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disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":6}],"term":"Skin hyperpigmentation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":6}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":13},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":6}],"term":"Thromboembolic event"}],"timeFrame":"Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months."}