{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":46,"description":"Bintrafusp alfa (M7824): 1200mg, over 60 minutes IV infusion The treatment will start within 1-5 days from enrollment. The treatment will be administered at day 1 of 14-day intervals .\n\nTreatment will be administered until unacceptable toxicity, loss of clinical benefit, disease progression or completion of 2 years of therapy. If the patient has benefit after 2 years, the trial chair and the sponsor must be consulted to evaluate how to continue with the treatment.","id":"EG000","otherNumAffected":16,"otherNumAtRisk":46,"seriousNumAffected":22,"seriousNumAtRisk":46,"title":"Experimental: Bintrafusp Alfa (M7824)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1}],"term":"Adrenal Insufficiency"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":46,"numEvents":5}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1}],"term":"Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1}],"term":"Allergic reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1}],"term":"Lipase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1}],"term":"Serum amylase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1}],"term":"Acute kidney injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2}],"term":"Rash maculo-papular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1}],"term":"Eczema"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1}],"term":"Acute kidney injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2}],"term":"Adrenal insufficiency"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1}],"term":"Allergic reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":46,"numEvents":9}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1}],"term":"Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46,"numEvents":1}],"term":"Rash maculo-papular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":46,"numEvents":2}],"term":"Eczema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":46,"numEvents":3}],"term":"Oher"}],"timeFrame":"Adverse events must be recorded and followed from the day patient signs the Informed consent for the study to 30 days from last dose of administration, up to 2 years."}