{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":20,"description":"Patients receive daratumumab and hyaluronidase-fihj SC over 3-5 minutes in the infusion center on day 1 of cycles 1, 2, 7, and 8 and at home on day 1 of cycles 3, 4, 5, and 6. 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polyps)","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"Neoplasms benign, malignant and unspecified- other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"bladder mass","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"Neoplasms benign, malignant and unspecified- other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"Oral pain (pain in lower jaw)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":20,"numEvents":9}],"term":"pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20,"numEvents":3}],"term":"Paresthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Teeth grinding","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"Gastrointestinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20,"numEvents":2}],"term":"Postnasal drip"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20,"numEvents":3}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20,"numEvents":2}],"term":"Rash Maculopapular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"rectal ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20,"numEvents":2}],"term":"sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"rash over leg, seems like bruising from seam of pants","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"Skin and subcutaneous disorders- other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"rash, drug eruption","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"Skin and subcutaneous disorders- other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"bilateral atopic dermatitis of the ear","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"Skin and subcutaneous disorders- other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"skin hyperpigmentation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"stomach pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":20,"numEvents":5}],"term":"upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20,"numEvents":2}],"term":"urinary frequency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"abnormal vision, floaters in the left eye, thinning of blood vessels","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"vascular disorders- other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"viremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"vision decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20,"numEvents":3}],"term":"vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"wheezing"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1}],"term":"stomach pain"}],"timeFrame":"The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, an average of 8 months. At each study visit, the investigator (or designee) will inquire about the occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until resolution or stabilization."}