Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-04-17 @ 9:03 AM
Study NCT ID:
NCT02139592
Status:
COMPLETED
Last Update Posted:
2020-07-13
First Post:
2014-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Brentuximab Vedotin (Recombinant) for IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D017728', 'term': 'Lymphoma, Large-Cell, Anaplastic'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079963', 'term': 'Brentuximab Vedotin'}], 'ancestors': [{'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 48 or until discontinuation of treatment', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.', 'eventGroups': [{'id': 'EG000', 'title': 'Brentuximab Vedotin Infusion', 'description': 'Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.', 'otherNumAtRisk': 284, 'deathsNumAtRisk': 284, 'otherNumAffected': 238, 'seriousNumAtRisk': 284, 'deathsNumAffected': 51, 'seriousNumAffected': 97}], 'otherEvents': [{'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 22}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 153}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 129}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 31}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Epstein-Barr virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Meningitis aseptic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Systemic candida', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumonia fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Herpes zoster disseminated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumocystis jirovecii pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': "Hodgkin's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 21}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Peripheral T-cell lymphoma unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gingival cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anaplastic large-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 13}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Graft versus host disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acute graft versus host disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Altered state of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Clonic convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cardiomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Small intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Generalised erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Renal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Brain herniation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brentuximab Vedotin Infusion', 'description': 'Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.'}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 48 or until discontinuation of treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set; The safety analysis set was defined as all participants who had the safety data defined on the protocol.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieve or Maintain Any Best Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brentuximab Vedotin Infusion', 'description': 'Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.'}], 'classes': [{'title': 'HL Participants with PET Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.9', 'groupId': 'OG000', 'lowerLimit': '53.22', 'upperLimit': '75.47'}]}]}, {'title': 'HL Participants without PET Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.5', 'groupId': 'OG000', 'lowerLimit': '26.29', 'upperLimit': '47.62'}]}]}, {'title': 'ALCL Participants with PET Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000', 'lowerLimit': '50.21', 'upperLimit': '81.99'}]}]}, {'title': 'ALCL Participants without PET Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '40.96', 'upperLimit': '72.28'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 48 or until discontinuation of treatment', 'description': "Best response is defined as the cumulative numbers of participants who achieve each level of best response including partial response (PR), complete response uncertain (CRu) (when no positron emission tomography \\[PET\\] data are available), and complete response (CR) after each cycle of treatment. Reported data are divided into 4 populations; Hodgkin's lymphoma (HL) participants with PET data, HL participants without PET data, anaplastic large cell lymphoma (ALCL) participants with PET data, and ALCL participants without PET data. PET is used in cancer diagnosis and treatment.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy assessment population; The efficacy assessment population was defined as participants who met the requirement of this study and had efficacy data available for analysis. The number analyzed is the number of participants with data available for analysis in the given timeframe.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Brentuximab Vedotin Infusion', 'description': 'Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.'}], 'classes': [{'title': 'HL Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82.7', 'groupId': 'OG000', 'lowerLimit': '75.4', 'upperLimit': '88.0'}]}]}, {'title': 'ALCL Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.3', 'groupId': 'OG000', 'lowerLimit': '68.4', 'upperLimit': '86.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 48 or until discontinuation of treatment', 'description': 'OS is defined as the period from the start of therapy in standard medical care to the time when death (regardless of the cause of death) is confirmed. Reported data as OS was point estimates of 1 year survival rate for HL and ALCL participants.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy assessment population; The efficacy assessment population was defined as participants who met the requirement of this study and had efficacy data available for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brentuximab Vedotin Infusion', 'description': 'Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '292'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '284'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Case Report Forms Uncollected', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 198 investigative sites in Japan, from 17 April 2014 to 30 June 2017. Registration period for patients was from 17 April 2014 to 30 September 2014.', 'preAssignmentDetails': "Participants with a historical diagnosis of relapsed/refractory CD30+ Hodgkin's lymphoma (HL) or anaplastic large cell lymphoma (ALCL) were enrolled. Participants received interventions as part of routine medical care."