Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT00500903
Status:
COMPLETED
Last Update Posted:
2019-03-14
First Post:
2007-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in Participants With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C550258', 'term': 'MLN 8237'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': "In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug to 30 days after the last dose (up to 1011 days)', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'PIC Dose Escalation', 'description': 'Alisertib 5, 10, 20, 40, 80, 110 or 150 mg, PIC, orally, once daily (QD) for 7 days, followed by a 14-day recovery period or alisertib 25 mg, PIC, orally, QD for 14 days, followed by a 14-day recovery period or alisertib 25, 50 or 70 mg, PIC, orally, QD for 21 days followed by a 14-day recovery period or alisertib 50 or 60 mg, PIC, orally, twice daily (BID) for 7 days followed by a 14-day recovery period or alisertib 40 mg, PIC, orally, BID for 14 days followed by a 14-day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).', 'otherNumAtRisk': 65, 'otherNumAffected': 65, 'seriousNumAtRisk': 65, 'seriousNumAffected': 26}, {'id': 'EG001', 'title': 'ECT Dose Escalation', 'description': 'Alisertib 10 or 20 mg, Enteric-coated Tablet (ECT) formulation, orally, once daily (QD) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 2 cycles).', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Relative Bioavailability', 'description': 'Alisertib 40 mg ECT or PIC formulation, orally, twice daily (BID) for 7 days followed by a 14--day recovery period in cycle 1, followed by alisertib 40 mg in the opposite formulation (PIC or ECT) orally, twice daily (BID) for 7 days followed by a 14--day recovery period in cycle 2, followed by alisertib 50 mg PIC formulation orally, twice daily (BID) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 9 cycles).', 'otherNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Catheter site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Onychorrhexis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Shoulder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Escherichia infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Mood altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Visual disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Hepatobiliary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}], 'seriousEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Small intestinal obstruction', 'notes': 'One treatment-emergent death occurred during treatment with alisertib 40 mg PIC BID14D (PIC dose escalation reporting group) and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Klebsiella bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Enterococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Jaundice cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Bile duct obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Bile duct stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Disease progression', 'notes': 'One treatment-emergent death occurred during treatment with alisertib 80 mg PIC QD7D (PIC dose escalation reporting group) and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Mental impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Pancreatic carcinoma metastatic', 'notes': 'One treatment-emergent death occurred during treatment with alisertib 40 mg PIC BID7D (PIC dose escalation reporting group) and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Restrictive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Hallucination, visual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Renal failure acute', 'notes': 'One treatment-emergent death occurred during treatment with alisertib 40 mg PIC QD7D (PIC dose escalation reporting group) and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Dose-Limiting Toxicity (DLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '11', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 5 mg PIC QD 7D', 'description': 'Alisertib 5 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 10 mg PIC QD 7D', 'description': 'Alisertib 10 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 20 mg PIC QD 7D', 'description': 'Alisertib 20 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 31 cycles).'}, {'id': 'OG003', 'title': 'Alisertib 40 mg PIC QD 7D', 'description': 'Alisertib 40 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 8 cycles).'}, {'id': 'OG004', 'title': 'Alisertib 80 mg PIC QD 7D', 'description': 'Alisertib 80 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).'}, {'id': 'OG005', 'title': 'Alisertib 110 mg PIC QD 7D', 'description': 'Alisertib 110 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG006', 'title': 'Alisertib 150 mg PIC QD 7D', 'description': 'Alisertib 150 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).'}, {'id': 'OG007', 'title': 'Alisertib 25 mg PIC QD 14D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}, {'id': 'OG008', 'title': 'Alisertib 25 mg PIC QD 21D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG009', 'title': 'Alisertib 50 mg PIC QD 21D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 7 cycles).'}, {'id': 'OG010', 'title': 'Alisertib 70 mg PIC QD 21D', 'description': 'Alisertib 70 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).'}, {'id': 'OG011', 'title': 'Alisertib 50 mg PIC BID 7D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG012', 'title': 'Alisertib 60 mg PIC BID 7D', 'description': 'Alisertib 60 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 35 cycles).'}, {'id': 'OG013', 'title': 'Alisertib 40 mg PIC BID 14D', 'description': 'Alisertib 40 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).'}, {'id': 'OG014', 'title': 'Alisertib 10 mg ECT QD7', 'description': 'Alisertib 10 mg, Enteric-coated Tablet (ECT) formulation, orally, once daily (QD) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 2 cycles).'}, {'id': 'OG015', 'title': 'Alisertib 20 mg ECT QD7', 'description': 'Alisertib 20 mg, Enteric-coated Tablet (ECT) formulation, orally, once daily (QD) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 2 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 Day 1 up to Day 35 (alisertib daily for 7 to 21 days followed by a 14-day recovery period)', 'description': "DLT was evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and was defined as any of the following events related to therapy with alisertib:\n\n1. Grade 4 neutropenia lasting ≥7 consecutive days\n2. Grade 4 neutropenia with fever and/or infection\n3. Platelet count \\<25,000/mm\\^3\n4. Grade 3 or greater nausea and/or emesis despite use of optimal antiemetic prophylaxis\n5. Grade 3 or greater diarrhea despite maximal supportive therapy with loperamide\n6. Any other Grade 3 or greater nonhematologic toxicity, with the following exceptions: Grade 3 arthralgia/myalgias, Any grade of alopecia, Brief (\\<1 week) Grade 3 fatigue\n7. Treatment delay of \\>1 week due to failure of adequate hematologic or nonhematologic recovery from previous cycle of treatment\n8. Other alisertib-related nonhematologic toxicities ≥Grade 2 that, in the opinion of the investigator, required a dose reduction or discontinuation of therapy with alisertib.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'DLT-Evaluable Population included all participants who received at least 75% of their planned alisertib doses for their first cycle of treatment (unless interrupted by DLT) and had sufficient follow-up data to allow the investigators and sponsor to determine whether DLT occurred.'}, {'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose (MTD) of Alisertib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib', 'description': 'Alisertib 5, 10, 20, 40, 80, 110 or 150 mg, PIC, orally, once daily (QD) for 7 days, followed by a 14-day recovery period or alisertib 25 mg, PIC, orally, QD for 14 days, followed by a 14-day recovery period or alisertib 25, 50 or 70 mg, PIC, orally, QD for 21 days followed by a 14-day recovery period or alisertib 50 or 60 mg, PIC, orally, twice daily (BID) for 7 days followed by a 14-day recovery period or alisertib 40 mg, PIC, orally, BID for 14 days followed by a 14-day recovery period or alisertib 10 or 20 mg ECT, orally QD for 7 days followed by a 14-day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug to 30 days after the last dose (up to 1011 days)', 'description': 'MTD was defined as the highest dose at which DLT occurred in 0/3 or 1/6 patients.', 'unitOfMeasure': 'mg BID for 7 Days', 'reportingStatus': 'POSTED', 'populationDescription': 'DLT-Evaluable Population included all participants who received at least 75% of their planned alisertib doses for their first cycle of treatment (unless interrupted by DLT) and had sufficient follow-up data to allow the investigators and sponsor to determine whether DLT occurred.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PIC Dose Escalation', 'description': 'Alisertib 5, 10, 20, 40, 80, 110 or 150 mg, PIC, orally, once daily (QD) for 7 days, followed by a 14-day recovery period or alisertib 25 mg, PIC, orally, QD for 14 days, followed by a 14-day recovery period or alisertib 25, 50 or 70 mg, PIC, orally, QD for 21 days followed by a 14-day recovery period or alisertib 50 or 60 mg, PIC, orally, twice daily (BID) for 7 days followed by a 14-day recovery period or alisertib 40 mg, PIC, orally, BID for 14 days followed by a 14-day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).'}, {'id': 'OG001', 'title': 'ECT Dose Escalation', 'description': 'Alisertib 10 or 20 mg, Enteric-coated Tablet (ECT) formulation, orally, once daily (QD) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 2 cycles).'}, {'id': 'OG002', 'title': 'Relative Bioavailability', 'description': 'Alisertib 40 mg ECT or PIC formulation, orally, twice daily (BID) for 7 days followed by a 14--day recovery period in cycle 1, followed by alisertib 40 mg in the opposite formulation (PIC or ECT) orally, twice daily (BID) for 7 days followed by a 14--day recovery period in cycle 2, followed by alisertib 50 mg PIC formulation orally, twice daily (BID) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 9 cycles).'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug to 30 days after the last dose (up to 1011 days)', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received any amount of study drug.'}, {'type': 'SECONDARY', 'title': 'Cmax: Maximum Observed Concentration for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 5 mg PIC QD 7D', 'description': 'Alisertib 5 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 10 mg PIC QD 7D', 'description': 'Alisertib 10 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 20 mg PIC QD 7D', 'description': 'Alisertib 20 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 31 cycles).'}, {'id': 'OG003', 'title': 'Alisertib 40 mg PIC QD 7D', 'description': 'Alisertib 40 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 8 cycles).'}, {'id': 'OG004', 'title': 'Alisertib 80 mg PIC QD 7D', 'description': 'Alisertib 80 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).'}, {'id': 'OG005', 'title': 'Alisertib 110 mg PIC QD 7D', 'description': 'Alisertib 110 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG006', 'title': 'Alisertib 150 mg PIC QD 7D', 'description': 'Alisertib 150 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '208.4', 'spread': '27.96', 'groupId': 'OG000'}, {'value': '279.1', 'spread': '46.20', 'groupId': 'OG001'}, {'value': '759.3', 'spread': '11.82', 'groupId': 'OG002'}, {'value': '1245.4', 'spread': '20.60', 'groupId': 'OG003'}, {'value': '1661.3', 'spread': '45.20', 'groupId': 'OG004'}, {'value': '2717.8', 'spread': '44.62', 'groupId': 'OG005'}, {'value': '4260.3', 'spread': '42.62', 'groupId': 'OG006'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '285.7', 'spread': '32.74', 'groupId': 'OG000'}, {'value': '931.5', 'spread': '81.68', 'groupId': 'OG001'}, {'value': '1114.1', 'spread': '36.96', 'groupId': 'OG002'}, {'value': '1681.6', 'spread': '64.62', 'groupId': 'OG003'}, {'value': '2376.3', 'spread': '51.06', 'groupId': 'OG004'}, {'value': '3586.4', 'spread': '48.28', 'groupId': 'OG005'}, {'value': '4467.8', 'spread': '24.58', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'nM', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Tmax: Time of First Occurrence of Cmax for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 5 mg PIC QD 7D', 'description': 'Alisertib 5 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 10 mg PIC QD 7D', 'description': 'Alisertib 10 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 20 mg PIC QD 7D', 'description': 'Alisertib 20 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 31 cycles).'