{"description":"CTCAE vr. 5 terms used","eventGroups":[{"deathsNumAffected":5,"deathsNumAtRisk":33,"description":"Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy.\n\nAcupuncture Therapy: Undergo acupuncture\n\nAcupressure Therapy: Undergo acupressure\n\nOral Cryotherapy: Undergo oral cryotherapy\n\nQuestionnaire Administration: Ancillary studies\n\nQuality-of-Life Assessment: Ancillary studies","id":"EG000","otherNumAffected":18,"otherNumAtRisk":33,"seriousNumAffected":0,"seriousNumAtRisk":33,"title":"Arm I (Acupuncture, Acupressure, Cryotherapy)"},{"deathsNumAffected":3,"deathsNumAtRisk":36,"description":"Patients undergo standard of care oral cryotherapy.\n\nOral Cryotherapy: Undergo oral cryotherapy\n\nQuestionnaire Administration: Ancillary studies\n\nQuality-of-Life Assessment: Ancillary studies","id":"EG001","otherNumAffected":26,"otherNumAtRisk":36,"seriousNumAffected":0,"seriousNumAtRisk":36,"title":"Arm II (Cryotherapy)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":33},{"groupId":"EG001","numAffected":22,"numAtRisk":36}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":33},{"groupId":"EG001","numAffected":26,"numAtRisk":36}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33},{"groupId":"EG001","numAffected":0,"numAtRisk":36}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Reported as Dry mouth; Mucositis oral; Oral pain; or Oral dysesthesia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":33},{"groupId":"EG001","numAffected":8,"numAtRisk":36}],"term":"Oral Symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Reported as Abdominal pain and Dyspepsia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":33},{"groupId":"EG001","numAffected":10,"numAtRisk":36}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"1 or more Events reported as Back pain, Muscle cramp, Pain in extremity, Non-cardiac chest pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33},{"groupId":"EG001","numAffected":7,"numAtRisk":36}],"term":"Other Body Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":33},{"groupId":"EG001","numAffected":5,"numAtRisk":36}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33},{"groupId":"EG001","numAffected":3,"numAtRisk":36}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":33},{"groupId":"EG001","numAffected":1,"numAtRisk":36}],"term":"Dysarthria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33},{"groupId":"EG001","numAffected":2,"numAtRisk":36}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":33},{"groupId":"EG001","numAffected":4,"numAtRisk":36}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33},{"groupId":"EG001","numAffected":8,"numAtRisk":36}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33},{"groupId":"EG001","numAffected":2,"numAtRisk":36}],"term":"Blurred Vision"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":33},{"groupId":"EG001","numAffected":13,"numAtRisk":36}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":33},{"groupId":"EG001","numAffected":16,"numAtRisk":36}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":33},{"groupId":"EG001","numAffected":5,"numAtRisk":36}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33},{"groupId":"EG001","numAffected":5,"numAtRisk":36}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":33},{"groupId":"EG001","numAffected":4,"numAtRisk":36}],"term":"Edema Limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":33},{"groupId":"EG001","numAffected":4,"numAtRisk":36}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":33},{"groupId":"EG001","numAffected":3,"numAtRisk":36}],"term":"Eye Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":33},{"groupId":"EG001","numAffected":2,"numAtRisk":36}],"term":"Gastroesophageal Reflux Disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":33},{"groupId":"EG001","numAffected":2,"numAtRisk":36}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":33},{"groupId":"EG001","numAffected":2,"numAtRisk":36}],"term":"Hot Flashes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33},{"groupId":"EG001","numAffected":3,"numAtRisk":36}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":33},{"groupId":"EG001","numAffected":12,"numAtRisk":36}],"term":"Paresthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33},{"groupId":"EG001","numAffected":3,"numAtRisk":36}],"term":"Peripheral Motor Neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":33},{"groupId":"EG001","numAffected":20,"numAtRisk":36}],"term":"Peripheral Sensory Neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33},{"groupId":"EG001","numAffected":3,"numAtRisk":36}],"term":"Rash Acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33},{"groupId":"EG001","numAffected":2,"numAtRisk":36}],"term":"Rhinorrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":33},{"groupId":"EG001","numAffected":2,"numAtRisk":36}],"term":"Small Intestinal Obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Any surgery or procedure completed","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":33},{"groupId":"EG001","numAffected":2,"numAtRisk":36}],"term":"Other Surgical and Medical Procedures"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":33},{"groupId":"EG001","numAffected":9,"numAtRisk":36}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33},{"groupId":"EG001","numAffected":0,"numAtRisk":36}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33},{"groupId":"EG001","numAffected":0,"numAtRisk":36}],"term":"Aspartate Aminotransferase Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33},{"groupId":"EG001","numAffected":1,"numAtRisk":36}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33},{"groupId":"EG001","numAffected":1,"numAtRisk":36}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33},{"groupId":"EG001","numAffected":1,"numAtRisk":36}],"term":"Hoarseness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33},{"groupId":"EG001","numAffected":1,"numAtRisk":36}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33},{"groupId":"EG001","numAffected":0,"numAtRisk":36}],"term":"Neutrophil Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33},{"groupId":"EG001","numAffected":0,"numAtRisk":36}],"term":"Platelet Count Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":33},{"groupId":"EG001","numAffected":1,"numAtRisk":36}],"term":"Rectal Hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33},{"groupId":"EG001","numAffected":0,"numAtRisk":36}],"term":"Sore Throat"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":33},{"groupId":"EG001","numAffected":0,"numAtRisk":36}],"term":"Upper Respiratory Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33},{"groupId":"EG001","numAffected":0,"numAtRisk":36}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":33},{"groupId":"EG001","numAffected":1,"numAtRisk":36}],"term":"White Blood Cell Decreased"}],"timeFrame":"22 weeks"}