{"description":"SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.","eventGroups":[{"description":"Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.\n\ncixutumumab: Given IV\n\nlaboratory biomarker analysis: Correlative studies","id":"EG000","otherNumAffected":5,"otherNumAtRisk":10,"seriousNumAffected":7,"seriousNumAtRisk":10,"title":"Group 1 - Recurrent or Refractory Hepatoblastoma"},{"description":"Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.\n\ncixutumumab: Given IV\n\nlaboratory biomarker analysis: Correlative studies","id":"EG001","otherNumAffected":7,"otherNumAtRisk":10,"seriousNumAffected":3,"seriousNumAtRisk":10,"title":"Group 2 - Recurrent or Refractory Synovial Sarcoma"},{"description":"Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.\n\ncixutumumab: Given IV\n\nlaboratory biomarker analysis: Correlative studies","id":"EG002","otherNumAffected":14,"otherNumAtRisk":20,"seriousNumAffected":4,"seriousNumAtRisk":20,"title":"Group 3 - Recurrent or Refractory Rhabdomyosarcoma"},{"description":"Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.\n\ncixutumumab: Given IV\n\nlaboratory biomarker analysis: Correlative studies","id":"EG003","otherNumAffected":5,"otherNumAtRisk":10,"seriousNumAffected":5,"seriousNumAtRisk":10,"title":"Grp 4-Recurrent or Refractory Adrenocortical Carcinoma"},{"description":"Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.\n\ncixutumumab: Given IV\n\nlaboratory biomarker analysis: Correlative studies","id":"EG004","otherNumAffected":8,"otherNumAtRisk":13,"seriousNumAffected":5,"seriousNumAtRisk":13,"title":"Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor"},{"description":"Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.\n\ncixutumumab: Given IV\n\nlaboratory biomarker analysis: Correlative studies","id":"EG005","otherNumAffected":9,"otherNumAtRisk":20,"seriousNumAffected":5,"seriousNumAtRisk":20,"title":"Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease"},{"description":"Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.\n\ncixutumumab: Given IV\n\nlaboratory biomarker analysis: Correlative studies","id":"EG006","otherNumAffected":9,"otherNumAtRisk":10,"seriousNumAffected":4,"seriousNumAtRisk":10,"title":"Grp 7-Neuroblastoma With Measurable Disease"},{"description":"Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.\n\ncixutumumab: Given IV\n\nlaboratory biomarker analysis: Correlative studies","id":"EG007","otherNumAffected":5,"otherNumAtRisk":9,"seriousNumAffected":4,"seriousNumAtRisk":9,"title":"Group 8 - Recurrent Osteosarcoma"},{"description":"Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.\n\ncixutumumab: Given IV\n\nlaboratory biomarker analysis: Correlative studies","id":"EG008","otherNumAffected":9,"otherNumAtRisk":9,"seriousNumAffected":5,"seriousNumAtRisk":9,"title":"Group 9 - Recurrent or Refractory Wilms Tumor"},{"description":"Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.\n\ncixutumumab: Given IV\n\nlaboratory biomarker analysis: Correlative studies","id":"EG009","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Group 10 - Recurrent or Refractory Retinoblastoma"}],"frequencyThreshold":"0","otherEvents":[{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Abdominal pain"},{"organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Agitation"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":3,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":1,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Alanine aminotransferase increased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Alkaline phosphatase increased"},{"organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Allergic reaction"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Allergic rhinitis"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":4,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":2,"numAtRisk":13},{"groupId":"EG005","numAffected":2,"numAtRisk":20},{"groupId":"EG006","numAffected":2,"numAtRisk":10},{"groupId":"EG007","numAffected":2,"numAtRisk":9},{"groupId":"EG008","numAffected":2,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Anemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Anorexia"},{"organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Anxiety"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Arthralgia"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":2,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Aspartate aminotransferase increased"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Atelectasis"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":2,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":2,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Back pain"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":2,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Bladder infection"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Bladder spasm"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":1,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Blood bilirubin increased"},{"organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Bruising"},{"organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Burn"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Cognitive disturbance"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Cough"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Creatinine increased"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Cushingoid"},{"organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Cytokine release syndrome"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":2,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Dehydration"},{"organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Depression"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Diarrhea"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Dizziness"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Duodenal obstruction"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Dyspnea"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Endocrine disorders - Other"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Epistaxis"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Extrapyramidal disorder"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Eye infection"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":2,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":4,"numAtRisk":13},{"groupId":"EG005","numAffected":2,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Fatigue"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":1,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Fever"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Fibrinogen decreased"},{"organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Fracture"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Gait disturbance"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":3,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"GGT increased"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Headache"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":2,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":2,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":2,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hyperglycemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hyperkalemia"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hypertension"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hypertriglyceridemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":2,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":1,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hypoalbuminemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hypocalcemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hypoglycemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hypomagnesemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hyponatremia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":2,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hypophosphatemia"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hypoxia"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Joint effusion"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Lung infection"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":2,"numAtRisk":10},{"groupId":"EG002","numAffected":3,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":4,"numAtRisk":13},{"groupId":"EG005","numAffected":2,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":2,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Lymphocyte count decreased"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Memory impairment"},{"organSystem":"Ear and labyrinth disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Middle ear inflammation"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Mucositis oral"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Myalgia"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":2,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":1,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Nausea"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Neck