{"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 MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.","id":"EG000","otherNumAffected":9,"otherNumAtRisk":9,"seriousNumAffected":0,"seriousNumAtRisk":9,"title":"Participants With Multiple Myeloma (MM)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9}],"term":"Paraesthesia oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Catheter site erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Catheter site related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Infusion site bruising"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9}],"term":"Injection site erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Vulvovaginal mycotic infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Heart rate irregular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Female- history of syphilis- previous treatment unknown. On Day 3 plerixafor therapy, tested positive for (1:16) rapid plasma reagin titer. Doxycycline given for 5 weeks. No post-treatment titer and no comment made at her 12-month follow-up visit.","organSystem":"Investigations","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Syphilis test positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Poor quality sleep"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Restlessness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Night sweats"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Swelling face"}],"timeFrame":"The first day of plerixafor administration up to the day prior to chemotherapy/ablative treatment."}