Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-31 @ 11:05 PM
Study NCT ID:
NCT00477594
Status:
COMPLETED
Last Update Posted:
2016-09-09
First Post:
2007-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D000090542', 'term': 'Homozygous Familial Hypercholesterolemia'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C524142', 'term': 'mipomersen'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '617-252-7832', 'title': 'Genzyme Medical Information', 'organization': 'Genzyme Corporation'}, 'certainAgreement': {'otherDetails': 'After the multicenter publication or 12 months after completion of the study the PI may publish the results of his/her data from the study. The PI shall provide the sponsor with an advance copy at least 60 days prior to planned submission and the Sponsor shall have 60 days to review (contracts have variable timeframes; maximum times are stated here). The sponsor may request the deletion of any confidential information, or a delay in submission for an additional period not to exceed 90 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 3 years.', 'description': 'In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.', 'eventGroups': [{'id': 'EG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.', 'otherNumAtRisk': 16, 'otherNumAffected': 16, 'seriousNumAtRisk': 16, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period.", 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cardiomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arteriovenous malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Thyroid cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arcus lipoides', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Lip swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Feeling jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site anaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site coldness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Back injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Post procedural discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Splinter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Wrong technique in drug usage process', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urine analysis abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Exostosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Sensation of heaviness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Angiomyolipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nerve compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Grief reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Mood altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chromaturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertonic bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Renal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Breast cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Breast mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Increased upper airway secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Week 52 [N=13, 4]', 'categories': [{'measurements': [{'value': '-16.2', 'groupId': 'OG000', 'lowerLimit': '-41.8', 'upperLimit': '-7.8'}, {'value': '-2.6', 'groupId': 'OG001', 'lowerLimit': '-10.2', 'upperLimit': '14.8'}]}]}, {'title': 'Week 104 [N=7, 1]', 'categories': [{'measurements': [{'value': '-32.4', 'groupId': 'OG000', 'lowerLimit': '-38.8', 'upperLimit': '-16.6'}, {'value': '30.6', 'groupId': 'OG001', 'lowerLimit': '30.6', 'upperLimit': '30.6'}]}]}, {'title': 'Week 104/Early Termination [N=16, 5]', 'categories': [{'measurements': [{'value': '-13.8', 'groupId': 'OG000', 'lowerLimit': '-31.4', 'upperLimit': '-3.0'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '11.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 52 and 104', 'description': "LDL cholesterol was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides \\<400 mg/dL, LDL-C was obtained using Friedewald's calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.", 'unitOfMeasure': 'percentage of baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all enrolled patients who received at least 1 injection of study drug. "N" indicates the number of participants with available data at the specified time point.'}, {'type': 'PRIMARY', 'title': 'Low-density Lipoprotein Cholesterol (LDL-C) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Baseline [N=16, 5]', 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000', 'lowerLimit': '134', 'upperLimit': '205'}, {'value': '131', 'groupId': 'OG001', 'lowerLimit': '124', 'upperLimit': '147'}]}]}, {'title': 'Week 52 [N=13, 4]', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000', 'lowerLimit': '106', 'upperLimit': '173'}, {'value': '127', 'groupId': 'OG001', 'lowerLimit': '124', 'upperLimit': '139'}]}]}, {'title': 'Week 104 [N=7, 1]', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000', 'lowerLimit': '82', 'upperLimit': '156'}, {'value': '162', 'groupId': 'OG001', 'lowerLimit': '162', 'upperLimit': '162'}]}]}, {'title': 'Week 104/Early Termination [N=16, 5}', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000', 'lowerLimit': '116', 'upperLimit': '213'}, {'value': '161', 'groupId': 'OG001', 'lowerLimit': '146', 'upperLimit': '162'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': "Samples were taken following an overnight fast. For patients with triglycerides \\<400 mg/dL, LDL-C was obtained using Friedewald's calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.", 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all enrolled patients who received at least 1 injection of study drug. "N" indicates the number of participants with available data at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Week 52 [N=13, 4]', 'categories': [{'measurements': [{'value': '-25.9', 'groupId': 'OG000', 'lowerLimit': '-39.1', 'upperLimit': '-11.0'}, {'value': '-7.3', 'groupId': 'OG001', 'lowerLimit': '-19.7', 'upperLimit': '7.7'}]}]}, {'title': 'Week 104 [N=7, 1]', 'categories': [{'measurements': [{'value': '-27.2', 'groupId': 'OG000', 'lowerLimit': '-39.7', 'upperLimit': '-22.4'}, {'value': '20.8', 'groupId': 'OG001', 'lowerLimit': '20.8', 'upperLimit': '20.8'}]}]}, {'title': 'Week 104/Early Termination [N=16, 5]', 'categories': [{'measurements': [{'value': '-15.8', 'groupId': 'OG000', 'lowerLimit': '-26.2', 'upperLimit': '-3.5'}, {'value': '-3.7', 'groupId': 'OG001', 'lowerLimit': '-14.9', 'upperLimit': '-1.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 52 and 104', 'description': 'Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.', 'unitOfMeasure': 'percentage of baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all enrolled patients who received at least 1 injection of study drug. "N" indicates the number of participants with available data at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Apolipoprotein B Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Baseline [N=16, 5]', 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000', 'lowerLimit': '127', 'upperLimit': '181'}, {'value': '124', 'groupId': 'OG001', 'lowerLimit': '109', 'upperLimit': '154'}]}]}, {'title': 'Week 52 [N=13, 4]', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000', 'lowerLimit': '102', 'upperLimit': '146'}, {'value': '110', 'groupId': 'OG001', 'lowerLimit': '104', 'upperLimit': '123'}]}]}, {'title': 'Week 104 [N=7, 1]', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '146'}, {'value': '128', 'groupId': 'OG001', 'lowerLimit': '128', 'upperLimit': '128'}]}]}, {'title': 'Week 104/Early Termination [N=16, 5]', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000', 'lowerLimit': '104', 'upperLimit': '175'}, {'value': '128', 'groupId': 'OG001', 'lowerLimit': '122', 'upperLimit': '131'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all enrolled patients who received at least 1 injection of study drug. "N" indicates the number of participants with available data at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Week 52 [N=13, 4]', 'categories': [{'measurements': [{'value': '-10.5', 'groupId': 'OG000', 'lowerLimit': '-26.8', 'upperLimit': '-6.4'}, {'value': '-6.5', 'groupId': 'OG001', 'lowerLimit': '-13.4', 'upperLimit': '8.6'}]}]}, {'title': 'Week 104 [N=7, 1]', 'categories': [{'measurements': [{'value': '-25.3', 'groupId': 'OG000', 'lowerLimit': '-29.2', 'upperLimit': '-18.0'}, {'value': '-1.5', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '-1.5'}]}]}, {'title': 'Week 104/Early Termination [N=16, 5]', 'categories': [{'measurements': [{'value': '-11.2', 'groupId': 'OG000', 'lowerLimit': '-24.2', 'upperLimit': '-2.4'}, {'value': '-1.5', 'groupId': 'OG001', 'lowerLimit': '-1.7', 'upperLimit': '2.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast.', 'unitOfMeasure': 'percentage of baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all enrolled patients who received at least 1 injection of study drug. "N" indicates the number of participants with available data at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Total Cholesterol Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Baseline [N=16, 5]', 'categories': [{'measurements': [{'value': '251', 'groupId': 'OG000', 'lowerLimit': '206', 'upperLimit': '293'}, {'value': '233', 'groupId': 'OG001', 'lowerLimit': '199', 'upperLimit': '235'}]}]}, {'title': 'Week 52 [N=13, 4]', 'categories': [{'measurements': [{'value': '216', 'groupId': 'OG000', 'lowerLimit': '173', 'upperLimit': '245'}, {'value': '203', 'groupId': 'OG001', 'lowerLimit': '192', 'upperLimit': '220'}]}]}, {'title': 'Week 104 [N=7, 1]', 'categories': [{'measurements': [{'value': '209', 'groupId': 'OG000', 'lowerLimit': '143', 'upperLimit': '209'}, {'value': '196', 'groupId': 'OG001', 'lowerLimit': '196', 'upperLimit': '196'}]}]}, {'title': 'Week 104/Early Termination [N=16, 5]', 'categories': [{'measurements': [{'value': '209', 'groupId': 'OG000', 'lowerLimit': '193', 'upperLimit': '297'}, {'value': '231', 'groupId': 'OG001', 'lowerLimit': '199', 'upperLimit': '239'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all enrolled patients who received at least 1 injection of study drug. "N" indicates the number of participants with available data at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Week 52 [N=13, 4]', 'categories': [{'measurements': [{'value': '-24.7', 'groupId': 'OG000', 'lowerLimit': '-40.5', 'upperLimit': '-12.6'}, {'value': '-6.7', 'groupId': 'OG001', 'lowerLimit': '-15.0', 'upperLimit': '9.5'}]}]}, {'title': 'Week 104 [N=7, 1]', 'categories': [{'measurements': [{'value': '-34.3', 'groupId': 'OG000', 'lowerLimit': '-37.9', 'upperLimit': '-21.6'}, {'value': '17.2', 'groupId': 'OG001', 'lowerLimit': '17.2', 'upperLimit': '17.2'}]}]}, {'title': 'Week 104/Early Termination [N=16, 5]', 'categories': [{'measurements': [{'value': '-16.5', 'groupId': 'OG000', 'lowerLimit': '-31.2', 'upperLimit': '-6.6'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '-3.0', 'upperLimit': '14.