{"description":"There were 341 patients randomized to Durvalumab + Gemcitabine + Cisplatin and 344 patients randomized to Placebo + Gemcitabine + Cisplatin (Full Analysis Set). Five of these patients did not receive treatment (resulting in 338 in Durvalumab arm and 342 in Placebo arm for Safety Analysis Set). Hence, the Total numbers at risk for all-cause mortality is 341 (Durvalumab) and 344 (Placebo), while the Total number at Risk by any Serious/Other Adverse Event is 338 (Durvalumab) and 342 (Placebo).","eventGroups":[{"deathsNumAffected":308,"deathsNumAtRisk":341,"description":"Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.","id":"EG000","otherNumAffected":326,"otherNumAtRisk":338,"seriousNumAffected":168,"seriousNumAtRisk":338,"title":"Durvalumab + Gemcitabine + Cisplatin"},{"deathsNumAffected":326,"deathsNumAtRisk":344,"description":"Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.","id":"EG001","otherNumAffected":330,"otherNumAtRisk":342,"seriousNumAffected":152,"seriousNumAtRisk":342,"title":"Placebo + Gemcitabine + Cisplatin"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":338,"numEvents":29},{"groupId":"EG001","numAffected":20,"numAtRisk":342,"numEvents":22}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":338,"numEvents":41},{"groupId":"EG001","numAffected":34,"numAtRisk":342,"numEvents":44}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":338,"numEvents":35},{"groupId":"EG001","numAffected":31,"numAtRisk":342,"numEvents":39}],"term":"Aspartate aminotransferase 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