{"analyses":[{"ciLowerLimit":"0.91","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.30","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","otherAnalysisDescription":"Comparing Arm II vs Arm I (reference group)","pValue":"0.93","pValueComment":"Comparing Arm II vs Arm I (reference group)","paramType":"Hazard Ratio (HR)","paramValue":"1.45","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.43","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.14","groupDescription":"Comparing Arm III vs Arm I","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.06","paramType":"Hazard Ratio (HR)","paramValue":"0.7","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.67","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.70","groupDescription":"Comparing Arm IV vs Arm VII","groupIds":["OG003","OG006"],"nonInferiorityType":"SUPERIORITY","pValue":"0.62","paramType":"Hazard Ratio (HR)","paramValue":"1.06","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.58","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.46","groupDescription":"Comparing Arm V vs Arm VII","groupIds":["OG004","OG006"],"nonInferiorityType":"SUPERIORITY","pValue":"0.36","paramType":"Hazard Ratio (HR)","paramValue":"0.92","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.49","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.25","groupDescription":"Comparing Arm VI vs VII","groupIds":["OG005","OG006"],"nonInferiorityType":"SUPERIORITY","pValue":"0.14","paramType":"Hazard Ratio (HR)","paramValue":"0.78","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.0","upperLimit":"5.4","value":"3.8"},{"groupId":"OG001","lowerLimit":"1.8","upperLimit":"4.7","value":"2.0"},{"groupId":"OG002","lowerLimit":"3.7","upperLimit":"8.3","value":"5.5"},{"groupId":"OG003","lowerLimit":"2.6","upperLimit":"6.0","value":"5.6"},{"groupId":"OG004","lowerLimit":"2.2","upperLimit":"4.9","value":"3.7"},{"groupId":"OG005","lowerLimit":"3.8","upperLimit":"7.8","value":"6.0"},{"groupId":"OG006","lowerLimit":"3.0","upperLimit":"7.0","value":"4.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"40"},{"groupId":"OG003","value":"42"},{"groupId":"OG004","value":"42"},{"groupId":"OG005","value":"43"},{"groupId":"OG006","value":"41"}],"units":"Participants"}],"description":"Progression-free survival is defined as the time from the date of study enrollment to the investigator-determined date of progression or death due to any cause, whichever occurs first. For individuals who are alive and progression-free, the censored time at risk will be defined as the time from the study enrollment date to the date of the patient's last radiographic disease assessment.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients randomized to Cedinarib reference arm during the recruitment period (09/04/2018-06/17/2019). Patients receive Cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.\n\nBiospecimen Collection: Undergo blood sample collection\n\nBone Marrow Aspirate: Undergo bone marrow aspiration and biopsy\n\nBone Marrow Biopsy: Undergo bone marrow aspiration and biopsy\n\nCediranib: Given PO\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT scan\n\nEchocardiography: Undergo Echo\n\nMultigated Acquisition Scan: Undergo MUGA","id":"OG000","title":"Arm I (Cediranib maleate_Reference Group 1)"},{"description":"Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.\n\nBiospecimen Collection: Undergo blood sample collection\n\nBone Marrow Aspirate: Undergo bone marrow aspiration and biopsy\n\nBone Marrow Biopsy: Undergo bone marrow aspiration and biopsy\n\nComputed Tomography: Undergo CT scan\n\nEchocardiography: Undergo Echo\n\nMultigated Acquisition Scan: Undergo MUGA\n\nOlaparib: Given PO","id":"OG001","title":"Arm II (Olaparib)"},{"description":"Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.\n\nBiospecimen Collection: Undergo blood sample collection\n\nBone Marrow Aspirate: Undergo bone marrow aspiration and biopsy\n\nBone Marrow Biopsy: Undergo bone marrow aspiration and biopsy\n\nCediranib: Given PO\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT scan\n\nEchocardiography: Undergo Echo\n\nMultigated Acquisition Scan: Undergo MUGA\n\nOlaparib: Given PO","id":"OG002","title":"Arm III (Cediranib Maleate, Olaparib)"},{"description":"Patients receive olaparib PO BID on days 1-28 and capivasertib PO BID on days 1-4 each week. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.\n\nBiospecimen Collection: Undergo blood sample collection\n\nBone Marrow Aspirate: Undergo bone marrow aspiration and biopsy\n\nBone Marrow Biopsy: Undergo bone marrow aspiration and biopsy\n\nCapivasertib: Given PO\n\nComputed Tomography: Undergo CT scan\n\nEchocardiography: Undergo Echo\n\nMultigated Acquisition Scan: Undergo MUGA\n\nOlaparib: Given PO","id":"OG003","title":"Arm IV (Olaparib, Capivasertib)"},{"description":"Patients receive olaparib PO BID on days 1-28 and durvalumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.\n\nBiospecimen Collection: Undergo blood sample collection\n\nBone Marrow Aspirate: Undergo bone marrow aspiration and biopsy\n\nBone Marrow Biopsy: Undergo bone marrow aspiration and biopsy\n\nComputed Tomography: Undergo CT scan\n\nDurvalumab: Given IV\n\nEchocardiography: Undergo Echo\n\nMultigated Acquisition Scan: Undergo MUGA\n\nOlaparib: Given PO","id":"OG004","title":"Arm V (Olaparib, Durvalumab)"},{"description":"Patients receive cediranib maleate PO QD on days 1-5 each week and durvalumab IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.\n\nBiospecimen Collection: Undergo blood sample collection\n\nBone Marrow Aspirate: Undergo bone marrow aspiration and biopsy\n\nBone Marrow Biopsy: Undergo bone marrow aspiration and biopsy\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT scan\n\nDurvalumab: Given IV\n\nEchocardiography: Undergo Echo\n\nMultigated Acquisition Scan: Undergo MUGA","id":"OG005","title":"Arm VI (Cediranib Maleate, Durvalumab)"},{"description":"Patients randomized to Cedinarib reference arm during the recruitment period (08/16/2021-06/28/2023).\n\nPatients receive cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.\n\nBiospecimen Collection: Undergo blood sample collection\n\nBone Marrow Aspirate: Undergo bone marrow aspiration and biopsy\n\nBone Marrow Biopsy: Undergo bone marrow aspiration and biopsy\n\nCediranib: Given PO\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT scan\n\nEchocardiography: Undergo Echo\n\nMultigated Acquisition Scan: Undergo MUGA","id":"OG006","title":"Arm VII (Cediranib maleate_Reference Group 2)"}],"paramType":"MEDIAN","populationDescription":"All patients randomized (Intent-to-Treat).","reportingStatus":"POSTED","timeFrame":"Scans were done every 8 weeks for the first year and then every 12 weeks thereafter until disease progression. Vital status was assessed every 3 months for 2 years and then every 6 months for 3 years (5-years total).","title":"Progression-free Survival","type":"PRIMARY","unitOfMeasure":"Months"}