Raw JSON
{'hasResults': False, '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': 'D000068876', 'term': 'Fingolimod Hydrochloride'}], 'ancestors': [{'id': 'D013110', 'term': 'Sphingosine'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011409', 'term': 'Propylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3076}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-28', 'studyFirstSubmitDate': '2011-08-21', 'studyFirstSubmitQcDate': '2011-09-26', 'lastUpdatePostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'For each of the selected safety outcomes, number of patients with a reported event since study start', 'timeFrame': 'Patients will be followed for an expected average of 5 years', 'description': 'Incidence of AEs for bradyarrhythmias, liver toxicity, macular edema, infections'}], 'secondaryOutcomes': [{'measure': 'Number of patients SAEs since study start', 'timeFrame': 'Patients will be followed for an expected average of 5 years'}, {'measure': 'PRIMUS activities, comparison of mean change between the 2 cohorts', 'timeFrame': 'Patients will be followed for an expected average of 5 years'}, {'measure': 'TSQM-9, comparison between the 2 cohorts', 'timeFrame': 'Patients will be followed for an expected average of 5 years'}, {'measure': 'WPAI-GH, comparison of mean change between the 2 cohorts', 'timeFrame': 'Patients will be followed for an expected average of 5 years'}, {'measure': 'MSIS-29, comparison of mean change between the 2 cohorts', 'timeFrame': 'Patients will be followed for an expected average of 5 years'}]}, 'conditionsModule': {'keywords': ['Multiple sclerosis', 'fingolimod', 'observational study'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17906', 'label': 'Study Results'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this world-wide prospective parallel-cohort study in patients with relapsing forms of MS, either newly treated with fingolimod or receiving another disease-modifying therapy, is to further explore the incidence of selected safety- related outcomes and to further monitor the overall safety profile of fingolimod under conditions of routine medical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with relapsing forms of MS that have been recently initiated on fingolimod by their treating physician or patients that are treated with other disease-modifying therapies as part of their MS treatment in accordance with the respective local prescribing information and routine clinical practice', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that as part of their routine clinical care and according to the locally approved label, are either;\n* Starting fingolimod at time of study entry.\n* Starting another approved DMT or started within maximum 6 months prior to study entry.\n* Patients, or a able legal representative of the patient, who are willing to provide written informed consent.\n\nFingolimod patients will constitute the fingolimod cohort while patients with the other DMT will constitute the parallel cohort\n\nExclusion Criteria:\n\n* Patients previously or currently treated with a cytotoxic agent (e.g. mitoxantrone, cladribine, alemtuzumab) or natalizumab\n* Patients participating simultaneously in another study with inclusion/exclusion criteria more restrictive than the label or an interventional study unless this is a study on fingolimod lasting 1 month maximum\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01442194', 'acronym': 'PASSAGE', 'briefTitle': 'Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Long-term, Prospective,Multinational, Parallel-cohort Study Monitoring Safety in Patients With MS Newly Started With Fingolimod Once Daily or Treated With Another Approved Disease-modifying Therapy', 'orgStudyIdInfo': {'id': 'CFTY720D2403'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fingolimod', 'description': 'non-interventional', 'interventionNames': ['Drug: Fingolimod']}, {'label': 'parallel cohort', 'description': 'non-interventional', 'interventionNames': ['Drug: other disease-modifying therapy']}], 'interventions': [{'name': 'other disease-modifying therapy', 'type': 'DRUG', 'armGroupLabels': ['parallel cohort']}, {'name': 'Fingolimod', 'type': 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