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast.', 'unitOfMeasure': 'percentage of baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all enrolled patients who received at least 1 injection of study drug. "N" indicates the number of participants with available data at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Non-High-Density Lipoprotein Cholesterol Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Baseline [N=16, 5]', 'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000', 'lowerLimit': '167', 'upperLimit': '253'}, {'value': '151', 'groupId': 'OG001', 'lowerLimit': '149', 'upperLimit': '203'}]}]}, {'title': 'Week 52 [N=13, 4]', 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000', 'lowerLimit': '134', 'upperLimit': '208'}, {'value': '150', 'groupId': 'OG001', 'lowerLimit': '140', 'upperLimit': '164'}]}]}, {'title': 'Week 104 [N=7, 1]', 'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '174'}, {'value': '177', 'groupId': 'OG001', 'lowerLimit': '177', 'upperLimit': '177'}]}]}, {'title': 'Week 104/Early Termination [N=16, 5]', 'categories': [{'measurements': [{'value': '164', 'groupId': 'OG000', 'lowerLimit': '151', 'upperLimit': '255'}, {'value': '177', 'groupId': 'OG001', 'lowerLimit': '170', 'upperLimit': '197'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all enrolled patients who received at least 1 injection of study drug. "N" indicates the number of participants with available data at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related adverse event', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Mild adverse event', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Moderate adverse event', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Severe adverse event', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serious adverse event', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Adverse event leading to treatment discontinuation', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'AEs were considered as related if assessed by the Investigator as possibly, probably or definitely related to study drug. The severity of each event was assessed using the following categories: Mild (symptom(s) barely noticeable to the patient or do not make the patient uncomfortable); Moderate (symptom(s) of a sufficient severity to make the patient uncomfortable, performance of daily activities is influenced) or Severe (symptom(s) of a sufficient severity to cause the patient severe discomfort, may cause cessation of treatment with the study drug). Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Clinical Chemistry Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Alanine aminotransferase (ALT)', 'categories': [{'measurements': [{'value': '63.73', 'spread': '112.98', 'groupId': 'OG000'}, {'value': '29.96', 'spread': '80.01', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase (AST)', 'categories': [{'measurements': [{'value': '48.73', 'spread': '86.00', 'groupId': 'OG000'}, {'value': '3.53', 'spread': '39.14', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin, Indirect', 'categories': [{'measurements': [{'value': '13.81', 'spread': '20.56', 'groupId': 'OG000'}, {'value': '12.50', 'spread': '29.86', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin, Total', 'categories': [{'measurements': [{'value': '34.79', 'spread': '57.97', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '10.96', 'groupId': 'OG001'}]}]}, {'title': 'Blood Urea Nitrogen (BUN)', 'categories': [{'measurements': [{'value': '6.08', 'spread': '22.90', 'groupId': 'OG000'}, {'value': '-11.06', 'spread': '16.56', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase', 'categories': [{'measurements': [{'value': '-17.24', 'spread': '36.85', 'groupId': 'OG000'}, {'value': '40.95', 'spread': '149.95', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine', 'categories': [{'measurements': [{'value': '-9.94', 'spread': '12.54', 'groupId': 'OG000'}, {'value': '-9.84', 'spread': '14.05', 'groupId': 'OG001'}]}]}, {'title': 'Glomerular Filtration Rate (GFR)', 'categories': [{'measurements': [{'value': '16.20', 'spread': '24.56', 'groupId': 'OG000'}, {'value': '15.49', 'spread': '21.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.', 'unitOfMeasure': 'percentage of baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Hematology Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Hematocrit', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '8.69', 'groupId': 'OG000'}, {'value': '-5.24', 'spread': '3.69', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin', 'categories': [{'measurements': [{'value': '0.90', 'spread': '7.61', 'groupId': 'OG000'}, {'value': '-4.24', 'spread': '4.44', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes', 'categories': [{'measurements': [{'value': '-0.80', 'spread': '31.95', 'groupId': 'OG000'}, {'value': '-5.99', 'spread': '43.17', 'groupId': 'OG001'}]}]}, {'title': 'Platelets', 'categories': [{'measurements': [{'value': '-8.55', 'spread': '11.88', 'groupId': 'OG000'}, {'value': '-1.36', 'spread': '12.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment', 'unitOfMeasure': 'percentage of baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '6.99', 'spread': '12.33', 'groupId': 'OG000'}, {'value': '2.35', 'spread': '12.54', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '-0.88', 'spread': '11.31', 'groupId': 'OG000'}, {'value': '10.67', 'spread': '15.