{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"3"}]}],"title":"Grades 1 and 2 Adverse Events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Grades 3 and 4 Adverse Events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"description":"Will be assessed by the incidence and severity of adverse events, serious adverse events, as classified and graded according to the current version of the Common Terminology Criteria for Adverse Events version 4.","groups":[{"description":"Patients receive cyclophosphamide IV on day 1 and IRX-2 via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection.\n\nCyclophosphamide: Given IV\n\nIndomethacin: Given PO\n\nIRX-2: Given via submucosal injection or SC\n\nLaboratory Biomarker Analysis: Correlative studies\n\nMultivitamin: Given zinc-containing multivitamin PO\n\nOmeprazole: Given PO\n\nTherapeutic Conventional Surgery: Undergo surgical resection","id":"OG000","title":"Arm I (IRX-2)"},{"description":"Patients receive cyclophosphamide IV on day 1 and placebo via submucosal injections in the cervix or SC for vulvar lesions on days 4-7. Patients also receive indomethacin PO TID, zinc-containing multivitamins PO QD and omeprazole PO on days 1-21. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Beginning week 25, patients undergo surgical resection.\n\nCyclophosphamide: Given IV\n\nIndomethacin: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nMultivitamin: Given zinc-containing multivitamin PO\n\nOmeprazole: Given PO\n\nPlacebo: Given via submucosal injections or SC\n\nTherapeutic Conventional Surgery: Undergo surgical resection","id":"OG001","title":"Arm II (Placebo)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All treated patients are included","reportingStatus":"POSTED","timeFrame":"Up to 30 months","title":"Incidence of Adverse Events of IRX-2 Administration","type":"SECONDARY","unitOfMeasure":"Participants"}