{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Grade 3 Alkaline phosphatase increased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Grade 3 Anemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Grade 3 Aspartate aminotransferase increased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Grade 3 Cardiac troponin I increased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Grade 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"}],"units":"Participants"}],"description":"Safety of the combination of (1) CV301, (2) N-803 (Anktiva) and (3) M7824 (MSB0011359C) in participants with advanced small bowel and colorectal cancers was assessed using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.","groups":[{"description":"Carcinoembryonic antigen (CEA)/ Mucin 1 (MUC1) Vaccines + (M7824 (MSB0011359C) + N-803 (Anktiva) (Triple Therapy).\n\nCV301: CV301 vaccine consists of modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301). MVA-BN-CV301 (4 x 10\\^8 infectious units/0.5 mL each) will be administered as four subcutaneous (SC) injections on Day (D)1 and D15. Starting on D29, FPV-CV301 (1 x 10\\^9 infectious units/ 0.5mL) will be administered as a single subcutaneous injection every 4 weeks on Arm 1 or every 6 weeks on Arm 2A and 2B for up to one year.\n\nMSB0011359C: Participants will receive M7824 via intravenous (IV) infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a \"flat\" dose of 1,200 mg or 300 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter.\n\nN-803: N-803 will be given via subcutaneous injection at a dose of 15 mcg/kg every four weeks on Arm 1. N-803 will be administered at as dose of 10 (Micro)g/kg by SC injection every 4 weeks on Arm 2A and Arm 2B.","id":"OG000","title":"Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241)"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Date treatment consent signed to date off study, approximately 29 months and 1 day for Cohort 1, Arm 1.","title":"Number of Participants With Grade 3, Grade 4, and/or Grade 5 Adverse Events Related to Triple Therapy","type":"SECONDARY","unitOfMeasure":"Participants"}