Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-31 @ 11:23 AM
Study NCT ID:
NCT00789828
Status:
COMPLETED
Last Update Posted:
2016-02-03
First Post:
2008-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014402', 'term': 'Tuberous Sclerosis'}, {'id': 'D001254', 'term': 'Astrocytoma'}], 'ancestors': [{'id': 'D006222', 'term': 'Hamartoma'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009378', 'term': 'Neoplasms, Multiple Primary'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D065703', 'term': 'Malformations of Cortical Development, Group I'}, {'id': 'D054220', 'term': 'Malformations of Cortical Development'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020752', 'term': 'Neurocutaneous Syndromes'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious Adverse Events were monitored from date of First Participant First Visit (FPFV) until Last Participant Last Visit (LPLV), 48 weeks and all other adverse events are monitored from First Participant First Treatment (FPFT) until LPLV, up to 4 years.', 'description': 'For safety, the reporting arms have been created on the basis of actual exposure to study treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Everolimus Treated (Core and Extension Period)', 'description': 'Participants who received everolimus treatment in core period and continued to receive evrolimus treatment in extension period.', 'otherNumAtRisk': 78, 'otherNumAffected': 77, 'seriousNumAtRisk': 78, 'seriousNumAffected': 33}, {'id': 'EG001', 'title': 'Placebo (Core) Then Everolimus Treated (Extension Period)', 'description': 'Participants who received placebo in core period and then received evrolimus treatment in extension period.', 'otherNumAtRisk': 33, 'otherNumAffected': 33, 'seriousNumAtRisk': 33, 'seriousNumAffected': 17}, {'id': 'EG002', 'title': 'Placebo Treated (Core Period)', 'description': 'Participants who received placebo in core period.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Body tinea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Gastrointestinal viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Tracheitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Acinetobacter bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Adenovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Ear infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Epstein-Barr virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Febrile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Infected bites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Mastoiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Meningitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Parainfluenzae virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Pertussis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Foreign body aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Patellofemoral pain syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Temporomandibular joint syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Tendon disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Complex partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Drooling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Affective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Focal segmental glomerulosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Asphyxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Pulmonary pneumatocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}, {'term': "Raynaud's phenomenon", 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Best Overall Subependymal Giant Cell Astrocytomas (SEGA) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus (Core Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.'}, {'id': 'OG001', 'title': 'Placebo (Core Period)', 'description': 'Participants received oral dose of placebo matching to everolimus daily.'}, {'id': 'OG002', 'title': 'Everolimus (Extension Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.6', 'groupId': 'OG000', 'lowerLimit': '24.2', 'upperLimit': '46.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '57.7', 'groupId': 'OG002', 'lowerLimit': '47.9', 'upperLimit': '67'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of core period (Week 48), and end of extension period (up to 4 years)', 'description': 'Participants were assessed for SEGA response, defined as 50% reduction from baseline in SEGA volume (where SEGA volume was the sum of the volumes of all target SEGA lesions identified at baseline, and confirmed with a second scan performed approximately 12 weeks later), no unequivocal worsening of non-target SEGA lesions, no new SEGA lesions (≥ 1 cm in longest diameter), and no new or worsening hydrocephalus. Multi-phase brain MRI was utilized to identify SEGA lesions. SEGA response rate was defined as the percentage of participants whose best overall status was SEGA response as determined by Independent Central Radiology Review. The Kaplan-Meier estimate was used for determining time to SEGA response.