Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-01-01 @ 5:59 AM
Study NCT ID:
NCT04934800
Status:
COMPLETED
Last Update Posted:
2025-06-24
First Post:
2021-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective Effectiveness and Safety Study of Cladribine in Participants Who Change First-line DMD Treatments for Multiple Sclerosis (CLAD CROSS)
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': 'D017338', 'term': 'Cladribine'}], 'ancestors': [{'id': 'D015762', 'term': '2-Chloroadenosine'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003839', 'term': 'Deoxyadenosines'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'service@emdgroup.com', 'phone': '6151-72-5200', 'title': 'Communication Center', 'phoneExt': '+49', 'organization': 'Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From start of study up to 2 years', 'description': 'Other AEs includes both serious and non-serious AEs as no separate NSAEs were calculated in the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Cladribine', 'description': 'Participants with relapsing-remitting multiple sclerosis who had switched from first-line disease-modifying drug (DMD) treatments to cladribine tablets as part of routine clinical practice. No intervention was administered as part of this study.', 'otherNumAtRisk': 256, 'deathsNumAtRisk': 256, 'otherNumAffected': 90, 'seriousNumAtRisk': 256, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Coronavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Skin bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Varicella zoster virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Occipital neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Sensory disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Central nervous system lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': "Lhermitte's sign", 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'CD4 lymphocytes decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Prurigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tooth fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Adjustment disorder with depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hepatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 4}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Morning sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Upper airway obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hyperhomocysteinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ovarian germ cell teratoma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': "Raynaud's phenomenon", 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Hepatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Annualized Relapse Rate (ARR) Between the Pre-Baseline 12-Month Period (Baseline) and Over the 12 Months Period Before the End of Study Follow-Up (2 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cladribine', 'description': 'Participants with relapsing-remitting multiple sclerosis who had switched from first-line disease-modifying drug (DMD) treatments to cladribine tablets as part of routine clinical practice. No intervention was administered as part of this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.12', 'groupId': 'OG000', 'lowerLimit': '-1.23', 'upperLimit': '-1.00'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12-months pre-baseline (Baseline) and 12 Months Prior to End of Study follow up (2 years)', 'description': 'ARR defined as the number of relapses per year. A relapse was defined as the appearance of new symptoms or the exacerbation of pre-existing symptoms that were attributed to Multiple Sclerosis (MS) and occurred over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. Baseline ARR was defined as the total number of relapses reported in the last 12 months prior to Cladribine treatment. ARR 12-months prior to End Of Study was calculated as the sum of the number of MS relapses reported at Visit 3 and Visit 4 divided by the number of days between Visit 4 date and Visit 2 date and multiplied by 365.25. For a change from baseline, 95 percent (%) Confidence Interval (CI) for the difference were presented together with summary statistics. These CIs were included as a descriptive measure of effect.', 'unitOfMeasure': 'relapses per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all the participants who provided informed consent and who received at least one dose of Cladribine. Here "Number Analyzed" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change in ARR Between the Pre-Baseline 12-Month Period (Baseline) and Over the 12 Months Period After the Start of Cladribine (1 Year)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cladribine', 'description': 'Participants with relapsing-remitting multiple sclerosis who had switched from first-line disease-modifying drug (DMD) treatments to cladribine tablets as part of routine clinical practice. No intervention was administered as part of this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.01', 'groupId': 'OG000', 'lowerLimit': '-1.13', 'upperLimit': '-0.89'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12-month pre-baseline period (baseline) and over the 12 months period after start of Cladribine treatment (1 year)', 'description': 'ARR defined as the number of relapses per year. A relapse was defined as the appearance of new symptoms or the exacerbation of pre-existing symptoms that were attributed to MS and occurred over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. ARR 12-months after start of Cladribine was calculated as the sum of the number of MS relapses reported at Visit 1 and Visit 2 divided by the number of days between Visit 2 date and Cladribine start date and multiplied by 365.25.For a change from baseline, 95% CIs for the difference were presented together with summary statistics. These CIs were included as a descriptive measure of effect.', 'unitOfMeasure': 'relapses per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all the participants who provided informed consent and who received at least one dose of Cladribine.