Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-04-23 @ 6:27 AM
Study NCT ID:
NCT02781792
Status:
COMPLETED
Last Update Posted:
2025-06-27
First Post:
2016-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Temozolomide Chronotherapy for High Grade Glioma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D001254', 'term': 'Astrocytoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mchheda@wustl.edu', 'phone': '314-747-2712', 'title': 'Dr. Milan Chheda', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality was collected from start of treatment through completion of follow-up (median length of follow-up 568.5 days, full range 1-1134 days) Adverse events were collected from start of treatment through end of treatment visit (median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles).', 'description': 'Only grade 3 or higher hematologic adverse events were collected along with all serious adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: Temozolomide Morning', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 4, 'seriousNumAtRisk': 22, 'deathsNumAffected': 7, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Arm 2: Temozolomide Evening', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'deathsNumAffected': 6, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Death due to disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vascular access complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of Patient Treatment Compliance as Measured by Number of Participants Who Were at Least 80% Compliance With Assigned Administration Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Temozolomide Morning', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG001', 'title': 'Arm 2: Temozolomide Evening', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through completion of treatment (median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)', 'description': 'Compliance is defined as no more than one of five doses of temozolomide per cycle taken outside of the assigned administration time.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who received one full cycle of TMZ are evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Temozolomide Morning', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG001', 'title': 'Arm 2: Temozolomide Evening', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}], 'timeFrame': 'Through completion of follow-up (estimated to be 30 months)', 'description': '* Response and progression will be evaluated in this study using the updated response assessment criteria for high-grade gliomas: Response Assessment in Neuro-Oncology (RANO) working group guideline \\[JCO 28(11): 1963-1972, 2010\\].\n* The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for this outcome measure. Duration of response was never listed as an objective in the protocol; however it was erroneously mentioned in the statistical analysis section of the protocol and therefore was listed as a primary outcome measure in error as well.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Experiencing Grade 3 or 4 Lymphopenia, Thrombocytopenia, Neutropenia, Leukopenia, and Anemia in Each Group as Measured by Standard Blood Draws', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Temozolomide Morning', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG001', 'title': 'Arm 2: Temozolomide Evening', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}], 'classes': [{'title': 'Lymphopenia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Thrombocytopenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neutropenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Anemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Leukopenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through completion of treatment (median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)', 'description': '* Lymphopenia grade 3 is \\<500-200/mm\\^3 and grade 4 is \\<200/mm\\^3\n* Leukopenia grade 3 is \\<2000-1000/mm\\^3 and grade 4 is \\<1000/mm\\^3\n* Neutropenia grade 3 is \\<1000-500/mm\\^3 and grade 4 is \\<500/mm\\^3\n* Thrombocytopenia grade 3 is \\<50,000-25,000/mm\\^3 and grade 4 is \\<25,000/mm\\^3\n* Anemia grade 3 is \\<8.0-6.5 g/dL and grade 4 is \\<6.5 g/dL', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life as Measured by FACT-Br Score - Physical Well-being Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Temozolomide Morning', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG001', 'title': 'Arm 2: Temozolomide Evening', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.23', 'spread': '4.17', 'groupId': 'OG000'}, {'value': '4.80', 'spread': '4.27', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.78', 'spread': '4.96', 'groupId': 'OG000'}, {'value': '4.00', 'spread': '2.83', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.66', 'spread': '6.92', 'groupId': 'OG000'}, {'value': '8.32', 'spread': '5.65', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.33', 'spread': '5.67', 'groupId': 'OG000'}, {'value': '7.69', 'spread': '5.31', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.18', 'spread': '4.09', 'groupId': 'OG000'}, {'value': '5.53', 'spread': '4.74', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.27', 'spread': '4.54', 'groupId': 'OG000'}, {'value': '7.03', 'spread': '5.80', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.64', 'spread': '3.44', 'groupId': 'OG000'}, {'value': '5.71', 'spread': '5.59', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.71', 'spread': '4.19', 'groupId': 'OG000'}, {'value': '3.00', 'spread': '2.71', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.83', 'spread': '4.36', 'groupId': 'OG000'}, {'value': '3.50', 'spread': '4.14', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.83', 'spread': '4.62', 'groupId': 'OG000'}, {'value': '4.00', 'spread': '4.64', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.35', 'spread': '4.65', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '1.63', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.60', 'spread': '5.59', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.50', 'spread': '5.92', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '1.00', 'groupId': 'OG001'}]}]}, {'title': 'End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.19', 'spread': '4.58', 'groupId': 'OG000'}, {'value': '5.46', 'spread': '3.