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis was performed in Full Analysis Set (FAS) population, defined as all randomized participants involved in the study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Frequency of Total Seizure Events Per 24 Hours at Week 24 in Both Core and Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus (Core Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.'}, {'id': 'OG001', 'title': 'Placebo (Core Period)', 'description': 'Participants received oral dose of placebo matching to everolimus daily.'}, {'id': 'OG002', 'title': 'Everolimus (Extension Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.24', 'spread': '6.12', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '-6.07', 'spread': '9.719', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Core period) to Week 24 (Core period), Baseline (Extension period, Week 24 post-core baseline) to Week 24 (Extension period, Week 48 post-core baseline)', 'description': 'Seizure frequency per 24 hours was defined as the number of seizures in the electroencephalography (EEG) divided by the number of hours in the EEG, multiplied by 24. Seizure frequency was evaluated using a 24-hour video-EEG. Seizure frequency was listed as missing if the actual EEG recording duration was \\< 18 hours.', 'unitOfMeasure': 'Seizure frequency', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed in the FAS population. Missing values were imputed using last observation carried forward approach for core period while raw count for extension period.'}, {'type': 'SECONDARY', 'title': 'Time to SEGA Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus (Core Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.'}, {'id': 'OG001', 'title': 'Placebo (Core Period)', 'description': 'Participants received oral dose of placebo matching to everolimus daily.'}, {'id': 'OG002', 'title': 'Everolimus (Extension Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median was not reached as no participant experienced disease progression during core period.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median was not reached as only 6 participants experienced disease progression during core period.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median was not reached as no participant experienced disease progression during extension period.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)', 'description': 'Time to SEGA progression was defined as time between randomisation to time to first SEGA progression. SEGA progression was defined as either one or more of the following criteria: 1. increase from nadir of ≥ 25% in SEGA volume to a value greater than baseline SEGA volume (where SEGA volume is the sum of the volumes of all target SEGA lesions identified at baseline, and nadir is the lowest SEGA volume obtained for the participant previously in the trial), 2. unequivocal worsening of non-target SEGA lesions, 3. appearance of new SEGA lesion ≥ 1.0 cm in longest diameter, 4. new or worsening hydrocephalus. The median TTSP based on central radiology review was not reached in any treatment arms; Only 6 events of SEGA progressions were observed in the placebo group of core period.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed in the FAS population. Here "Number of participants analysed" signifies the participants assessed for time to SEGA progression during the study for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Time to SEGA Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus (Core Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.'}, {'id': 'OG001', 'title': 'Everolimus (Extension Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.99', 'groupId': 'OG000', 'lowerLimit': '2.79', 'upperLimit': '5.36'}, {'value': '5.32', 'groupId': 'OG001', 'lowerLimit': '3.02', 'upperLimit': '5.59'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)', 'description': 'Participants were assessed for time to SEGA response, defined as 50% reduction from baseline in SEGA volume (where SEGA volume was the sum of the volumes of all target SEGA lesions identified at baseline, and confirmed with a second scan performed approximately 12 weeks later), no unequivocal worsening of non-target SEGA lesions, no new SEGA lesions (≥ 1 cm in longest diameter), and no new or worsening hydrocephalus. Multi-phase brain MRI was utilised to identify SEGA lesions. SEGA response rate was defined as the percentage of participants whose best overall status was SEGA response as determined by Independent Central Radiology Review. The Kaplan-Meier estimate was used for determining time to SEGA response.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed in the FAS population.'}, {'type': 'SECONDARY', 'title': 'Duration of SEGA Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus (Core Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.'