{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.62","upperLimit":"164.5","value":"41.80"},{"groupId":"OG001","lowerLimit":"23.89","upperLimit":"77.16","value":"42.93"},{"groupId":"OG002","lowerLimit":"34.42","upperLimit":"62.94","value":"46.54"},{"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":"69.37","upperLimit":"330.4","value":"151.4"},{"groupId":"OG006","lowerLimit":"25.26","upperLimit":"49.69","value":"35.43"},{"groupId":"OG007","lowerLimit":"34.12","upperLimit":"68.64","value":"48.40"},{"groupId":"OG008","lowerLimit":"25.52","upperLimit":"120.7","value":"55.51"},{"groupId":"OG009","lowerLimit":"40.26","upperLimit":"93.30","value":"61.29"}]}],"title":"Day 1 (n=5, 9, 31, 2, 1, 3, 20, 17, 12, 12)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"15.16","upperLimit":"75.26","value":"33.78"},{"groupId":"OG001","lowerLimit":"22.39","upperLimit":"81.85","value":"42.81"},{"groupId":"OG002","lowerLimit":"34.68","upperLimit":"76.13","value":"51.38"},{"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":"9.667","upperLimit":"892.8","value":"92.90"},{"groupId":"OG006","lowerLimit":"20.78","upperLimit":"41.26","value":"29.28"},{"groupId":"OG007","lowerLimit":"31.25","upperLimit":"75.88","value":"48.69"},{"groupId":"OG008","lowerLimit":"20.38","upperLimit":"128.8","value":"51.24"},{"groupId":"OG009","lowerLimit":"38.64","upperLimit":"109.9","value":"65.16"}]}],"title":"Day 15 (n=6, 8, 25, 1, 1, 3, 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":"The total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the dose with area under the plasma concentration time curve from time zero to infinity (AUC 0-inf)=Dose/AUC 0-inf.","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":"Total Body Clearance (CL/f) of SAR245409","type":"SECONDARY","unitOfMeasure":"litre per hour"}