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.', 'unitOfMeasure': 'percentage of baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'categories': [{'measurements': [{'value': '4.89', 'spread': '14.41', 'groupId': 'OG000'}, {'value': '6.28', 'spread': '17.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.', 'unitOfMeasure': 'percentage of baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'categories': [{'measurements': [{'value': '0.87', 'spread': '10.57', 'groupId': 'OG000'}, {'value': '-4.44', 'spread': '13.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.', 'unitOfMeasure': 'percentage of baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Week 52 [N=13, 4]', 'categories': [{'measurements': [{'value': '-30.2', 'groupId': 'OG000', 'lowerLimit': '-36.3', 'upperLimit': '-26.7'}, {'value': '-27.0', 'groupId': 'OG001', 'lowerLimit': '-43.0', 'upperLimit': '-3.1'}]}]}, {'title': 'Week 104 [N=7, 1]', 'categories': [{'measurements': [{'value': '-46.8', 'groupId': 'OG000', 'lowerLimit': '-58.2', 'upperLimit': '-30.2'}, {'value': '-44.8', 'groupId': 'OG001', 'lowerLimit': '-44.8', 'upperLimit': '-44.8'}]}]}, {'title': 'Week 104/Early Termination [N=16, 5]', 'categories': [{'measurements': [{'value': '-34.3', 'groupId': 'OG000', 'lowerLimit': '-42.9', 'upperLimit': '2.2'}, {'value': '-34.7', 'groupId': 'OG001', 'lowerLimit': '-36.1', 'upperLimit': '9.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'Triglycerides were measured in mg/dL. Samples were taken following an overnight fast.', 'unitOfMeasure': 'percentage of baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all enrolled patients who received at least 1 injection of study drug. "N" indicates the number of participants with available data at the specified time point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Triglycerides Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Baseline [N=16, 5]', 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '254'}, {'value': '134', 'groupId': 'OG001', 'lowerLimit': '92', 'upperLimit': '199'}]}]}, {'title': 'Week 52 [N=13, 4]', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000', 'lowerLimit': '67', 'upperLimit': '150'}, {'value': '90', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '123'}]}]}, {'title': 'Week 104 [N=7, 1]', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000', 'lowerLimit': '67', 'upperLimit': '113'}, {'value': '74', 'groupId': 'OG001', 'lowerLimit': '74', 'upperLimit': '74'}]}]}, {'title': 'Week 104/Early Termination [N=16, 5]', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '76', 'upperLimit': '180'}, {'value': '122', 'groupId': 'OG001', 'lowerLimit': '97', 'upperLimit': '130'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all enrolled patients who received at least 1 injection of study drug. "N" indicates the number of participants with available data at the specified time point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Lipoprotein(a)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Week 52 [N=13, 4]', 'categories': [{'measurements': [{'value': '-20.2', 'groupId': 'OG000', 'lowerLimit': '-34.3', 'upperLimit': '-4.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-27.3', 'upperLimit': '0.0'}]}]}, {'title': 'Week 104 [N=7, 1]', 'categories': [{'measurements': [{'value': '-30.7', 'groupId': 'OG000', 'lowerLimit': '-32.7', 'upperLimit': '-24.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'Week 104/Early Termination [N=16, 5]', 'categories': [{'measurements': [{'value': '-18.2', 'groupId': 'OG000', 'lowerLimit': '-31.0', 'upperLimit': '0.0'}, {'value': '-20.0', 'groupId': 'OG001', 'lowerLimit': '-25.0', 'upperLimit': '0.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'Lipoprotein(a) was measured in mg/dL. Samples were taken following an overnight fast.', 'unitOfMeasure': 'percentage of baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all enrolled patients who received at least 1 injection of study drug. "N" indicates the number of participants with available data at the specified time point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Lipoprotein(a) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Baseline [N=16, 5]', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '98'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '11'}]}]}, {'title': 'Week 52 [N=13, 4]', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '75'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '5'}]}]}, {'title': 'Week 104 [N=7, 1]', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000', 'lowerLimit': '33', 'upperLimit': '79'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3'}]}]}, {'title': 'Week 104/Early Termination [N=16, 5]', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '71'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all enrolled patients who received at least 1 injection of study drug. "N" indicates the number of participants with available data at the specified time point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Very-Low-Density Lipoprotein (VLDL) Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Week 52 [N=13, 4]', 'categories': [{'measurements': [{'value': '-31.6', 'groupId': 'OG000', 'lowerLimit': '-37.1', 'upperLimit': '-25.0'}, {'value': '-25.9', 'groupId': 'OG001', 'lowerLimit': '-43.6', 'upperLimit': '-2.8'}]}]}, {'title': 'Week 104 [N=7, 1]', 'categories': [{'measurements': [{'value': '-48.6', 'groupId': 'OG000', 'lowerLimit': '-58.3', 'upperLimit': '-31.6'}, {'value': '-44.4', 'groupId': 'OG001', 'lowerLimit': '-44.4', 'upperLimit': '-44.4'}]}]}, {'title': 'Week 104/Early Termination [N=16, 5]', 'categories': [{'measurements': [{'value': '-34.0', 'groupId': 'OG000', 'lowerLimit': '-44.0', 'upperLimit': '2.8'}, {'value': '-35.0', 'groupId': 'OG001', 'lowerLimit': '-35.7', 'upperLimit': '5.