{"denoms":[{"counts":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}],"units":"Participants"}],"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":"BG000","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":"BG001","title":"Arm 2 - Closed"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"12.1","upperLimit":"21.9","value":"16.1"},{"groupId":"BG001","lowerLimit":"5.7","upperLimit":"5.9","value":"5.8"},{"groupId":"BG002","lowerLimit":"5.7","upperLimit":"21.9","value":"12.1"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}]}],"title":"United States"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}]}]}],"description":"WHO grading of pediatric brain tumors range from Grade 1 (Low Grade) - Slow-growing, to Grade 4 (High Grade) - The most aggressive which grows and spreads rapidly and is difficult to treat. In this study all patients were high grade which means the tumor is already classified as aggressive and likely to spread and come back (recur) after treatment. These tumors have a poorer prognosis (outlook) than low-grade ones.","paramType":"COUNT_OF_PARTICIPANTS","title":"WHO High Grade at Baseline","unitOfMeasure":"Participants"}],"populationDescription":"The baseline population includes every subject who received at least one dose of any study drug recorded in the Data Management (DM) database excluding screen failures. One patient in arm 2 withdrew consent prior to dosing and is considered a screen failure and one patient in Arm 2 only received Ad-RTS-hIL-12 (veledimex was not administered due to a serious adverse event."}