{"description":"Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm.\n\nAll-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.","eventGroups":[{"deathsNumAffected":161,"deathsNumAtRisk":2487,"description":"Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.","id":"EG000","otherNumAffected":151,"otherNumAtRisk":2062,"seriousNumAffected":14,"seriousNumAtRisk":2062,"title":"Chemo and Endocrine Therapy"},{"deathsNumAffected":175,"deathsNumAtRisk":2497,"description":"Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.","id":"EG001","otherNumAffected":2,"otherNumAtRisk":2342,"seriousNumAffected":9,"seriousNumAtRisk":2342,"title":"Endocrine Therapy Alone"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":151,"numAtRisk":2062},{"groupId":"EG001","numAffected":2,"numAtRisk":2342}],"term":"Neutrophil count decreased"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2062},{"groupId":"EG001","numAffected":0,"numAtRisk":2342}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":2062},{"groupId":"EG001","numAffected":2,"numAtRisk":2342}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2062},{"groupId":"EG001","numAffected":0,"numAtRisk":2342}],"term":"Gastrointestinal disorders-Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2062},{"groupId":"EG001","numAffected":0,"numAtRisk":2342}],"term":"Typhlitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2062},{"groupId":"EG001","numAffected":0,"numAtRisk":2342}],"term":"Upper gastrointestinal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2062},{"groupId":"EG001","numAffected":1,"numAtRisk":2342}],"term":"Death NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2062},{"groupId":"EG001","numAffected":1,"numAtRisk":2342}],"term":"Multi-organ failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2062},{"groupId":"EG001","numAffected":0,"numAtRisk":2342}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":2062},{"groupId":"EG001","numAffected":0,"numAtRisk":2342}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2062},{"groupId":"EG001","numAffected":0,"numAtRisk":2342}],"term":"Injury, poison and procedural complications - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2062},{"groupId":"EG001","numAffected":0,"numAtRisk":2342}],"term":"Leukemia secondary to oncology chemotherapy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2062},{"groupId":"EG001","numAffected":1,"numAtRisk":2342}],"term":"Neoplasms benign, malignant and unspecified - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2062},{"groupId":"EG001","numAffected":3,"numAtRisk":2342}],"term":"Stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Pregnancy, puerperium and perinatal conditions","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2062},{"groupId":"EG001","numAffected":1,"numAtRisk":2342}],"term":"Pregnancy, puerperium and perinatal conditions-Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":2062},{"groupId":"EG001","numAffected":0,"numAtRisk":2342}],"term":"Thromboembolic event"}],"timeFrame":"Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting."}