{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"}],"units":"Participants"}],"description":"Safety will be assessed on clinical examination and measurement of laboratory parameters. All safety assessments including adverse events, clinical laboratory evaluations, and vital signs will be summarized with descriptive statistics, where appropriate, and listed in the data listings using MedDRA terms.","groups":[{"description":"Patients undergo standard of care radiation therapy for a total of 35 fractions over 7 weeks and receive tolinapant PO daily for 7 days during weeks 1, 3, 5, and 7 of radiation therapy in the absence of disease progression or unacceptable toxicity.\n\nTolinapant: Given PO\n\nRadiation Therapy: Undergo radiation therapy","id":"OG000","title":"Treatment (Tolinapant, Radiation Therapy)"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Up to 60 days post-treatment","title":"Safety of Tolinapant + Radiation (Number of Patients With Adverse Events Per CTCAE v5.0)","type":"PRIMARY","unitOfMeasure":"Participants"}