{"description":"Both serious and non-serious AEs were collected. We reported SAEs and all AEs. Non serious AEs are accounted for in the all AEs report. All AEs report is included in the Other (Not Including Serious) section. All-cause mortality was assessed in the intent to treat population defined as all randomized patients. SAEs and all AEs were assessed in the randomized patients who have started their allocated treatments","eventGroups":[{"deathsNumAffected":107,"deathsNumAtRisk":189,"description":"radiation therapy alone\n\nDNA methylation analysis: MGMT methylation status is used for stratification at randomization.\n\nlaboratory biomarker analysis: Prognostic factor analyses\n\nquality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression\n\nradiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule","id":"EG000","otherNumAffected":182,"otherNumAtRisk":186,"seriousNumAffected":13,"seriousNumAtRisk":186,"title":"RT Alone"},{"deathsNumAffected":97,"deathsNumAtRisk":188,"description":"Radiotherapy and concurrent temozolomide chemotherapy\n\ntemozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.\n\nDNA methylation analysis: MGMT methylation status is used for stratification at randomization.\n\nlaboratory biomarker analysis: Prognostic factor analyses\n\nquality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression\n\nradiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule","id":"EG001","otherNumAffected":183,"otherNumAtRisk":185,"seriousNumAffected":27,"seriousNumAtRisk":185,"title":"RT & Concurrent CT"},{"deathsNumAffected":78,"deathsNumAtRisk":186,"description":"Radiotherapy plus adjuvant temozolomide chemotherapy\n\ntemozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.\n\nDNA methylation analysis: MGMT methylation status is used for stratification at randomization.\n\nlaboratory biomarker analysis: Prognostic factor analyses\n\nadjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.\n\nquality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression\n\nradiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule","id":"EG002","otherNumAffected":182,"otherNumAtRisk":183,"seriousNumAffected":32,"seriousNumAtRisk":183,"title":"RT + Adjuvant CT"},{"deathsNumAffected":74,"deathsNumAtRisk":188,"description":"Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy\n\ntemozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.\n\nDNA methylation analysis: MGMT methylation status is used for stratification at randomization.\n\nlaboratory biomarker analysis: Prognostic factor analyses\n\nadjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy.\n\nquality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression\n\nradiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule","id":"EG003","otherNumAffected":185,"otherNumAtRisk":185,"seriousNumAffected":32,"seriousNumAtRisk":185,"title":"RT & Concurrent CT + Adjuvant CT"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":186},{"groupId":"EG001","numAffected":7,"numAtRisk":185},{"groupId":"EG002","numAffected":5,"numAtRisk":183},{"groupId":"EG003","numAffected":7,"numAtRisk":185}],"term":"VASCULAR"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":186},{"groupId":"EG001","numAffected":0,"numAtRisk":185},{"groupId":"EG002","numAffected":0,"numAtRisk":183},{"groupId":"EG003","numAffected":0,"numAtRisk":185}],"term":"SURGERY/INTRA-OPERATIVE INJURY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":186},{"groupId":"EG001","numAffected":9,"numAtRisk":185},{"groupId":"EG002","numAffected":11,"numAtRisk":183},{"groupId":"EG003","numAffected":9,"numAtRisk":185}],"term":"ALLERGY/IMMUNOLOGY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":151,"numAtRisk":186},{"groupId":"EG001","numAffected":160,"numAtRisk":185},{"groupId":"EG002","numAffected":170,"numAtRisk":183},{"groupId":"EG003","numAffected":160,"numAtRisk":185}],"term":"CONSTITUTIONAL