{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"41"},{"groupId":"OG003","value":"31"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"19"},{"groupId":"OG006","value":"6"}]}],"title":">=1 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"40"},{"groupId":"OG003","value":"30"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"19"},{"groupId":"OG006","value":"6"}]}],"title":"Grade >=3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"24"},{"groupId":"OG003","value":"26"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"12"},{"groupId":"OG006","value":"4"}]}],"title":"Grade >=4"},{"categories":[{"measurements":[{"comment":"investigator misunderstanding of meaning","groupId":"OG000","value":"NA"},{"comment":"investigator misunderstanding of meaning","groupId":"OG001","value":"NA"},{"comment":"investigator misunderstanding of meaning","groupId":"OG002","value":"NA"},{"comment":"investigator misunderstanding of meaning","groupId":"OG003","value":"NA"},{"comment":"investigator misunderstanding of meaning","groupId":"OG004","value":"NA"},{"comment":"investigator misunderstanding of meaning","groupId":"OG005","value":"NA"},{"comment":"investigator misunderstanding of meaning","groupId":"OG006","value":"NA"}]}],"title":"Grade >=5"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"31"},{"groupId":"OG003","value":"23"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"11"},{"groupId":"OG006","value":"5"}]}],"title":"Serious AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"23"},{"groupId":"OG003","value":"7"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"7"},{"groupId":"OG006","value":"2"}]}],"title":"Leading to interruption of AMG 820"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"3"}]}],"title":"Leading to discontinuation AMG 820"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"2"}]}],"title":"---- SAE leading to d/c AMG 820"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"1"}]}],"title":"----Non-serious AE leading to d/c AMG 820"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"3"}]}],"title":"Leading to discontinuation of PEM"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"2"}]}],"title":"---- SAE leading to d/c PEM"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"1"}]}],"title":"----Non-serious AE leading to d/c PEM"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"2"}]}],"title":"Fatal TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"1"}]}],"title":"TEAE related to study procedure/activity"}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"41"},{"groupId":"OG003","value":"31"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"19"},{"groupId":"OG006","value":"6"}],"units":"Participants"}],"description":"TEAEs include any adverse event starting on or after the first dose of AMG 820 or pembrolizumab. Relation to study drugs was determined by the investigator. Adverse events (AEs) were graded by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, where Grade 1 = mild AE, Grade 2 = moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening AE, and Grade 5 = death due to AE. Errors in the case report form design resulted in investigators misunderstanding the CTCAE definition for severity grade 5. Therefore data are not reported for severity grade 5. Readers are referred to the 'Fatal TEAE' line in the table below for counts of participants who died during the TEAE timeframe.","groups":[{"description":"Part 1 Cohort 2 includes participants with advanced solid tumors who were treated with 1100 mg AMG 820 plus 200 mg pembrolizumab (Pem) every three weeks (Q3W) to determine safety. Participants could be treated up to 24 months if treatment was tolerable and clinical benefit was observed.","id":"OG000","title":"Part 1, Cohort 2: AMG 820 1100 mg + Pem 200 mg"},{"description":"Part 1 Cohort 1 includes participants with advanced solid tumors who were treated with 1400 mg AMG 820 plus 200 mg pembrolizumab (Pem) every three weeks (Q3W) to determine safety. Participants could be treated up to 24 months if treatment was tolerable and clinical benefit was observed.\n\nIf \\>= 3 participants had dose limiting toxicities (DLTs), a second cohort was created with a lower AMG 820 dose + Pem 200 mg.","id":"OG001","title":"Part 1, Cohort 1: AMG 820 1400 mg + Pem 200 mg"},{"description":"Group 1 is comprised of participants with colorectal cancer (CRC) who are proficient in mismatch repair genes (MMR).\n\nAMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.","id":"OG002","title":"Part 2, Group 1: CRC MMR-proficient"},{"description":"Group 2 is comprised of participants with advanced pancreatic cancer who are naïve to anti programmed-death 1 (PD-1), anti PD-ligand 1 (PD-L1), colony stimulating factor 1 (CSF-1) and colony stimulating factor 1 receptor (CSF-1R) therapies.\n\nAMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.","id":"OG003","title":"Part 2, Group 2: Pancreatic Cancer"},{"description":"Group 3 is comprised of participants with non-small cell lung cancer (NSCLC) who have low (\\< 50%) tumor PD-L1- expression and are naïve to anti-PD-1/PD-L1/CSF-1/CSF-1R agents.\n\nAMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.","id":"OG004","title":"Part 2, Group 3: NSCLC PD-L1 Low, Naïve"},{"description":"Group 4a is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have low PD-L1 tumor expression (\\<50%).\n\nAMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.","id":"OG005","title":"Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low"},{"description":"Group 4b is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have high PD-L1 tumor expression (\\>=50%).\n\nAMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.","id":"OG006","title":"Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Analysis Set","reportingStatus":"POSTED","timeFrame":"Day 1 up to 207 days for Part 1 and Day 1 up to 572 days for Part 2","title":"Participants With Treatment -Emergent Adverse Events (TEAEs)","type":"PRIMARY","unitOfMeasure":"Participants"}