{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":48,"description":"The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grade superior or equal to 2 stomatitis injuries. The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by an abacus.\n\nlow level laser therapy","id":"EG000","otherNumAffected":23,"otherNumAtRisk":48,"seriousNumAffected":11,"seriousNumAtRisk":48,"title":"Laser Low-level Energy Functional"},{"deathsNumAffected":0,"deathsNumAtRisk":49,"description":"The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute.\n\nplacebo (laser low level energy nonfunctional)","id":"EG001","otherNumAffected":18,"otherNumAtRisk":49,"seriousNumAffected":8,"seriousNumAtRisk":49,"title":"Laser Low-level Energy Nonfunctional"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":48,"numEvents":23},{"groupId":"EG001","numAffected":18,"numAtRisk":49,"numEvents":18}],"term":"mucositis"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":49,"numEvents":2}],"term":"Implant site infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":49,"numEvents":0}],"term":"pneumopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":49,"numEvents":0}],"term":"Hypovolaemic shock"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":49,"numEvents":1}],"term":"mucite"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":49,"numEvents":0}],"term":"Hemorrhage symptom"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":49,"numEvents":1}],"term":"aphagia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":49,"numEvents":0}],"term":"Diabetic ketoacidosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":48,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":49,"numEvents":1}],"term":"Renal failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":49,"numEvents":0}],"term":"Arrest of urinary output"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":48,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":49,"numEvents":1}],"term":"stroke"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":49,"numEvents":1}],"term":"Acute respiratory distress syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":49,"numEvents":0}],"term":"pneumopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (10.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":49,"numEvents":1}],"term":"Hyperthermia"}],"timeFrame":"60 months"}