}, {'id': 'OG003', 'title': 'Alisertib 40 mg PIC QD 7D', 'description': 'Alisertib 40 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 8 cycles).'}, {'id': 'OG004', 'title': 'Alisertib 80 mg PIC QD 7D', 'description': 'Alisertib 80 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).'}, {'id': 'OG005', 'title': 'Alisertib 110 mg PIC QD 7D', 'description': 'Alisertib 110 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG006', 'title': 'Alisertib 150 mg PIC QD 7D', 'description': 'Alisertib 150 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2.000', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '3.00'}, {'value': '2.000', 'groupId': 'OG001', 'lowerLimit': '1.50', 'upperLimit': '3.00'}, {'value': '1.500', 'groupId': 'OG002', 'lowerLimit': '1.50', 'upperLimit': '1.50'}, {'value': '2.000', 'groupId': 'OG003', 'lowerLimit': '1.50', 'upperLimit': '6.00'}, {'value': '2.000', 'groupId': 'OG004', 'lowerLimit': '1.50', 'upperLimit': '3.00'}, {'value': '2.000', 'groupId': 'OG005', 'lowerLimit': '1.48', 'upperLimit': '5.57'}, {'value': '2.000', 'groupId': 'OG006', 'lowerLimit': '1.45', 'upperLimit': '3.00'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.500', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.50'}, {'value': '3.750', 'groupId': 'OG001', 'lowerLimit': '1.50', 'upperLimit': '6.00'}, {'value': '1.500', 'groupId': 'OG002', 'lowerLimit': '1.50', 'upperLimit': '2.00'}, {'value': '2.000', 'groupId': 'OG003', 'lowerLimit': '1.97', 'upperLimit': '6.00'}, {'value': '2.000', 'groupId': 'OG004', 'lowerLimit': '1.98', 'upperLimit': '3.05'}, {'value': '3.710', 'groupId': 'OG005', 'lowerLimit': '1.42', 'upperLimit': '6.02'}, {'value': '2.000', 'groupId': 'OG006', 'lowerLimit': '1.48', 'upperLimit': '3.93'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'hours (h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'AUCt: Area Under the Concentration-Time Curve From Time 0 to Time t for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 5 mg PIC QD 7D', 'description': 'Alisertib 5 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 10 mg PIC QD 7D', 'description': 'Alisertib 10 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 20 mg PIC QD 7D', 'description': 'Alisertib 20 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 31 cycles).'}, {'id': 'OG003', 'title': 'Alisertib 40 mg PIC QD 7D', 'description': 'Alisertib 40 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 8 cycles).'}, {'id': 'OG004', 'title': 'Alisertib 80 mg PIC QD 7D', 'description': 'Alisertib 80 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).'}, {'id': 'OG005', 'title': 'Alisertib 110 mg PIC QD 7D', 'description': 'Alisertib 110 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG006', 'title': 'Alisertib 150 mg PIC QD 7D', 'description': 'Alisertib 150 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1682.4', 'spread': '31.06', 'groupId': 'OG000'}, {'value': '2525.8', 'spread': '21.87', 'groupId': 'OG001'}, {'value': '5772.1', 'spread': '10.68', 'groupId': 'OG002'}, {'value': '12045.4', 'spread': '57.01', 'groupId': 'OG003'}, {'value': '20958.1', 'spread': '38.92', 'groupId': 'OG004'}, {'value': '29460.7', 'spread': '39.43', 'groupId': 'OG005'}, {'value': '38582.1', 'spread': '45.95', 'groupId': 'OG006'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2919.5', 'spread': '32.31', 'groupId': 'OG000'}, {'value': '10602.9', 'spread': '107.87', 'groupId': 'OG001'}, {'value': '10927.5', 'spread': '45.27', 'groupId': 'OG002'}, {'value': '21976.0', 'spread': '96.64', 'groupId': 'OG003'}, {'value': '27825.5', 'spread': '53.59', 'groupId': 'OG004'}, {'value': '46271.1', 'spread': '33.38', 'groupId': 'OG005'}, {'value': '53031.9', 'spread': '26.22', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'nM*h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Terminal Half-Life (t1/2) for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 5 mg PIC QD 7D', 'description': 'Alisertib 5 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 10 mg PIC QD 7D', 'description': 'Alisertib 10 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 20 mg PIC QD 7D', 'description': 'Alisertib 20 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 31 cycles).'}, {'id': 'OG003', 'title': 'Alisertib 40 mg PIC QD 7D', 'description': 'Alisertib 40 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 8 cycles).'}, {'id': 'OG004', 'title': 'Alisertib 80 mg PIC QD 7D', 'description': 'Alisertib 80 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).'}, {'id': 'OG005', 'title': 'Alisertib 110 mg PIC QD 7D', 'description': 'Alisertib 110 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG006', 'title': 'Alisertib 150 mg PIC QD 7D', 'description': 'Alisertib 150 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '24.950', 'spread': '20.4354', 'groupId': 'OG000'}, {'value': '35.150', 'spread': '23.4052', 'groupId': 'OG001'}, {'value': '26.400', 'spread': '19.7684', 'groupId': 'OG002'}, {'value': '18.155', 'spread': '12.5087', 'groupId': 'OG003'}, {'value': '39.333', 'spread': '18.8006', 'groupId': 'OG004'}, {'value': '13.427', 'spread': '4.3465', 'groupId': 'OG005'}, {'value': '16.766', 'spread': '9.7804', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio (Rac) for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 5 mg PIC QD 7D', 'description': 'Alisertib 5 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 10 mg PIC QD 7D', 'description': 'Alisertib 10 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 20 mg PIC QD 7D', 'description': 'Alisertib 20 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 31 cycles).'}, {'id': 'OG003', 'title': 'Alisertib 40 mg PIC QD 7D', 'description': 'Alisertib 40 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 8 cycles).'}, {'id': 'OG004', 'title': 'Alisertib 80 mg PIC QD 7D', 'description': 'Alisertib 80 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).'}, {'id': 'OG005', 'title': 'Alisertib 110 mg PIC QD 7D', 'description': 'Alisertib 110 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG006', 'title': 'Alisertib 150 mg PIC QD 7D', 'description': 'Alisertib 150 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.753', 'spread': '0.2754', 'groupId': 'OG000'}, {'value': '6.350', 'spread': '7.2408', 'groupId': 'OG001'}, {'value': '2.037', 'spread': '0.9708', 'groupId': 'OG002'}, {'value': '1.997', 'spread': '0.9393', 'groupId': 'OG003'}, {'value': '1.535', 'spread': '0.3323', 'groupId': 'OG004'}, {'value': '1.677', 'spread': '0.6788', 'groupId': 'OG005'}, {'value': '1.588', 'spread': '0.4129', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Peak/Trough Ratio for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 5 mg PIC QD 7D', 'description': 'Alisertib 5 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 10 mg PIC QD 7D', 'description': 'Alisertib 10 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 20 mg PIC QD 7D', 'description': 'Alisertib 20 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 31 cycles).'}, {'id': 'OG003', 'title': 'Alisertib 40 mg PIC QD 7D', 'description': 'Alisertib 40 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 8 cycles).'}, {'id': 'OG004', 'title': 'Alisertib 80 mg PIC QD 7D', 'description': 'Alisertib 80 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).'}, {'id': 'OG005', 'title': 'Alisertib 110 mg PIC QD 7D', 'description': 'Alisertib 110 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG006', 'title': 'Alisertib 150 mg PIC QD 7D', 'description': 'Alisertib 150 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.107', 'spread': '0.8460', 'groupId': 'OG000'}, {'value': '5.195', 'spread': '3.9527', 'groupId': 'OG001'}, {'value': '5.430', 'spread': '2.4856', 'groupId': 'OG002'}, {'value': '3.907', 'spread': '2.3944', 'groupId': 'OG003'}, {'value': '3.850', 'spread': '2.0612', 'groupId': 'OG004'}, {'value': '4.922', 'spread': '2.5890', 'groupId': 'OG005'}, {'value': '4.610', 'spread': '0.5314', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 5 mg PIC QD 7D', 'description': 'Alisertib 5 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 10 mg PIC QD 7D', 'description': 'Alisertib 10 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 20 mg PIC QD 7D', 'description': 'Alisertib 20 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 31 cycles).'}, {'id': 'OG003', 'title': 'Alisertib 40 mg PIC QD 7D', 'description': 'Alisertib 40 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 8 cycles).'}, {'id': 'OG004', 'title': 'Alisertib 80 mg PIC QD 7D', 'description': 'Alisertib 80 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).'}, {'id': 'OG005', 'title': 'Alisertib 110 mg PIC QD 7D', 'description': 'Alisertib 110 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG006', 'title': 'Alisertib 150 mg PIC QD 7D', 'description': 'Alisertib 150 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.302', 'spread': '35.8915', 'groupId': 'OG000'}, {'value': '1.817', 'spread': '107.8347', 'groupId': 'OG001'}, {'value': '3.525', 'spread': '49.1267', 'groupId': 'OG002'}, {'value': '3.511', 'spread': '72.1346', 'groupId': 'OG003'}, {'value': '5.545', 'spread': '41.0258', 'groupId': 'OG004'}, {'value': '4.348', 'spread': '61.5266', 'groupId': 'OG005'}, {'value': '5.450', 'spread': '37.3021', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'liters (L)/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Ae: Amount of Alisertib Excreted in Urine Over the Collection Period for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 5 mg PIC QD 7D', 'description': 'Alisertib 5 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 10 mg PIC QD 7D', 'description': 'Alisertib 10 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 20 mg PIC QD 7D', 'description': 'Alisertib 20 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 31 cycles).'}, {'id': 'OG003', 'title': 'Alisertib 40 mg PIC QD 7D', 'description': 'Alisertib 40 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 8 cycles).'}, {'id': 'OG004', 'title': 'Alisertib 80 mg PIC QD 7D', 'description': 'Alisertib 80 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).'}, {'id': 'OG005', 'title': 'Alisertib 110 mg PIC QD 7D', 'description': 'Alisertib 110 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG006', 'title': 'Alisertib 150 mg PIC QD 7D', 'description': 'Alisertib 150 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '4806.7', 'spread': '8325.39', 'groupId': 'OG003'}, {'value': '18815.0', 'spread': '1675.84', 'groupId': 'OG004'}, {'value': '13813.3', 'spread': '16387.22', 'groupId': 'OG005'}, {'value': '14473.3', 'spread': '15603.71', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose', 'unitOfMeasure': 'ng', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.'}, {'type': 'SECONDARY', 'title': 'CLr: Renal Clearance of Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 40 mg PIC QD 7D', 'description': 'Alisertib 40 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 8 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 80 mg PIC QD 7D', 'description': 'Alisertib 80 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 110 mg PIC QD 7D', 'description': 'Alisertib 110 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG003', 'title': 'Alisertib 150 mg PIC QD 7D', 'description': 'Alisertib 150 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0012630', 'spread': 'NA', 'comment': 'Cannot be calculated for 1 participant', 'groupId': 'OG000'}, {'value': '0.0013860', 'spread': 'NA', 'comment': 'Cannot be calculated for 1 participant', 'groupId': 'OG001'}, {'value': '0.0009414', 'spread': '0.00063956', 'groupId': 'OG002'}, {'value': '0.0006710', 'spread': '0.00060091', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.'