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With 6-Month Disability Progression Measured With Expanded Disability Status Scale (EDSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cladribine', 'description': 'Participants with relapsing-remitting multiple sclerosis who had switched from first-line disease-modifying drug (DMD) treatments to cladribine tablets as part of routine clinical practice. No intervention was administered as part of this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '0.43', 'upperLimit': '3.95'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At EOS (24 months follow-up)', 'description': 'EDSS assessed disability in 8 functional systems. It was a scale based on a standardized EDSS neurological examination, which comprised optic, brain stem, pyramidal, cerebellar, sensory, and cerebral functions, as well as walking ability. An overall score ranged from 0 (normal) to 10 (death due to MS) was calculated. Progression on EDSS was defined as at least a 1-point increase in the score or an increase of at least 1.5 points if the baseline EDSS score was 0.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all the participants who provided informed consent and who received at least one dose of Cladribine. Here "Number Analyzed" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Overall 6-Month Disability Progression Measured With EDSS, Timed 25 Foot Walk (T25FW) or 9 Hole Peg Test (9HPT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cladribine', 'description': 'Participants with relapsing-remitting multiple sclerosis who had switched from first-line disease-modifying drug (DMD) treatments to cladribine tablets as part of routine clinical practice. No intervention was administered as part of this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '2.45', 'upperLimit': '8.04'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At EOS (24 months follow-up)', 'description': 'Disability progression was assessed if at least one assessment (EDSS, T25FW or 9HPT) was available. As per definition, disability progression was derived as "Yes" if at least one of the below cases occured: 1. Visit 4 EDSS is greater than (\\>=) equal to (≥) 1 point \\>= Visit 3 EDSS if Visit 3 EDSS is \\> 0; 2. Visit 4 EDSS is 1.5 or \\> when Visit 3 EDSS is 0; 3. 20% increase in the T25FW score (average of the two trials) from Visit 3 to Visit 4; 4. 20% increase in the 9HPT score (The two trials for each hand are averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals are averaged) from Visit 3 to Visit 4. If none of those cases occurred, disability progression will be set to "No". The percentage of participants with 6-month disability progression at the EOS was presented including associated 95% Clopper Pearson exact intervals.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all the participants who provided informed consent and who received at least one dose of Cladribine. Here "Number Analyzed" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With 6-Month Disability Improvement Measured With EDSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cladribine', 'description': 'Participants with relapsing-remitting multiple sclerosis who had switched from first-line disease-modifying drug (DMD) treatments to cladribine tablets as part of routine clinical practice. No intervention was administered as part of this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '0.43', 'upperLimit': '3.95'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At EOS (24 months follow-up)', 'description': 'EDSS assessed disability in 8 functional systems. It was a scale based on standardized neurological examination which comprised of optic, brain stem, pyramidal, cerebellar, sensory \\& cerebral functions, as well as walking ability. An overall score ranged from 0 (normal) to 10 (death due to MS) was calculated. Improvement on EDSS was defined as a decrease in EDSS by at least 1 point (1.5 points if baseline EDSS was 1.5).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all the participants who provided informed consent and who received at least one dose of Cladribine. Here "Number Analyzed" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Overall 6-Month Disability Improvement Measured With EDSS, Timed 25 Foot Walk (T25FW) or 9 Hole Peg Test(9HPT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cladribine', 'description': 'Participants with relapsing-remitting multiple sclerosis who had switched from first-line disease-modifying drug (DMD) treatments to cladribine tablets as part of routine clinical practice. No intervention was administered as part of this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '2.45', 'upperLimit': '8.04'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At EOS (24 months follow-up)', 'description': 'Disability improvement was assessed if at least one assessment (EDSS, T25FW or 9HPT) was available. As per definition, disability improvement was derived as "Yes" if at least one of the below cases occur:1. Visit 4 EDSS is ≥1 point smaller than Visit 3 EDSS if Visit 3 EDSS is greater than 1.5;2. Visit 4 EDSS is 0 when Visit 3 EDSS is 1.5;3. 