{"description":"Treated set (TS): all patients who were administered trial medication.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":1,"description":"Intravenous infusion of BI 836909 (0.2 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.","id":"EG000","otherNumAffected":1,"otherNumAtRisk":1,"seriousNumAffected":1,"seriousNumAtRisk":1,"title":"Intravenous Infusion of BI 836909 (0.2 μg/d)"},{"deathsNumAffected":0,"deathsNumAtRisk":1,"description":"Intravenous infusion of BI 836909 (0.4 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.","id":"EG001","otherNumAffected":1,"otherNumAtRisk":1,"seriousNumAffected":0,"seriousNumAtRisk":1,"title":"Intravenous Infusion of BI 836909 (0.4 μg/d)"},{"deathsNumAffected":0,"deathsNumAtRisk":2,"description":"Intravenous infusion of BI 836909 (0.8 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.","id":"EG002","otherNumAffected":1,"otherNumAtRisk":2,"seriousNumAffected":1,"seriousNumAtRisk":2,"title":"Intravenous Infusion of BI 836909 (0.8 μg/d)"},{"deathsNumAffected":0,"deathsNumAtRisk":1,"description":"Intravenous infusion of BI 836909 (1.6 Microgram Per Day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.","id":"EG003","otherNumAffected":1,"otherNumAtRisk":1,"seriousNumAffected":0,"seriousNumAtRisk":1,"title":"Intravenous Infusion of BI 836909 (1.6 μg/d)"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Intravenous infusion of BI 836909 (3.2 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.","id":"EG004","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"Intravenous Infusion of BI 836909 (3.2 μg/d)"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Intravenous infusion of BI 836909 (6.5 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.","id":"EG005","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":3,"seriousNumAtRisk":3,"title":"Intravenous Infusion of BI 836909 (6.5 μg/d)"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Intravenous infusion of BI 836909 (13 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.","id":"EG006","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"Intravenous Infusion of BI 836909 (13 μg/d)"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Intravenous infusion of BI 836909 (25 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.","id":"EG007","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"Intravenous Infusion of BI 836909 (25 μg/d)"},{"deathsNumAffected":1,"deathsNumAtRisk":5,"description":"Intravenous infusion of BI 836909 (50 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.","id":"EG008","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":3,"seriousNumAtRisk":5,"title":"Intravenous Infusion of BI 836909 (50 μg/d)"},{"deathsNumAffected":0,"deathsNumAtRisk":4,"description":"Intravenous infusion of BI 836909 (100 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.","id":"EG009","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":2,"seriousNumAtRisk":4,"title":"Intravenous Infusion of BI 836909 (100 μg/d)"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Intravenous infusion of BI 836909 (200 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.","id":"EG010","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":3,"seriousNumAtRisk":3,"title":"Intravenous Infusion of BI 836909 (200 μg/d)"},{"deathsNumAffected":1,"deathsNumAtRisk":10,"description":"Intravenous infusion of BI 836909 (400 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.","id":"EG011","otherNumAffected":10,"otherNumAtRisk":10,"seriousNumAffected":8,"seriousNumAtRisk":10,"title":"Intravenous Infusion of BI 836909 (400 μg/d)"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Intravenous infusion of BI 836909 (800 microgram per day (μg/d)). BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable adverse events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles.","id":"EG012","otherNumAffected":2,"otherNumAtRisk":3,"seriousNumAffected":3,"seriousNumAtRisk":3,"title":"Intravenous Infusion of BI 836909 (800 μg/d)"},{"deathsNumAffected":2,"deathsNumAtRisk":42,"description":"BI 836909 was administered as 4-week continuous intravenous infusion (c.i.v.) followed by a 2-week treatment break for 5 cycles or until progression, unacceptable Adverse Events, or any other reason necessitating withdrawal. In case of ongoing clinical benefit and if considered indicated by the investigator, 5 additional treatment cycles could be done, leading to a maximum of 10 cycles. The first 4 dose levels (0.2, 0.4,0.8, and 1.6 Microgram Per Day (μg/d)) were tested in single patient cohorts. Dose levels ≥3.2 μg/d (3.2, 6.5, 13, 25, 50, 100, 200, 400, and 800 μg/d) were tested in a 3+3 design.","id":"EG013","otherNumAffected":40,"otherNumAtRisk":42,"seriousNumAffected":27,"seriousNumAtRisk":42,"title":"Intravenous Infusion of BI 836909 (Total Dose Escalation)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":3},{"groupId":"EG006","numAffected":0,"numAtRisk":3},{"groupId":"EG007","numAffected":0,"numAtRisk":3},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":3},{"groupId":"EG011","numAffected":0,"numAtRisk":10},{"groupId":"EG012","numAffected":0,"numAtRisk":3},{"groupId":"EG013","numAffected":1,"numAtRisk":42}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 22.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":3},{"groupId":"EG005","numAffected":0,"numAtRisk":3},{"groupId":"EG006","numAffected":0,"numAtRisk":3},{"groupId":"EG007","numAffected":0,"numAtRisk":3},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":3},{"groupId":"EG011","numAffected":0,"numAtRisk":10},{"groupId":"EG012","numAffected":0,"numAtRisk":3},{"groupId":"EG013","numAffected":1,"numAtRisk":42}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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