SYMPTOMS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":129,"numAtRisk":186},{"groupId":"EG001","numAffected":131,"numAtRisk":185},{"groupId":"EG002","numAffected":138,"numAtRisk":183},{"groupId":"EG003","numAffected":131,"numAtRisk":185}],"term":"PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":186},{"groupId":"EG001","numAffected":4,"numAtRisk":185},{"groupId":"EG002","numAffected":7,"numAtRisk":183},{"groupId":"EG003","numAffected":4,"numAtRisk":185}],"term":"SEXUAL/REPRODUCTIVE FUNCTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":186},{"groupId":"EG001","numAffected":15,"numAtRisk":185},{"groupId":"EG002","numAffected":17,"numAtRisk":183},{"groupId":"EG003","numAffected":15,"numAtRisk":185}],"term":"CARDIAC(GENERAL)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":186},{"groupId":"EG001","numAffected":9,"numAtRisk":185},{"groupId":"EG002","numAffected":17,"numAtRisk":183},{"groupId":"EG003","numAffected":9,"numAtRisk":185}],"term":"PULMONARY/UPPER RESPIRATORY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":186},{"groupId":"EG001","numAffected":12,"numAtRisk":185},{"groupId":"EG002","numAffected":10,"numAtRisk":183},{"groupId":"EG003","numAffected":12,"numAtRisk":185}],"term":"BLOOD"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":186},{"groupId":"EG001","numAffected":10,"numAtRisk":185},{"groupId":"EG002","numAffected":14,"numAtRisk":183},{"groupId":"EG003","numAffected":10,"numAtRisk":185}],"term":"LYMPHATICS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":147,"numAtRisk":186},{"groupId":"EG001","numAffected":153,"numAtRisk":185},{"groupId":"EG002","numAffected":148,"numAtRisk":183},{"groupId":"EG003","numAffected":153,"numAtRisk":185}],"term":"NEUROLOGY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":186},{"groupId":"EG001","numAffected":62,"numAtRisk":185},{"groupId":"EG002","numAffected":48,"numAtRisk":183},{"groupId":"EG003","numAffected":62,"numAtRisk":185}],"term":"OCULAR/VISUAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":186},{"groupId":"EG001","numAffected":23,"numAtRisk":185},{"groupId":"EG002","numAffected":33,"numAtRisk":183},{"groupId":"EG003","numAffected":23,"numAtRisk":185}],"term":"AUDITORY/EAR"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":107,"numAtRisk":186},{"groupId":"EG001","numAffected":136,"numAtRisk":185},{"groupId":"EG002","numAffected":158,"numAtRisk":183},{"groupId":"EG003","numAffected":136,"numAtRisk":185}],"term":"GASTROINTESTINAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":186},{"groupId":"EG001","numAffected":7,"numAtRisk":185},{"groupId":"EG002","numAffected":16,"numAtRisk":183},{"groupId":"EG003","numAffected":7,"numAtRisk":185}],"term":"RENAL/GENITOURINARY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":186},{"groupId":"EG001","numAffected":0,"numAtRisk":185},{"groupId":"EG002","numAffected":0,"numAtRisk":183},{"groupId":"EG003","numAffected":0,"numAtRisk":185}],"term":"HEPATOBILIAR/PANCREAS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":146,"numAtRisk":186},{"groupId":"EG001","numAffected":139,"numAtRisk":185},{"groupId":"EG002","numAffected":147,"numAtRisk":183},{"groupId":"EG003","numAffected":139,"numAtRisk":185}],"term":"DERMATOLOGY/SKIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":186},{"groupId":"EG001","numAffected":17,"numAtRisk":185},{"groupId":"EG002","numAffected":23,"numAtRisk":183},{"groupId":"EG003","numAffected":17,"numAtRisk":185}],"term":"MUSCULOSKELETAL/SOFT TISSUE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":186},{"groupId":"EG001","numAffected":8,"numAtRisk":185},{"groupId":"EG002","numAffected":9,"numAtRisk":183},{"groupId":"EG003","numAffected":8,"numAtRisk":185}],"term":"ENDOCRINE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":186},{"groupId":"EG001","numAffected":7,"numAtRisk":185},{"groupId":"EG002","numAffected":8,"numAtRisk":183},{"groupId":"EG003","numAffected":7,"numAtRisk":185}],"term":"METABOLIC/LABORATORY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":186},{"groupId":"EG001","numAffected":35,"numAtRisk":185},{"groupId":"EG002","numAffected":72,"numAtRisk":183},{"groupId":"EG003","numAffected":35,"numAtRisk":185}],"term":"INFECTION"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