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))', 'description': '7-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range is 0-28. A higher score indicates a lower physical well-being quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed for each timepoint may be different from the overall number of participants analyzed if any participant did not complete the questionnaire at that time point.'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life as Measured by FACT-Br Score - Social/Family Well-being Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Temozolomide Morning', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG001', 'title': 'Arm 2: Temozolomide Evening', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.10', 'spread': '4.09', 'groupId': 'OG000'}, {'value': '22.94', 'spread': '3.98', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.29', 'spread': '4.13', 'groupId': 'OG000'}, {'value': '22.59', 'spread': '4.52', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.45', 'spread': '7.32', 'groupId': 'OG000'}, {'value': '23.12', 'spread': '4.18', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.14', 'spread': '5.93', 'groupId': 'OG000'}, {'value': '22.26', 'spread': '5.67', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.21', 'spread': '3.71', 'groupId': 'OG000'}, {'value': '23.06', 'spread': '4.78', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.91', 'spread': '4.72', 'groupId': 'OG000'}, {'value': '22.30', 'spread': '5.59', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.44', 'spread': '5.41', 'groupId': 'OG000'}, {'value': '23.05', 'spread': '5.13', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.95', 'spread': '6.31', 'groupId': 'OG000'}, {'value': '24.86', 'spread': '2.86', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.78', 'spread': '3.15', 'groupId': 'OG000'}, {'value': '22.47', 'spread': '4.26', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.25', 'spread': '4.40', 'groupId': 'OG000'}, {'value': '22.52', 'spread': '4.92', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.94', 'spread': '5.56', 'groupId': 'OG000'}, {'value': '23.25', 'spread': '2.63', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.77', 'spread': '3.09', 'groupId': 'OG000'}, {'value': '26.08', 'spread': '2.01', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.00', 'spread': '2.94', 'groupId': 'OG000'}, {'value': '24.39', 'spread': '1.99', 'groupId': 'OG001'}]}]}, {'title': 'End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.95', 'spread': '4.21', 'groupId': 'OG000'}, {'value': '22.73', 'spread': '4.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))', 'description': '7-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range 0-28. A higher score indicates a higher social/family well-being quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed for each timepoint may be different from the overall number of participants analyzed if any participant did not complete the questionnaire at that time point.'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life as Measured by FACT-Br Score - Emotional Well-being Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Temozolomide Morning', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG001', 'title': 'Arm 2: Temozolomide Evening', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.72', 'spread': '3.72', 'groupId': 'OG000'}, {'value': '7.60', 'spread': '3.19', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.69', 'spread': '4.69', 'groupId': 'OG000'}, {'value': '8.11', 'spread': '2.85', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.06', 'spread': '4.82', 'groupId': 'OG000'}, {'value': '6.77', 'spread': '2.10', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.63', 'spread': '3.48', 'groupId': 'OG000'}, {'value': '6.92', 'spread': '2.14', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.04', 'spread': '3.25', 'groupId': 'OG000'}, {'value': '5.47', 'spread': '2.70', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.68', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '5.36', 'spread': '2.01', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.23', 'spread': '3.45', 'groupId': 'OG000'}, {'value': '5.57', 'spread': '1.51', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.29', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '5.14', 'spread': '2.73', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.50', 'spread': '3.15', 'groupId': 'OG000'}, {'value': '5.67', 'spread': '1.51', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.33', 'spread': '2.73', 'groupId': 'OG000'}, {'value': '4.70', 'spread': '1.99', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.08', 'spread': '3.58', 'groupId': 'OG000'}, {'value': '5.25', 'spread': '1.71', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.60', 'spread': '3.21', 'groupId': 'OG000'}, {'value': '5.50', 'spread': '1.91', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.25', 'spread': '2.22', 'groupId': 'OG000'}, {'value': '8.33', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': 'End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.44', 'spread': '3.22', 'groupId': 'OG000'}, {'value': '5.62', 'spread': '2.