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'Very-Low-Density Lipoprotein (VLDL) Cholesterol was measured in mg/dL. Samples were taken following an overnight fast.', 'unitOfMeasure': 'percentage of baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all enrolled patients who received at least 1 injection of study drug. "N" indicates the number of participants with available data at the specified time point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Very-Low-Density Lipoprotein (VLDL) Cholesterol Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Baseline [N=16, 5]', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '51'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '40'}]}]}, {'title': 'Week 52 [N=13, 4]', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '30'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '25'}]}]}, {'title': 'Week 104 [N=7, 1]', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '23'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '15'}]}]}, {'title': 'Week 104/Early Termination [N=16, 5]', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '36'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '26'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all enrolled patients who received at least 1 injection of study drug. "N" indicates the number of participants with available data at the specified time point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Ratio of Low-density Lipoprotein Cholesterol to High-density Lipoprotein Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Week 52 [N=13, 4]', 'categories': [{'measurements': [{'value': '-33.5', 'groupId': 'OG000', 'lowerLimit': '-43.6', 'upperLimit': '-25.8'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '-11.8', 'upperLimit': '10.2'}]}]}, {'title': 'Week 104 [N=7, 1]', 'categories': [{'measurements': [{'value': '-41.2', 'groupId': 'OG000', 'lowerLimit': '-57.8', 'upperLimit': '-34.6'}, {'value': '230.1', 'groupId': 'OG001', 'lowerLimit': '230.1', 'upperLimit': '230.1'}]}]}, {'title': 'Week 104/Early Termination [N=16, 5]', 'categories': [{'measurements': [{'value': '-24.9', 'groupId': 'OG000', 'lowerLimit': '-38.2', 'upperLimit': '-18.5'}, {'value': '15.2', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '35.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'unitOfMeasure': 'percentage of baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all enrolled patients who received at least 1 injection of study drug. "N" indicates the number of participants with available data at the specified time point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Ratio of Low-density Lipoprotein Cholesterol to High-density Lipoprotein Cholesterol Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Baseline [N=16, 5]', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '6'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '4'}]}]}, {'title': 'Week 52 [N=13, 4]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': 'Week 104 [N=7, 1]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '9'}]}]}, {'title': 'Week 104/Early Termination [N=16, 5]', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all enrolled patients who received at least 1 injection of study drug. "N" indicates the number of participants with available data at the specified time point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in Apolipoprotein A1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Week 52 [N=13, 4]', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '-4.3', 'upperLimit': '11.2'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '-5.3', 'upperLimit': '17.0'}]}]}, {'title': 'Week 104 [N=7, 1]', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '-2.7', 'upperLimit': '7.6'}, {'value': '-55.1', 'groupId': 'OG001', 'lowerLimit': '-55.1', 'upperLimit': '-55.1'}]}]}, {'title': 'Week 104/Early Termination [N=16, 5]', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '9.5'}, {'value': '-7.9', 'groupId': 'OG001', 'lowerLimit': '-11.8', 'upperLimit': '-3.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast.', 'unitOfMeasure': 'percentage of baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all enrolled patients who received at least 1 injection of study drug. "N" indicates the number of participants with available data at the specified time point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Apolipoprotein A1 Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Baseline [N=16, 5]', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000', 'lowerLimit': '120', 'upperLimit': '149'}, {'value': '149', 'groupId': 'OG001', 'lowerLimit': '147', 'upperLimit': '178'}]}]}, {'title': 'Week 52 [N=13, 4]', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000', 'lowerLimit': '123', 'upperLimit': '160'}, {'value': '159', 'groupId': 'OG001', 'lowerLimit': '144', 'upperLimit': '178'}]}]}, {'title': 'Week 104 [N=7, 1]', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000', 'lowerLimit': '113', 