{"description":"Serious adverse events should be reported within 24 hours of learning of the occurrence. Non-serious adverse events and non-serious adverse device effects will be reported to Lumicell on the adverse events Case Report Forms during the study.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":357,"description":"The LUM Imaging Device was used to examine inside the lumpectomy cavity to determine if the dye indicated any areas that might contain residual tumor. If the imaging tested positive for the cancer cells remaining in the lumpectomy cavity, the surgeon would remove an additional piece of tissue. This process was continued until a negative reading from the device was obtained or a maximum of 2 shaves of additional tissue had been removed. Patients in this arm received the study drug, LUM015.\n\nStudy Device Arm: LUM015 was administered 2 to 6 hours prior to surgery. The LUM Imaging device was used to assist in the removal of additional tumor tissue.","id":"EG000","otherNumAffected":334,"otherNumAtRisk":357,"seriousNumAffected":3,"seriousNumAtRisk":357,"title":"Device Intervention: LUM Imaging System Used During Surgery"},{"deathsNumAffected":0,"deathsNumAtRisk":35,"description":"The LUM Imaging Device was not used to guide additional tissue removal. Patients in this arm will receive the study drug, LUM015.","id":"EG001","otherNumAffected":32,"otherNumAtRisk":35,"seriousNumAffected":0,"seriousNumAtRisk":35,"title":"Standard of Care Arm"},{"deathsNumAffected":0,"deathsNumAtRisk":14,"description":"All the patients injected with LUM015 but withdrawn before randomization.","id":"EG002","otherNumAffected":13,"otherNumAtRisk":14,"seriousNumAffected":2,"seriousNumAtRisk":14,"title":"Withdrawn Before Randomization"}],"frequencyThreshold":"1","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":325,"numAtRisk":357,"numEvents":325},{"groupId":"EG001","numAffected":30,"numAtRisk":35,"numEvents":30},{"groupId":"EG002","numAffected":13,"numAtRisk":14,"numEvents":13}],"term":"Chromaturia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":357,"numEvents":22},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":14,"numEvents":2}],"term":"Breast pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":357,"numEvents":11},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":357,"numEvents":10},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Procedural pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":357,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":357,"numEvents":6},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":357,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":357,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Ecchymosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":357,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":35,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":357,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":357,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":357,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Blood creatinine decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":357,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":35,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Extravasation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":357,"numEvents":22},{"groupId":"EG001","numAffected":3,"numAtRisk":35,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Seroma"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Breast cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Vascular pseudoaneurysm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":357,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA version 22.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":357,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":35,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Anaphylactic reaction"}],"timeFrame":"All adverse events and adverse device effects, both serious and non-serious, and deaths that are encountered from initiation of study intervention, throughout the study, and within the first post-operative follow-up visit should be followed to their resolution, or until the principal investigator assesses them as stable, or the principal investigator determines the event to be irreversible, or the subject is lost to follow-up. Adverse events were assessed up to 30 days after enrollment."}