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Brentuximab Vedotin Infusion', 'description': 'Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '56.7', 'spread': '19.80', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '100', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '184', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '284', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': "Duration of Diagnosis of Hodgkin's Lymphoma (HL) or Anaplastic Large Cell Lymphoma (ALCL)", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': '< 1 Year', 'measurements': [{'value': '75', 'groupId': 'BG000'}]}, {'title': '>= 1 Year and < 3 Years', 'measurements': [{'value': '105', 'groupId': 'BG000'}]}, {'title': '>= 3 Years and < 5 Years', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': '>= 5 Years', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Mean duration between start of study and first time of diagnosis of HL or ALCL was reported.', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'HL', 'measurements': [{'value': '182', 'groupId': 'BG000'}]}, {'title': 'ALCL', 'measurements': [{'value': '101', 'groupId': 'BG000'}]}, {'title': 'Others', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Recurrent and Refractory or Primary', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Recurrent and Refractory', 'measurements': [{'value': '281', 'groupId': 'BG000'}]}, {'title': 'Primary', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants with CD30 Positive', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '284', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ALK Positive or Negative', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}]}], 'categories': [{'title': 'ALK-Positive', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'ALK-Negative', 'measurements': [{'value': '77', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This baseline characteristic was analyzed only in participants who had been diagnosed with ALCL.'}, {'title': 'Staging of Lymphoma', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Stage 1', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Stage 2', 'measurements': [{'value': '63', 'groupId': 'BG000'}]}, {'title': 'Stage 3', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}, {'title': 'Stage 4', 'measurements': [{'value': '140', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Lymphoma is classified with following stages. Stage 1; Lymphoma in only 1 group of lymph nodes. Stage 2; Lymphoma in 2 or more groups of lymph nodes. Stage 3; There are lymph nodes that contain lymphoma on both sides of the diaphragm. Stage 4; The most advanced stage of lymphoma and lymphoma cells have spread to at least 1 body organ outside the lymphatic system.', 'unitOfMeasure': 'Participants'}, {'title': 'B Symptom', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had B symptom', 'measurements': [{'value': '124', 'groupId': 'BG000'}]}, {'title': 'Had No B symptom', 'measurements': [{'value': '160', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'B symptom means participants have 1 or more these symptoms as following; Unintentional weight loss (more than 10% in the 6 months before you were diagnosed), Night sweats, Fevers (temperatures above 38 Celsius degrees).', 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '114', 'groupId': 'BG000'}]}, {'title': '1', 'measurements': [{'value': '104', 'groupId': 'BG000'}]}, {'title': '2', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': '3', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': '4', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \\>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair.', 'unitOfMeasure': 'Participants'}, {'title': 'Healthcare Category', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Outpatient', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'Inpatient', 'measurements': [{'value': '238', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were categorized as outpatient and inpatient.', 'unitOfMeasure': 'Participants'}, {'title': 'Predisposition to Hypersensitivity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had Predisposition to Hypersensitivity', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': 'Had No Predisposition to Hypersensitivity', 'measurements': [{'value': '231', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity.', 'unitOfMeasure': 'Participants'}, {'title': 'Hepatitis C Virus (HCV) Antibody Positive or Negative', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'HCV Antibody-Positive', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'HCV Antibody- Negative', 'measurements': [{'value': '274', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hepatitis B Surface (HBs) Antigen Positive or Negative', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'HBs Antigen-Positive', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'HBs Antigen-Negative', 'measurements': [{'value': '271', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HBs Antibody Positive or Negative', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'HBs Antibody-Positive', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'HBs Antibody- Negative', 'measurements': [{'value': '208', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Positive or Negative', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'HBV DNA-Positive', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'HBV DNA-Negative', 'measurements': [{'value': '106', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '174', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Medical History of Lung Disorder', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had Medical History', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Had No Medical History', 'measurements': [{'value': '275', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above.', 'unitOfMeasure': 'Participants'}, {'title': 'Medical Complications of Lung Disorder', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had Presence of Medical Complications', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Had No Presence of Medical Complications', 'measurements': [{'value': '264', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.', 'unitOfMeasure': 'Participants'}, {'title': 'Medical History of Malignant Tumor', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had Presence of Medical History', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Had No Presence of Medical History', 'measurements': [{'value': '251', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above.', 'unitOfMeasure': 'Participants'}, {'title': 'Medical Complications of Malignant Tumor', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had Presence of Medical Complications', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Had No Presence of Medical Complications', 'measurements': [{'value': '279', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.', 'unitOfMeasure': 'Participants'}, {'title': 'Medical History (Other Than Lung Disorder or Malignant Tumor)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had Presence of Medical History', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}, {'title': 'Had No Presence of Medical History', 'measurements': [{'value': '216', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above.', 'unitOfMeasure': 'Participants'}, {'title': 'Medical Complications (Other Than Lung Disorder or Malignant Tumor)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had Presence of Medical Complications', 'measurements': [{'value': '182', 'groupId': 'BG000'}]}, {'title': 'Had No Presence of Medical Complications', 'measurements': [{'value': '102', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.', 'unitOfMeasure': 'Participants'}, {'title': 'Concomitant Hepatic Disorder', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had Concomitant Hepatic Disorder', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Had No Concomitant Hepatic Disorder', 'measurements': [{'value': '259', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Concomitant Renal Disorder', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had Concomitant