{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"82.11","value":"51.74"},{"groupId":"OG001","spread":"56.28","value":"52.42"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"217"},{"groupId":"OG001","value":"252"}],"units":"Participants"}],"title":"Day 22, pre-dose"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"81.57","value":"49.56"},{"groupId":"OG001","spread":"56.56","value":"52.78"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"221"},{"groupId":"OG001","value":"254"}],"units":"Participants"}],"title":"Day 22, 1-hour post-dose"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"80.80","value":"47.77"},{"groupId":"OG001","spread":"61.54","value":"43.89"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"206"},{"groupId":"OG001","value":"252"}],"units":"Participants"}],"title":"Day 43, pre-dose"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"80.00","value":"46.48"},{"groupId":"OG001","spread":"60.66","value":"44.89"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"208"},{"groupId":"OG001","value":"252"}],"units":"Participants"}],"title":"Day 43, 1-hour post-dose"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"71.52","value":"49.19"},{"groupId":"OG001","spread":"56.20","value":"47.14"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"195"},{"groupId":"OG001","value":"239"}],"units":"Participants"}],"title":"Day 43, 2-hour post-dose"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"67.61","value":"52.44"},{"groupId":"OG001","spread":"54.33","value":"50.92"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"192"},{"groupId":"OG001","value":"237"}],"units":"Participants"}],"title":"Day 43, 4-hour post-dose"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"65.94","value":"53.04"},{"groupId":"OG001","spread":"53.01","value":"50.89"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"187"},{"groupId":"OG001","value":"237"}],"units":"Participants"}],"title":"Day 43, 6-hour post-dose"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"64.86","value":"47.33"},{"groupId":"OG001","spread":"57.71","value":"41.09"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"150"},{"groupId":"OG001","value":"227"}],"units":"Participants"}],"title":"Day 106, pre-dose"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"65.49","value":"47.17"},{"groupId":"OG001","spread":"57.60","value":"41.30"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"223"}],"units":"Participants"}],"title":"Day 106, 1-hour post-dose"}],"denoms":[{"counts":[{"groupId":"OG000","value":"244"},{"groupId":"OG001","value":"263"}],"units":"Participants"}],"description":"An analysis will be performed to assess whether the plasma concentration of metabolite AZ5104 is affected when given with or without chemotherapy. Samples were collected pre-dose and 1-hour post-dose on day 22 and day 106; on day 43 samples were collected pre-dose and 1-, 2-, 4-, and 6-hours post-dose.","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Osimertinib (AZD9291) 80 mg in combination with pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles for 4 cycles, followed by Osimertinib (AZD9291) 80 mg QD with Pemetrexed maintenance (500 mg/m2) Q3W","id":"OG000","title":"Randomized: AZD9291 + Chemo"},{"description":"Osimertinib (AZD9291) 80mg QD.","id":"OG001","title":"Randomized: AZD9291"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"Pharmacokinetic Analysis Set, includes all randomized participants that received at least 1 dose of study treatment, have at least 1 measurable PK concentration and no missing doses 7 days prior to the PK sample, without any protocol deviation that affects PK, supported by the relevant date and time of this sample.","reportingStatus":"POSTED","timeFrame":"Pre-dose and 1-hour post-dose on Day 22; pre-dose, 1-, 2-, 4-, and 6-hours post-dose on Day 43; pre-dose and 1-hour post-dose on Day 106.","title":"Plasma Concentration of Metabolite AZ5104 When Osimertinib is Given With or Without Chemotherapy (Randomized Component)","type":"SECONDARY","unitOfMeasure":"nM"}