":186},{"groupId":"EG001","numAffected":1,"numAtRisk":185},{"groupId":"EG002","numAffected":1,"numAtRisk":183},{"groupId":"EG003","numAffected":0,"numAtRisk":185}],"term":"VASCULAR"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":186},{"groupId":"EG001","numAffected":0,"numAtRisk":185},{"groupId":"EG002","numAffected":2,"numAtRisk":183},{"groupId":"EG003","numAffected":2,"numAtRisk":185}],"term":"ALLERGY/IMMUNOLOGY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":186},{"groupId":"EG001","numAffected":7,"numAtRisk":185},{"groupId":"EG002","numAffected":2,"numAtRisk":183},{"groupId":"EG003","numAffected":2,"numAtRisk":185}],"term":"CONSTITUTIONAL SYMPTOMS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":186},{"groupId":"EG001","numAffected":2,"numAtRisk":185},{"groupId":"EG002","numAffected":4,"numAtRisk":183},{"groupId":"EG003","numAffected":3,"numAtRisk":185}],"term":"PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":186},{"groupId":"EG001","numAffected":0,"numAtRisk":185},{"groupId":"EG002","numAffected":0,"numAtRisk":183},{"groupId":"EG003","numAffected":1,"numAtRisk":185}],"term":"CARDIAC(GENERAL)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":186},{"groupId":"EG001","numAffected":2,"numAtRisk":185},{"groupId":"EG002","numAffected":2,"numAtRisk":183},{"groupId":"EG003","numAffected":5,"numAtRisk":185}],"term":"BLOOD"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":186},{"groupId":"EG001","numAffected":0,"numAtRisk":185},{"groupId":"EG002","numAffected":1,"numAtRisk":183},{"groupId":"EG003","numAffected":0,"numAtRisk":185}],"term":"LYMPHATICS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":186},{"groupId":"EG001","numAffected":0,"numAtRisk":185},{"groupId":"EG002","numAffected":0,"numAtRisk":183},{"groupId":"EG003","numAffected":1,"numAtRisk":185}],"term":"PULMONARY/UPPER RESPIRATORY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":186},{"groupId":"EG001","numAffected":15,"numAtRisk":185},{"groupId":"EG002","numAffected":12,"numAtRisk":183},{"groupId":"EG003","numAffected":10,"numAtRisk":185}],"term":"NEUROLOGY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":186},{"groupId":"EG001","numAffected":2,"numAtRisk":185},{"groupId":"EG002","numAffected":0,"numAtRisk":183},{"groupId":"EG003","numAffected":1,"numAtRisk":185}],"term":"OCULAR/VISUAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":186},{"groupId":"EG001","numAffected":2,"numAtRisk":185},{"groupId":"EG002","numAffected":4,"numAtRisk":183},{"groupId":"EG003","numAffected":5,"numAtRisk":185}],"term":"GASTROINTESTINAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":186},{"groupId":"EG001","numAffected":0,"numAtRisk":185},{"groupId":"EG002","numAffected":1,"numAtRisk":183},{"groupId":"EG003","numAffected":1,"numAtRisk":185}],"term":"RENAL/GENITOURINARY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":186},{"groupId":"EG001","numAffected":2,"numAtRisk":185},{"groupId":"EG002","numAffected":0,"numAtRisk":183},{"groupId":"EG003","numAffected":2,"numAtRisk":185}],"term":"DERMATOLOGY/SKIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":186},{"groupId":"EG001","numAffected":0,"numAtRisk":185},{"groupId":"EG002","numAffected":1,"numAtRisk":183},{"groupId":"EG003","numAffected":0,"numAtRisk":185}],"term":"MUSCULOSKELETAL/SOFT TISSUE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":186},{"groupId":"EG001","numAffected":2,"numAtRisk":185},{"groupId":"EG002","numAffected":1,"numAtRisk":183},{"groupId":"EG003","numAffected":1,"numAtRisk":185}],"term":"METABOLIC/LABORATORY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":186},{"groupId":"EG001","numAffected":4,"numAtRisk":185},{"groupId":"EG002","numAffected":8,"numAtRisk":183},{"groupId":"EG003","numAffected":6,"numAtRisk":185}],"term":"INFECTION"}],"timeFrame":"Adverse Events (AEs) were collected from first dose of radiotherapy up to 14.5 months after patient enrolment in the study. All-Cause Mortality was assessed through study completion, up to 10.9 years after patient enrolment in the study."}