}, {'type': 'SECONDARY', 'title': 'Cmax: Maximum Observed Concentration for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 14D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '778.7', 'spread': '24.28', 'groupId': 'OG000'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '995.5', 'spread': '43.21', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '808.9', 'spread': '37.96', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'nM', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.'}, {'type': 'SECONDARY', 'title': 'Tmax: Time of First Occurrence of Cmax for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 14D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '4.000', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '8.88'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '2.000', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '2.00'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '2.000', 'groupId': 'OG000', 'lowerLimit': '1.098', 'upperLimit': '2.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.'}, {'type': 'SECONDARY', 'title': 'AUCt: Area Under the Concentration--Time Curve From Time 0 to Time t for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 14D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '8061.6', 'spread': '17.30', 'groupId': 'OG000'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '8634.0', 'spread': '42.70', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '8978.0', 'spread': '20.15', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'nM*h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.'}, {'type': 'SECONDARY', 'title': 'Terminal Half-Life for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 14D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '65.67', 'spread': '43.859', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 14 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio (Rac) for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 14D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}], 'classes': [{'title': 'Day 7', 'categories': [{'measurements': [{'value': '1.203', 'spread': '0.6964', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '1.133', 'spread': '0.2303', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Days 7 and 14 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.'}, {'type': 'SECONDARY', 'title': 'Peak/Trough Ratio for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 14D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}], 'classes': [{'title': 'Day 7', 'categories': [{'measurements': [{'value': '6.877', 'spread': '1.1151', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '5.073', 'spread': '2.2113', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Days 7 and 14 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.'}, {'type': 'SECONDARY', 'title': 'CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 14D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}], 'classes': [{'title': 'Day 7', 'categories': [{'measurements': [{'value': '6.030', 'spread': '2.9963', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '5.433', 'spread': '0.9808', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Days 7 and 14 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.'}, {'type': 'SECONDARY', 'title': 'Ae: Amount of Alisertib Excreted in Urine Over the Collection Period for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 14D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '800.0', 'spread': '1385.64', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose', 'unitOfMeasure': 'ng', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.'}, {'type': 'SECONDARY', 'title': 'CLr: Renal Clearance of Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 14D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0004930', 'spread': 'NA', 'comment': 'Cannot be calculated for 1 participant', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.'}, {'type': 'SECONDARY', 'title': 'Cmax: Maximum Observed Concentration for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 21D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 50 mg PIC QD 21D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 7 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 70 mg PIC QD 21D', 'description': 'Alisertib 70 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '898.2', 'spread': '86.35', 'groupId': 'OG000'}, {'value': '1725.9', 'spread': '54.70', 'groupId': 'OG001'}, {'value': '2237.0', 'spread': '54.18', 'groupId': 'OG002'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1343.3', 'spread': '60.32', 'groupId': 'OG000'}, {'value': '1722.0', 'spread': '38.82', 'groupId': 'OG001'}, {'value': '2598.3', 'spread': '12.49', 'groupId': 'OG002'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1104.7', 'spread': '45.15', 'groupId': 'OG000'}, {'value': '1564.2', 'spread': '38.80', 'groupId': 'OG001'}, {'value': '1974.5', 'spread': '59.49', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple timepoints up to 24 hours postdose and Days 14 and 21 predose and at multiple time points (up to 10 hours) postdose', 'unitOfMeasure': 'nM', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Tmax: Time of First Occurrence of Cmax for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 21D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 50 mg PIC QD 21D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 7 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 70 mg PIC QD 21D', 'description': 'Alisertib 70 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.020', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '4.00'}, {'value': '2.285', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '4.00'}, {'value': '2.000', 'groupId': 'OG002', 'lowerLimit': '2.00', 'upperLimit': '2.02'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.000', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '2.18'}, {'value': '2.000', 'groupId': 'OG001', 'lowerLimit': '1.98', 'upperLimit': '2.03'}, {'value': '2.000', 'groupId': 'OG002', 'lowerLimit': '2.00', 'upperLimit': '2.05'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.000', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '2.02'}, {'value': '2.000', 'groupId': 'OG001', 'lowerLimit': '1.93', 'upperLimit': '9.92'}, {'value': '2.000', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '6.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple timepoints up to 24 hours postdose and Days 14 and 21 predose and at multiple time points (up to 10 hours) postdose', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'AUCt: Area Under the Concentration-time Curve From Time 0 to Time t for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 21D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 50 mg PIC QD 21D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 7 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 70 mg PIC QD 21D', 'description': 'Alisertib 70 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10058.0', 'spread': '66.85', 'groupId': 'OG000'}, {'value': '14686.6', 'spread': '44.04', 'groupId': 'OG001'}, {'value': '22114.8', 'spread': '68.66', 'groupId': 'OG002'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15131.7', 'spread': '49.89', 'groupId': 'OG000'}, {'value': '17168.2', 'spread': '32.09', 'groupId': 'OG001'}, {'value': '23197.2', 'spread': '17.75', 'groupId': 'OG002'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13199.3', 'spread': '70.05', 'groupId': 'OG000'}, {'value': '19336.3', 'spread': '26.85', 'groupId': 'OG001'}, {'value': '23499.8', 'spread': '65.64', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple timepoints up to 24 hours postdose and Days 14 and 21 predose and at multiple time points (up to 10 hours) postdose', 'unitOfMeasure': 'nM*h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Terminal Half-Life (t1/2) for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 21D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 50 mg PIC QD 21D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 7 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 70 mg PIC QD 21D', 'description': 'Alisertib 70 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '31.667', 'spread': '6.7122', 'groupId': 'OG000'}, {'value': '23.650', 'spread': '16.9487', 'groupId': 'OG001'}, {'value': '22.378', 'spread': '19.8802', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 21 predose and at multiple time points (up to 10 hours) postdose', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio (Rac) for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 21D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 50 mg PIC QD 21D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 7 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 70 mg PIC QD 21D', 'description': 'Alisertib 70 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).'}], 'classes': [{'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.560', 'spread': '0.5543', 'groupId': 'OG000'}, {'value': '1.230', 'spread': '0.4193', 'groupId': 'OG001'}, {'value': '1.440', 'spread': '0.1493', 'groupId': 'OG002'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.560', 'spread': '1.0516', 'groupId': 'OG000'}, {'value': '1.373', 'spread': '0.4474', 'groupId': 'OG001'}, {'value': '1.335', 'spread': '0.4749', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Days 14 and 21 predose and at multiple timepoints (up to 10 hours) postdose', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Peak/Trough Ratio for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 21D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 50 mg PIC QD 21D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 7 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 70 mg PIC QD 21D', 'description': 'Alisertib 70 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).'}], 'classes': [{'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.773', 'spread': '0.9001', 'groupId': 'OG000'}, {'value': '7.543', 'spread': '5.4982', 'groupId': 'OG001'}, {'value': '6.392', 'spread': '2.0824', 'groupId': 'OG002'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.637', 'spread': '1.8675', 'groupId': 'OG000'}, {'value': '4.157', 'spread': '2.1051', 'groupId': 'OG001'}, {'value': '5.570', 'spread': '2.5772', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Days 14 and 21 predose and at multiple timepoints up to 10 hours postdose', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 21D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 50 mg PIC QD 21D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 7 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 70 mg PIC QD 21D', 'description': 'Alisertib 70 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).'}], 'classes': [{'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.181', 'spread': '42.5706', 'groupId': 'OG000'}, {'value': '5.612', 'spread': '28.6881', 'groupId': 'OG001'}, {'value': '5.825', 'spread': '17.7291', 'groupId': 'OG002'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.656', 'spread': '89.5750', 'groupId': 'OG000'}, {'value': '4.984', 'spread': '25.6945', 'groupId': 'OG001'}, {'value': '5.745', 'spread': '42.3818', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Days 14 and 21 predose and at multiple timepoints up to 10 hours postdose', 'unitOfMeasure': 'L/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Ae: Amount of Alisertib Excreted in Urine Over the Collection Period for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 21D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 50 mg PIC QD 21D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 7 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 70 mg PIC QD 21D', 'description': 'Alisertib 70 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '3047.7', 'spread': '5278.71', 'groupId': 'OG000'}, {'value': '5766.7', 'spread': '7971.95', 'groupId': 'OG001'}, {'value': '9391.4', 'spread': '11410.18', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time points (up to 24 hours) postdose', 'unitOfMeasure': 'ng', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.'