'upperLimit': '155'}, {'value': '66', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '66'}]}]}, {'title': 'Week 104/Early Termination [N=16, 5]', 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000', 'lowerLimit': '129', 'upperLimit': '153'}, {'value': '144', 'groupId': 'OG001', 'lowerLimit': '126', 'upperLimit': '164'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all enrolled patients who received at least 1 injection of study drug. "N" indicates the number of participants with available data at the specified time point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline in High-Density Lipoprotein Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Week 52 [N=13, 4]', 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '32.4'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '-4.9', 'upperLimit': '12.0'}]}]}, {'title': 'Week 104 [N=7, 1]', 'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '43.8'}, {'value': '-60.4', 'groupId': 'OG001', 'lowerLimit': '-60.4', 'upperLimit': '-60.4'}]}]}, {'title': 'Week 104/Early Termination [N=16, 5]', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '26.9'}, {'value': '-17.9', 'groupId': 'OG001', 'lowerLimit': '-19.6', 'upperLimit': '6.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'High-Density Lipoprotein (HDL) Cholesterol was measured in mg/dL. Samples were taken following an overnight fast.', 'unitOfMeasure': 'percentage of baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all enrolled patients who received at least 1 injection of study drug. "N" indicates the number of participants with available data at the specified time point.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'High-Density Lipoprotein Cholesterol Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'OG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'classes': [{'title': 'Baseline [N=16, 5]', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '33', 'upperLimit': '46'}, {'value': '52', 'groupId': 'OG001', 'lowerLimit': '48', 'upperLimit': '56'}]}]}, {'title': 'Week 52 [N=13, 4]', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '50'}, {'value': '54', 'groupId': 'OG001', 'lowerLimit': '43', 'upperLimit': '66'}]}]}, {'title': 'Week 104 [N=7, 1]', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '48'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '19'}]}]}, {'title': 'Week 104/Early Termination [N=16, 5]', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '50'}, {'value': '45', 'groupId': 'OG001', 'lowerLimit': '34', 'upperLimit': '58'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all enrolled patients who received at least 1 injection of study drug. "N" indicates the number of participants with available data at the specified time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'FG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}], 'periods': [{'title': 'Year 1 and Year 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Year 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Follow-up Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients who completed dosing in study 301012-CS8 (NCT00280995) or 301012-CS9 (NCT00281008) at a site in the U.S. with an acceptable safety profile, per Investigator judgment, were eligible to enroll in this study.', 'preAssignmentDetails': 'Patients who participated in Cohorts A, B, or C in study 301012-CS9 were randomized in a 1:1 ratio to mipomersen 200 mg once a week (QW) or 200 mg mipomersen every other week (QOW). Patients who participated in study 301012-CS8 or Cohort D of study 301012-CS9 received 200 mg mipomersen QW.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mipomersen 200 mg Per Week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.'}, {'id': 'BG001', 'title': 'Mipomersen 200 mg Every Other Week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.1', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '54.6', 'spread': '15.7', 'groupId': 'BG001'}, {'value': '48.9', 'spread': '12.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Other race', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'spread': '5.60', 'groupId': 'BG000'}, {'value': '27.4', 'spread': '4.81', 'groupId': 'BG001'}, {'value': '28.6', 'spread': '5.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Metabolic syndrome', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'A patient was classified as having metabolic syndrome if any 3 of the following risk factors existed: 1) Waist circumference ≥102 cm (men) or ≥88 cm (women); 2) Triglycerides ≥150 mg/dL\\*; 3) High density lipoprotein cholesterol \\<40 mg/dL (men) or \\<50 mg/dL (women)\\*; 4) Systolic blood pressure ≥130 or diastolic ≥85 mmHg\\*; 5) Fasting glucose ≥100 mg/dL\\*.\n\n\\* = or on medication for the specified risk factor.', 'unitOfMeasure': 'participants'}, {'title': 'Tobacco Use', 'classes': [{'title': 'Current', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Non-current', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Never', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Alcohol use', 'classes': [{'title': 'Current', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Non-current', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Never', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'dispFirstSubmitDate': '2012-01-18', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-01', 'studyFirstSubmitDate': '2007-05-22', 'dispFirstSubmitQcDate': '2012-01-18', 'resultsFirstSubmitDate': '2013-02-25', 'studyFirstSubmitQcDate': '2007-05-22', 'dispFirstPostDateStruct': {'date': '2012-01-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-25', 'studyFirstPostDateStruct': {'date': '2007-05-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percent Change From Baseline in Triglycerides', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'Triglycerides were measured in mg/dL. Samples were taken following an overnight fast.'