20% decrease in the T25FW score (average of the two trials) from Visit 3 to Visit 4;4. 20% decrease in the 9HPT score (The two trials for each hand are averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals are averaged) from Visit 3 to Visit 4. If none of those cases occurred, disability improvement was set to "No". The percentage of participants with 6-month disability improvement at the end of study was presented including associated 95% Clopper Pearson exact intervals.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all the participants who provided informed consent and who received at least one dose of Cladribine. Here "Number Analyzed" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cladribine', 'description': 'Participants with relapsing-remitting multiple sclerosis who had switched from first-line disease-modifying drug (DMD) treatments to cladribine tablets as part of routine clinical practice. No intervention was administered as part of this study.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study up to 2 years', 'description': 'An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, regardless if it is considered related to the medicinal product. Serious AE: AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs are defined as AEs that were reported or worsened on or after start of study drug dosing through the Safety Follow-up Visit. TEAEs included both serious TEAEs and non-serious TEAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all the participants who provided informed consent and who received at least one dose of Cladribine.'}, {'type': 'SECONDARY', 'title': 'Quality of Life as Assessed by Multiple Sclerosis Impact Scale (MSIS-29) Score: Physical and Psychological Impact', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cladribine', 'description': 'Participants with relapsing-remitting multiple sclerosis who had switched from first-line disease-modifying drug (DMD) treatments to cladribine tablets as part of routine clinical practice. No intervention was administered as part of this study.'}], 'classes': [{'title': 'Psychological Impact: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.8', 'spread': '23.30', 'groupId': 'OG000'}]}]}, {'title': 'Psychological Impact: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.8', 'spread': '21.33', 'groupId': 'OG000'}]}]}, {'title': 'Psychological Impact: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.7', 'spread': '21.09', 'groupId': 'OG000'}]}]}, {'title': 'Physical Impact: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.1', 'spread': '19.99', 'groupId': 'OG000'}]}]}, {'title': 'Physical Impact: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.4', 'spread': '17.09', 'groupId': 'OG000'}]}]}, {'title': 'Physical Impact: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.2', 'spread': '19.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 12 and 24', 'description': 'MSIS-29 was a 29-item self-report measure with 20 items related to physical scale and 9 items with psychological scale. All items have 5 options:1-not at all to 5-extremely. Each of2 scales are scored by summing responses across items, converting to 0-100 scale where 100 indicates great impact of disease on daily function (worse health). Physical impact score computed by summing items 1-20 inclusive (observed score). This score was then transformed to a score on a scale of 0-100 using the formula:\\[100 multiplied by(observed score minus(-)20)\\] divided by(100-20). The psychological impact score was computed by summing items number21-29 inclusive(observed score). This score was then transformed to score on scale of 0-100 using the formula:\\[100 multiplied by(observed score minus 9)\\]divided by(45-9). Total score range ranges from 0-100, lower total score shows less psychological/physical-related impact while a higher total score indicated greater psychological/physical-related impact.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all the participants who provided informed consent and who received at least one dose of Cladribine. . Here "Number Analyzed" signifies those participants who were evaluable at specific timepoint.'}, {'type': 'SECONDARY', 'title': 'Quality of Life as Assessed by EuroQol Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D-3L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cladribine', 'description': 'Participants with relapsing-remitting multiple sclerosis who had switched from first-line disease-modifying drug (DMD) treatments to cladribine tablets as part of routine clinical practice. No intervention was administered as part of this study.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.6', 'spread': '19.07', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.9', 'spread': '15.17', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.4', 'spread': '17.17', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 12 and 24', 'description': 'Quality of Life was measured using the EQ-5D-3L questionnaire. The EQ-5D-3L asks participants to rate the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D-5L VAS was used to record a participants rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 =worst imaginable health state and 100 = best imaginable health state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all the participants who provided informed consent and who received at least one dose of Cladribine. Here "Number Analyzed" signifies those participants who were evaluated at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Treatment Satisfaction as Assessed by Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM v1.4) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cladribine', 'description': 'Participants with relapsing-remitting multiple sclerosis who had switched from first-line disease-modifying drug (DMD) treatments to cladribine tablets as part of routine clinical practice. No intervention was administered as part of this study.'