{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"12"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"18"}],"units":"Participants"}],"description":"A TESAE was any untoward medical occurrence that at any dose: resulted in death; life threatening condition; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was medically important due to other reasons than the above mentioned criteria. An adverse event was defined as any untoward medical occurrence in a participant administered an investigational product.","groups":[{"description":"Participants with recurrent or refractory solid tumors received lenvatinib 8 mg/m\\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.","id":"OG000","title":"Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2"},{"description":"Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.","id":"OG001","title":"Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus).","reportingStatus":"POSTED","timeFrame":"From date of first dose up to 28 days after the last dose of study treatment (Up to 17.5 months)","title":"Phase 1: Number of Participants With Any Treatment-emergent Serious Adverse Event (TESAE)","type":"PRIMARY","unitOfMeasure":"Participants"}