}, {'measure': 'Triglycerides Over Time', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.'}, {'measure': 'Percent Change From Baseline in Lipoprotein(a)', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'Lipoprotein(a) was measured in mg/dL. Samples were taken following an overnight fast.'}, {'measure': 'Lipoprotein(a) Over Time', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.'}, {'measure': 'Percent Change From Baseline in Very-Low-Density Lipoprotein (VLDL) Cholesterol', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'Very-Low-Density Lipoprotein (VLDL) Cholesterol was measured in mg/dL. Samples were taken following an overnight fast.'}, {'measure': 'Very-Low-Density Lipoprotein (VLDL) Cholesterol Over Time', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.'}, {'measure': 'Percent Change From Baseline in Ratio of Low-density Lipoprotein Cholesterol to High-density Lipoprotein Cholesterol', 'timeFrame': 'Baseline and Weeks 52 and 104.'}, {'measure': 'Ratio of Low-density Lipoprotein Cholesterol to High-density Lipoprotein Cholesterol Over Time', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.'}, {'measure': 'Percent Change From Baseline in Apolipoprotein A1', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'Apolipoprotein A1 was measured in mg/dL. Samples were taken following an overnight fast.'}, {'measure': 'Apolipoprotein A1 Over Time', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.'}, {'measure': 'Percent Change From Baseline in High-Density Lipoprotein Cholesterol', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'High-Density Lipoprotein (HDL) Cholesterol was measured in mg/dL. Samples were taken following an overnight fast.'}, {'measure': 'High-Density Lipoprotein Cholesterol Over Time', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.'}], 'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)', 'timeFrame': 'Baseline and Weeks 52 and 104', 'description': "LDL cholesterol was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides \\<400 mg/dL, LDL-C was obtained using Friedewald's calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study."}, {'measure': 'Low-density Lipoprotein Cholesterol (LDL-C) Over Time', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': "Samples were taken following an overnight fast. For patients with triglycerides \\<400 mg/dL, LDL-C was obtained using Friedewald's calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study."}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Apolipoprotein B', 'timeFrame': 'Baseline and Weeks 52 and 104', 'description': 'Apolipoprotein B was measured in mg/dL. Samples were taken following an overnight fast. For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.'}, {'measure': 'Apolipoprotein B Over Time', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.'}, {'measure': 'Percent Change From Baseline in Total Cholesterol', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'Total cholesterol was measured in mg/dL. Samples were taken following an overnight fast.'}, {'measure': 'Total Cholesterol Over Time', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.'}, {'measure': 'Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'Non-high-density lipoprotein cholesterol was measured in mg/dL. Samples were taken following an overnight fast.'}, {'measure': 'Non-High-Density Lipoprotein Cholesterol Over Time', 'timeFrame': 'Baseline and Weeks 52 and 104.', 'description': 'For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior to first dose in this study. For participants who took their last dose of mipomersen less than 6 months before starting this study, Baseline is defined as the last measurement taken prior to receiving a first dose in the index study.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs)', 'timeFrame': '2 years', 'description': 'AEs were considered as related if assessed by the Investigator as possibly, probably or definitely related to study drug. The severity of each event was assessed using the following categories: Mild (symptom(s) barely noticeable to the patient or do not make the patient uncomfortable); Moderate (symptom(s) of a sufficient severity to make the patient uncomfortable, performance of daily activities is influenced) or Severe (symptom(s) of a sufficient severity to cause the patient severe discomfort, may cause cessation of treatment with the study drug). Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.'}, {'measure': 'Percent Change From Baseline in Clinical Chemistry Parameters', 'timeFrame': 'Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.'}, {'measure': 'Percent Change From Baseline in Hematology Parameters', 'timeFrame': 'Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment'}, {'measure': 'Percent Change From Baseline in Blood Pressure', 'timeFrame': 'Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.'}, {'measure': 'Percent Change From Baseline in Pulse Rate', 'timeFrame': 'Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.'