{"description":"In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator (\"number of affected participants\") of both adverse event tables. Each AE table includes events, regardless of reported relationship to study treatment or grade.","eventGroups":[{"description":"Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\\*10\\^6 CD34+ cells/kg were collected.","id":"EG000","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":2,"seriousNumAtRisk":4,"title":"Non-Hodgkin's Lymphoma (NHL)"},{"description":"Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\\*10\\^6 CD34+ cells/kg were collected.","id":"EG001","otherNumAffected":20,"otherNumAtRisk":31,"seriousNumAffected":0,"seriousNumAtRisk":31,"title":"Multiple Myeloma (MM)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":2,"numAtRisk":31}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":31}],"term":"Lymphadenopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":2,"numAtRisk":31}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":2,"numAtRisk":31}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":3,"numAtRisk":31}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":3,"numAtRisk":31}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":31}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Catheter site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":3,"numAtRisk":31}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Bacterial infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Staphylococcal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Mouth injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":31}],"term":"Post procedural diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Procedural pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Blood potassium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"C-reactive protein increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":5,"numAtRisk":31}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":2,"numAtRisk":31}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Medical review concluded that this event, which was not related to study drug, would have been more appropriately coded to hypertension.","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Hypertonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Medical review concluded that this event, which was not related to study drug, would have been more appropriately coded to hypotension.","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Hypotonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":2,"numAtRisk":31}],"term":"Sleep disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Renal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Cardiovascular insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":31}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":31}],"term":"Diabetes mellitus non-insulin-dependent"}],"timeFrame":"First day of G-CSF administration to the day prior to chemotherapy/ablative treatment in preparation of first transplant. This period includes the G-CSF, plerixafor treatment and rest period."}