}, {'id': 'OG001', 'title': 'Everolimus (Extension Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median was not achieved as no case of SEGA progression was observed.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median was not achieved as only 5 events of SEGA progression were observed.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)', 'description': 'Duration of SEGA response was defined as time from the date of the first documented SEGA response until the date of the first documented SEGA progression. Duration of SEGA response was evaluated only for participants who achieved a SEGA response. The time to SEGA progression was censored if SEGA progression was not observed before the first to occur out of (i) analysis cut-off date (ii) the date when systemic anti-SEGA medication is started, (iii) the date of a SEGA-related surgery or (iv) the date of death. Since, no case of SEGA progression was observed in core study which resulted in censored duration of SEGA response. Only 5 SEGA responders experienced a SEGA progression in extension period.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed in the FAS population. Here, "Number of participants analysed" signifies the participants assessed for SEGA progression during the study for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Time to SEGA Worsening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus (Core Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.'}, {'id': 'OG001', 'title': 'Placebo (Core Period)', 'description': 'Participants received oral dose of placebo matching to everolimus daily.'}, {'id': 'OG002', 'title': 'Everolimus (Extension Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median was not achieved as only 7 events of SEGA progression were observed.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median was not achieved as only 8 events of SEGA progression were observed.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '55.72', 'comment': 'Median upper value was not available as only single of SEGA progression were observed.', 'groupId': 'OG002', 'lowerLimit': '55.72', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)', 'description': 'Time to SEGA worsening was defined as the time from the start of everolimus to date of the first SEGA worsening. SEGA worsening was defined as either; increase from nadir of ≥ 25% in SEGA volume or unequivocal worsening of non-target SEGA lesions, or appearance of new SEGA lesion ≥ 1.0 cm in longest diameter, or new or worsening hydrocephalus. The median value was not reached in either treatment arm of core period as SEGA worsening was observed in less participants (everolimus - 7 and placebo - 8).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed in the FAS population. Here, "Number of participants analysed" signifies the participants assessed for time to SEGA worsening during the study for each arm, respectively.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With Skin Lesions Assessed Using Physician's Global Assessement Overall Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus (Core Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.'}, {'id': 'OG001', 'title': 'Placebo (Core Period)', 'description': 'Participants received oral dose of placebo matching to everolimus daily.'}, {'id': 'OG002', 'title': 'Everolimus (Extension Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000', 'lowerLimit': '30.2', 'upperLimit': '53.9'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '24.8'}, {'value': '58.1', 'groupId': 'OG002', 'lowerLimit': '48.1', 'upperLimit': '67.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of core period (Week 48), and end of extension period (up to 4 years)', 'description': "Skin lesions included hypomelanotic macules, the shagreen patch, periungual or subungual fibromas, facial angiofibromas and/or forehead plaques. Response was evaluated using the Physician's Global Assessment of Clinical Condition (PGA) on a 7-point scale: Grade 0 = complete clinical response, indicated absence of disease, Grade 1, 2, and 3 = partial response, indicated improvements of ≥ 50% but \\< 100%, Grade 4, 5 = stable disease, indicated some or no improvements of 25% - \\< 50% and 6 = progressive disease, indicated worse than at baseline evaluation by \\> 25%. Response rate was determined for participants with ≥ 1 skin lesion at baseline, defined as the percentage of participants with overall status as complete clinical response or partial response.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed in the FAS population. Here, "Number of participants analysed" signifies the participants assessed for skin lesion response during the study for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Duration of Skin Lesion Response in Everolimus Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus (Core Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.'}, {'id': 'OG001', 'title': 'Everolimus (Extension Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median was not achieved as no case of skin lesion was observed.