{"description":"The frequencies of any serious adverse event or other adverse events (grade 2 or higher) by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported. Adverse events were collected by Organ System Class.","eventGroups":[{"description":"Arm 1: Methotrexate 30 mg/m2 IM weekly","id":"EG000","otherNumAffected":50,"otherNumAtRisk":107,"seriousNumAffected":0,"seriousNumAtRisk":107,"title":"Arm 1: Methotrexate 30 mg/m2 IM Weekly"},{"description":"Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks","id":"EG001","otherNumAffected":68,"otherNumAtRisk":107,"seriousNumAffected":1,"seriousNumAtRisk":107,"title":"Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":107},{"groupId":"EG001","numAffected":7,"numAtRisk":107}],"term":"Leukopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":107},{"groupId":"EG001","numAffected":20,"numAtRisk":107}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":107},{"groupId":"EG001","numAffected":1,"numAtRisk":107}],"term":"Thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":107},{"groupId":"EG001","numAffected":14,"numAtRisk":107}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":107},{"groupId":"EG001","numAffected":1,"numAtRisk":107}],"term":"Other Hemotologic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":107},{"groupId":"EG001","numAffected":0,"numAtRisk":107}],"term":"Allergy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":107},{"groupId":"EG001","numAffected":1,"numAtRisk":107}],"term":"Auditory"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":107},{"groupId":"EG001","numAffected":2,"numAtRisk":107}],"term":"Cardiovascular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":107},{"groupId":"EG001","numAffected":0,"numAtRisk":107}],"term":"Coagulation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":107},{"groupId":"EG001","numAffected":15,"numAtRisk":107}],"term":"Constitutional"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":107},{"groupId":"EG001","numAffected":0,"numAtRisk":107}],"term":"Dermatologic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":107},{"groupId":"EG001","numAffected":2,"numAtRisk":107}],"term":"Endocrine"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":107},{"groupId":"EG001","numAffected":14,"numAtRisk":107}],"term":"Gastrointestinal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":107},{"groupId":"EG001","numAffected":21,"numAtRisk":107}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":107},{"groupId":"EG001","numAffected":14,"numAtRisk":107}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":107},{"groupId":"EG001","numAffected":1,"numAtRisk":107}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":107},{"groupId":"EG001","numAffected":1,"numAtRisk":107}],"term":"Stomatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":107},{"groupId":"EG001","numAffected":0,"numAtRisk":107}],"term":"Genitourinary/Renal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":107},{"groupId":"EG001","numAffected":13,"numAtRisk":107}],"term":"Hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":107},{"groupId":"EG001","numAffected":3,"numAtRisk":107}],"term":"Hepatic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":107},{"groupId":"EG001","numAffected":4,"numAtRisk":107}],"term":"Infection/Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":107},{"groupId":"EG001","numAffected":2,"numAtRisk":107}],"term":"Metabolic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":107},{"groupId":"EG001","numAffected":0,"numAtRisk":107}],"term":"Musculoskeletal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":107},{"groupId":"EG001","numAffected":5,"numAtRisk":107}],"term":"Neurologic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":107},{"groupId":"EG001","numAffected":4,"numAtRisk":107}],"term":"Ocular/Visual"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":107},{"groupId":"EG001","numAffected":14,"numAtRisk":107}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":107},{"groupId":"EG001","numAffected":8,"numAtRisk":107}],"term":"Pulmonary"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":107},{"groupId":"EG001","numAffected":1,"numAtRisk":107}],"term":"Sexual"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":107},{"groupId":"EG001","numAffected":1,"numAtRisk":107}],"term":"Dyspnea"}],"timeFrame":"Through Study completion, an average of 7 months."}