pain"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":5,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":3,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":3,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Neutrophil count decreased"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Non-cardiac chest pain"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Otitis externa"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Otitis media"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Pain"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":2,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Pain in extremity"},{"organSystem":"Reproductive system and breast disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Pelvic pain"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Peripheral motor neuropathy"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":2,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":2,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Peripheral sensory neuropathy"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":2,"numAtRisk":13},{"groupId":"EG005","numAffected":4,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Platelet count decreased"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Proteinuria"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Pruritus"},{"organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Psychosis"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":2,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Purpura"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Rash maculo-papular"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Respiratory, thoracic and mediastinal disorders - Other"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Sinus tachycardia"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Sinusitis"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Skin infection"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Toothache"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Tracheitis"},{"organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Tumor pain"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":3,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Upper respiratory infection"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Urinary tract infection"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Urinary tract pain"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":2,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":1,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Vomiting"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":1,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Weight loss"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":4,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"White blood cell decreased"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Wound infection"}],"seriousEvents":[{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":2,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Abdominal pain"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Acidosis"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Alanine aminotransferase increased"},{"organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Anaphylaxis"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Anemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Anorexia"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Appendicitis"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Aspartate aminotransferase increased"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Asystole"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Back pain"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Bladder infection"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Chest wall pain"},{"organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Confusion"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Cough"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Creatinine increased"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Cystitis noninfective"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":1,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Death NOS"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Dehydration"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Device related infection"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Diarrhea"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Dry mouth"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Dyspnea"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Epistaxis"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Fatigue"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"GGT increased"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Headache"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hyperkalemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hypermagnesemia"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hypertension"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hyperuricemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hypoalbuminemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":1,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hypocalcemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hypoglycemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":2,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hypokalemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":1,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hypophosphatemia"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hypotension"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hypothyroidism"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Hypoxia"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":2,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Infections and infestations - Other"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"INR increased"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Intra-abdominal hemorrhage"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Investigations - Other"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":2,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Lymphocyte count decreased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":1,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Neutrophil count decreased"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Non-cardiac chest pain"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Pain"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":2,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Pain in extremity"},{"organSystem":"Reproductive system and breast disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Pelvic pain"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Peripheral sensory neuropathy"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":2,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":1,"numAtRisk":20},{"groupId":"EG006","numAffected":1,"numAtRisk":10},{"groupId":"EG007","numAffected":1,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Platelet count decreased"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":1,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Pleural effusion"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":1,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Pneumothorax"},{"organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Postoperative hemorrhage"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Proteinuria"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Renal and urinary disorders - Other"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Respiratory, thoracic and mediastinal disorders - Other"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Small intestinal obstruction"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Syncope"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Upper respiratory infection"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Urinary tract infection"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Urinary tract obstruction"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10},{"groupId":"EG002","numAffected":1,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":0,"numAtRisk":9},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"Vomiting"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10},{"groupId":"EG002","numAffected":0,"numAtRisk":20},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":13},{"groupId":"EG005","numAffected":0,"numAtRisk":20},{"groupId":"EG006","numAffected":0,"numAtRisk":10},{"groupId":"EG007","numAffected":1,"numAtRisk":9},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":0}],"term":"White blood cell decreased"}],"timeFrame":"Group 2, 12 enrolled 1 ineligible, 1 progressive disease prior to first dose of therapy. Group 3, 21 enrolled, 1 ineligible. Group 5, 14 enrolled, 1 ineligible. Group 8, 10 enrolled, 1 not evaluable (patient didn't receive any drug)."}