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))', 'description': '6-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range 0-24. A higher score indicates a lower emotional well-being quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed for each timepoint may be different from the overall number of participants analyzed if any participant did not complete the questionnaire at that time point.'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life as Measured by FACT-Br Score - Functional Well-being Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Temozolomide Morning', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG001', 'title': 'Arm 2: Temozolomide Evening', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.19', 'spread': '6.39', 'groupId': 'OG000'}, {'value': '16.35', 'spread': '7.06', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.71', 'spread': '7.09', 'groupId': 'OG000'}, {'value': '15.89', 'spread': '7.59', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.94', 'spread': '8.68', 'groupId': 'OG000'}, {'value': '16.11', 'spread': '7.17', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.37', 'spread': '5.59', 'groupId': 'OG000'}, {'value': '17.69', 'spread': '5.86', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.75', 'spread': '6.82', 'groupId': 'OG000'}, {'value': '18.78', 'spread': '6.93', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.32', 'spread': '7.23', 'groupId': 'OG000'}, {'value': '19.27', 'spread': '7.86', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.64', 'spread': '7.66', 'groupId': 'OG000'}, {'value': '20.00', 'spread': '7.28', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.71', 'spread': '6.34', 'groupId': 'OG000'}, {'value': '23.57', 'spread': '5.77', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.50', 'spread': '7.18', 'groupId': 'OG000'}, {'value': '21.00', 'spread': '5.59', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.00', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '20.00', 'spread': '6.89', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.58', 'spread': '8.48', 'groupId': 'OG000'}, {'value': '25.00', 'spread': '3.16', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.80', 'spread': '4.60', 'groupId': 'OG000'}, {'value': '23.50', 'spread': '4.12', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.50', 'spread': '6.24', 'groupId': 'OG000'}, {'value': '23.33', 'spread': '6.43', 'groupId': 'OG001'}]}]}, {'title': 'End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.13', 'spread': '8.24', 'groupId': 'OG000'}, {'value': '18.54', 'spread': '6.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))', 'description': '7-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range 0-28. A higher score indicates a higher emotional well-being quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed for each timepoint may be different from the overall number of participants analyzed if any participant did not complete the questionnaire at that time point.'}, {'type': 'SECONDARY', 'title': 'Median Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Temozolomide Morning', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG001', 'title': 'Arm 2: Temozolomide Evening', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.5978', 'groupId': 'OG000', 'lowerLimit': '7.1952', 'upperLimit': '29.6680'}, {'value': '8.1809', 'comment': 'If fewer than half of the group have not experienced progression then upper 95% CI cannot be calculated.', 'groupId': 'OG001', 'lowerLimit': '3.1869', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through completion of follow-up (median length of follow-up 568.5 days, full range 1-1134 days)', 'description': 'PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Temozolomide Morning', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG001', 'title': 'Arm 2: Temozolomide Evening', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}], 'classes': [{'categories': [{'measurements': [{'value': '26.9739', 'groupId': 'OG000', 'lowerLimit': '10.6121', 'upperLimit': '44.3869'}, {'value': '17.1831', 'comment': 'If fewer than half of the group have not experienced death then upper 95% CI cannot be calculated.', 'groupId': 'OG001', 'lowerLimit': '8.3451', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through completion of follow-up (median length of follow-up 568.5 days, full range 1-1134 days)', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Comparison of Sleep Questionnaire in Participants Receiving Temozolomide in the Morning Versus Participants Receiving Temozolomide in the Evening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Temozolomide Morning', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG001', 'title': 'Arm 2: Temozolomide Evening', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))', 'description': 'Sleep Questionnaire - 1 yes/no question of "do you have problems getting to sleep or staying asleep?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Sleep questionnaires were only collected on 6 patients in each arm. If one of the 12 patients didn't complete a sleep questionnaire then they are not included in that timepoint."