{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"136"},{"groupId":"OG001","value":"126"}]}],"title":"TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"69"}]}],"title":"SAE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"137"},{"groupId":"OG001","value":"127"}],"units":"Participants"}],"description":"An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/ birth defect or is a medically important event.","groups":[{"description":"Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).","id":"OG000","title":"Alisertib"},{"description":"Pralatrexate 30 mg/m\\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).","id":"OG001","title":"Pralatrexate, or Romidepsin, or Gemcitabine"}],"paramType":"NUMBER","populationDescription":"Safety population was defined as all participants who received at least 1 dose of alisertib, or one of the comparator drugs. Participants were analyzed according to the treatment actually received.","reportingStatus":"POSTED","timeFrame":"First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)","title":"Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)","type":"SECONDARY","unitOfMeasure":"participants"}