}, {'type': 'SECONDARY', 'title': 'CLr: Renal Clearance of Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 21D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 50 mg PIC QD 21D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 7 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 70 mg PIC QD 21D', 'description': 'Alisertib 70 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0008640', 'spread': 'NA', 'comment': 'Cannot be calculated for 1 participant', 'groupId': 'OG000'}, {'value': '0.0012323', 'spread': '0.00111840', 'groupId': 'OG001'}, {'value': '0.0007865', 'spread': '0.00042447', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time points (up to 24 hours) postdose', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.'}, {'type': 'SECONDARY', 'title': 'Cmax: Maximum Observed Concentration for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 50 mg PIC BID 7D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 60 mg PIC BID 7D', 'description': 'Alisertib 60 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 35 cycles).'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1581.1', 'spread': '37.34', 'groupId': 'OG000'}, {'value': '1867.1', 'spread': '29.03', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3376.4', 'spread': '41.74', 'groupId': 'OG000'}, {'value': '3080.8', 'spread': '38.79', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'nM', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Tmax: Time of First Occurrence of Cmax for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 50 mg PIC BID 7D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 60 mg PIC BID 7D', 'description': 'Alisertib 60 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 35 cycles).'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.000', 'groupId': 'OG000', 'lowerLimit': '1.98', 'upperLimit': '8.00'}, {'value': '2.000', 'groupId': 'OG001', 'lowerLimit': '1.60', 'upperLimit': '4.00'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.015', 'groupId': 'OG000', 'lowerLimit': '0.98', 'upperLimit': '6.05'}, {'value': '2.000', 'groupId': 'OG001', 'lowerLimit': '1.98', 'upperLimit': '6.03'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'AUCt: Area Under the Concentration-time Curve From Time 0 to Time t for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 50 mg PIC BID 7D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 60 mg PIC BID 7D', 'description': 'Alisertib 60 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 35 cycles).'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11166.3', 'spread': '37.45', 'groupId': 'OG000'}, {'value': '13200.4', 'spread': '26.70', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32291.5', 'spread': '40.82', 'groupId': 'OG000'}, {'value': '27386.1', 'spread': '37.43', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'nM*h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Terminal Half-Life (t1/2) for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 50 mg PIC BID 7D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 60 mg PIC BID 7D', 'description': 'Alisertib 60 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 35 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '20.215', 'spread': '15.5083', 'groupId': 'OG000'}, {'value': '18.200', 'spread': '3.2212', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 8', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio (Rac) for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 50 mg PIC BID 7D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 60 mg PIC BID 7D', 'description': 'Alisertib 60 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 35 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.474', 'spread': '1.0467', 'groupId': 'OG000'}, {'value': '2.543', 'spread': '0.1950', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Peak/Trough Ratio for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 50 mg PIC BID 7D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 60 mg PIC BID 7D', 'description': 'Alisertib 60 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 35 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.193', 'spread': '1.1346', 'groupId': 'OG000'}, {'value': '1.890', 'spread': '0.2012', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 50 mg PIC BID 7D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 60 mg PIC BID 7D', 'description': 'Alisertib 60 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 35 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.984', 'spread': '43.8719', 'groupId': 'OG000'}, {'value': '4.220', 'spread': '47.9681', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'L/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Ae: Amount of Alisertib Excreted in Urine Over the Collection Period for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 50 mg PIC BID 7D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 60 mg PIC BID 7D', 'description': 'Alisertib 60 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 35 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '13775.0', 'spread': '7937.14', 'groupId': 'OG000'}, {'value': '8498.3', 'spread': '6866.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose', 'unitOfMeasure': 'ng', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.'}, {'type': 'SECONDARY', 'title': 'CLr: Renal Clearance of Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 50 mg PIC BID 7D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 60 mg PIC BID 7D', 'description': 'Alisertib 60 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 35 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.001', 'spread': '0.0011', 'groupId': 'OG000'}, {'value': '0.001', 'spread': '0.0004', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose', 'unitOfMeasure': 'ng', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.'}, {'type': 'SECONDARY', 'title': 'Cmax: Maximum Observed Concentration for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 14 Days (BID14D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 40 mg PIC BID 14D', 'description': 'Alisertib 40 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1236.6', 'spread': '37.29', 'groupId': 'OG000'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2060.0', 'spread': 'NA', 'comment': 'Geometric Coefficient of Variation cannot be calculated for 1 participant.', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Days 1 and 7 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'nM', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Tmax: Time of First Occurrence of Cmax for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 14 Days (BID14D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 40 mg PIC BID 14D', 'description': 'Alisertib 40 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '4.0'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.70', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '1.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Days 1 and 7 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'AUCt: Area Under the Concentration-time Curve From Time 0 to Time t for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 14 Days (BID14D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 40 mg PIC BID 14D', 'description': 'Alisertib 40 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '9684.8', 'spread': '71.50', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose', 'unitOfMeasure': 'nM*h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.'}, {'type': 'SECONDARY', 'title': 'AUCt: Area Under the Concentration-time Curve From Time 0 to Time t as Assessment of Relative Bioavailability for Alisertib as Enteric-coated Tablet (ECT) Versus PIC at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 40 mg ECT BID 7D', 'description': 'Alisertib 40 mg, Enteric-coated tablet (ECT), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period for 1 cycle.'}, {'id': 'OG001', 'title': 'Alisertib 40 mg PIC BID 7D', 'description': 'Alisertib 40 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period for 1 cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '12700.0', 'spread': '6557.58', 'groupId': 'OG000'}, {'value': '14190.7', 'spread': '7097.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'nM*h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.'}, {'type': 'SECONDARY', 'title': 'Cmax: Maximum Observed Concentration as Assessment of Relative Bioavailability for Alisertib as Enteric-coated Tablet (ECT) Versus PIC at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 40 mg ECT BID 7D', 'description': 'Alisertib 40 mg, Enteric-coated tablet (ECT), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period for 1 cycle.'}, {'id': 'OG001', 'title': 'Alisertib 40 mg PIC BID 7D', 'description': 'Alisertib 40 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period for 1 cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '1666.1', 'spread': '765.28', 'groupId': 'OG000'}, {'value': '2027.9', 'spread': '928.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose', 'unitOfMeasure': 'nM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Mitotic Index With PIC Once Daily for 7 Days (QD7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 5 mg PIC QD 7D', 'description': 'Alisertib 5 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 10 mg PIC QD 7D', 'description': 'Alisertib 10 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 20 mg PIC QD 7D', 'description': 'Alisertib 20 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 31 cycles).'}, {'id': 'OG003', 'title': 'Alisertib 40 mg PIC QD 7D', 'description': 'Alisertib 40 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 8 cycles).'}, {'id': 'OG004', 'title': 'Alisertib 80 mg PIC QD 7D', 'description': 'Alisertib 80 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).'}, {'id': 'OG005', 'title': 'Alisertib 110 mg PIC QD 7D', 'description': 'Alisertib 110 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG006', 'title': 'Alisertib 150 mg PIC QD 7D', 'description': 'Alisertib 150 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).'}], 'classes': [{'title': 'Day 1, Hour 6', 'categories': [{'measurements': [{'value': '0.405', 'spread': '0.2701', 'groupId': 'OG000'}, {'value': '0.614', 'spread': '0.5437', 'groupId': 'OG001'}, {'value': '0.263', 'spread': '0.1461', 'groupId': 'OG002'}, {'value': '0.168', 'spread': '0.5146', 'groupId': 'OG003'}, {'value': '0.488', 'spread': '1.0215', 'groupId': 'OG004'}, {'value': '0.261', 'spread': '0.4597', 'groupId': 'OG005'}, {'value': '0.865', 'spread': '0.9420', 'groupId': 'OG006'}]}]}, {'title': 'Day 1, Hour 24', 'categories': [{'measurements': [{'value': '0.019', 'spread': '0.1914', 'groupId': 'OG000'}, {'value': '-0.103', 'spread': '0.0186', 'groupId': 'OG001'}, {'value': '0.005', 'spread': '0.0709', 'groupId': 'OG002'}, {'value': '0.141', 'spread': '0.3852', 'groupId': 'OG003'}, {'value': '0.108', 'spread': '0.4081', 'groupId': 'OG004'}, {'value': '1.764', 'spread': '2.6380', 'groupId': 'OG005'}, {'value': '0.239', 'spread': '0.6992', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose', 'description': 'Mitotic index was defined as the mean number of mitotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Mitotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with fluorescent-tagged antibodies specific to 2 mitotic markers-serine 10 phosphohistone H3 (pHistH3) and MPM2. Deoxyribonucleic acid (DNA) was stained with a fluorescent marker as well. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'mitotic cells/millimeter of BEL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time-points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Apoptotic Index With PIC Once Daily for 7 Days (QD7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 5 mg PIC QD 7D', 'description': 'Alisertib 5 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 10 mg PIC QD 7D', 'description': 'Alisertib 10 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 20 mg PIC QD 7D', 'description': 'Alisertib 20 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 31 cycles).'