}, {'type': 'SECONDARY', 'title': 'Comparison of Sleep Questionnaire in Participants Receiving Temozolomide in the Morning Versus Participants Receiving Temozolomide in the Evening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}, {'value': '1', 'groupId': 'OG019'}, {'value': '3', 'groupId': 'OG020'}, {'value': '1', 'groupId': 'OG021'}, {'value': '2', 'groupId': 'OG022'}, {'value': '1', 'groupId': 'OG023'}, {'value': '2', 'groupId': 'OG024'}, {'value': '1', 'groupId': 'OG025'}, {'value': '3', 'groupId': 'OG026'}, {'value': '6', 'groupId': 'OG027'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Temozolomide Morning BASELINE', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG001', 'title': 'Arm 2: Temozolomide Evening BASELINE', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}, {'id': 'OG002', 'title': 'Arm 1: Temozolomide Morning CYCLE 1', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG003', 'title': 'Arm 2: Temozolomide Evening CYCLE 1', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}, {'id': 'OG004', 'title': 'Arm 1: Temozolomide Morning CYCLE 2', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG005', 'title': 'Arm 2: Temozolomide Evening CYCLE 2', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}, {'id': 'OG006', 'title': 'Arm 1: Temozolomide Morning CYCLE 3', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG007', 'title': 'Arm 2: Temozolomide Evening CYCLE 3', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}, {'id': 'OG008', 'title': 'Arm 1: Temozolomide Morning CYCLE 4', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG009', 'title': 'Arm 2: Temozolomide Evening CYCLE 4', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}, {'id': 'OG010', 'title': 'Arm 1: Temozolomide Morning CYCLE 5', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG011', 'title': 'Arm 2: Temozolomide Evening CYCLE 5', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}, {'id': 'OG012', 'title': 'Arm 1: Temozolomide Morning CYCLE 6', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG013', 'title': 'Arm 2: Temozolomide Evening CYCLE 6', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}, {'id': 'OG014', 'title': 'Arm 1: Temozolomide Morning CYCLE 7', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG015', 'title': 'Arm 2: Temozolomide Evening CYCLE 7', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}, {'id': 'OG016', 'title': 'Arm 1: Temozolomide Morning CYCLE 8', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG017', 'title': 'Arm 2: Temozolomide Evening CYCLE 8', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}, {'id': 'OG018', 'title': 'Arm 1: Temozolomide Morning CYCLE 9', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG019', 'title': 'Arm 2: Temozolomide Evening CYCLE 9', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}, {'id': 'OG020', 'title': 'Arm 1: Temozolomide Morning CYCLE 10', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG021', 'title': 'Arm 2: Temozolomide Evening CYCLE 10', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}, {'id': 'OG022', 'title': 'Arm 1: Temozolomide Morning CYCLE 11', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG023', 'title': 'Arm 2: Temozolomide Evening CYCLE 11', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}, {'id': 'OG024', 'title': 'Arm 1: Temozolomide Morning CYCLE 12', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG025', 'title': 'Arm 2: Temozolomide Evening CYCLE 12', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}, {'id': 'OG026', 'title': 'Arm 1: Temozolomide Morning END OF TREATMENT', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG027', 'title': 'Arm 2: Temozolomide Evening END OF TREATMENT', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}], 'classes': [{'title': 'Difficulty falling asleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}, {'value': '1', 'groupId': 'OG019'}, {'value': '3', 'groupId': 'OG020'}, {'value': '1', 'groupId': 'OG021'}, {'value': '2', 'groupId': 'OG022'}, {'value': '1', 'groupId': 'OG023'}, {'value': '2', 'groupId': 'OG024'}, {'value': '1', 'groupId': 'OG025'}, {'value': '3', 'groupId': 'OG026'}, {'value': '6', 'groupId': 'OG027'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '1', 'groupId': 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'groupId': 'OG019'}, {'value': '1', 'groupId': 'OG020'}, {'value': '1', 'groupId': 'OG021'}, {'value': '1', 'groupId': 'OG022'}, {'value': '1', 'groupId': 'OG023'}, {'value': '0', 'groupId': 'OG024'}, {'value': '1', 'groupId': 'OG025'}, {'value': '0', 'groupId': 'OG026'}, {'value': '3', 'groupId': 'OG027'}]}, {'title': '2', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': 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{'value': '0', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}, {'value': '0', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '0', 'groupId': 'OG023'}, {'value': '0', 'groupId': 'OG024'}, {'value': '0', 'groupId': 'OG025'}, {'value': '0', 'groupId': 'OG026'}, {'value': '0', 'groupId': 'OG027'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 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'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '1', 'groupId': 'OG019'}, {'value': '2', 'groupId': 'OG020'}, {'value': '1', 'groupId': 'OG021'}, {'value': '1', 'groupId': 'OG022'}, {'value': '1', 'groupId': 'OG023'}, {'value': '1', 'groupId': 'OG024'}, {'value': '1', 'groupId': 'OG025'}, {'value': '0', 'groupId': 'OG026'}, {'value': '4', 'groupId': 'OG027'}]}, {'title': '2', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}, {'value': '0', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '0', 'groupId': 'OG023'}, {'value': '0', 'groupId': 'OG024'}, {'value': '0', 'groupId': 'OG025'}, {'value': '0', 'groupId': 'OG026'}, {'value': '2', 'groupId': 'OG027'}]}, {'title': '3', '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': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}, {'value': '0', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '0', 'groupId': 'OG023'}, {'value': '0', 'groupId': 'OG024'}, {'value': '0', 'groupId': 'OG025'}, {'value': '0', 'groupId': 'OG026'}, {'value': '0', 