{"classes":[{"categories":[{"measurements":[{"comment":"All subjects had BLQ values at this time point. BLQ was reported as \\<2.4 pg/mL.","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"Subject's result was BLQ at this time point. BLQ was reported as \\<2.4 pg/mL.","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Serum IFN-gamma - Day 0"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0","value":"4.4"},{"groupId":"OG001","spread":"0","value":"11.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Serum IFN-gamma - Day 3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0","value":"6.4"},{"comment":"Subject's result was BLQ at this time point. BLQ was reported as \\<2.4 pg/mL.","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Serum IFN-gamma - Day 7"},{"categories":[{"measurements":[{"comment":"Two subjects had BLQ values at this time point. BLQ was reported as \\<2.4 pg/mL.","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"Subject's result was BLQ at this time point. BLQ was reported as \\<2.4 pg/mL.","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Serum IFN-gamma - Day 14"},{"categories":[{"measurements":[{"comment":"Two subjects had BLQ values at this time point. BLQ was reported as \\<2.4 pg/mL.","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"Subject's result was BLQ at this time point. BLQ was reported as \\<2.4 pg/mL.","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Serum IFN-gamma - Day 28"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0","value":"12"},{"comment":"Subject's result was BLQ at this time point. BLQ was reported as \\<1.6 pg/mL.","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Serum IL-12 - Day 0"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.1","value":"11.1"},{"comment":"Subject's result was BLQ at this time point. BLQ was reported as \\<1.6 pg/mL.","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"1.6Serum IL-12 - Day 3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"4.7","value":"6.6"},{"comment":"Subject's result was BLQ at this time point. BLQ was reported as \\<1.6 pg/mL.","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Serum IL-12 - Day 7"},{"categories":[{"measurements":[{"comment":"Two subjects had BLQ values at this time point. BLQ was reported as \\<2.4 pg/mL.","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"Subject's result was BLQ at this time point. BLQ was reported as \\<1.6 pg/mL.","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Serum IL-12 - Day 14"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0","value":"1.6"},{"comment":"Subject's result was BLQ at this time point. BLQ was reported as \\<1.6 pg/mL.","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"Serum IL-12 - Day 28"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"description":"Samples for serum cytokine analysis were collected on Days 0, 3, 7, 14, and 28. For the results, participants who had samples analyzed were included in the \"number analyzed\" counts; however, values that were below the limit of quantitation (BLQ) were excluded from the calculation of mean and standard deviation.","dispersionType":"Standard Deviation","groups":[{"description":"Intratumoral Ad-RTS-hIL-12 freehand injection after tumor resection and oral veledimex (activator ligand) in pediatric patients with brain tumors.\n\nAd-RTS-hIL-12: 2.0 x 10\\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12\n\nOral Veledimex - Arm 1 (Pediatric Brain Tumor):\n\n* Planned: 1 dose level (10mg/day) 15 oral daily doses of veledimex\n* Actual: All patients received 1 dose level (10 mg/day veledimex)","id":"OG000","title":"Arm 1 - Closed"},{"description":"Intratumoral Ad-RTS-hIL-12 stereotactic injection and oral veledimex (activator ligand) in pediatric patients with DIPG.\n\nAd-RTS-hIL-12: 2.0 x 10\\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12\n\nOral Veledimex - Arm 2 (DIPG):\n\n* Planned:2 dose levels (10mg/day, 20mg/day)\n* Actual: 1 patient received 5 mg/day veledimex. The other patient did not receive veledimex due to SAE.","id":"OG001","title":"Arm 2 - Closed"}],"paramType":"MEAN","populationDescription":"The Biomarker Evaluation Population (BEP) includes all subjects who received Ad-RTS-hIL-12 + at least one dose of their cohort-specific dose of veledimex who have adequate biomarker sample(s) at screening (baseline) and at least one non-missing follow-up biomarker assessment, excluding the disqualified assessments. All biomarker related data presentation will be based on the BEP unless specified otherwise. Note: In Arm 2, only 1 subject met this criteria.","reportingStatus":"POSTED","timeFrame":"Day 0, Day 3, Day 7, Day 14, and Day 28","title":"Measure Immune Response of Ad-RTS-hIL-12 and Veledimex by a Quantitative Multiplex Immunoassay for Determination of IL-12 and IFNg Levels","type":"SECONDARY","unitOfMeasure":"pg/mL"}