}, {'id': 'OG003', 'title': 'Alisertib 40 mg PIC QD 7D', 'description': 'Alisertib 40 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 8 cycles).'}, {'id': 'OG004', 'title': 'Alisertib 80 mg PIC QD 7D', 'description': 'Alisertib 80 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).'}, {'id': 'OG005', 'title': 'Alisertib 110 mg PIC QD 7D', 'description': 'Alisertib 110 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG006', 'title': 'Alisertib 150 mg PIC QD 7D', 'description': 'Alisertib 150 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).'}], 'classes': [{'title': 'Day 1, Hour 6', 'categories': [{'measurements': [{'value': '0.010', 'spread': '0.1175', 'groupId': 'OG000'}, {'value': '-0.090', 'spread': '0.1278', 'groupId': 'OG001'}, {'value': '0.042', 'spread': '0.0731', 'groupId': 'OG002'}, {'value': '0.040', 'spread': '0.0701', 'groupId': 'OG003'}, {'value': '0.121', 'spread': '0.1317', 'groupId': 'OG004'}, {'value': '0.036', 'spread': '0.0530', 'groupId': 'OG005'}, {'value': '-0.042', 'spread': '0.1262', 'groupId': 'OG006'}]}]}, {'title': 'Day 1, Hour 24', 'categories': [{'measurements': [{'value': '0.009', 'spread': '0.1164', 'groupId': 'OG000'}, {'value': '0.065', 'spread': '0.1404', 'groupId': 'OG001'}, {'value': '0.000', 'spread': '0.0000', 'groupId': 'OG002'}, {'value': '0.037', 'spread': '0.0634', 'groupId': 'OG003'}, {'value': '0.074', 'spread': '0.1286', 'groupId': 'OG004'}, {'value': '0.151', 'spread': '0.1721', 'groupId': 'OG005'}, {'value': '0.139', 'spread': '0.2069', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose', 'description': 'Apoptotic index was defined as the mean number of apoptotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Apoptotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with hematoxylin-eosin. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'apoptotic cells/millimeter of BEL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time-points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Mitotic Index With PIC Once Daily for 14 Days (QD14D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 14D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}], 'classes': [{'title': 'Day 1, Hour 6', 'categories': [{'measurements': [{'value': '0.134', 'spread': '0.1723', 'groupId': 'OG000'}]}]}, {'title': 'Day 1, Hour 24', 'categories': [{'measurements': [{'value': '0.047', 'spread': '0.0589', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose', 'description': 'Mitotic index was defined as the mean number of mitotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Mitotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with fluorescent-tagged antibodies specific to 2 mitotic markers-serine 10 phosphohistone H3 (pHistH3) and MPM2. Deoxyribonucleic acid (DNA) was stained with a fluorescent marker as well. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'mitotic cells/millimeter of BEL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time-points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Apoptotic Index With PIC Once Daily for 14 Days (QD14D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 14D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 5 cycles).'}], 'classes': [{'title': 'Day 1, Hour 6', 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.0000', 'groupId': 'OG000'}]}]}, {'title': 'Day 1, Hour 24', 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.0000', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose', 'description': 'Apoptotic index was defined as the mean number of apoptotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Apoptotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with hematoxylin-eosin. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'apoptotic cells/millimeter of BEL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time-points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Mitotic Index With PIC Once Daily for 21 Days (QD21D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 21D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 50 mg PIC QD 21D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 7 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 70 mg PIC QD 21D', 'description': 'Alisertib 70 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).'}], 'classes': [{'title': 'Day 1, Hour 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.380', 'spread': '0.4165', 'groupId': 'OG000'}, {'value': '0.405', 'spread': '0.4690', 'groupId': 'OG001'}, {'value': '0.510', 'spread': 'NA', 'comment': 'Cannot be calculated for 1 participant', 'groupId': 'OG002'}]}]}, {'title': 'Day 1, Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.021', 'spread': '0.1081', 'groupId': 'OG000'}, {'value': '0.082', 'spread': '0.1796', 'groupId': 'OG001'}, {'value': '0.289', 'spread': '0.5746', 'groupId': 'OG002'}]}]}, {'title': 'Day 7, Hour 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.479', 'spread': '0.3040', 'groupId': 'OG002'}]}]}, {'title': 'Day 21, Hour 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.045', 'spread': 'NA', 'comment': 'Cannot be calculated for 1 participant.', 'groupId': 'OG001'}, {'value': '0.742', 'spread': '0.5782', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose and Days 7 and 21, 6 hours postdose', 'description': 'Mitotic index was defined as the mean number of mitotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Mitotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with fluorescent-tagged antibodies specific to 2 mitotic markers-serine 10 phosphohistone H3 (pHistH3) and MPM2. Deoxyribonucleic acid (DNA) was stained with a fluorescent marker as well. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'mitotic cells/millimeter of BEL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Apoptotic Index With PIC Once Daily for 21 Days (QD21D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 25 mg PIC QD 21D', 'description': 'Alisertib 25 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 6 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 50 mg PIC QD 21D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 7 cycles).'}, {'id': 'OG002', 'title': 'Alisertib 70 mg PIC QD 21D', 'description': 'Alisertib 70 mg, Powder-in-Capsule (PIC), orally, once daily (QD) for 21 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).'}], 'classes': [{'title': 'Day 1, Hour 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.122', 'spread': '0.2117', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.0000', 'groupId': 'OG001'}, {'value': '0.000', 'spread': 'NA', 'comment': 'Cannot be calculated for 1 participant', 'groupId': 'OG002'}]}]}, {'title': 'Day 1, Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.042', 'spread': '0.0722', 'groupId': 'OG000'}, {'value': '0.042', 'spread': '0.0719', 'groupId': 'OG001'}, {'value': '0.000', 'spread': '0.0000', 'groupId': 'OG002'}]}]}, {'title': 'Day 7, Hour 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.0000', 'groupId': 'OG002'}]}]}, {'title': 'Day 21, Hour 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.099', 'spread': 'NA', 'comment': 'Cannot be calculated for 1 participant.', 'groupId': 'OG001'}, {'value': '0.032', 'spread': '0.0552', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose and Days 7 and 21, 6 hours postdose', 'description': 'Apoptotic index was defined as the mean number of apoptotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Apoptotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with hematoxylin-eosin. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'apoptotic cells/millimeter of BEL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Mitotic Index With PIC Twice Daily for 7 Days (BID7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 50 mg PIC BID 7D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 60 mg PIC BID 7D', 'description': 'Alisertib 60 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 35 cycles).'}], 'classes': [{'title': 'Day 1, Hour 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.054', 'spread': '0.3022', 'groupId': 'OG000'}, {'value': '0.364', 'spread': '0.2574', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.578', 'spread': '2.2875', 'groupId': 'OG000'}, {'value': '1.435', 'spread': '0.8329', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, Hour 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.486', 'spread': '5.8688', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose and Day 7, 6 hours postdose', 'description': 'Mitotic index was defined as the mean number of mitotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Mitotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with fluorescent-tagged antibodies specific to 2 mitotic markers-serine 10 phosphohistone H3 (pHistH3) and MPM2. Deoxyribonucleic acid (DNA) was stained with a fluorescent marker as well. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'mitotic cells/millimeter of BEL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Apoptotic Index With PIC Twice Daily for 7 Days (BID7D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 50 mg PIC BID 7D', 'description': 'Alisertib 50 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 4 cycles).'}, {'id': 'OG001', 'title': 'Alisertib 60 mg PIC BID 7D', 'description': 'Alisertib 60 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 35 cycles).'}], 'classes': [{'title': 'Day 1, Hour 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.016', 'spread': '0.0494', 'groupId': 'OG000'}, {'value': '0.020', 'spread': '0.0491', 'groupId': 'OG001'}]}]}, {'title': 'Day 1, Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.055', 'spread': '0.1691', 'groupId': 'OG000'}, {'value': '0.080', 'spread': '0.1958', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, Hour 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.142', 'spread': '3.2510', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose and Day 7, 6 hours postdose', 'description': 'Apoptotic index was defined as the mean number of apoptotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Apoptotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with hematoxylin-eosin. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'apoptotic cells/millimeter of BEL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis. Here number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Mitotic Index With PIC Twice Daily for 14 Days (BID14D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 40 mg PIC BID 14D', 'description': 'Alisertib 40 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.507', 'spread': 'NA', 'comment': 'Cannot be calculated for 1 participant', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Cycle 1 Day 7, 6 hours postdose', 'description': 'Mitotic index was defined as the mean number of mitotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Mitotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with fluorescent-tagged antibodies specific to 2 mitotic markers-serine 10 phosphohistone H3 (pHistH3) and MPM2. Deoxyribonucleic acid (DNA) was stained with a fluorescent marker as well. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'mitotic cells/millimeter of BEL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Apoptotic Index With PIC Twice Daily for 14 Days (BID14D) Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 40 mg PIC BID 14D', 'description': 'Alisertib 40 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 14 days (D) followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.837', 'spread': 'NA', 'comment': 'Cannot be calculated for 1 participant', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Cycle 1 Day 7, 6 hours postdose', 'description': 'Apoptotic index was defined as the mean number of apoptotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Apoptotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with hematoxylin-eosin. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'apoptotic cells/millimeter of BEL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK)-Evaluable Population included all participants for whom there were sufficient dosing and alisertib concentration-time data to permit noncompartmental PK analysis, with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Polymorphisms in Gene Encoding Enzyme UGT1A1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib', 'description': 'Alisertib 5, 10, 20, 40, 80, 110 or 150 mg, PIC, orally, once daily (QD) for 7 days, followed by a 14-day recovery period or alisertib 25 mg, PIC, orally, QD for 14 days, followed by a 14-day recovery period or alisertib 25, 50 or 70 mg, PIC, orally, QD for 21 days followed by a 14-day recovery period or alisertib 50 or 60 mg, PIC, orally, twice daily (BID) for 7 days followed by a 14-day recovery period or alisertib 40 mg, PIC, orally, BID for 14 days followed by a 14-day recovery period or alisertib 10 or 20 mg ECT, orally QD for 7 days followed by a 14-day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).'}], 'classes': [{'title': 'wt/wt', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'wt/*28', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': '*28/*28', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': '*28/other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'other/other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Not Determined', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 Day 1 predose', 'description': 'One peripheral blood sample (approximately 4 mL) was to be obtained on Day 1 of Cycle 1 prior to the first dose of alisertib to genotype patients for polymorphisms in UGT1A1 because UGT1A1 is one of the enzymes responsible for glucuronidation of alisertib, which is expected to contribute to the clearance of alisertib.\n\nwt=wild type\n\n\\*28=polymorphism in the promoter region of a UGT1A1 allele resulting in reduced UGT1A1 expression.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received any amount of study drug.'}, {'type': 'SECONDARY', 'title': 'Best Overall Response Based on Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib', 'description': 'Alisertib 5, 10, 20, 40, 80, 110 or 150 mg, PIC, orally, once daily (QD) for 7 days, followed by a 14-day recovery period or alisertib 25 mg, PIC, orally, QD for 14 days, followed by a 14-day recovery period or alisertib 25, 50 or 70 mg, PIC, orally, QD for 21 days followed by a 14-day recovery period or alisertib 50 or 60 mg, PIC, orally, twice daily (BID) for 7 days followed by a 14-day recovery period or alisertib 40 mg, PIC, orally, BID for 14 days followed by a 14-day recovery period or alisertib 10 or 20 mg ECT, orally QD for 7 days followed by a 14-day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Beginning at the end of Cycle 2, every 2 cycles until progressive disease (PD); Participants who discontinue study drug before PD: Follow-Up (FU) every 8-12 weeks until PD or as per institutional practice (Up to 33.2 months)', 'description': 'Best overall response is defined as the percentage of participants with Complete Response (CR) + Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1. According to RECIST: CR is defined as disappearance of all target and nontarget lesions and normalization of tumor marker level (if applicable); PR is defined as ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, persistence of 1 or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received any amount of study drug.'}, {'type': 'SECONDARY', 'title': 'Duration Of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib', 'description': 'Alisertib 5, 10, 20, 40, 80, 110 or 150 mg, PIC, orally, once daily (QD) for 7 days, followed by a 14-day recovery period or alisertib 25 mg, PIC, orally, QD for 14 days, followed by a 14-day recovery period or alisertib 25, 50 or 70 mg, PIC, orally, QD for 21 days followed by a 14-day recovery period or alisertib 50 or 60 mg, PIC, orally, twice daily (BID) for 7 days followed by a 14-day recovery period or alisertib 40 mg, PIC, orally, BID for 14 days followed by a 14-day recovery period or alisertib 10 or 20 mg ECT, orally QD for 7 days followed by a 14-day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).'}], 'classes': [{'categories': [{'measurements': [{'value': '470', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Beginning at the end of Cycle 2, every 2 cycles until progressive disease (PD); Participants who discontinue study drug before PD: Follow-Up (FU) every 8-12 weeks until PD or as per institutional practice (Up to 33.2 months)', 'description': 'DOR is defined as the time from the date of first documentation of a confirmed response to the date of first documented PD. PD is defined as 20% increase in the sum of the longest diameter of target lesions.', 'unitOfMeasure': 'days', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received any amount of study drug.'}, {'type': 'SECONDARY', 'title': 'Effect of Food on the Pharmacokinetics (PK) of Alisertib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alisertib 40 mg ECT BID 7D', 'description': 'Alisertib 40 mg, Enteric-coated tablet (ECT), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period for 1 cycle.'}, {'id': 'OG001', 'title': 'Alisertib 40 mg PIC BID 7D', 'description': 'Alisertib 40 mg, Powder-in-Capsule (PIC), orally, twice daily (BID) for 7 days (D) followed by a 14--day recovery period for 1 cycle.'}], 'timeFrame': 'Up to 6 months', 'description': 'The effects of food on the PK of alisertib were to be evaluated using the preferred alisertib regimen (unit dose and formulation) based on the results from the relative bioavailability study.', 'reportingStatus': 'POSTED', 'populationDescription': 'The effects of food on the PK of alisertib was not conducted. As the development of alisertib was transitioned from the PIC to the ECT formulation and the clinical dose of alisertib ECT had not been determined yet, it was decided that the effect of food would be evaluated in a different study at the appropriate clinical dose, administered as ECT.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PIC Dose Escalation', 'description': 'Alisertib 5, 10, 20, 40, 80, 110 or 150 mg, PIC, orally, once daily (QD) for 7 days, followed by a 14-day recovery period or alisertib 25 mg, PIC, orally, QD for 14 days, followed by a 14-day recovery period or alisertib 25, 50 or 70 mg, PIC, orally, QD for 21 days followed by a 14-day recovery period or alisertib 50 or 60 mg, PIC, orally, twice daily (BID) for 7 days followed by a 14-day recovery period or alisertib 40 mg, PIC, orally, BID for 14 days followed by a 14-day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).'}, {'id': 'FG001', 'title': 'ECT Dose Escalation', 'description': 'Alisertib 10 or 20 mg, Enteric-coated Tablet (ECT) formulation, orally, once daily (QD) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 2 cycles).'}, {'id': 'FG002', 'title': 'Relative Bioavailability', 'description': 'Alisertib 40 mg ECT or PIC formulation, orally, twice daily (BID) for 7 days followed by a 14--day recovery period in cycle 1, followed by alisertib 40 mg in the opposite formulation (PIC or ECT) orally, twice daily (BID) for 7 days followed by a 14--day recovery period in cycle 2, followed by alisertib 50 mg PIC formulation orally, twice daily (BID) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 9 cycles).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Occurrence of Adverse Event(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Unsatisfactory Therapeutic Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Patient Declined Further Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Symptomatic Deterioration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 3 investigative sites in the United States from 15 May 2007 to 23 February 2011.', 'preAssignmentDetails': 'Participants with a diagnosis of advanced malignancies were enrolled in 1 of 3 treatment groups, alisertib 5 to 150 mg Powder-in-Capsule (PIC) dose escalation cohort, alisertib 10 or 20 mg Enteric-coated Tablet (ECT) dose escalation cohort, or alisertib 40 mg PIC/ECT in a crossover design followed by alisertib 50 mg relative bioavailability cohort.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'PIC Dose Escalation', 'description': 'Alisertib 5, 10, 20, 40, 80, 110 or 150 mg, PIC, orally, once daily (QD) for 7 days, followed by a 14-day recovery period or alisertib 25 mg, PIC, orally, QD for 14 days, followed by a 14-day recovery period or alisertib 25, 50 or 70 mg, PIC, orally, QD for 21 days followed by a 14-day recovery period or alisertib 50 or 60 mg, PIC, orally, twice daily (BID) for 7 days followed by a 14-day recovery period or alisertib 40 mg, PIC, orally, BID for 14 days followed by a 14-day recovery period in each cycle until disease progression or unacceptable alisertib-related toxicity (up to 51 cycles).'}, {'id': 'BG001', 'title': 'ECT Dose Escalation', 'description': 'Alisertib 10 or 20 mg, Enteric-coated Tablet (ECT) formulation, orally, once daily (QD) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 2 cycles).'}, {'id': 'BG002', 'title': 'Relative Bioavailability', 'description': 'Alisertib 40 mg ECT or PIC formulation, orally, twice daily (BID) for 7 days followed by a 14--day recovery period in cycle 1, followed by alisertib 40 mg in the opposite formulation (PIC or ECT) orally, twice daily (BID) for 7 days followed by a 14--day recovery period in cycle 2, followed by alisertib 50 mg PIC formulation orally, twice daily (BID) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 9 cycles).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.6', 'spread': '10.44', 'groupId': 'BG000'}, {'value': '57.0', 'spread': '15.56', 'groupId': 'BG001'}, {'value': '56.9', 'spread': '11.71', 'groupId': 'BG002'}, {'value': '60.4', 'spread': '10.88', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '169.3', 'spread': '10.06', 'groupId': 'BG000'}, {'value': '165.1', 'spread': '0.00', 'groupId': 'BG001'}, {'value': '171.5', 'spread': '12.51', 'groupId': 'BG002'}, {'value': '169.7', 'spread': '10.55', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '78.24', 'spread': '18.130', 'groupId': 'BG000'}, {'value': '67.36', 'spread': '11.226', 'groupId': 'BG001'}, {'value': '83.97', 'spread': '21.706', 'groupId': 'BG002'}, {'value': '79.33', 'spread': '18.976', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Surface Area (BSA)', 'classes': [{'categories': [{'measurements': [{'value': '1.91', 'spread': '0.263', 'groupId': 'BG000'}, {'value': '1.75', 'spread': '0.147', 'groupId': 'BG001'}, {'value': '1.99', 'spread': '0.294', 'groupId': 'BG002'}, {'value': '1.92', 'spread': '0.270', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'BSA=square root\\[height (cm) x weight (kg)/3600\\]', 'unitOfMeasure': 'm^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Safety Population included all participants who received any amount of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2011-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-29', 'studyFirstSubmitDate': '2007-07-12', 'resultsFirstSubmitDate': '2018-01-04', 'studyFirstSubmitQcDate': '2007-07-12', 'lastUpdatePostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-29', 'studyFirstPostDateStruct': {'date': '2007-07-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dose-Limiting Toxicity (DLT)', 'timeFrame': 'Cycle 1 Day 1 up to Day 35 (alisertib daily for 7 to 21 days followed by a 14-day recovery period)', 'description': "DLT was evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and was defined as any of the following events related to therapy with alisertib:\n\n1. Grade 4 neutropenia lasting ≥7 consecutive days\n2. Grade 4 neutropenia with fever and/or infection\n3. Platelet count \\<25,000/mm\\^3\n4. Grade 3 or greater nausea and/or emesis despite use of optimal antiemetic prophylaxis\n5. Grade 3 or greater diarrhea despite maximal supportive therapy with loperamide\n6. Any other Grade 3 or greater nonhematologic toxicity, with the following exceptions: Grade 3 arthralgia/myalgias, Any grade of alopecia, Brief (\\<1 week) Grade 3 fatigue\n7. Treatment delay of \\>1 week due to failure of adequate hematologic or nonhematologic recovery from previous cycle of treatment\n8. Other alisertib-related nonhematologic toxicities ≥Grade 2 that, in the opinion of the investigator, required a dose reduction or discontinuation of therapy with alisertib."