}], 'classes': [{'title': 'Global Satisfaction: Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.3', 'spread': '17.78', 'groupId': 'OG000'}]}]}, {'title': 'Global Satisfaction: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.4', 'spread': '18.81', 'groupId': 'OG000'}]}]}, {'title': 'Global Satisfaction: Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.0', 'spread': '20.06', 'groupId': 'OG000'}]}]}, {'title': 'Global Satisfaction: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.2', 'spread': '19.82', 'groupId': 'OG000'}]}]}, {'title': 'Effectiveness: Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.7', 'spread': '20.56', 'groupId': 'OG000'}]}]}, {'title': 'Effectiveness: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '72.6', 'spread': '22.04', 'groupId': 'OG000'}]}]}, {'title': 'Effectiveness: Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '72.3', 'spread': '21.68', 'groupId': 'OG000'}]}]}, {'title': 'Effectiveness: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.5', 'spread': '18.62', 'groupId': 'OG000'}]}]}, {'title': 'Side Effects: Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.6', 'spread': '11.87', 'groupId': 'OG000'}]}]}, {'title': 'Side Effects: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.1', 'spread': '13.45', 'groupId': 'OG000'}]}]}, {'title': 'Side Effects: Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.8', 'spread': '11.65', 'groupId': 'OG000'}]}]}, {'title': 'Side Effects: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.2', 'spread': '11.27', 'groupId': 'OG000'}]}]}, {'title': 'Convenience: Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.4', 'spread': '13.77', 'groupId': 'OG000'}]}]}, {'title': 'Convenience: Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.9', 'spread': '13.97', 'groupId': 'OG000'}]}]}, {'title': 'Convenience: Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.3', 'spread': '13.26', 'groupId': 'OG000'}]}]}, {'title': 'Convenience: Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.9', 'spread': '12.20', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 6, 12, 18 and 24', 'description': "TSQM version 1.4 was a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions:12-14). Global Satisfaction- Question 12 scored as 1 (not at all confident) to 5 (extremely confident); question 13 scored as 1 (not at all certain) to 5 (extremely certain); and question 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all the participants who provided informed consent and who received at least one dose of Cladribine. Here "Number Analyzed" signifies those participants who were evaluated at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cladribine', 'description': 'Participants with relapsing-remitting multiple sclerosis who had switched from first-line disease-modifying drug (DMD) treatments to cladribine tablets as part of routine clinical practice. No intervention was administered as part of this study.'}], 'classes': [{'title': '90%-100%', 'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Month 24', 'description': 'According to the World Health Organization (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term). Adherence to treatment, calculated as 100 × Taken tablets/Prescribed tablets', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all the participants who provided informed consent and who received at least one dose of Cladribine. . Here "Number Analyzed" signifies those participants who were evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cladribine', 'description': 'Participants with relapsing-remitting multiple sclerosis who had switched from first-line disease-modifying drug (DMD) treatments to cladribine tablets as part of routine clinical practice. No intervention was administered as part of this study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '256'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '234'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Enrolled but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cladribine', 'description': 'Participants with relapsing-remitting multiple sclerosis who had switched from first-line disease-modifying drug (DMD) treatments to cladribine tablets as part of routine clinical practice. No intervention was administered as part of this study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.3', 'spread': '10.90', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '174', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '82', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '256', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '253', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-07', 'size': 32805300, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-20T04:43', 'hasProtocol': True}, {'date': '2021-11-17', 'size': 2129541, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-20T04:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 256}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2021-06-17', 'resultsFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2021-06-17', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-23', 'studyFirstPostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Annualized Relapse Rate (ARR) Between the Pre-Baseline 12-Month Period (Baseline) and Over the 12 Months Period Before the End of Study Follow-Up (2 Years)', 'timeFrame': '12-months pre-baseline (Baseline) and 12 Months Prior to End of Study follow up (2 years)', 'description': 'ARR defined as the number of relapses per year. A relapse was defined as the appearance of new symptoms or the exacerbation of pre-existing symptoms that were attributed to Multiple Sclerosis (MS) and occurred over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. Baseline ARR was defined as the total number of relapses reported in the last 12 months prior to Cladribine treatment. ARR 12-months prior to End Of Study was calculated as the sum of the number of MS relapses reported at Visit 3 and Visit 4 divided by the number of days between Visit 4 date and Visit 2 date and multiplied by 365.25. For a change from baseline, 95 percent (%) Confidence Interval (CI) for the difference were presented together with summary statistics. These CIs were included as a descriptive measure of effect.'}], 'secondaryOutcomes': [{'measure': 'Change in ARR Between the Pre-Baseline 12-Month Period (Baseline) and Over the 12 Months Period After the Start of Cladribine (1 Year)', 'timeFrame': '12-month pre-baseline period (baseline) and over the 12 months period after start of Cladribine treatment (1 year)', 'description': 'ARR defined as the number of relapses per year. A relapse was defined as the appearance of new symptoms or the exacerbation of pre-existing symptoms that were attributed to MS and occurred over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. ARR 12-months after start of Cladribine was calculated as the sum of the number of MS relapses reported at Visit 1 and Visit 2 divided by the number of days between Visit 2 date and Cladribine start date and multiplied by 365.25.For a change from baseline, 95% CIs for the difference were presented together with summary statistics. These CIs were included as a descriptive measure of effect.'}, {'measure': 'Percentage of Participants With 6-Month Disability Progression Measured With Expanded Disability Status Scale (EDSS)', 'timeFrame': 'At EOS (24 months follow-up)', 'description': 'EDSS assessed disability in 8 functional systems. It was a scale based on a standardized EDSS neurological examination, which comprised optic, brain stem, pyramidal, cerebellar, sensory, and cerebral functions, as well as walking ability. An overall score ranged from 0 (normal) to 10 (death due to MS) was calculated. Progression on EDSS was defined as at least a 1-point increase in the score or an increase of at least 1.5 points if the baseline EDSS score was 0.'}, {'measure': 'Percentage of Participants With Overall 6-Month Disability Progression Measured With EDSS, Timed 25 Foot Walk (T25FW) or 9 Hole Peg Test (9HPT)', 'timeFrame': 'At EOS (24 months follow-up)', 'description': 'Disability progression was assessed if at least one assessment (EDSS, T25FW or 9HPT) was available. As per definition, disability progression was derived as "Yes" if at least one of the below cases occured: 1. Visit 4 EDSS is greater than (\\>=) equal to (≥) 1 point \\>= Visit 3 EDSS if Visit 3 EDSS is \\> 0; 2. Visit 4 EDSS is 1.5 or \\> when Visit 3 EDSS is 0; 3. 20% increase in the T25FW score (average of the two trials) from Visit 3 to Visit 4; 4. 20% increase in the 9HPT score (The two trials for each hand are averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals are averaged) from Visit 3 to Visit 4. If none of those cases occurred, disability progression will be set to "No". The percentage of participants with 6-month disability progression at the EOS was presented including associated 95% Clopper Pearson exact intervals.'}, {'measure': 'Percentage of Participants With 6-Month Disability Improvement Measured With EDSS', 'timeFrame': 'At EOS (24 months follow-up)', 'description': 'EDSS assessed disability in 8 functional systems. It was a scale based on standardized neurological examination which comprised of optic, brain stem, pyramidal, cerebellar, sensory \\& cerebral functions, as well as walking ability. An overall score ranged from 0 (normal) to 10 (death due to MS) was calculated. Improvement on EDSS was defined as a decrease in EDSS by at least 1 point (1.5 points if baseline EDSS was 1.5).'}, {'measure': 'Percentage of Participants With Overall 6-Month Disability Improvement Measured With EDSS, Timed 25 Foot Walk (T25FW) or 9 Hole Peg Test(9HPT)', 'timeFrame': 'At EOS (24 months follow-up)', 'description': 'Disability improvement was assessed if at least one assessment (EDSS, T25FW or 9HPT) was available. As per definition, disability improvement was derived as "Yes" if at least one of the below cases occur:1. Visit 4 EDSS is ≥1 point smaller than Visit 3 EDSS if Visit 3 EDSS is greater than 1.5;2. Visit 4 EDSS is 0 when Visit 3 EDSS is 1.5;3. 20% decrease in the T25FW score (average of the two trials) from Visit 3 to Visit 4;4. 20% decrease in the 9HPT score (The two trials for each hand are averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals are averaged) from Visit 3 to Visit 4. If none of those cases occurred, disability improvement was set to "No". The percentage of participants with 6-month disability improvement at the end of study was presented including associated 95% Clopper Pearson exact intervals.