{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"}],"units":"Participants"}],"description":"Severity of AEs graded as per CTCAE v4.03. Phase 1b lead-in, AEs occurring during DLT observation period, that attributable to one or more study drug in combination was classified as DLT: Hematologic: Grade (G)4 neutropenia lasting \\>7 day; Febrile neutropenia; Neutropenic infection; G \\>=3 thrombocytopenia with bleeding; G4 thrombocytopenia; G4 anemia. Non-Hematologic (Non-Laboratory): Any G3 toxicity, except following: Transient (24 H) G3 fatigue, local reaction, or headache that resolved to G1; G3-4 nausea/vomiting controlled by medical therapy within 72H; G3 hypertension controlled by medical therapy; G3 diarrhea improved to G \\<=2 within 72H after medical therapy; G3 skin toxicity resolved to G \\<=1 in \\<7 days after medical management; G \\>=3 amylase or lipase abnormality not associated with pancreatitis;G3 endocrinopathies controlled with medical therapy; Tumor flare phenomenon.G4 or G3 CRS lasting \\>24 H despite treatment.","groups":[{"description":"During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 sub-cutaneous \\[SC\\] administered at weekly intervals, followed by 5 intra tumoral \\[IT\\] administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W. Phase 2 was not planned.","id":"OG000","title":"Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab"},{"description":"During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus utomilumab 100 mg administered IV Q4W. Phase 2 was not planned.","id":"OG001","title":"Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg"},{"description":"During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus PF-04518600 at 0.3 mg/kg administered IV Q2W. Phase 2 was not planned.","id":"OG002","title":"Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The analysis population included all participants enrolled in Phase 1b who were in the safety analysis set (all participants who received at least one dose of study drug) and received at least 75% of the prescribed doses unless due to treatment-related toxicity or either experienced DLT during the first cycle (1 cycle = 4 weeks) or completed observation period for the first cycle of treatment. Here, \"N''=number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Baseline up to first Cycle (up to 4 weeks)","title":"Phase 1b Lead-in: Number of Participants With First Cycle DLT for Combination F","type":"PRIMARY","unitOfMeasure":"Participants"}