}, {'measure': 'Maximum Tolerated Dose (MTD) of Alisertib', 'timeFrame': 'From first dose of study drug to 30 days after the last dose (up to 1011 days)', 'description': 'MTD was defined as the highest dose at which DLT occurred in 0/3 or 1/6 patients.'}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From first dose of study drug to 30 days after the last dose (up to 1011 days)', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.'}], 'secondaryOutcomes': [{'measure': 'Cmax: Maximum Observed Concentration for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'Tmax: Time of First Occurrence of Cmax for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'AUCt: Area Under the Concentration-Time Curve From Time 0 to Time t for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'Terminal Half-Life (t1/2) for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing', 'timeFrame': 'Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'Accumulation Ratio (Rac) for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing', 'timeFrame': 'Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'Peak/Trough Ratio for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing', 'timeFrame': 'Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing', 'timeFrame': 'Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'Ae: Amount of Alisertib Excreted in Urine Over the Collection Period for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose'}, {'measure': 'CLr: Renal Clearance of Alisertib as Powder-in-Capsule (PIC) With Once Daily for 7 Days (QD7D) Dosing', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose'}, {'measure': 'Cmax: Maximum Observed Concentration for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'Tmax: Time of First Occurrence of Cmax for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'AUCt: Area Under the Concentration--Time Curve From Time 0 to Time t for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'Terminal Half-Life for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing', 'timeFrame': 'Cycle 1 Day 14 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'Accumulation Ratio (Rac) for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing', 'timeFrame': 'Cycle 1 Days 7 and 14 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'Peak/Trough Ratio for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing', 'timeFrame': 'Cycle 1 Days 7 and 14 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing', 'timeFrame': 'Cycle 1 Days 7 and 14 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'Ae: Amount of Alisertib Excreted in Urine Over the Collection Period for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose'}, {'measure': 'CLr: Renal Clearance of Alisertib as Powder-in-Capsule (PIC) With Once Daily for 14 Days (QD14D) Dosing', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose'}, {'measure': 'Cmax: Maximum Observed Concentration for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple timepoints up to 24 hours postdose and Days 14 and 21 predose and at multiple time points (up to 10 hours) postdose'}, {'measure': 'Tmax: Time of First Occurrence of Cmax for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple timepoints up to 24 hours postdose and Days 14 and 21 predose and at multiple time points (up to 10 hours) postdose'}, {'measure': 'AUCt: Area Under the Concentration-time Curve From Time 0 to Time t for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple timepoints up to 24 hours postdose and Days 14 and 21 predose and at multiple time points (up to 10 hours) postdose'}, {'measure': 'Terminal Half-Life (t1/2) for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing', 'timeFrame': 'Cycle 1 Day 21 predose and at multiple time points (up to 10 hours) postdose'}, {'measure': 'Accumulation Ratio (Rac) for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing', 'timeFrame': 'Cycle 1 Days 14 and 21 predose and at multiple timepoints (up to 10 hours) postdose'}, {'measure': 'Peak/Trough Ratio for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing', 'timeFrame': 'Cycle 1 Days 14 and 21 predose and at multiple timepoints up to 10 hours postdose'}, {'measure': 'CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing', 'timeFrame': 'Cycle 1 Days 14 and 21 predose and at multiple timepoints up to 10 hours postdose'}, {'measure': 'Ae: Amount of Alisertib Excreted in Urine Over the Collection Period for Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time points (up to 24 hours) postdose'}, {'measure': 'CLr: Renal Clearance of Alisertib as Powder-in-Capsule (PIC) With Once Daily for 21 Days (QD21D) Dosing', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time points (up to 24 hours) postdose'}, {'measure': 'Cmax: Maximum Observed Concentration for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'Tmax: Time of First Occurrence of Cmax for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'AUCt: Area Under the Concentration-time Curve From Time 0 to Time t for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose and Day 7 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'Terminal Half-Life (t1/2) for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing', 'timeFrame': 'Cycle 1 Day 8'}, {'measure': 'Accumulation Ratio (Rac) for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing', 'timeFrame': 'Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'Peak/Trough Ratio for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing', 'timeFrame': 'Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'CLss/F: Apparent Oral Clearance at Steady State for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing', 'timeFrame': 'Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'Ae: Amount of Alisertib Excreted in Urine Over the Collection Period for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose'}, {'measure': 'CLr: Renal Clearance of Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 7 Days (BID7D) Dosing', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose'}, {'measure': 'Cmax: Maximum Observed Concentration for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 14 Days (BID14D) Dosing', 'timeFrame': 'Cycle 1 Days 1 and 7 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'Tmax: Time of First Occurrence of Cmax for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 14 Days (BID14D) Dosing', 'timeFrame': 'Cycle 1 Days 1 and 7 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'AUCt: Area Under the Concentration-time Curve From Time 0 to Time t for Alisertib as Powder-in-Capsule (PIC) With Twice Daily for 14 Days (BID14D) Dosing', 'timeFrame': 'Cycle 1 Day 1 predose and at multiple time-points (up to 24 hours) postdose'}, {'measure': 'AUCt: Area Under the Concentration-time Curve From Time 0 to Time t as Assessment of Relative Bioavailability for Alisertib as Enteric-coated Tablet (ECT) Versus PIC at Day 7', 'timeFrame': 'Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'Cmax: Maximum Observed Concentration as Assessment of Relative Bioavailability for Alisertib as Enteric-coated Tablet (ECT) Versus PIC at Day 7', 'timeFrame': 'Cycle 1 Day 7 predose and at multiple time-points (up to 10 hours) postdose'}, {'measure': 'Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Mitotic Index With PIC Once Daily for 7 Days (QD7D) Dosing', 'timeFrame': 'Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose', 'description': 'Mitotic index was defined as the mean number of mitotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Mitotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with fluorescent-tagged antibodies specific to 2 mitotic markers-serine 10 phosphohistone H3 (pHistH3) and MPM2. Deoxyribonucleic acid (DNA) was stained with a fluorescent marker as well. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Apoptotic Index With PIC Once Daily for 7 Days (QD7D) Dosing', 'timeFrame': 'Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose', 'description': 'Apoptotic index was defined as the mean number of apoptotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Apoptotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with hematoxylin-eosin. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Mitotic Index With PIC Once Daily for 14 Days (QD14D) Dosing', 'timeFrame': 'Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose', 'description': 'Mitotic index was defined as the mean number of mitotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Mitotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with fluorescent-tagged antibodies specific to 2 mitotic markers-serine 10 phosphohistone H3 (pHistH3) and MPM2. Deoxyribonucleic acid (DNA) was stained with a fluorescent marker as well. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Apoptotic Index With PIC Once Daily for 14 Days (QD14D) Dosing', 'timeFrame': 'Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose', 'description': 'Apoptotic index was defined as the mean number of apoptotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Apoptotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with hematoxylin-eosin. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Mitotic Index With PIC Once Daily for 21 Days (QD21D) Dosing', 'timeFrame': 'Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose and Days 7 and 21, 6 hours postdose', 'description': 'Mitotic index was defined as the mean number of mitotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Mitotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with fluorescent-tagged antibodies specific to 2 mitotic markers-serine 10 phosphohistone H3 (pHistH3) and MPM2. Deoxyribonucleic acid (DNA) was stained with a fluorescent marker as well. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Apoptotic Index With PIC Once Daily for 21 Days (QD21D) Dosing', 'timeFrame': 'Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose and Days 7 and 21, 6 hours postdose', 'description': 'Apoptotic index was defined as the mean number of apoptotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Apoptotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with hematoxylin-eosin. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Mitotic Index With PIC Twice Daily for 7 Days (BID7D) Dosing', 'timeFrame': 'Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose and Day 7, 6 hours postdose', 'description': 'Mitotic index was defined as the mean number of mitotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Mitotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with fluorescent-tagged antibodies specific to 2 mitotic markers-serine 10 phosphohistone H3 (pHistH3) and MPM2. Deoxyribonucleic acid (DNA) was stained with a fluorescent marker as well. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Apoptotic Index With PIC Twice Daily for 7 Days (BID7D) Dosing', 'timeFrame': 'Baseline and Cycle 1 Day 1, 6 hours and 24 hours postdose and Day 7, 6 hours postdose', 'description': 'Apoptotic index was defined as the mean number of apoptotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Apoptotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with hematoxylin-eosin. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Mitotic Index With PIC Twice Daily for 14 Days (BID14D) Dosing', 'timeFrame': 'Baseline and Cycle 1 Day 7, 6 hours postdose', 'description': 'Mitotic index was defined as the mean number of mitotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Mitotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with fluorescent-tagged antibodies specific to 2 mitotic markers-serine 10 phosphohistone H3 (pHistH3) and MPM2. Deoxyribonucleic acid (DNA) was stained with a fluorescent marker as well. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in Alisertib Skin Punch Biopsy as Measured by Apoptotic Index With PIC Twice Daily for 14 Days (BID14D) Dosing', 'timeFrame': 'Baseline and Cycle 1 Day 7, 6 hours postdose', 'description': 'Apoptotic index was defined as the mean number of apoptotic cells per millimeter (mm) length of the basoepithelial layer (BEL). Apoptotic cells were counted manually within the BEL of 4, 5 µM skin sections by staining with hematoxylin-eosin. A positive change from Baseline indicates improvement.'