{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}],"title":"Grade 1"},{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"4"}],"title":"Grade 2"},{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"8"}],"title":"Grade 3"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}],"title":"Grade 4"},{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}],"title":"Grade 5"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}],"title":"No Adverse Events Reported"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"description":"Adverse events were summarized by maximum reported Common Terminology Criteria for Adverse Event (CTCAE) grade, version 5.0.\n\nGrade 1 (Mild): asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.\n\nGrade 2 (Moderate): minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living.\n\nGrade 3 (Severe or medically significant but not immediately life-threatening): hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living.\n\nGrade 4 (Life-threatening consequences): urgent intervention indicated.\n\nGrade 5: Death related to AE.\n\nIncludes adverse events with onset date on or after the date of first dose and up to and including 28 days following discontinuation of treatment but prior to the start of a new anti-cancer therapy.","groups":[{"description":"Osimertinib (AZD9291) 80 mg once daily (QD) with Carboplatin (AUC of 5 mg/mL/min \\[AUC5\\]) and Pemetrexed (500 mg/m2), both administered every 3 weeks (Q3W) for 4 cycles, followed by Osimertinib 80 mg once daily plus Pemetrexed maintenance (500 mg/m2) Q3W","id":"OG000","title":"Safety Run-In: AZD9291 + Carboplatin + Pemetrexed"},{"description":"Osimertinib (AZD9291) 80 mg once daily (QD) with Cisplatin (75 mg/m2) and Pemetrexed (500 mg/m2), both administered every 3 weeks (Q3W) for 4 cycles, followed by Osimertinib 80 mg once daily plus Pemetrexed maintenance (500 mg/m2) Q3W","id":"OG001","title":"Safety Run-In: AZD9291 + Cisplatin + Pemetrexed"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Participants from the Safety Analysis Set, which includes all participants in the Safety Run-In Treatment Arms who received at least 1 dose of study treatment (osimertinib, cisplatin, carboplatin, or pemetrexed).","reportingStatus":"POSTED","timeFrame":"From first dose date to 28 days following last dose, up to 45 months","title":"Adverse Events Graded by Common Terminology Criteria for Adverse Event v5 (Safety Run-In Treatment Arms Only)","type":"PRIMARY","unitOfMeasure":"Participants"}