Renal Disorder', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Had No Concomitant Renal Disorder', 'measurements': [{'value': '264', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '58.158', 'spread': '13.0751', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '22.00', 'spread': '3.991', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index = weight (kg)/\\[height (m)\\^2\\]', 'unitOfMeasure': 'kg/meter (m)^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking Classification', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Never Smoked', 'measurements': [{'value': '130', 'groupId': 'BG000'}]}, {'title': 'Current Smoker', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Ex-Smoker', 'measurements': [{'value': '84', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Drug Therapy before Start of Brentuximab Vedotin Administration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had Drug Therapy', 'measurements': [{'value': '279', 'groupId': 'BG000'}]}, {'title': 'Had No Drug Therapy', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Regimens before Start of Brentuximab Vedotin Administration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.57', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Number of Regimens', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Population Analysis Description: This baseline characteristic was analyzed only in participants who had drug therapy before start of Brentuximab Vedotin administration.'}, {'title': 'Time in Days from Last Month of Previous Drug Therapy Regimen to First Cycle of Brentuximab Vendotin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '299.1', 'spread': '564.04', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Radiotherapy before Start of Brentuximab Vedotin Administration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had Radiotherapy', 'measurements': [{'value': '105', 'groupId': 'BG000'}]}, {'title': 'Had No Radiotherapy', 'measurements': [{'value': '179', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time in Days from Last Month of Most Recent Radiotherapy to First Cycle of Brentuximab Vendotin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '703.4', 'spread': '954.27', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Days', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Population Analysis Description: This baseline characteristic was analyzed only in participants who had radiotherapy before start of Brentuximab Vedotin administration. The number analyzed is the number of participants with data available for analysis.'}, {'title': 'Hematopoietic Stem Cell Transplantation before Start of Brentuximab Vedotin Administration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had No Hematopoietic Stem Cell Transplantation', 'measurements': [{'value': '219', 'groupId': 'BG000'}]}, {'title': 'Had Autologous Transplantation', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'Had Allogeneic Transplantation', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Had Autologous and Allogeneic Transplantation', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants Who Were Not Pregnant', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This baseline characteristic was analyzed only in female participants.'}], 'populationDescription': 'Safety Analysis Set; The safety analysis set was defined as all participants who had the safety data defined on the protocol.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-02', 'size': 2024094, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-01T00:28', 'hasProtocol': True}, {'date': '2017-01-27', 'size': 2315278, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-02-01T00:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-25', 'studyFirstSubmitDate': '2014-04-17', 'resultsFirstSubmitDate': '2018-06-25', 'studyFirstSubmitQcDate': '2014-05-13', 'lastUpdatePostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-01', 'studyFirstPostDateStruct': {'date': '2014-05-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)', 'timeFrame': 'Up to Week 48 or until discontinuation of treatment'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieve or Maintain Any Best Response', 'timeFrame': 'Up to Week 48 or until discontinuation of treatment', 'description': "Best response is defined as the cumulative numbers of participants who achieve each level of best response including partial response (PR), complete response uncertain (CRu) (when no positron emission tomography \\[PET\\] data are available), and complete response (CR) after each cycle of treatment. Reported data are divided into 4 populations; Hodgkin's lymphoma (HL) participants with PET data, HL participants without PET data, anaplastic large cell lymphoma (ALCL) participants with PET data, and ALCL participants without PET data. PET is used in cancer diagnosis and treatment."}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to Week 48 or until discontinuation of treatment', 'description': 'OS is defined as the period from the start of therapy in standard medical care to the time when death (regardless of the cause of death) is confirmed. Reported data as OS was point estimates of 1 year survival rate for HL and ALCL participants.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacological therapy'], 'conditions': ["Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the safety of brentuximab vedotin (recombinant) for intravenous (IV) infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma in the routine clinical setting, as well as to collect efficacy information for reference.", 'detailedDescription': 'The present survey was designed to evaluate the safety of brentuximab vedotin (recombinant) for IV infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+ Hodgkin\'s lymphoma or anaplastic large cell lymphoma in the routine clinical setting.\n\nThe usual adult dosage is 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) infused intravenously once every three weeks. The dose should be adjusted depending on the participant\'s condition. See the "PRECAUTIONS" section of the package insert.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Relapsed or refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients treated with brentuximab vedotin IV Infusion\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02139592', 'briefTitle': 'Brentuximab Vedotin (Recombinant) for IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin\'s Lymphoma or Anaplastic Large Cell Lymphoma"', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Brentuximab Vedotin (ADCETRIS) IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin\'s Lymphoma or Anaplastic Large Cell Lymphoma"', 'orgStudyIdInfo': {'id': '291-011'}, 'secondaryIdInfos': [{'id': 'JapicCTI-142455', 'type': 'REGISTRY', 'domain': 'JapicCTI'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'brentuximab vedotin (recombinant) Intravenous infusion', 'description': 'Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks', 'interventionNames': ['Drug: Brentuximab vedotin (recombinant)']}], 'interventions': [{'name': 'Brentuximab vedotin (recombinant)', 'type': 'DRUG', 'otherNames': ['ADCETRIS IV Infusion 50 mg'], 'description': 'Brentuximab vedotin (recombinant) for IV infusion', 'armGroupLabels': ['brentuximab vedotin (recombinant) Intravenous infusion']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}