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median was not achieved as no case of skin lesion was observed.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)', 'description': 'Duration of skin lesion response was defined as the time from the first skin lesion response until the first skin lesion progression, defined as worsening of lesion by \\> 25% or more from baseline.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed in the FAS population. Here, "Number of participants analysed" signifies everolimus treated responders with best overall skin lesion response during the core and extension period, respectively.'}, {'type': 'SECONDARY', 'title': 'Everolimus Blood Concentration (C2h) at 2 Hours Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus (Core Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.'}, {'id': 'OG001', 'title': 'Everolimus (Extension Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.'}], 'classes': [{'title': 'Week 6 (n= 37, 47)', 'categories': [{'measurements': [{'value': '27.52', 'spread': '15.24', 'groupId': 'OG000'}, {'value': '27.74', 'spread': '16.202', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n= 11, 13)', 'categories': [{'measurements': [{'value': '38.7', 'spread': '15.76', 'groupId': 'OG000'}, {'value': '39.25', 'spread': '14.662', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 (n= 1, 3)', 'categories': [{'measurements': [{'value': '23.2', 'spread': 'NA', 'comment': 'Only one participant was evaluable, so value was not available.', 'groupId': 'OG000'}, {'value': '49.73', 'spread': '28.884', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 (n= 0, 6)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participant was evaluable, so value was not available.', 'groupId': 'OG000'}, {'value': '31.63', 'spread': '21.902', 'groupId': 'OG001'}]}]}, {'title': 'Week 144 (n= 0, 6)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participant was evaluable, so value was not available.', 'groupId': 'OG000'}, {'value': '26.33', 'spread': '11.908', 'groupId': 'OG001'}]}]}, {'title': 'Week 240 (n= 0, 0)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participant was evaluable, so value was not available.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No participant was evaluable, so value was not available.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 hours post dose on Week 6, Week 24, Week 48, Week 96, Week 144, and Week 240', 'description': 'The participants were assessed for everolimus blood concentration at 2 hours time point after dose administration on the same day, if the participant did not vomit between previous dose and blood sample collection. Tandem liquid chromatography-mass spectrometry method was used for evaluation. C2h values were categorized as \\< 20 ng/mL, 20-50 ng/mL, and \\> 50 ng/mL, concentrations below the lower limit of quantification were entered as 0 ng/mL.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis was performed in the Safety Set population (Only evaluable PK Samples), defined as participants who received at least one dose of the double-blind study drug, with a valid post baseline assessment. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Everolimus Trough Concentrations (Cmin) at 24 Hours After Last Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus (Core Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.'}, {'id': 'OG001', 'title': 'Everolimus (Extension Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain blood trough concentrations in range of 5-15 ng/mL.'}], 'classes': [{'title': 'Week 6 (n= 64, 94)', 'categories': [{'measurements': [{'value': '5.8', 'spread': '3.68', 'groupId': 'OG000'}, {'value': '6.09', 'spread': '3.708', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n= 64, 89)', 'categories': [{'measurements': [{'value': '6.59', 'spread': '3.43', 'groupId': 'OG000'}, {'value': '6.86', 'spread': '3.504', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 (n= 23, 86)', 'categories': [{'measurements': [{'value': '7.28', 'spread': '3.11', 'groupId': 'OG000'}, {'value': '7.07', 'spread': '3.214', 'groupId': 'OG001'}]}]}, {'title': 'Week 72 (n= 4, 92)', 'categories': [{'measurements': [{'value': '6.08', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '7.25', 'spread': '3.66', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 (n= 0, 83)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participant was evaluable, so value was not available.', 'groupId': 'OG000'}, {'value': '7.09', 'spread': '3.697', 'groupId': 'OG001'}]}]}, {'title': 'Week 144 (n= 0, 69)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participant was evaluable, so value was not available.', 'groupId': 'OG000'}, {'value': '7.28', 'spread': '3.35', 'groupId': 'OG001'}]}]}, {'title': 'Week 240 (n= 0, 13)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participant was evaluable, so value was not available.', 'groupId': 'OG000'}, {'value': '5.85', 'spread': '2.507', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours post dose on Week 6, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 240', 'description': 'The participants were assessed for everolimus trough concentration (Cmin) at 24 hours time point after previous dose administration, at a steady state following 5 days of consistent dosing, if the participant did not vomit within 4 hours of previous dose. Tandem liquid chromatography-mass spectrometry method was used for evaluation. Cmin values were categorized as \\<5 ng/mL, 5-10 ng/mL, and \\>10 ng/mL, concentrations below the lower limit of quantification were entered as 0 ng/mL.