}, {'measure': 'Number of Participants With Polymorphisms in Gene Encoding Enzyme UGT1A1', 'timeFrame': 'Cycle 1 Day 1 predose', 'description': 'One peripheral blood sample (approximately 4 mL) was to be obtained on Day 1 of Cycle 1 prior to the first dose of alisertib to genotype patients for polymorphisms in UGT1A1 because UGT1A1 is one of the enzymes responsible for glucuronidation of alisertib, which is expected to contribute to the clearance of alisertib.\n\nwt=wild type\n\n\\*28=polymorphism in the promoter region of a UGT1A1 allele resulting in reduced UGT1A1 expression.'}, {'measure': 'Best Overall Response Based on Investigator Assessment', 'timeFrame': 'Beginning at the end of Cycle 2, every 2 cycles until progressive disease (PD); Participants who discontinue study drug before PD: Follow-Up (FU) every 8-12 weeks until PD or as per institutional practice (Up to 33.2 months)', 'description': 'Best overall response is defined as the percentage of participants with Complete Response (CR) + Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1. According to RECIST: CR is defined as disappearance of all target and nontarget lesions and normalization of tumor marker level (if applicable); PR is defined as ≥30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, persistence of 1 or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits.'}, {'measure': 'Duration Of Response (DOR)', 'timeFrame': 'Beginning at the end of Cycle 2, every 2 cycles until progressive disease (PD); Participants who discontinue study drug before PD: Follow-Up (FU) every 8-12 weeks until PD or as per institutional practice (Up to 33.2 months)', 'description': 'DOR is defined as the time from the date of first documentation of a confirmed response to the date of first documented PD. PD is defined as 20% increase in the sum of the longest diameter of target lesions.'}, {'measure': 'Effect of Food on the Pharmacokinetics (PK) of Alisertib', 'timeFrame': 'Up to 6 months', 'description': 'The effects of food on the PK of alisertib were to be evaluated using the preferred alisertib regimen (unit dose and formulation) based on the results from the relative bioavailability study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug therapy'], 'conditions': ['Advanced Malignancies']}, 'descriptionModule': {'briefSummary': 'To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of MLN8237 when given by mouth (PO) for a minimum of 7 and a maximum of 21 consecutive days, followed by a 14-day recovery period.', 'detailedDescription': 'The drug tested in this study is called alisertib. Alisertib is being tested to treat people who have advanced malignancies. This study determined the dose-limiting toxicity, maximum tolerated dose, safety and pharmacokinetics (how the drug moves through the body) for alisertib when given once or twice a day for 7 to 21 days. This open label study enrolled 87 participants. Participants were enrolled in one of 3 treatment groups:\n\n* Powder-in-Capsule (PIC) Dose Escalation (alisertib 5, 10, 20, 40, 80, 110 or 150 mg PIC , once daily (QD) for 7 days (D),or alisertib 25 mg, PIC, orally, QD 14D, or alisertib 25, 50 or 70 mg, PIC, orally, QD 21D, or alisertib 50 or 60 mg, PIC, orally, twice daily (BID) 7D, alisertib 40 mg, PIC, orally, BID 14D\n* ECT Dose Escalation (alisertib 10 or 20 mg, Enteric-coated Tablets (ECT), orally, QD for 7 to 21 days\n* Relative Bioavailability (alisertib 40 mg ECT or PIC, orally, BID 7D in cycle 1, followed by alisertib 40 mg in the opposite formulation (PIC or ECT) orally, BID 7D in cycle 2, followed by alisertib 50 mg PIC orally, BID 7D in each additional All participants received treatment until their disease progressed or they experienced unacceptable alisertib-related toxicity. This multi-center trial was conducted in the United States. The overall time to participate in this study was 1011 days. Participants made multiple visits to the clinic, including a final visit 30 days after receiving their last dose of alisertib for a follow-up assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic and/or advanced solid tumors (including lymphomas) for which no effective standard treatment is available\n* Aged 18 years or more\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Expected survival longer than 3 months from enrollment in the study\n* Radiographically or clinically evaluable tumor; however, measurable disease as defined by (RECIST) criteria is not required for participation in this study\n* Suitable venous access for the conduct of blood sampling for MLN8237 PK\n* Recovered from the reversible effects of prior antineoplastic therapy (with the exception of alopecia and grade 1 neuropathy) with at least 4 weeks elapsed since the last exposure to cytotoxic chemotherapy or to radiotherapy and at least 6 weeks elapsed since exposure to nitrosoureas or mitomycin C. Participants treated with fully human monoclonal antibodies must not have received treatment with such antibodies for at least 6 weeks, and those treated with chimeric monoclonal antibodies must not have received treatment with such antibodies for at least 4 weeks. Participants treated with noncytotoxic small molecule drugs (eg, tyrosine kinase inhibitors, such as Tarceva®, and hormonal agents, such as Femara®) must not have received treatment with these drugs for at least 2 weeks before the first dose of MLN8237 is given.\n* Male participants must use an appropriate method of barrier contraception (eg, condoms) and inform any sexual partners that they must also use a reliable method of contraception (eg, birth control pills) from the time of informed consent until 3 months after the last dose of study treatment.\n* Female participants must be postmenopausal, surgically sterilized, or willing to use reliable methods of birth control (eg, a hormonal contraceptive, an intrauterine device, diaphragm with spermicide, or abstinence) and inform male sexual partners that they must also use a reliable method of contraception (eg, condoms) from the time of informed consent until 3 months after the last dose of study treatment.\n* Willing and able to give written informed consent before the conduct of any study related procedure that is not part of normal medical care, and willing to comply with the protocol\n\nExclusion Criteria:\n\n* Pregnant or lactating\n* Major surgery or serious infection within the 28 days preceding the first dose of study treatment\n* Life-threatening illness or uncontrolled medical illness unrelated to cancer\n* Ongoing nausea or vomiting of any severity\n* \\> Grade 1 diarrhea\n* Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of MLN8237. Examples include but are not limited to partial gastrectomy, history of small intestine surgery, and celiac disease.\n* History of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary disease.\n* Difficulty swallowing capsules\n* Inability to take nothing by mouth except for water and prescribed medications for 2 hours before and 1 hour after each dose of MLN8237\n* Received more than 4 previous cytotoxic chemotherapeutic regimens including regimens used as adjuvant or neo-adjuvant therapies. There is no limit on the number of noncytotoxic therapies (eg, hormonal and immunologic) that participants may have received. Tyrosine kinase inhibitors (eg, Tarceva and Iressa®) are considered noncytotoxic compounds.\n* Prior treatment with high-dose chemotherapy, defined as chemotherapy requiring the use of peripheral blood or bone marrow stem cell support for hematopoietic reconstitution\n* Prior treatment with radiation therapy involving ≥25% of the hematopoietically active bone marrow\n* Clinical and/or radiographic evidence of cerebral metastases. However, participants who have a history of central nervous system (CNS) metastasis but who have no radiographic or clinical evidence of residual tumor (eg, following complete surgical resection or stereotactic radiosurgery) are not excluded from participation in this study\n* Absolute neutrophil count \\<1500/mm\\^3; platelet count \\<100,000/mm\\^3\n* Serum creatinine \\>1.6 mg/dl or a measured or estimated creatinine clearance \\<40 mL/minute\n* Bilirubin \\>1.5 times the upper limit of the normal range (ULN); aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \\>2.5 times the ULN, and alkaline phosphatase (ALP) \\>2.5 times the ULN. Both the AST and ALP may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of metastatic disease to liver and/or to bone; however, the ALT must in all circumstances be \\<2.5 times the ULN\n* Abnormalities on 12-lead electrocardiogram (ECG) considered by the investigator to be clinically significant or baseline prolongation of the rate-corrected QT interval (eg, repeated demonstration of QTc interval \\> 450 milliseconds)\n* Left ventricular ejection fraction (LVEF) \\< 50%\n* Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection. Testing for these agents is not required in the absence of clinical findings or suspicion.\n* Less than 4 weeks between the last dose of an investigational agent and the first dose of MLN8237\n* Admission or evidence of benzodiazepine dependence or abuse and/or alcohol abuse or an inability to restrict consumption of alcohol to no more than 1 standard unit of alcohol per day during the study and for 30 days from the last dose of study treatment. A standard unit of alcohol is defined as one 12-oz (150mL) beer, 1.5 oz (45mL) of 80-proof alcohol, or one 6-oz (175mL) glass of wine.\n* Lactose intolerant, for the food effect cohort only.'}, 'identificationModule': {'nctId': 'NCT00500903', 'briefTitle': 'A Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in Participants With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'An Open-Label, Dose Escalation Phase 1 Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'C14001'}, 'secondaryIdInfos': [{'id': 'U1111-1187-1087', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PIC Dose Escalation', 'description': 'Alisertib 5, 10, 20, 40, 80, 110 or 150 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 7 to 21 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 51 cycles).', 'interventionNames': ['Drug: Alisertib']}, {'type': 'EXPERIMENTAL', 'label': 'ECT Dose Escalation', 'description': 'Alisertib 10 or 20 mg, Enteric-coated Tablet (ECT) formulation, orally, once daily (QD) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 2 cycles).', 'interventionNames': ['Drug: Alisertib']}, {'type': 'EXPERIMENTAL', 'label': 'Relative Bioavailability', 'description': 'Alisertib 40 mg ECT or PIC formulation, orally, twice daily (BID) for 7 days followed by a 14--day recovery period in cycle 1, followed by alisertib 40 mg in the opposite formulation (PIC or ECT) orally, twice daily (BID) for 7 days followed by a 14--day recovery period in cycle 2, followed by alisertib 50 mg PIC formulation orally, twice daily (BID) for 7 days followed by a 14--day recovery period in each cycle until disease progression or unacceptable alisertib--related toxicity (up to 9 cycles).', 'interventionNames': ['Drug: Alisertib']}], 'interventions': [{'name': 'Alisertib', 'type': 'DRUG', 'otherNames': ['MLN8237'], 'description': 'Alisertib (MLN8237) will be supplied in capsules of 5 or 25 mg and will be given on an empty stomach, with patients remaining nothing by mouth except for water and prescribed medications for 2 hours before and 1 hour after each dose. Each dose will be given by mouth with 8 ounces of water for 7 to 21 consecutive days. A 14-day recovery period will follow each dosing period regardless of its duration.', 'armGroupLabels': ['ECT Dose Escalation', 'PIC Dose Escalation', 'Relative Bioavailability']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute (SCRI)', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Millennium Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Millennium Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}