial Subset on Autoinjector Instructions Grading Scale', 'timeFrame': 'Day 8', 'description': 'Participants in the Initial Subset were asked to answer the question "How satisfied are you with the presentation of the autoinjector instructions?" on a rating scale of 0 (extremely dissatisfied) to 10 (extremely satisfied).'}, {'measure': 'Percentage of Participants Who Indicated No Difficulty With the Injection Procedure of the Manual Injection or the Avonex Single-use Autoinjector', 'timeFrame': 'Day 1, Day 8, Day 15, Day 22', 'description': 'Participants assessed whether they had experienced any difficulty with the procedure in preparing, injecting, removing, and disposing process after each injection with the Avonex single-use autoinjector by answering yes or no to the following question: "Did you have any difficulty with your injection?" The percentage of participants answering no to this question for both the manual injection on Day 1 and the autoinjector on Days 8. 15 and 22 are presented.'}, {'measure': 'Percentage of Participants Who Indicated a Preference for the Avonex Single-use Autoinjector Over the Manual Avonex Prefilled Syringe', 'timeFrame': 'Day 23', 'description': 'Participants were asked whether they preferred using the Avonex single-use autoinjector over the manual Avonex prefilled syringe. Preference was defined as participants answering yes to the following question: Do you prefer this single-use autoinjector over the manual injection?'}, {'measure': 'Mean Pain Score After Injection', 'timeFrame': 'Day 1, Day 8, Day 15, Day 22', 'description': 'Participants scored their pain level after the use of the manual prefilled syringe on Day 1 and the Avonex single-use autoinjector on Days 8, 15, and 22 on a scale ranging from 0 (no pain) to 10 (extremely painful).'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants in the Main Subset With Overall Success Using the Avonex Single-Use Autoinjector', 'timeFrame': 'Day 22', 'description': "A trainer/observer documented the participant's ability to self-inject with the Avonex single-use autoinjector and completed an observation form. Overall success in using the device for each participant was defined as no failures occurring in any step (ie, device set-up, self-administration of injection, and capping/disposal of the device) during the participant's use of the single-use Avonex autoinjector."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '21999176', 'type': 'DERIVED', 'citation': 'Phillips JT, Fox E, Grainger W, Tuccillo D, Liu S, Deykin A. An open-label, multicenter study to evaluate the safe and effective use of the single-use autoinjector with an Avonex(R) prefilled syringe in multiple sclerosis subjects. BMC Neurol. 2011 Oct 14;11:126. doi: 10.1186/1471-2377-11-126.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study was to evaluate the safe and effective use of the single-use autoinjector for the intramuscular (IM) delivery of liquid Avonex® (interferon beta-1a) in participants with multiple sclerosis (MS).', 'detailedDescription': 'The Main Study was a 4-week treatment period which consisted of 1 Avonex manual injection using a prefilled syringe, followed by 3 Avonex injections using the single-use autoinjector. The Extension Study was designed to provide continuation of treatment with the Avonex single-use autoinjector to eligible participants who completed the Main Study for up to an additional 12 weeks, and to obtain additional safety and preference data for the Avonex single-use autoinjector.\n\nParticipants were enrolled under the initial study protocol (Initial Subject Subset); the study was subsequently suspended. Changes were made to the protocol (including modifications to the autoinjector needle), and additional participants were enrolled (Main Subject Subset).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.\n2. Must be 18 to 65 years old, inclusive, at the time of informed consent.\n3. Must currently be self-administering Avonex Prefilled Syringes to treat MS and must have been self-administering Avonex Prefilled Syringes for the 12 weeks prior to the Screening Visit.\n4. In the investigator's opinion, subjects must be willing and able to self-administer all injections required by the protocol.\n5. Must speak English.\n6. All male subjects and female subjects of child-bearing potential must practice effective contraception during the study.\n\nExclusion Criteria:\n\n1. History of seizure disorder or unexplained blackouts OR history of a seizure within 3 months prior to the Screening Visit.\n2. History of suicidal ideation within 3 months prior to Day 1 or an episode of severe depression within 3 months prior to Day 1. Severe depression is defined as any episode of depression that requires hospitalization, or the initiation of antidepressant therapy, or an increase in the dose of an existing regimen of antidepressant therapy. NOTE: Subjects receiving ongoing antidepressant therapy are not excluded from the study unless the dose has been increased within the 3 months prior to the Screening Visit.\n3. Clinically significant local infection (for example cellulitis, abscess) or systemic infection (pneumonia, septicemia), at the discretion of the Investigator.\n4. Known history of Human Immunodeficiency Virus (HIV).\n5. Known history of, or positive test result for hepatitis C virus (test for hepatitis C virus antibody \\[HCV Ab\\]) or Hepatitis B virus (test for Hepatitis B Surface Antigen \\[HBsAg\\] and/or Hepatitis B Core Antibody \\[HBcAb\\])."}, 'identificationModule': {'nctId': 'NCT00828204', 'briefTitle': 'Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinjector in Multiple Sclerosis Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'An Open-Label, Multicenter Study to Evaluate the Safe and Effective Use of the Single-Use Autoinjector With an Avonex® Prefilled Syringe in Multiple Sclerosis Subjects', 'orgStudyIdInfo': {'id': '108MS302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Avonex Single-Use Autoinjector', 'description': 'Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.\n\nIn the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.', 'interventionNames': ['Device: single-use autoinjector with a prefilled liquid Avonex syringe', 'Device: Avonex prefilled syringe via manual IM injection', 'Drug: BG9418 (interferon beta-1a)']}], 'interventions': [{'name': 'single-use autoinjector with a prefilled liquid Avonex syringe', 'type': 'DEVICE', 'armGroupLabels': ['Avonex Single-Use Autoinjector']}, {'name': 'Avonex prefilled syringe via manual IM injection', 'type': 'DEVICE', 'armGroupLabels': ['Avonex Single-Use Autoinjector']}, {'name': 'BG9418 (interferon beta-1a)', 'type': 'DRUG', 'otherNames': ['Avonex'], 'armGroupLabels': ['Avonex Single-Use Autoinjector']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '30327', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Fort Wayne Neurological Center', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '2135', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '28595', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Institute for Neurological Disorders', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11772', 'city': 'Patchogue', 'state': 'New York', 'country': 'United States', 'facility': 'Comprehensive Multiple Sclerosis Care Center', 'geoPoint': {'lat': 40.76565, 'lon': -73.01511}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '4320', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Neurology & Neuroscience Associates, Inc.', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '75214', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78681', 'city': 'Round Rock', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}, {'zip': '84103', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '25301', 'city': 'Charleston', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}