'groupId': 'OG027'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}, {'value': '0', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '0', 'groupId': 'OG023'}, {'value': '0', 'groupId': 'OG024'}, {'value': '0', 'groupId': 'OG025'}, {'value': '0', 'groupId': 'OG026'}, {'value': '0', 'groupId': 'OG027'}]}]}, {'title': 'How noticeable to others is your sleep problem is in terms of impairing the quality of your life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}, {'value': '1', 'groupId': 'OG019'}, {'value': '3', 'groupId': 'OG020'}, {'value': '1', 'groupId': 'OG021'}, {'value': '2', 'groupId': 'OG022'}, {'value': '1', 'groupId': 'OG023'}, {'value': '2', 'groupId': 'OG024'}, {'value': '1', 'groupId': 'OG025'}, {'value': '3', 'groupId': 'OG026'}, {'value': '6', 'groupId': 'OG027'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '1', 'groupId': 'OG020'}, {'value': '0', 'groupId': 'OG021'}, {'value': '1', 'groupId': 'OG022'}, {'value': '0', 'groupId': 'OG023'}, {'value': '1', 'groupId': 'OG024'}, {'value': '0', 'groupId': 'OG025'}, {'value': '3', 'groupId': 'OG026'}, {'value': '2', 'groupId': 'OG027'}]}, {'title': '1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '2', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}, {'value': '1', 'groupId': 'OG019'}, {'value': '2', 'groupId': 'OG020'}, {'value': '1', 'groupId': 'OG021'}, {'value': '1', 'groupId': 'OG022'}, {'value': '1', 'groupId': 'OG023'}, {'value': '1', 'groupId': 'OG024'}, {'value': '1', 'groupId': 'OG025'}, {'value': '0', 'groupId': 'OG026'}, {'value': '2', 'groupId': 'OG027'}]}, {'title': '2', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}, {'value': '0', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '0', 'groupId': 'OG023'}, {'value': '0', 'groupId': 'OG024'}, {'value': '0', 'groupId': 'OG025'}, {'value': '0', 'groupId': 'OG026'}, {'value': '2', 'groupId': 'OG027'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}, {'value': '0', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '0', 'groupId': 'OG023'}, {'value': '0', 'groupId': 'OG024'}, {'value': '0', 'groupId': 'OG025'}, {'value': '0', 'groupId': 'OG026'}, {'value': '0', 'groupId': 'OG027'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}, {'value': '0', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '0', 'groupId': 'OG023'}, {'value': '0', 'groupId': 'OG024'}, {'value': '0', 'groupId': 'OG025'}, {'value': '0', 'groupId': 'OG026'}, {'value': '0', 'groupId': 'OG027'}]}]}, {'title': 'How worried or distressed are you about your current sleep problem?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '2', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}, {'value': '3', 'groupId': 'OG018'}, {'value': '1', 'groupId': 'OG019'}, {'value': '3', 'groupId': 'OG020'}, {'value': '1', 'groupId': 'OG021'}, {'value': '2', 'groupId': 'OG022'}, {'value': '1', 'groupId': 'OG023'}, {'value': '2', 'groupId': 'OG024'}, {'value': '1', 'groupId': 'OG025'}, {'value': '3', 'groupId': 'OG026'}, {'value': '6', 'groupId': 'OG027'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '4', 'groupId': 'OG013'}, {'value': '1', 'groupId': 'OG014'}, {'value': '1', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '1', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}, {'value': '1', 'groupId': 'OG019'}, {'value': '1', 'groupId': 'OG020'}, {'value': '1', 'groupId': 'OG021'}, {'value': '1', 'groupId': 'OG022'}, {'value': '1', 'groupId': 'OG023'}, {'value': '1', 'groupId': 'OG024'}, {'value': '1', 'groupId': 'OG025'}, {'value': '2', 'groupId': 'OG026'}, {'value': '5', 'groupId': 'OG027'}]}, {'title': '1', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '2', 'groupId': 'OG020'}, {'value': '0', 'groupId': 'OG021'}, {'value': '1', 'groupId': 'OG022'}, {'value': '0', 'groupId': 'OG023'}, {'value': '1', 'groupId': 'OG024'}, {'value': '0', 'groupId': 'OG025'}, {'value': '1', 'groupId': 'OG026'}, {'value': '1', 'groupId': 'OG027'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '1', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}, {'value': '0', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '0', 'groupId': 'OG023'}, {'value': '0', 'groupId': 'OG024'}, {'value': '0', 'groupId': 'OG025'}, {'value': '0', 'groupId': 'OG026'}, {'value': '0', 'groupId': 'OG027'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '1', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}, {'value': '0', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '0', 'groupId': 'OG023'}, {'value': '0', 'groupId': 'OG024'}, {'value': '0', 'groupId': 'OG025'}, {'value': '0', 'groupId': 'OG026'}, {'value': '0', 'groupId': 'OG027'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}, {'value': '0', 'groupId': 'OG016'}, {'value': '0', 'groupId': 'OG017'}, {'value': '0', 'groupId': 'OG018'}, {'value': '0', 'groupId': 'OG019'}, {'value': '0', 'groupId': 'OG020'}, {'value': '0', 'groupId': 'OG021'}, {'value': '0', 'groupId': 'OG022'}, {'value': '0', 'groupId': 'OG023'}, {'value': '0', 'groupId': 'OG024'}, {'value': '0', 'groupId': 'OG025'}, {'value': '0', 'groupId': 'OG026'}, {'value': '0', 'groupId': 'OG027'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))', 'description': '\\- Sleep Questionnaire:\n\n* Difficulty falling asleep/difficulty staying asleep/problem waking up too early: Answers range from 0=none, mild=1, moderate=2, severe=3, very=4.\n* How satisfied or dissatisfied are you with your current sleeping pattern question: Answers range from 0=very satisfied to 4=very dissatisfied.\n* To what extent do you consider your sleep problem to interfere with your daily functioning question: Answers range from 0=not at all interfering, 1=a little, 2=somewhat, 3=much, 4=very much interfering.