{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"}]}],"title":"WHITE BLOOD CELL COUNT DECREASED (INVESTIGATIONS)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"}]}],"title":"LYMPHOCYTE COUNT DECREASED (INVESTIGATIONS)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}],"title":"VOMITING (GASTROINTESTINAL DISORDERS)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}],"title":"HEADACHE (NERVOUS SYSTEM DISORDERS)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"title":"PYREXIA (GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}],"title":"ANAEMIA (BLOOD AND LYMPHATIC SYSTEM DISORDERS)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"APHASIA (NERVOUS SYSTEM DISORDERS)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"FATIGUE (GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}],"title":"HYPONATRAEMIA (METABOLISM AND NUTRITION DISORDERS)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"NAUSEA (GASTROINTESTINAL DISORDERS)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}],"title":"PLATELET COUNT DECREASED (INVESTIGATIONS)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}],"title":"TACHYCARDIA (CARDIAC DISORDERS)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"description":"Subjects with Ad-RTS-hIL-12 and veledimex related adverse events will be assessed for safety by CTCAE v5.0","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":"NUMBER","populationDescription":"The Full Analysis Set (FAS) or the OSP includes every subject who received at least one dose of any study drug recorded in the Data Management (DM) database excluding screen failures.\n\n• The data analysis for Adverse Events or other Safety variables will be performed on the OSP.","reportingStatus":"POSTED","timeFrame":"2 Years","title":"Subjects With Ad-RTS-hIL-12 and Veledimex Related Adverse Events Will be Assessed for Safety by CTCAE v5.0","type":"SECONDARY","unitOfMeasure":"participants"}