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From start of study up to 2 years', 'description': 'An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, regardless if it is considered related to the medicinal product. Serious AE: AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs are defined as AEs that were reported or worsened on or after start of study drug dosing through the Safety Follow-up Visit. TEAEs included both serious TEAEs and non-serious TEAEs.'}, {'measure': 'Quality of Life as Assessed by Multiple Sclerosis Impact Scale (MSIS-29) Score: Physical and Psychological Impact', 'timeFrame': 'Baseline, Months 12 and 24', 'description': 'MSIS-29 was a 29-item self-report measure with 20 items related to physical scale and 9 items with psychological scale. All items have 5 options:1-not at all to 5-extremely. Each of2 scales are scored by summing responses across items, converting to 0-100 scale where 100 indicates great impact of disease on daily function (worse health). Physical impact score computed by summing items 1-20 inclusive (observed score). This score was then transformed to a score on a scale of 0-100 using the formula:\\[100 multiplied by(observed score minus(-)20)\\] divided by(100-20). The psychological impact score was computed by summing items number21-29 inclusive(observed score). This score was then transformed to score on scale of 0-100 using the formula:\\[100 multiplied by(observed score minus 9)\\]divided by(45-9). Total score range ranges from 0-100, lower total score shows less psychological/physical-related impact while a higher total score indicated greater psychological/physical-related impact.'}, {'measure': 'Quality of Life as Assessed by EuroQol Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D-3L)', 'timeFrame': 'Baseline, Months 12 and 24', 'description': 'Quality of Life was measured using the EQ-5D-3L questionnaire. The EQ-5D-3L asks participants to rate the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D-5L VAS was used to record a participants rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 =worst imaginable health state and 100 = best imaginable health state.'}, {'measure': 'Treatment Satisfaction as Assessed by Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM v1.4) Scale', 'timeFrame': 'Months 6, 12, 18 and 24', 'description': "TSQM version 1.4 was a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions:12-14). Global Satisfaction- Question 12 scored as 1 (not at all confident) to 5 (extremely confident); question 13 scored as 1 (not at all certain) to 5 (extremely certain); and question 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction."}, {'measure': 'Number of Participants With Treatment Adherence', 'timeFrame': 'Up to Month 24', 'description': 'According to the World Health Organization (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term). Adherence to treatment, calculated as 100 × Taken tablets/Prescribed tablets'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Cladribine', 'MAVENCLAD ®'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS700568_0070', 'label': 'Trial Awareness and Transparency website'}, {'url': 'https://www.merckgroup.com/en/company/contact-us/medinfo-contact-map.html', 'label': 'Medical Information Location Map - Med Info Contacts'}]}, 'descriptionModule': {'briefSummary': 'The main aim was to study in the real world setting the effectiveness of Cladribine tablets in terms of Annualized Relapse Rate (ARR) and disability progression, in participants who switched from a first line Disease Modifying Drug (DMD) (Interferons, Glatiramer Acetate, Teriflunomide, (Dymethyl fumarate) \\[DMF\\]) to treatment with Cladribine tablets in routine clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with a confirmed diagnosis of Highly Active Relapsing-Remitting Multiple Sclerosis (RRMS).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with confirmed diagnosis of RRMS diagnosed by the treating physician according to applicable clinical practice guidelines -(currently McDonald 2017 criteria), with high disease activity\n* Participants should have been treated with the same first-line DMD (Interferons, Glatiramer Acetate, Teriflunomide, DMF) and at a stable dose for at least one year prior to switch to Cladribine tablets and should have been prescribed Cladribine tablets, according to the decision of the treating physician, prior to enrollment in the study. Any washout period and/or washout methods required before switching (such as elimination of Teriflunomide) must have been conducted, according to the decision of the treating physician\n* Required history data should be available: Multiple Sclerosis (MS) data for the 12-months pre-baseline period (annualized relapse rate); MS Medication History (prior DMDs)\n* Fulfilment of the criteria for treatment with Cladribine tablets per standard of care in accordance with the local Summary of Product Characteristics (SmPC)\n\nExclusion Criteria:\n\n* Contraindications to use of cladribine tablets according to the SmPC\n* Participants with history of alcohol or drug abuse that could potentially interfere with their participation in the study\n* Participants that have received Cladribine in the past\n* Concurrent participation in an investigational study in which participant assessment and/or treatment may be dictated by a protocol'}, 'identificationModule': {'nctId': 'NCT04934800', 'briefTitle': 'Prospective Effectiveness and Safety Study of Cladribine in Participants Who Change First-line DMD Treatments for Multiple Sclerosis (CLAD