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The analysis was performed in the Safety Set population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Renal Impairment During Core Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus (Core Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.'}, {'id': 'OG001', 'title': 'Placebo (Core Period)', 'description': 'Participants received oral dose of placebo matching to everolimus daily.'}], 'classes': [{'title': 'Grade 3 or 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 1 or 2', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 0', 'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 28 days after end of treatment (Core period)', 'description': "Renal function was assessed using glomerular filtration rate (GFR) based on age measure; Modification of Diet in Renal Disease (MDRD) formula for participants aged 18 years or older, defined as GFR equal to 32788\\*(serum creatinine (micromol/L)\\^-1.154)\\*(age\\^-0.203 )\\*(0.742, if female)\\*(1.210, if black), and Schwartz formula for participants less than 18 years defined as GFR equal to 0.41\\*height (cm)/ Serum creatinine (mg/dL). Participants with severe renal impairment defined as GFR \\< 30 mL/min/1.73 m\\^2 and participants with National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade 3/4 serum creatinine were reported.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed in the SAF population. Here, "Number of participants analysed" signifies the participants assessed for renal function during the study for each arm, respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Everolimus', 'description': 'Participants received oral dose of everolimus 4.5 milligram/square meter (mg/m\\^2) daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 nanogram/millilitre (ng/mL). Dose adjustments were permitted based on safety and whole blood trough concentrations.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received oral dose of placebo matching to everolimus daily.'}], 'periods': [{'title': 'Core Period (48 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Open-label Extension Period (4 Years)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Of 117 participants only 111 completed the core period and continued in the extension period', 'groupId': 'FG000', 'numSubjects': '111'}, {'comment': 'No participant received placebo.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'New treatment for indication under study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted at 24 centers in 10 countries.', 'preAssignmentDetails': 'A total of 117 participants were enrolled and randomized into the core period. Only 111 participants completing the core period, continued in the open-label extension period of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Everolimus (Core Period)', 'description': 'Participants received oral dose of everolimus 4.5 mg/m\\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.'}, {'id': 'BG001', 'title': 'Placebo (Core Period)', 'description': 'Participants received oral dose of placebo matching to everolimus daily.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '10.3', 'spread': '7.3', 'groupId': 'BG001'}, {'value': '10.2', 'spread': '6.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<3 years', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': '3-18 years', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}, {'title': '≥18 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-04', 'studyFirstSubmitDate': '2008-11-12', 'resultsFirstSubmitDate': '2012-03-01', 'studyFirstSubmitQcDate': '2008-11-12', 'lastUpdatePostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-04', 'studyFirstPostDateStruct': {'date': '2008-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Best Overall Subependymal Giant Cell Astrocytomas (SEGA) Response', 'timeFrame': 'End of core period (Week 48), and end of extension period (up to 4 years)', 'description': 'Participants were assessed for SEGA response, defined as 50% reduction from baseline in SEGA volume (where SEGA volume was the sum of the volumes of all target SEGA lesions identified at baseline, and confirmed with a second scan performed approximately 12 weeks later), no unequivocal worsening of non-target SEGA lesions, no new SEGA lesions (≥ 1 cm in longest diameter), and no new or worsening hydrocephalus. Multi-phase brain MRI was utilized to identify SEGA lesions. SEGA response rate was defined as the percentage of participants whose best overall status was SEGA response as determined by Independent Central Radiology Review. The Kaplan-Meier estimate was used for determining time to SEGA response.