{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"71.24","upperLimit":"429.0","value":"174.8"},{"groupId":"OG001","lowerLimit":"116.2","upperLimit":"429.6","value":"223.4"},{"groupId":"OG002","lowerLimit":"179.0","upperLimit":"317.8","value":"238.5"},{"comment":"Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG005","lowerLimit":"211.9","upperLimit":"2044","value":"658.0"},{"groupId":"OG006","lowerLimit":"123.9","upperLimit":"247.9","value":"175.2"},{"groupId":"OG007","lowerLimit":"158.4","upperLimit":"398.9","value":"251.4"},{"groupId":"OG008","lowerLimit":"177.1","upperLimit":"705.8","value":"353.6"},{"groupId":"OG009","lowerLimit":"175.6","upperLimit":"416.0","value":"270.3"}]}],"title":"Day 1 (n=5, 9, 31, 2, 1, 3, 20, 17, 12, 12)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"99.48","upperLimit":"276.1","value":"165.7"},{"groupId":"OG001","lowerLimit":"156.7","upperLimit":"422.1","value":"257.2"},{"groupId":"OG002","lowerLimit":"212.5","upperLimit":"596.2","value":"355.9"},{"comment":"Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Data was not estimable if evaluable subjects were less than 3 as per the planned decision because only 2 collected values were not sufficient to calculate a reliable estimation.","groupId":"OG005","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG006","lowerLimit":"96.16","upperLimit":"183.4","value":"132.8"},{"groupId":"OG007","lowerLimit":"149.4","upperLimit":"410.7","value":"247.1"},{"groupId":"OG008","lowerLimit":"128.0","upperLimit":"1769","value":"475.9"},{"groupId":"OG009","lowerLimit":"141.6","upperLimit":"607.7","value":"293.4"}]}],"title":"Day 15 (n=6, 8, 25, 1, 1, 2, 17, 17, 10, 13 )"}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"36"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"26"},{"groupId":"OG007","value":"24"},{"groupId":"OG008","value":"18"},{"groupId":"OG009","value":"15"}],"units":"Participants"}],"description":"Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Apparent volume of distribution during the terminal phase, calculated by CL/f/λz. Terminal rate constant (λz). The regression analysis (determination of λz) was to contain as many data points as possible (but excluding Cmax) and had to include concentration data from at least 3 different time points, consistent with the assessment of a straight line (the terminal elimination phase) on the log-transformed scale.","dispersionType":"95% Confidence Interval","groups":[{"description":"SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).","id":"OG000","title":"SAR245409 30mg"},{"description":"SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).","id":"OG001","title":"SAR245409 50mg"},{"description":"SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).","id":"OG002","title":"SAR245409 70mg"},{"description":"SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).","id":"OG003","title":"SAR245409 90mg"},{"description":"SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).","id":"OG004","title":"SAR245409 30mg Twice Daily"},{"description":"SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).","id":"OG005","title":"SAR245409 50mg Twice Daily"},{"description":"SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).","id":"OG006","title":"TNBC: SAR245409 70mg Once Daily"},{"description":"SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).","id":"OG007","title":"NSCLC: SAR245409 70mg Once Daily"},{"description":"SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).","id":"OG008","title":"CRC: SAR245409 70mg Once Daily"},{"description":"SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).","id":"OG009","title":"MEL: SAR245409 70mg Once Daily"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"The PK analysis set. Here \"n\" signifies the number of subjects evaluable at the specific time points.","reportingStatus":"POSTED","timeFrame":"Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts","title":"Apparent Volume of Distribution of Total SAR245409 During the Terminal Phase Following Oral Administration (Vz/f)","type":"SECONDARY","unitOfMeasure":"litre"}