{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"52.15","value":"22.77"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"236"}],"units":"Participants"}],"title":"Week 0: peak concentration"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"81.68","value":"4.245"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"227"}],"units":"Participants"}],"title":"Week 3: trough concentration"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"59.25","value":"7.576"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"148"}],"units":"Participants"}],"title":"Week 12: trough concentration"}],"denoms":[{"counts":[{"groupId":"OG000","value":"257"}],"units":"Participants"}],"description":"To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of tremelimumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"During Chemotherapy:\n\nPatients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).\n\nPost-Chemotherapy:\n\nPatients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.","id":"OG000","title":"Global Cohort: D + T + EP"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"The global PK analysis set included all patients randomized prior to the end of global recruitment who received at least 1 dose of IP, per the protocol for whom any post-dose PK data were available. PK for tremelimumab was performed for the D + T + EP group only.","reportingStatus":"POSTED","timeFrame":"Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the global cohort final analysis DCO (27 January 2020).","title":"PK of Tremelimumab; Peak and Trough Serum Concentrations in the Global Cohort","type":"SECONDARY","unitOfMeasure":"μg/mL"}