CROSS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany'}, 'officialTitle': 'Oral CLADribine in Patients That Change From First-line Disease Modifying Treatments for Multiple Sclerosis: a pROspective effectivenesS and Safety Study (CLAD CROSS)', 'orgStudyIdInfo': {'id': 'MS700568_0070'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cladribine', 'interventionNames': ['Drug: Cladribine']}], 'interventions': [{'name': 'Cladribine', 'type': 'DRUG', 'otherNames': ['MAVENCLAD ®'], 'description': 'No intervention will be administered as a part of this study. Participants who had switched from first-line DMD treatments to treatment with cladribine tablets in routine clinical practice will be assessed for 2 years in this study.', 'armGroupLabels': ['Cladribine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Eisenstadt', 'country': 'Austria', 'facility': 'KH der Barmherzige Brüder Eisenstadt - Neurology', 'geoPoint': {'lat': 47.84565, 'lon': 16.52327}}, {'city': 'Sankt Veit an der Glan', 'country': 'Austria', 'facility': 'Dr. Reinhard Krendl-Head', 'geoPoint': {'lat': 46.76806, 'lon': 14.36028}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Klinik Florisdorf', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Alexandroupoli', 'country': 'Greece', 'facility': 'University of Thrace, Medical School - Neurology Department', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}, {'city': 'Athens', 'country': 'Greece', 'facility': '251 General Air Force Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': '417 NIMITS Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': "Aeginiteion Hospital, University of Athens - A' Neurology Department", 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Attikon University Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Evangelismos Hospital - Neurology Department', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Genaral Hospital of Elefsina "Thriasio"', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'General Hospital of Athens "Evangelismos"', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Ioannina', 'country': 'Greece', 'facility': 'University of Ioannina - Neurology Department, Ioannina', 'geoPoint': {'lat': 39.66341, 'lon': 20.85187}}, {'city': 'Larissa', 'country': 'Greece', 'facility': 'University General Hospital of Larissa - Rheumatology Clinic', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'city': 'Palaió Fáliro', 'country': 'Greece', 'facility': 'Iatriko Palaioy Faliroy, Medical Center - Neurology Department', 'geoPoint': {'lat': 37.92812, 'lon': 23.70105}}, {'city': 'Pátrai', 'country': 'Greece', 'facility': 'General Hospital of Patra "Agios Andreas"', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'city': 'Pátrai', 'country': 'Greece', 'facility': 'University General Hospital of Patra', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'AHEPA General Hospital of Thessaloniki', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'General Hospital of Thessaloniki "G. Papanikolaou"', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Interbalkan Hospital of Thessaloniki', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Papageorgiou General Hospital Thessaloniki', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': "St Luke's Hospital", 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Bergamo', 'country': 'Italy', 'facility': 'Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) - Dipartimento di Neurologia', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'city': 'Cefalù', 'country': 'Italy', 'facility': 'Fondazione Istituto G.Giglio di Cefalù - Neurologia-Centro Sclerosi Multipla', 'geoPoint': {'lat': 38.03856, 'lon': 14.02285}}, {'city': 'Chieti', 'country': 'Italy', 'facility': "Università degli Studi G. D'Annunzio", 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}, {'city': 'Cona', 'country': 'Italy', 'facility': "Azienda Ospedaliera Universitaria Arcispedale Sant'Anna - Neurologia", 'geoPoint': {'lat': 44.80583, 'lon': 11.7069}}, {'city': 'Foggia', 'country': 'Italy', 'facility': 'Ospedali Riuniti di Foggia - Neurology', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}, {'city': 'Gallarate', 'country': 'Italy', 'facility': 'Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate) - Neurologia 2 - Sclerosi Multipla', 'geoPoint': {'lat': 45.66019, 'lon': 8.79164}}, {'city': 'Lucca', 'country': 'Italy', 'facility': 'Ospedale San Luca - S.C.Oncologia', 'geoPoint': {'lat': 43.84369, 'lon': 10.50447}}, {'city': 'L’Aquila', 'country': 'Italy', 'facility': "ASL 1 Avezzano L'Aquila Sulmona- Ospedale Regionale San Salvatore - Dipartimento di Neurologia", 'geoPoint': {'lat': 42.35055, 'lon': 13.39954}}, {'city': 'Messina', 'country': 'Italy', 'facility': 'IRCCS Centro Neurolesi Bonino Pulejo - U.O. di Neurofisipatologia ed Ambulatori', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli - U.O.S. Malattie Degenerative del S.N.C.', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Novara', 'country': 'Italy', 'facility': 'Ospedale Maggiore della carità - Novara', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'city': 'Orbassano', 'country': 'Italy', 'facility': 'Centro di Riferimento Regionale per la Sclerosi Multipla (CRESM) - SCDO Neurologia', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'city': 'Palermo', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone - Dipartimento di Neuroscienze', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Perugia', 'country': 'Italy', 'facility': 'Azienda Ospedaliera di Udine Ospedale S. 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