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Frequency of Total Seizure Events Per 24 Hours at Week 24 in Both Core and Extension Period', 'timeFrame': 'Baseline (Core period) to Week 24 (Core period), Baseline (Extension period, Week 24 post-core baseline) to Week 24 (Extension period, Week 48 post-core baseline)', 'description': 'Seizure frequency per 24 hours was defined as the number of seizures in the electroencephalography (EEG) divided by the number of hours in the EEG, multiplied by 24. Seizure frequency was evaluated using a 24-hour video-EEG. Seizure frequency was listed as missing if the actual EEG recording duration was \\< 18 hours.'}, {'measure': 'Time to SEGA Progression', 'timeFrame': 'Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)', 'description': 'Time to SEGA progression was defined as time between randomisation to time to first SEGA progression. SEGA progression was defined as either one or more of the following criteria: 1. increase from nadir of ≥ 25% in SEGA volume to a value greater than baseline SEGA volume (where SEGA volume is the sum of the volumes of all target SEGA lesions identified at baseline, and nadir is the lowest SEGA volume obtained for the participant previously in the trial), 2. unequivocal worsening of non-target SEGA lesions, 3. appearance of new SEGA lesion ≥ 1.0 cm in longest diameter, 4. new or worsening hydrocephalus. The median TTSP based on central radiology review was not reached in any treatment arms; Only 6 events of SEGA progressions were observed in the placebo group of core period.'}, {'measure': 'Time to SEGA Response', 'timeFrame': 'Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)', 'description': 'Participants were assessed for time to SEGA response, defined as 50% reduction from baseline in SEGA volume (where SEGA volume was the sum of the volumes of all target SEGA lesions identified at baseline, and confirmed with a second scan performed approximately 12 weeks later), no unequivocal worsening of non-target SEGA lesions, no new SEGA lesions (≥ 1 cm in longest diameter), and no new or worsening hydrocephalus. Multi-phase brain MRI was utilised to identify SEGA lesions. SEGA response rate was defined as the percentage of participants whose best overall status was SEGA response as determined by Independent Central Radiology Review. The Kaplan-Meier estimate was used for determining time to SEGA response.'}, {'measure': 'Duration of SEGA Response', 'timeFrame': 'Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)', 'description': 'Duration of SEGA response was defined as time from the date of the first documented SEGA response until the date of the first documented SEGA progression. Duration of SEGA response was evaluated only for participants who achieved a SEGA response. The time to SEGA progression was censored if SEGA progression was not observed before the first to occur out of (i) analysis cut-off date (ii) the date when systemic anti-SEGA medication is started, (iii) the date of a SEGA-related surgery or (iv) the date of death. Since, no case of SEGA progression was observed in core study which resulted in censored duration of SEGA response. Only 5 SEGA responders experienced a SEGA progression in extension period.'}, {'measure': 'Time to SEGA Worsening', 'timeFrame': 'Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)', 'description': 'Time to SEGA worsening was defined as the time from the start of everolimus to date of the first SEGA worsening. SEGA worsening was defined as either; increase from nadir of ≥ 25% in SEGA volume or unequivocal worsening of non-target SEGA lesions, or appearance of new SEGA lesion ≥ 1.0 cm in longest diameter, or new or worsening hydrocephalus. The median value was not reached in either treatment arm of core period as SEGA worsening was observed in less participants (everolimus - 7 and placebo - 8).'}, {'measure': "Percentage of Participants With Skin Lesions Assessed Using Physician's Global Assessement Overall Score", 'timeFrame': 'End of core period (Week 48), and end of extension period (up to 4 years)', 'description': "Skin lesions included hypomelanotic macules, the shagreen patch, periungual or subungual fibromas, facial angiofibromas and/or forehead plaques. Response was evaluated using the Physician's Global Assessment of Clinical Condition (PGA) on a 7-point scale: Grade 0 = complete clinical response, indicated absence of disease, Grade 1, 2, and 3 = partial response, indicated improvements of ≥ 50% but \\< 100%, Grade 4, 5 = stable disease, indicated some or no improvements of 25% - \\< 50% and 6 = progressive disease, indicated worse than at baseline evaluation by \\> 25%. Response rate was determined for participants with ≥ 1 skin lesion at baseline, defined as the percentage of participants with overall status as complete clinical response or partial response."