{"description":"At each visit the investigator documented any occurrence of adverse events and clinically significant abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety analysis set included all enrolled participants who received at least 1 dose of study drug.","eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":4,"description":"Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.","id":"EG000","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":0,"seriousNumAtRisk":4,"title":"Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.","id":"EG001","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"title":"Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg"},{"deathsNumAffected":7,"deathsNumAtRisk":12,"description":"Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.","id":"EG002","otherNumAffected":12,"otherNumAtRisk":12,"seriousNumAffected":1,"seriousNumAtRisk":12,"title":"Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg"},{"deathsNumAffected":6,"deathsNumAtRisk":22,"description":"Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.","id":"EG003","otherNumAffected":21,"otherNumAtRisk":22,"seriousNumAffected":8,"seriousNumAtRisk":22,"title":"Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg"},{"deathsNumAffected":1,"deathsNumAtRisk":3,"description":"Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.","id":"EG004","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg"},{"deathsNumAffected":1,"deathsNumAtRisk":6,"description":"Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.","id":"EG005","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":2,"seriousNumAtRisk":6,"title":"Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":2,"numAtRisk":22},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Abnormal loss of weight"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":3,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":3,"numAtRisk":12},{"groupId":"EG003","numAffected":4,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":2,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":4,"numAtRisk":12},{"groupId":"EG003","numAffected":5,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":2,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":2,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Blood pressure increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":2,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Bruxism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"COVID-19 pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Cancer pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Clavicle fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Coccydynia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":3,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":6}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Coronavirus test positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":3,"numAtRisk":12},{"groupId":"EG003","numAffected":2,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":6}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Cranial nerve paralysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":2,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":3,"numAtRisk":22},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Diverticulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Dyskinesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":2,"numAtRisk":12},{"groupId":"EG003","numAffected":2,"numAtRisk":22},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Early satiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Erectile dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":4,"numAtRisk":12},{"groupId":"EG003","numAffected":5,"numAtRisk":22},{"groupId":"EG004","numAffected":2,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":6}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Folliculitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Fungal skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":2,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Gingival pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":4,"numAtRisk":12},{"groupId":"EG003","numAffected":2,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":2,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":2,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":4,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":2,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":3,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Injection site haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":3,"numAtRisk":12},{"groupId":"EG003","numAffected":5,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Iron deficiency anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Joint range of motion decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Joint stiffness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Joint swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":2,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Ligament sprain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":6}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":2,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":2,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":3,"numAtRisk":12},{"groupId":"EG003","numAffected":3,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":6}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":2,"numAtRisk":22},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":6}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":3,"numAtRisk":6}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Nocturia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":4,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Oesophageal candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":2,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Pathological fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Peripheral swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Plasmacytoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Pleuritic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":3,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Pollakiuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":2,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Rash follicular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Rotator cuff syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Skin laceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Skin mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Sleep apnoea syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Soft tissue infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Spinal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Thermal burn"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":2,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Tongue ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Tooth infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":2,"numAtRisk":12},{"groupId":"EG003","numAffected":7,"numAtRisk":22},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":6}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Upper-airway cough syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":2,"numAtRisk":6}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Varicose vein"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Venous thrombosis limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Viral upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":1,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":2,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Vitamin D deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Vomiting"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":1,"numAtRisk":6}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":1,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Diverticulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Pancreatitis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Pathological fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":2,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":1,"numAtRisk":12},{"groupId":"EG003","numAffected":0,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Soft tissue infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4},{"groupId":"EG001","numAffected":0,"numAtRisk":3},{"groupId":"EG002","numAffected":0,"numAtRisk":12},{"groupId":"EG003","numAffected":1,"numAtRisk":22},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":6}],"term":"Urinary tract infection"}],"timeFrame":"From the first dose of study drug through 30 days after the last dose (up to approximately 3.7 years)"}