Viewing Study NCT01013350

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Ignite Creation Date: 2025-12-24 @ 4:46 PM
Ignite Modification Date: 2025-12-28 @ 8:53 AM
Study NCT ID: NCT01013350
Status: COMPLETED
Last Update Posted: 2019-11-15
First Post: 2009-11-11
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Prospective Observational Long-term Safety Registry of Multiple Sclerosis Participants Who Have Participated in Cladribine Clinical Trials
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'service@emdgroup.com', 'phone': '+49-6151-72-5200', 'title': 'Communication Center', 'organization': 'Merck KGaA, Darmstadt, Germany'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'up to 3251 days', 'description': 'Safety analysis set included all participants in the current study who either received placebo matched to cladribine or cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826, NCT00641537 and NCT00725985).', 'eventGroups': [{'id': 'EG000', 'title': 'Never Exposed to Cladribine', 'description': 'All participants who received placebo matched to cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826, NCT00641537 and NCT00725985).', 'otherNumAtRisk': 198, 'deathsNumAtRisk': 198, 'otherNumAffected': 26, 'seriousNumAtRisk': 198, 'deathsNumAffected': 3, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Exposed to Cladribine', 'description': 'All participants who received cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826, NCT00641537 and NCT00725985).', 'otherNumAtRisk': 950, 'deathsNumAtRisk': 950, 'otherNumAffected': 124, 'seriousNumAtRisk': 950, 'deathsNumAffected': 5, 'seriousNumAffected': 63}], 'otherEvents': [{'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 76}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 48}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}], 'seriousEvents': [{'term': 'Immune thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Coronary artery insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Dandy-Walker syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Thyroid mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Gastrointestinal melanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Accidental death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Meningoencephalitis herpetic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Brain herniation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Subdural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Breast cancer stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Cervix carcinoma stage 0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Colon cancer stage 0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Metastases to lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Nonkeratinising carcinoma of nasopharynx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Ovarian germ cell teratoma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Polycythaemia vera', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Rectal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Thyroid adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Cerebellar syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Hemiparaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Monoparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Multiple sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Optic neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Relapsing-remitting multiple sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Abortion missed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Abortion 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198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Premature separation of placenta', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Jealous delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 950, 'numAffected': 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Pregnancy outcomes were Live birth, Induced abortion (Termination), Spontaneous loss (Miscarriage) (\\< 22 weeks), Foetal death (stillbirth) (\\>=22 weeks), Ectopic pregnancy, Congenital malformations and others (unknown). Number of participants as per pregnancy outcome category were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set. Here, "Overall Number of Participants Analyzed" signifies number of participants with pregnancies.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Never Exposed to Cladribine', 'description': 'All participants who received placebo matched to cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826 , NCT00641537, NCT00938366 and NCT00725985).'}, {'id': 'FG001', 'title': 'Exposed to Cladribine', 'description': 'All participants who received cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826, NCT00641537, NCT00938366 and NCT00725985).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '963'}]}, {'type': 'Safety Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '950'}]}, {'type': 'COMPLETED', 'achievements': 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'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis set included all participants in the current study who either received placebo matched to cladribine or cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826 , NCT00641537 and NCT00725985).