{"description":"Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.","eventGroups":[{"deathsNumAffected":170,"deathsNumAtRisk":2426,"description":"Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily)\n\nLetrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously","id":"EG000","otherNumAffected":2257,"otherNumAtRisk":2411,"seriousNumAffected":1004,"seriousNumAtRisk":2411,"title":"Arm A: Continuous Letrozole"},{"deathsNumAffected":146,"deathsNumAtRisk":2425,"description":"Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\\> 36 mo) plus 1 x 12 mo in yr 5 -\\> 48 months\n\nLetrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\\> 36 mo) plus 1 x 12 mo in yr 5 -\\> 48 months","id":"EG001","otherNumAffected":2261,"otherNumAtRisk":2417,"seriousNumAffected":1052,"seriousNumAtRisk":2417,"title":"Arm B: Intermittent Letrozole"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":2411},{"groupId":"EG001","numAffected":23,"numAtRisk":2417}],"term":"Cardiac-ischemia/infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":1025,"numAtRisk":2411},{"groupId":"EG001","numAffected":954,"numAtRisk":2417}],"term":"Fatigue (asthenia, lethargy, malaise)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"NCI CTCAE 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V.3","stats":[{"groupId":"EG000","numAffected":634,"numAtRisk":2411},{"groupId":"EG001","numAffected":613,"numAtRisk":2417}],"term":"Pain - Bone"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":1506,"numAtRisk":2411},{"groupId":"EG001","numAffected":1453,"numAtRisk":2417}],"term":"Pain - Joint"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":841,"numAtRisk":2411},{"groupId":"EG001","numAffected":818,"numAtRisk":2417}],"term":"Pain - Muscle"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":2411},{"groupId":"EG001","numAffected":4,"numAtRisk":2417}],"term":"Hemorrhage, CNS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":2411},{"groupId":"EG001","numAffected":8,"numAtRisk":2417}],"term":"CNS cerebrovascular ischemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":983,"numAtRisk":2411},{"groupId":"EG001","numAffected":961,"numAtRisk":2417}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":767,"numAtRisk":2411},{"groupId":"EG001","numAffected":762,"numAtRisk":2417}],"term":"Mood alteration - depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":1240,"numAtRisk":2411},{"groupId":"EG001","numAffected":1217,"numAtRisk":2417}],"term":"Hot flashes/flushes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":539,"numAtRisk":2411},{"groupId":"EG001","numAffected":493,"numAtRisk":2417}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2411},{"groupId":"EG001","numAffected":1,"numAtRisk":2417}],"term":"Hemoglobin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":2411},{"groupId":"EG001","numAffected":2,"numAtRisk":2417}],"term":"Cardiac Arrhythmia-Other (Specify)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":2411},{"groupId":"EG001","numAffected":22,"numAtRisk":2417}],"term":"Cardiac-ischemia/infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2411},{"groupId":"EG001","numAffected":2,"numAtRisk":2417}],"term":"Conduction abnormality/Atrioventricular heart block - AV block-2nd degree Mobitz Type I (Wenckebach)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":2411},{"groupId":"EG001","numAffected":0,"numAtRisk":2417}],"term":"Conduction abnormality/Atrioventricular heart block - AV block-third degree (complete AV block)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2411},{"groupId":"EG001","numAffected":1,"numAtRisk":2417}],"term":"Conduction abnormality/Atrioventricular heart block - Wolff-Parkinson-White syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2411},{"groupId":"EG001","numAffected":0,"numAtRisk":2417}],"term":"Left ventricular diastolic dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":2411},{"groupId":"EG001","numAffected":3,"numAtRisk":2417}],"term":"Left ventricular systolic dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2411},{"groupId":"EG001","numAffected":0,"numAtRisk":2417}],"term":"Pain - Cardiac/heart"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2411},{"groupId":"EG001","numAffected":0,"numAtRisk":2417}],"term":"Pericardial effusion (non-malignant)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2411},{"groupId":"EG001","numAffected":2,"numAtRisk":2417}],"term":"Restrictive cardiomyopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2411},{"groupId":"EG001","numAffected":2,"numAtRisk":2417}],"term":"Right ventricular dysfunction (cor pulmonale)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":2411},{"groupId":"EG001","numAffected":17,"numAtRisk":2417}],"term":"Supraventricular and nodal arrhythmia - Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":2411},{"groupId":"EG001","numAffected":0,"numAtRisk":2417}],"term":"Supraventricular and nodal arrhythmia - Atrial flutter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":2411},{"groupId":"EG001","numAffected":1,"numAtRisk":2417}],"term":"Supraventricular and nodal arrhythmia - Atrial tachycardia/paroxysmal atrial tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2411},{"groupId":"EG001","numAffected":1,"numAtRisk":2417}],"term":"Supraventricular and nodal arrhythmia - Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2411},{"groupId":"EG001","numAffected":0,"numAtRisk":2417}],"term":"Supraventricular and nodal arrhythmia - Supraventricular arrhythmia NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2411},{"groupId":"EG001","numAffected":0,"numAtRisk":2417}],"term":"Supraventricular and nodal arrhythmia - Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":2411},{"groupId":"EG001","numAffected":6,"numAtRisk":2417}],"term":"Valvular heart disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2411},{"groupId":"EG001","numAffected":0,"numAtRisk":2417}],"term":"Ventricular arrhythmia - Ventricular arrhythmia NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":2411},{"groupId":"EG001","numAffected":1,"numAtRisk":2417}],"term":"Ventricular arrhythmia - Ventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":2411},{"groupId":"EG001","numAffected":8,"numAtRisk":2417}],"term":"Auditory/Ear-Other (Specify)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2411},{"groupId":"EG001","numAffected":1,"numAtRisk":2417}],"term":"Hearing: patients without baseline audiogram and not enrolled in a monitoring program"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2411},{"groupId":"EG001","numAffected":1,"numAtRisk":2417}],"term":"Thyroid function, high (hyperthyroidism, thyrotoxicosis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2411},{"groupId":"EG001","numAffected":2,"numAtRisk":2417}],"term":"Thyroid function, low (hypothyroidism)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine 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disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2411},{"groupId":"EG001","numAffected":3,"numAtRisk":2417}],"term":"Ocular/Visual-Other (Specify)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2411},{"groupId":"EG001","numAffected":0,"numAtRisk":2417}],"term":"Ophthalmoplegia/diplopia (double vision)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"NCI CTCAE V.3","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2411},{"groupId":"EG001","numAffected":1,"numAtRisk":2417}],"term":"Retinal detachment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"NCI CTCAE 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