\n* How noticeable to others do you think your sleep problem is in terms of impairing the quality of your life question: Answers range from 0=not at all noticeable, 1=barely, 2 = somewhat, 3 =much, 4=very noticeable.\n* How worried or distressed are you about your current sleep problem question: Answers range from 0=not at all=0, 1=a little, 2=somewhat, 3=much, 4=very much.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Sleep questionnaires were only collected on 6 patients in each arm. If one of the 12 patients didn't complete a sleep questionnaire then they are not included in that timepoint."}, {'type': 'SECONDARY', 'title': 'Mean Circadian Amplitude', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Temozolomide Morning', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG001', 'title': 'Arm 2: Temozolomide Evening', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}], 'classes': [{'title': 'AM Patient #1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.02', 'groupId': 'OG000'}]}]}, {'title': 'AM Patient #2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.01', 'groupId': 'OG000'}]}]}, {'title': 'PM Patient #1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.81', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'PM Patient #2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'PM Patient #3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.77', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'PM Patient #4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.81', 'spread': '0.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From start of treatment through 2 months after end of treatment (median length 100 days, full range 78-240 days)', 'description': '* The ActTrust Condor Instrument watches are wrist actimetry/accelerometers. Patients will wear an accelerometer on their wrist to measure activity level during the day and at night until two months after the end of treatment.\n* Circadian amplitude, refers to the difference between the highest and lowest points of a circadian rhythm over a 24-hour cycle, is typically measured in the units of the rhythm being quantified.\n* The circadian mean amplitude was calculated per day for each patient with the mean and standard deviation reported across all days for each individual patient.', 'unitOfMeasure': 'counts/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Actimetry data was only collected on 6 participants.'}, {'type': 'SECONDARY', 'title': 'Mean Sleep Regularity Index (SRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Temozolomide Morning', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'OG001', 'title': 'Arm 2: Temozolomide Evening', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}], 'classes': [{'title': 'AM Patient #1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.70', 'spread': '0.09', 'groupId': 'OG000'}]}]}, {'title': 'AM Patient #2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.79', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'PM Patient #1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'PM Patient #2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.69', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'PM Patient #3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'PM Patient #4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From start of treatment through 2 months after end of treatment (median length 100 days, full range 78-240 days)', 'description': '* The ActTrust Condor Instrument watches are wrist actimetry/accelerometers. Patients will wear an accelerometer on their wrist to measure activity level during the day and at night until two months after the end of treatment.\n* Sleep regularity index (SRI) is the probability of being at rest, calculated per day for each patient. An SRI closer to 0 indicates irregular sleep patterns (i.e., more variable day to day), while values closer to 1 indicate regular sleep patterns. The SRI index scale is 0\\~1.\n* The SRI was calculated per day for each patient with the mean and standard deviation reported across all days for each individual patient.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Actimetry data was only collected on 6 participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1: Temozolomide Morning', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'FG001', 'title': 'Arm 2: Temozolomide Evening', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Hospice', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1: Temozolomide Morning', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).'}, {'id': 'BG001', 'title': 'Arm 2: Temozolomide Evening', 'description': '-Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.59', 'spread': '12.35', 'groupId': 'BG000'}, {'value': '53.05', 'spread': '17.52', 'groupId': 'BG001'}, {'value': '55.95', 'spread': '15.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-20', 'size': 1053806, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-14T12:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2016-05-20', 'resultsFirstSubmitDate': '2025-05-06', 'studyFirstSubmitQcDate': '2016-05-20', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-17', 'studyFirstPostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Patient Treatment Compliance as Measured by Number of Participants Who Were at Least 80% Compliance With Assigned Administration Time', 'timeFrame': 'Through completion of treatment (median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)', 'description': 'Compliance is defined as no more than one of five doses of temozolomide per cycle taken outside of the assigned administration time.'