{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"19"},{"groupId":"OG007","value":"14"},{"groupId":"OG008","value":"3"},{"groupId":"OG009","value":"3"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"26"},{"groupId":"OG012","value":"24"},{"groupId":"OG013","value":"18"},{"groupId":"OG014","value":"15"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"19"},{"groupId":"OG007","value":"14"},{"groupId":"OG008","value":"3"},{"groupId":"OG009","value":"3"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"26"},{"groupId":"OG012","value":"24"},{"groupId":"OG013","value":"18"},{"groupId":"OG014","value":"15"}],"units":"Participants"}],"description":"An adverse event (AE) was defined as any untoward medical occurrence in a subject administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as those AEs that started between first dose of study drug and up to 30 days after last dose.","groups":[{"description":"Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).","id":"OG000","title":"Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily"},{"description":"Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).","id":"OG001","title":"Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily"},{"description":"Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).","id":"OG002","title":"Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily"},{"description":"Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).","id":"OG003","title":"Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily"},{"description":"Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).","id":"OG004","title":"Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily"},{"description":"Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).","id":"OG005","title":"Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily"},{"description":"Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).","id":"OG006","title":"Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily"},{"description":"Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).","id":"OG007","title":"Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily"},{"description":"Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).","id":"OG008","title":"Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily"},{"description":"Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).","id":"OG009","title":"Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily"},{"description":"Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).","id":"OG010","title":"MSC1936369B (Pimasertib) 45mg and SAR245409 50mg Twice Daily"},{"description":"Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.","id":"OG011","title":"TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily"},{"description":"Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.","id":"OG012","title":"NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily"},{"description":"Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.","id":"OG013","title":"CRC: Pimasertib 60mg and SAR245409 70mg Once Daily"},{"description":"Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator's decision to discontinue treatment, or withdrawal of consent by the subject.","id":"OG014","title":"MEL: Pimasertib 60mg and SAR245409 70mg Once Daily"}],"paramType":"NUMBER","populationDescription":"The safety analysis set (SAF) analysis set was to include all subjects who had received at least 1 (non-zero) administration of the trial investigational medicinal products (IMPs) MSC1936369B (pimasertib) and/or SAR245409.","reportingStatus":"POSTED","timeFrame":"Baseline up to 30 Days after last dose; assessed up to 4 years","title":"Number of Subjects Experiencing Any Treatment-Emergent Adverse Events (TEAEs)","type":"SECONDARY","unitOfMeasure":"subjects"}