}, {'measure': 'Duration of Skin Lesion Response in Everolimus Treated Participants', 'timeFrame': 'Baseline up to week 48 (end of core period), and end of extension period (up to 4 years)', 'description': 'Duration of skin lesion response was defined as the time from the first skin lesion response until the first skin lesion progression, defined as worsening of lesion by \\> 25% or more from baseline.'}, {'measure': 'Everolimus Blood Concentration (C2h) at 2 Hours Post Dose', 'timeFrame': '2 hours post dose on Week 6, Week 24, Week 48, Week 96, Week 144, and Week 240', 'description': 'The participants were assessed for everolimus blood concentration at 2 hours time point after dose administration on the same day, if the participant did not vomit between previous dose and blood sample collection. Tandem liquid chromatography-mass spectrometry method was used for evaluation. C2h values were categorized as \\< 20 ng/mL, 20-50 ng/mL, and \\> 50 ng/mL, concentrations below the lower limit of quantification were entered as 0 ng/mL.'}, {'measure': 'Everolimus Trough Concentrations (Cmin) at 24 Hours After Last Dose', 'timeFrame': '24 hours post dose on Week 6, Week 24, Week 48, Week 72, Week 96, Week 144, and Week 240', 'description': 'The participants were assessed for everolimus trough concentration (Cmin) at 24 hours time point after previous dose administration, at a steady state following 5 days of consistent dosing, if the participant did not vomit within 4 hours of previous dose. Tandem liquid chromatography-mass spectrometry method was used for evaluation. Cmin values were categorized as \\<5 ng/mL, 5-10 ng/mL, and \\>10 ng/mL, concentrations below the lower limit of quantification were entered as 0 ng/mL.'}, {'measure': 'Percentage of Participants With Renal Impairment During Core Period', 'timeFrame': 'Day 1 up to 28 days after end of treatment (Core period)', 'description': "Renal function was assessed using glomerular filtration rate (GFR) based on age measure; Modification of Diet in Renal Disease (MDRD) formula for participants aged 18 years or older, defined as GFR equal to 32788\\*(serum creatinine (micromol/L)\\^-1.154)\\*(age\\^-0.203 )\\*(0.742, if female)\\*(1.210, if black), and Schwartz formula for participants less than 18 years defined as GFR equal to 0.41\\*height (cm)/ Serum creatinine (mg/dL). Participants with severe renal impairment defined as GFR \\< 30 mL/min/1.73 m\\^2 and participants with National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade 3/4 serum creatinine were reported."}]}, 'conditionsModule': {'keywords': ['SEGA', 'Tuberous Sclerosis', 'Subependymal Giant Cell Astrocytoma', 'mTOR', 'RAD001', 'Mamalian Target Rapamycin', 'Everolimus', 'TSC'], 'conditions': ['Tuberous Sclerosis', 'Subependymal Giant Cell Astrocytoma']}, 'referencesModule': {'references': [{'pmid': '30053159', 'type': 'DERIVED', 'citation': 'Bissler JJ, Budde K, Sauter M, Franz DN, Zonnenberg BA, Frost MD, Belousova E, Berkowitz N, Ridolfi A, Christopher Kingswood J. Effect of everolimus on renal function in patients with tuberous sclerosis complex: evidence from EXIST-1 and EXIST-2. Nephrol Dial Transplant. 2019 Jun 1;34(6):1000-1008. doi: 10.1093/ndt/gfy132.'}, {'pmid': '29023494', 'type': 'DERIVED', 'citation': 'Sparagana S, Franz DN, Krueger DA, Bissler JJ, Berkowitz N, Burock K, Kingswood JC. Pooled analysis of menstrual irregularities from three major clinical studies evaluating everolimus for the treatment of tuberous sclerosis complex. PLoS One. 2017 Oct 12;12(10):e0186235. doi: 10.1371/journal.pone.0186235. eCollection 2017.'}, {'pmid': '27351628', 'type': 'DERIVED', 'citation': 'Franz DN, Belousova E, Sparagana S, Bebin EM, Frost MD, Kuperman R, Witt O, Kohrman MH, Flamini JR, Wu JY, Curatolo P, de Vries PJ, Berkowitz N, Niolat J, Jozwiak S. Long-Term Use of Everolimus in Patients with Tuberous Sclerosis Complex: Final Results from the EXIST-1 Study. PLoS One. 2016 Jun 28;11(6):e0158476. doi: 10.1371/journal.pone.0158476. eCollection 2016.'}, {'pmid': '26858193', 'type': 'DERIVED', 'citation': 'Jozwiak S, Kotulska K, Berkowitz N, Brechenmacher T, Franz DN. Safety of Everolimus in Patients Younger than 3 Years of Age: Results from EXIST-1, a Randomized, Controlled Clinical Trial. J Pediatr. 2016 May;172:151-155.e1. doi: 10.1016/j.jpeds.2016.01.027. Epub 2016 Feb 6.'}, {'pmid': '25682485', 'type': 'DERIVED', 'citation': 'Goyer I, Dahdah N, Major P. Use of mTOR inhibitor everolimus in three neonates for treatment of tumors associated with tuberous sclerosis complex. Pediatr Neurol. 2015 Apr;52(4):450-3. doi: 10.1016/j.pediatrneurol.2015.01.004. Epub 2015 Jan 14.'