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subcutaneous tissue disorders - Other, specify"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":160},{"groupId":"EG001","numAffected":1,"numAtRisk":158},{"groupId":"EG002","numAffected":0,"numAtRisk":174},{"groupId":"EG003","numAffected":0,"numAtRisk":180}],"term":"Skin ulceration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":160},{"groupId":"EG001","numAffected":0,"numAtRisk":158},{"groupId":"EG002","numAffected":0,"numAtRisk":174},{"groupId":"EG003","numAffected":1,"numAtRisk":180}],"term":"Capillary leak syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 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(4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":160},{"groupId":"EG001","numAffected":0,"numAtRisk":158},{"groupId":"EG002","numAffected":0,"numAtRisk":174},{"groupId":"EG003","numAffected":1,"numAtRisk":180}],"term":"Phlebitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":160},{"groupId":"EG001","numAffected":2,"numAtRisk":158},{"groupId":"EG002","numAffected":3,"numAtRisk":174},{"groupId":"EG003","numAffected":0,"numAtRisk":180}],"term":"Thromboembolic event"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":160},{"groupId":"EG001","numAffected":1,"numAtRisk":158},{"groupId":"EG002","numAffected":1,"numAtRisk":174},{"groupId":"EG003","numAffected":0,"numAtRisk":180}],"term":"Vascular disorders - Other, specify"}],"timeFrame":"Arms I and II: From step 1 randomization (gemcitabine versus vs. gemcitabine/erlotinib) to the date of last follow-up. Maximum follow-up at the time of the phase II analysis was 6.2 years. Arms III and IV: From the date of enrollment to the date of last follow-up. Maximum follow-up at time of phase III analysis was 13.2 years."}