{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"65.62","value":"23.17"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"294"}],"units":"Participants"}],"title":"Week 0"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"80.83","value":"4.16"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"285"}],"units":"Participants"}],"title":"Week 3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"75.68","value":"7.82"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"183"}],"units":"Participants"}],"title":"Week 12"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"87.65","value":"0.86"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"105"}],"units":"Participants"}],"title":"Follow-up (3 months)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"327"}],"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 (combination) stage:\n\nPatients received tremelimumab 75 mg + durvalumab 1500 mg combination therapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).\n\nThe SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).\n\nPost-chemotherapy (maintenance) stage:\n\nPatients then continued to receive durvalumab monotherapy 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 (in combination with durvalumab) at Week 16 post-chemotherapy.\n\nNon-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.","id":"OG000","title":"T + D + SoC"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"Global cohort: The PK analysis set included all patients who received at least 1 dose of durvalumab or tremelimumab per the protocol for whom any post-dose PK data were available and without any protocol deviations that would significantly affect the PK analyses. PK for tremelimumab was performed for the T + D + SoC treatment arm only.","reportingStatus":"POSTED","timeFrame":"Samples were collected post-dose on Day 1 (Week 0), pre-dose on Weeks 3 and 12 and at follow-up (3 months after the last valid dose). Assessed at the global cohort DCO of 12 March 2021.","title":"PK of Tremelimumab; Peak and Trough Serum Concentrations","type":"SECONDARY","unitOfMeasure":"μg/mL"}