{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.8","value":"95.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"}],"units":"Participants"}],"description":"The FACT-H\\&N (v4) consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\\&N cancer specific items (the HN subscale, scores 0 to 40). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Patients indicate how true 27 statements are for them during the past 7 days. Responses range from not at all (0), to very much (4) on a 5-point scale, with total scores of 0 to 108. Total scores for the 39 items range from 0 to 148 with higher scores indicating better quality of life.","dispersionType":"Standard Deviation","groups":[{"description":"Patients received pembrolizumab IV over 30 minutes on day 1 of each cycle. Starting on day 7, patients also receive 10 mg of BAY 1895344 PO BID on days 7-9 and 14-16 during cycle 1, and before and after each SBRT treatment during cycle 2 for a total of 9 doses. Beginning cycle 2, patients underwent SBRT starting between days 2 and 8 for 3 fractions with 2-3 days between fractions. Treatment repeated every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity (8 Gy x 3 SBRT). Patients also underwent CT scan and/or PET-CT scan and collection of blood samples throughout the trial.\n\nBiospecimen Collection: Undergo blood sample collection\n\nComputed Tomography: Undergo CT and/or PET-CT scan\n\nElimusertib: Given PO\n\nPembrolizumab: Given IV\n\nPositron Emission Tomography: Undergo PET-CT scan\n\nQuality-of-Life Assessment: Ancillary studies\n\nStereotactic Body Radiation Therapy: Undergo SBRT","id":"OG000","title":"Treatment (Pembrolizumab, BAY 1895344, SBRT)"}],"paramType":"MEAN","populationDescription":"Enrolled patients who complete assessment at indicated timepoint.","reportingStatus":"POSTED","timeFrame":"At 6 months from start of treatment","title":"Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score","type":"SECONDARY","unitOfMeasure":"score on a scale"}