}, {'measure': 'Duration of Response', 'timeFrame': 'Through completion of follow-up (estimated to be 30 months)', 'description': '* Response and progression will be evaluated in this study using the updated response assessment criteria for high-grade gliomas: Response Assessment in Neuro-Oncology (RANO) working group guideline \\[JCO 28(11): 1963-1972, 2010\\].\n* The duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).'}], 'secondaryOutcomes': [{'measure': 'Number of Patients Experiencing Grade 3 or 4 Lymphopenia, Thrombocytopenia, Neutropenia, Leukopenia, and Anemia in Each Group as Measured by Standard Blood Draws', 'timeFrame': 'Through completion of treatment (median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles)', 'description': '* Lymphopenia grade 3 is \\<500-200/mm\\^3 and grade 4 is \\<200/mm\\^3\n* Leukopenia grade 3 is \\<2000-1000/mm\\^3 and grade 4 is \\<1000/mm\\^3\n* Neutropenia grade 3 is \\<1000-500/mm\\^3 and grade 4 is \\<500/mm\\^3\n* Thrombocytopenia grade 3 is \\<50,000-25,000/mm\\^3 and grade 4 is \\<25,000/mm\\^3\n* Anemia grade 3 is \\<8.0-6.5 g/dL and grade 4 is \\<6.5 g/dL'}, {'measure': 'Change in Quality of Life as Measured by FACT-Br Score - Physical Well-being Score', 'timeFrame': 'Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))', 'description': '7-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range is 0-28. A higher score indicates a lower physical well-being quality of life.'}, {'measure': 'Change in Quality of Life as Measured by FACT-Br Score - Social/Family Well-being Score', 'timeFrame': 'Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))', 'description': '7-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range 0-28. A higher score indicates a higher social/family well-being quality of life.'}, {'measure': 'Change in Quality of Life as Measured by FACT-Br Score - Emotional Well-being Score', 'timeFrame': 'Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))', 'description': '6-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range 0-24. A higher score indicates a lower emotional well-being quality of life.'}, {'measure': 'Change in Quality of Life as Measured by FACT-Br Score - Functional Well-being Score', 'timeFrame': 'Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))', 'description': '7-item questionnaire measuring over the past 7 days. Answers range from 0=not at all to 4=very much. Total score range 0-28. A higher score indicates a higher emotional well-being quality of life.'}, {'measure': 'Median Progression-free Survival (PFS)', 'timeFrame': 'Through completion of follow-up (median length of follow-up 568.5 days, full range 1-1134 days)', 'description': 'PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.'}, {'measure': 'Median Overall Survival', 'timeFrame': 'Through completion of follow-up (median length of follow-up 568.5 days, full range 1-1134 days)'}, {'measure': 'Comparison of Sleep Questionnaire in Participants Receiving Temozolomide in the Morning Versus Participants Receiving Temozolomide in the Evening', 'timeFrame': 'Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))', 'description': 'Sleep Questionnaire - 1 yes/no question of "do you have problems getting to sleep or staying asleep?"'}, {'measure': 'Comparison of Sleep Questionnaire in Participants Receiving Temozolomide in the Morning Versus Participants Receiving Temozolomide in the Evening', 'timeFrame': 'Baseline, beginning of each cycle (each cycle is 28 days), and 1 month after completion of treatment (up to 13 months, median length of treatment 6 cycles - each cycle is 28 days (full range 2-12 cycles))', 'description': '\\- Sleep Questionnaire:\n\n* Difficulty falling asleep/difficulty staying asleep/problem waking up too early: Answers range from 0=none, mild=1, moderate=2, severe=3, very=4.\n* How satisfied or dissatisfied are you with your current sleeping pattern question: Answers range from 0=very satisfied to 4=very dissatisfied.\n* To what extent do you consider your sleep problem to interfere with your daily functioning question: Answers range from 0=not at all interfering, 1=a little, 2=somewhat, 3=much, 4=very much interfering.\n* How noticeable to others do you think your sleep problem is in terms of impairing the quality of your life question: Answers range from 0=not at all noticeable, 1=barely, 2 = somewhat, 3 =much, 4=very noticeable.\n* How worried or distressed are you about your current sleep problem question: Answers range from 0=not at all=0, 1=a little, 2=somewhat, 3=much, 4=very much.'}, {'measure': 'Mean Circadian Amplitude', 'timeFrame': 'From start of treatment through 2 months after end of treatment (median length 100 days, full range 78-240 days)', 'description': '* The ActTrust Condor Instrument watches are wrist actimetry/accelerometers. Patients will wear an accelerometer on their wrist to measure activity level during the day and at night until two months after the end of treatment.\n* Circadian amplitude, refers to the difference between the highest and lowest points of a circadian rhythm over a 24-hour cycle, is typically measured in the units of the rhythm being quantified.\n* The circadian mean amplitude was calculated per day for each patient with the mean and standard deviation reported across all days for each individual patient.'}, {'measure': 'Mean Sleep Regularity Index (SRI)', 'timeFrame': 'From start of treatment through 2 months after end of treatment (median length 100 days, full range 78-240 days)', 'description': '* The ActTrust Condor Instrument watches are wrist actimetry/accelerometers. Patients will wear an accelerometer on their wrist to measure activity level during the day and at night until two months after the end of treatment.