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-20', 'size': 5217769, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-24T10:48', 'hasProtocol': True}, {'date': '2018-11-21', 'size': 1675867, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-24T10:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1161}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-24', 'studyFirstSubmitDate': '2009-11-11', 'resultsFirstSubmitDate': '2019-10-24', 'studyFirstSubmitQcDate': '2009-11-12', 'lastUpdatePostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-24', 'studyFirstPostDateStruct': {'date': '2009-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Serious Adverse Drug Reactions (SADRs)', 'timeFrame': 'up to 3251 days', 'description': 'SADR is an adverse drug reaction that fulfils at least one of the seriousness criterion; results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is otherwise considered as medically important. An adverse drug reaction (ADR) is a response to a medicinal product which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the restoration, correction, or modification or physiological functions. Number of participants with SADRs were reported.'}, {'measure': 'Time to Resolution of Lymphopenia, Among Registry Participants With Persistent Lymphopenia', 'timeFrame': 'up to 3251 days', 'description': 'Persistent lymphopenia was defined as Grade 3 (less than \\[\\<\\] 500-200 per millimeter \\[mm\\] \\^3 or \\< 0.5-0.2 multiply \\[\\*\\]10\\^9 per Liter) or Grade 4 (\\< 200/mm\\^3 or \\< 0.2\\*10\\^9 per Liter) lymphopenia as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The resolution is the achievement of a CTCAE Grade 1 (\\< lower limit of normal \\[LLN\\] to 800 per mm\\^3 or \\< LLN to 0.8\\*10\\^9 per Liter) or Grade 0 (\\< 910 per mm\\^3 ) lymphocyte count. Persistent Lymphopenia was reported only in Cladribine group, hence results are reported only for "Exposed to Cladribine" arm. Time to resolution is reported.'}, {'measure': 'Number of Participants With Adverse Events (AEs) in the "Blood and Lymphatic System Disorders" System Organ Class (SOC) and in the "Neoplasms Benign, Malignant, and Unspecified" SOC', 'timeFrame': 'up to 3251 days', 'description': 'An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Pregnancy Outcomes', 'timeFrame': 'up to 3251 days', 'description': 'Pregnancies occurred among female participants exposed to cladribine were identified by a participant-reported positive pregnancy test and at least a 2-week delay in menses, or a participant-reported pregnancy diagnosed by a physician. Pregnancy outcomes were Live birth, Induced abortion (Termination), Spontaneous loss (Miscarriage) (\\< 22 weeks), Foetal death (stillbirth) (\\>=22 weeks), Ectopic pregnancy, Congenital malformations and others (unknown). Number of participants as per pregnancy outcome category were reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Cladribine', 'PREMIERE', 'Observational study'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '32447743', 'type': 'DERIVED', 'citation': 'Giovannoni G, Galazka A, Schick R, Leist T, Comi G, Montalban X, Damian D, Dangond F, Cook S. Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis: An Integrated Analysis of Safety. Drug Saf. 2020 Jul;43(7):635-643. doi: 10.1007/s40264-020-00948-x.'}]}, 'descriptionModule': {'briefSummary': 'Prospective Observational Long-term Safety Registry of Multiple Sclerosis Participants who Have Participated in Cladribine Clinical Trials'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with Multiple Sclerosis and had already participated in Sponsor oral cladribine clinical development trials', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prior enrollment into selected oral cladribine clinical trials as of randomization to either study drug or placebo, once participation in the clinical trial has ended\n* Written informed consent was given\n\nExclusion Criteria:\n\n* Participants who cannot be reached by telephone\n* Participants unable to answer the registry questionnaires and who do not have a next of kin or caregiver able to answer the registry questionnaires\n* Participants who - either during the lag interval or subsequently enter an interventional study'}, 'identificationModule': {'nctId': 'NCT01013350', 'acronym': 'PREMIERE', 'briefTitle': 'Prospective Observational Long-term Safety Registry of Multiple Sclerosis Participants Who Have Participated in Cladribine Clinical Trials', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMD Serono'}, 'officialTitle': 'Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients Who Have Participated in Cladribine Clinical Studies (PREMIERE)', 'orgStudyIdInfo': {'id': 'EMR700568-012'}, 'secondaryIdInfos': [{'id': '2009-017978-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Never Exposed to Cladribine', 'description': 'All participants who received placebo matched to cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826 , NCT00641537, NCT00938366 and NCT00725985).'}, {'label': 'Exposed to Cladribine', 'description': 'All participants who received cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826, NCT00641537, NCT00938366 and NCT00725985).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02139', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Outcome Sciences, Inc', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'overallOfficials': [{'name': 'Medical Responsible', 'role': 'STUDY_DIRECTOR', 'affiliation': 'EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMD Serono', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}