{"description":"Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The \"AE Other\" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.","eventGroups":[{"deathsNumAffected":10,"deathsNumAtRisk":189,"description":"Patients start with three drug chemotherapy (Regimen VAD; vincristine, dactinomycin and doxorubicin) and are evaluated and six and 12 weeks for feasibility of undergoing a partial nephrectomy/renal sparing surgery. At week 12 definitive surgery takes place followed by chemotherapy and radiation therapy based on histology and stage. Treatment continues for 25 or 31 weeks depending on histology. Patients are followed for up to 10 years following end of therapy.\n\nDactinomycin: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nRadiation Therapy: Undergo radiation therapy\n\nTherapeutic Conventional Surgery: Undergo surgical resection\n\nVincristine Sulfate: Given IV","id":"EG000","otherNumAffected":34,"otherNumAtRisk":189,"seriousNumAffected":12,"seriousNumAtRisk":189,"title":"Arm 1 (Bilateral Wilms Tumors)"},{"deathsNumAffected":0,"deathsNumAtRisk":36,"description":"Patients start with either 2 drug or three drug chemotherapy (Regimen VA, VAD) and are evaluated a 6 and 12 weeks for feasibility of undergoing a partial nephrectomy. At week 12 definitive surgery takes place followed by chemotherapy.\n\nDactinomycin: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nRadiation Therapy: Undergo radiation therapy\n\nTherapeutic Conventional Surgery: Undergo surgical resection\n\nVincristine Sulfate: Given IV","id":"EG001","otherNumAffected":1,"otherNumAtRisk":36,"seriousNumAffected":1,"seriousNumAtRisk":36,"title":"Arm 2 (Unilateral High Risk Tumors Bilaterally Predisposed)"},{"deathsNumAffected":0,"deathsNumAtRisk":9,"description":"Patients with this rare disease are diagnosed based on cross-sectional imaging characteristics and undergo 2 drug chemotherapy (Regimen;VA). Patients are reassessed at 6 weeks and 12 weeks. If disease has responded or stayed stable chemotherapy is completed for 19 weeks (Regimen EE4A). If disease has progress a biopsy is performed to assess histology and adjust therapy based on the biopsy. This therapy may include, nephrectomy, chemotherapy or radiation therapy.\n\nDactinomycin: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nRadiation Therapy: Undergo radiation therapy\n\nTherapeutic Conventional Surgery: Undergo surgical resection\n\nVincristine Sulfate: Given IV","id":"EG002","otherNumAffected":0,"otherNumAtRisk":9,"seriousNumAffected":0,"seriousNumAtRisk":9,"title":"Arm 3 (DHPLN)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCv4","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":189,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":36,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":9,"numEvents":0}],"term":"10300-Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition 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