{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Any AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"AEs leading to death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Serious AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"AEs leading to drug withdrawn (BBI608)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"AEs leading to drug interrupted (BBI608)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"AEs leading to dose reduced (BBI608)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Any ADRs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"ADRs leading to death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Serious ADRs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"ADRs leading to drug withdrawn (BBI608)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"ADRs leading to drug interrupted (BBI608)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"ADRs leading to dose reduced (BBI608)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"}],"units":"Participants"}],"description":"An AE is any untoward medical occurrence in a study subject administered an investigational drug and which does not necessarily have a causal relationship with this treatment.\n\nA SAE was an AE that met one or more of the following criteria:\n\n* Results in death\n* Is life-threatening\n* Requires hospitalization or prolongation of existing hospitalization\n* Results in persistent or significant disability or incapacity\n* Is a congenital anomaly or birth defect\n* Is an important medical event that may jeopardize the subject or may require a medical or surgical intervention to prevent one of the outcomes listed above. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization.\n\nAn ADR was defined as adverse events assessed to be related to the investigational drug","groups":[{"description":"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.\n\nPremeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.","id":"OG000","title":"MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 Part)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety analysis populations (Phase 1 part)","reportingStatus":"POSTED","timeFrame":"Between initial dosing of the investigational drug and final evaluation in the follow-up observation period, about 17 months","title":"Phase 1 Part: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Drug Reactions (ADRs)","type":"PRIMARY","unitOfMeasure":"Participants"}