}, {'pmid': '25456370', 'type': 'DERIVED', 'citation': 'Franz DN, Belousova E, Sparagana S, Bebin EM, Frost M, Kuperman R, Witt O, Kohrman MH, Flamini JR, Wu JY, Curatolo P, de Vries PJ, Berkowitz N, Anak O, Niolat J, Jozwiak S. Everolimus for subependymal giant cell astrocytoma in patients with tuberous sclerosis complex: 2-year open-label extension of the randomised EXIST-1 study. Lancet Oncol. 2014 Dec;15(13):1513-1520. doi: 10.1016/S1470-2045(14)70489-9. Epub 2014 Nov 10.'}, {'pmid': '24729041', 'type': 'DERIVED', 'citation': 'Kingswood JC, Jozwiak S, Belousova ED, Frost MD, Kuperman RA, Bebin EM, Korf BR, Flamini JR, Kohrman MH, Sparagana SP, Wu JY, Brechenmacher T, Stein K, Berkowitz N, Bissler JJ, Franz DN. The effect of everolimus on renal angiomyolipoma in patients with tuberous sclerosis complex being treated for subependymal giant cell astrocytoma: subgroup results from the randomized, placebo-controlled, Phase 3 trial EXIST-1. Nephrol Dial Transplant. 2014 Jun;29(6):1203-10. doi: 10.1093/ndt/gfu013. Epub 2014 Apr 11.'}, {'pmid': '23733802', 'type': 'DERIVED', 'citation': 'Kotulska K, Borkowska J, Jozwiak S. Possible prevention of tuberous sclerosis complex lesions. Pediatrics. 2013 Jul;132(1):e239-42. doi: 10.1542/peds.2012-3607. Epub 2013 Jun 3.'}, {'pmid': '23158522', 'type': 'DERIVED', 'citation': 'Franz DN, Belousova E, Sparagana S, Bebin EM, Frost M, Kuperman R, Witt O, Kohrman MH, Flamini JR, Wu JY, Curatolo P, de Vries PJ, Whittemore VH, Thiele EA, Ford JP, Shah G, Cauwel H, Lebwohl D, Sahmoud T, Jozwiak S. Efficacy and safety of everolimus for subependymal giant cell astrocytomas associated with tuberous sclerosis complex (EXIST-1): a multicentre, randomised, placebo-controlled phase 3 trial. Lancet. 2013 Jan 12;381(9861):125-32. doi: 10.1016/S0140-6736(12)61134-9. Epub 2012 Nov 14.'}], 'seeAlsoLinks': [{'url': 'http://www.novartisclinicaltrials.com/webapp/portals/EXISTClinicalTrials/page.do', 'label': 'Visit EXIST-1 NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluated the efficacy and safety of Everolimus in treating patients with Subependymal Giant Cell Astrocytomas associated with Tuberous Sclerosis Complex.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All Ages\n* Definite diagnosis of Tuberous Sclerosis according to the modified Gomez criteria\n* At least one Subependymal Giant Cell Astrocytoma of at least 1 cm in diameter\n* Evidence of SEGA worsening as compared to prior MRI scans\n* Females of child bearing potential must use birth control\n* Written informed consent\n\nExclusion Criteria:\n\n* SEGA related surgery is likely to be required in the opinion of the investigator\n* Recent heart attack, cardiac related chest pain or stroke\n* Severely impaired lung function\n* Severe liver dysfunction\n* Severe kidney dysfunction\n* Pregnancy or breast feeding\n* Current infection\n* History of organ transplant\n* Surgery within two months prior to study enrollment\n* Prior therapy with a medication in the same class as Everolimus\n* Uncontrolled high cholesterol\n* Uncontrolled diabetes\n* HIV\n* Patients with metal implants thus prohibiting MRI evaluations\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00789828', 'acronym': 'EXIST-1', 'briefTitle': 'Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study of Everolimus in the Treatment of Patients With Subependymal Giant Cell Astrocytomas (SEGA) Associated With Tuberous Sclerosis Complex (TSC)', 'orgStudyIdInfo': {'id': 'CRAD001M2301'}, 'secondaryIdInfos': [{'id': '2007-006997-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Everolimus', 'description': 'Everolimus was administered orally at a starting dose of 4.5mg/m\\^2 daily and subsequently titrated to attain whole blood trough concentration of 5 to 15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.', 'interventionNames': ['Drug: Everolimus']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching Placebo administered orally.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Everolimus', 'type': 'DRUG', 'otherNames': ['RAD001'], 'description': 'Everolimus was formulated as tablets of 1.0-mg strength and was blisterpacked under aluminum foil in units of 10 tablets.', 'armGroupLabels': ['Everolimus']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo was provided as a matching tablet and was blisterpacked under aluminum foil in units of 10.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Barrow Tuberous Sclerosis Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94609-1809', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Oakland Hematology/Oncology Dept", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637-1470', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "University of CHicago Comer Children's Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital Mass General', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital Boston SC-1", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55102-2383', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Epilepsy Group - 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