}, {'measure': 'Percent Change From Baseline in Respiratory Rate', 'timeFrame': 'Baseline and Week 104 or the Early Termination visit for participants who did not complete 2 years of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Familial Hypercholesterolemia', 'Heterozygous Familial Hypercholesterolemia', 'Homozygous Familial Hypercholesterolemia', 'ISIS 301012', 'mipomersen', 'Open Label Extension'], 'conditions': ['Lipid Metabolism, Inborn Errors', 'Hypercholesterolemia, Autosomal Dominant', 'Hyperlipidemias', 'Metabolic Diseases', 'Hyperlipoproteinemia Type II', 'Metabolism, Inborn Errors', 'Genetic Diseases, Inborn', 'Infant, Newborn, Diseases', 'Metabolic Disorder', 'Congenital Abnormalities', 'Hypercholesterolemia', 'Hyperlipoproteinemias', 'Dyslipidemias', 'Lipid Metabolism Disorders']}, 'referencesModule': {'references': [{'pmid': '20707601', 'type': 'DERIVED', 'citation': 'Patel N, Hegele RA. Mipomersen as a potential adjunctive therapy for hypercholesterolemia. Expert Opin Pharmacother. 2010 Oct;11(15):2569-72. doi: 10.1517/14656566.2010.512006.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of extended dosing of mipomersen in patients with familial hypercholesterolemia on lipid-lowering therapy who have completed either the 301012-CS8 (NCT00280995) or 301012-CS9 (NCT00281008) clinical drug trials.', 'detailedDescription': "Familial Hypercholesterolemia (FH) is an autosomal dominant metabolic disorder characterized by markedly elevated low density lipoprotein (LDL), premature onset of atherosclerosis, and development of xanthomata. There are two distinct subpopulations that have a high unmet medical need due to the lack of alternative therapy: homozygotes, who have two defective LDL receptor (LDL-R) genes, and heterozygotes with a history of cardiovascular disease (CVD) on maximally tolerated therapy. Treatment for FH is directed at lowering plasma levels of LDL-C.\n\nMipomersen is an antisense drug targeted to human apolipoprotein B (apoB), the principal apolipoprotein of atherogenic LDL-C and its metabolic precursor, very low density lipoprotein (VLDL). Mipomersen is complimentary to the coding region of the messenger ribonucleic acid (mRNA) for apo-B. Inhibition of apo-B would be expected to impair VLDL synthesis and result in lowered levels of LDL-C.\n\nIn early clinical trials, mipomersen has been shown to reduce levels of LDL-C to recommended target levels in some participants.\n\nThis was an open-label extension study, which consisted of a ≤2-week screening period, up to 3 years of treatment with mipomersen, and a 24-week post-treatment follow-up period. Patients who participated in Cohorts A, B, or C in study 301012-CS9 were randomized in a 1:1 ratio to mipomersen 200 mg once a week (QW) or 200 mg mipomersen every other week (QOW) for up to 3 years. Patients randomized to mipomersen 200 mg QOW were allowed to receive mipomersen 200 mg QW at the Investigator's discretion after the first 52 weeks of the treatment period. Patients who participated in study 301012-CS8 or Cohort D of study 301012-CS9 received 200 mg mipomersen QW for up to 3 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- Satisfactory completion of dosing and Week 7 or Week 15 assessments (depending on the treatment and dose received) in their initial study (Protocol 301012-CS8 (NCT00280995) or 301012-CS9 (NCT00281008)).\n\nExclusion Criteria:\n\n\\- Have a new condition or worsening of existing condition which in the opinion of the Investigator would make the patient unsuitable for enrollment, or could interfere with patient's participation in or completion of the study."}, 'identificationModule': {'nctId': 'NCT00477594', 'briefTitle': 'Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kastle Therapeutics, LLC'}, 'officialTitle': 'An Open-Label Extension Study to Assess the Long-term Safety and Efficacy of Mipomersen in Subjects With Familial Hypercholesterolemia', 'orgStudyIdInfo': {'id': '301012-CS17'}, 'secondaryIdInfos': [{'id': '2007-001024-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mipomersen 200 mg per week', 'description': 'Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.', 'interventionNames': ['Drug: mipomersen sodium']}, {'type': 'EXPERIMENTAL', 'label': 'Mipomersen 200 mg every other week', 'description': "Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator's discretion after the first 52 weeks of the treatment period.", 'interventionNames': ['Drug: mipomersen sodium']}], 'interventions': [{'name': 'mipomersen sodium', 'type': 'DRUG', 'otherNames': ['ISIS 301012', 'Kynamro™'], 'description': '200 mg/ml, in 1 ml solution for subcutaneous injection.', 'armGroupLabels': ['Mipomersen 200 mg every other week', 'Mipomersen 200 mg per week']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60654', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '04210', 'city': 'Auburn', 'state': 'Maine', 'country': 'United States', 'geoPoint': {'lat': 44.09785, 'lon': -70.23117}}, {'zip': '04005', 'city': 'Biddeford', 'state': 'Maine', 'country': 'United States', 'geoPoint': {'lat': 43.49258, 'lon': -70.45338}}, {'zip': '04074', 'city': 'Scarborough', 'state': 'Maine', 'country': 'United States', 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genzyme, a Sanofi Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kastle Therapeutics, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ionis Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}