\n* Sleep regularity index (SRI) is the probability of being at rest, calculated per day for each patient. An SRI closer to 0 indicates irregular sleep patterns (i.e., more variable day to day), while values closer to 1 indicate regular sleep patterns. The SRI index scale is 0\\~1.\n* The SRI was calculated per day for each patient with the mean and standard deviation reported across all days for each individual patient.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioma', 'Glioblastoma Multiforme']}, 'referencesModule': {'references': [{'pmid': '35601970', 'type': 'DERIVED', 'citation': 'Damato AR, Katumba RGN, Luo J, Atluri H, Talcott GR, Govindan A, Slat EA, Weilbaecher KN, Tao Y, Huang J, Butt OH, Ansstas G, Johanns TM, Chheda MG, Herzog ED, Rubin JB, Campian JL. A randomized feasibility study evaluating temozolomide circadian medicine in patients with glioma. Neurooncol Pract. 2022 Jan 31;9(3):193-200. doi: 10.1093/nop/npac003. eCollection 2022 May.'}], 'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'Temozolomide (TMZ) is the chemotherapy drug approved by the FDA to increase survival in glioblastoma (GBM) patients beyond surgical resection and radiation therapy alone. Give its activity in astrocytomas, TMZ is commonly used in grade III anaplastic astrocytoma (AA) as well. Both grade III AA and grade IV GBM are high grade gliomas (HGG). The short half-life of this drug and known oscillations in DNA damage repair make it an ideal candidate for chronotherapy.\n\nChronotherapy is the improvement of treatment outcomes by minimizing treatment toxicity and maximizing efficacy through delivery of a medication according to the timing of biological rhythms within a patient. Chronotherapy has improved outcomes through the reduction of side effects and increase in anti-tumor activity for a variety of cancers, but has never been applied to the treatment of gliomas.\n\nBased on the preliminary preclinical data for chronotherapeutic TMZ treatment of intracranial glioma xenografts and the success of chronotherapy in the treatment of other cancers, the investigators hypothesize that the timing of TMZ treatment will alter its efficacy and toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed and recurrent high grade gliomas (WHO grades III \\& IV) and high risk WHO grade II gliomas who are to begin treatment with monthly high dose temozolomide therapy.\n* Scheduled to receive adjuvant temozolomide therapy after having completed concurrent temozolomide and radiation therapy.\n* At least 18 years of age.\n* Karnofsky performance status ≥ 60%\n* Ability to understand and willingness to sign an IRB approved written informed consent document\n\nExclusion Criteria:.\n\n-Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.'}, 'identificationModule': {'nctId': 'NCT02781792', 'briefTitle': 'Temozolomide Chronotherapy for High Grade Glioma', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'A Randomized Feasibility Study Evaluating Temozolomide Chronotherapy for High Grade Glioma', 'orgStudyIdInfo': {'id': '201605081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Temozolomide morning', 'description': '* Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m\\^2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the morning (before 10:00).\n* FACT-Br quality of life at baseline, at the beginning of each cycle of chemotherapy, and 1 month after the final chemotherapy treatment', 'interventionNames': ['Drug: Temozolomide', 'Other: Functional Assessment of Cancer Therapy - Brain', 'Other: ActTrust Condor Instrument Watch']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Temozolomide evening', 'description': '* Temozolomide will be given as per standard of care. Typical dosing is 150 to 200 mg/m2 on Days 1 through 5 of a 28-day treatment cycle. Patients will be randomized to take their temozolomide doses in the evening (after 20:00).\n* FACT-Br quality of life at baseline, at the beginning of each cycle of chemotherapy, and 1 month after the final chemotherapy treatment', 'interventionNames': ['Drug: Temozolomide', 'Other: Functional Assessment of Cancer Therapy - Brain', 'Other: ActTrust Condor Instrument Watch']}], 'interventions': [{'name': 'Temozolomide', 'type': 'DRUG', 'otherNames': ['Temodar'], 'description': '-Given standard of care', 'armGroupLabels': ['Arm 1: Temozolomide morning', 'Arm 2: Temozolomide evening']}, {'name': 'Functional Assessment of Cancer Therapy - Brain', 'type': 'OTHER', 'otherNames': ['FACT-Br'], 'description': '* 23-item questionnaire that can be completed in 5 to 10 minutes with little or no assistance in patients who are not neurologically incapacitated. This brain subscale is usually used along with the core (general) questionnaire \\[2\\] that includes 27 items.\n* Patients rate all 5 items using a five-point Likert scale ranging from 0 "not at all" to 4 "very much." Overall, higher ratings suggest higher QOL. Items are totaled to produce the following subscales, along with an overall QOL score: physical well-being (7 items); social/family well-being (7 items); emotional well-being (6 items); functional well-being (7 items); and concerns relevant to patients with brain tumors (23 items)\n* The sleep portion of this questionnaire consists of 17 questions about sleeping patterns and the ability to rate severity of insomnia.', 'armGroupLabels': ['Arm 1: Temozolomide morning', 'Arm 2: Temozolomide evening']}, {'name': 'ActTrust Condor Instrument Watch', 'type': 'OTHER', 'description': '-Will be required to wear 24 hours per day and will only be removed at specified data collection time points', 'armGroupLabels': ['Arm 1: Temozolomide morning', 'Arm 2: Temozolomide evening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Milan Chheda, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}