{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"32.6","value":"203.133538"},{"groupId":"OG001","spread":"31.7","value":"196.218276"},{"groupId":"OG002","spread":"32.7","value":"183.414442"},{"comment":"As pre-specified in the Statistical Analysis Plan, three observations above the lower limit of quantification (LLOQ) are required as a minimum for a serum concentration to be summarised. Two observations above the LLOQ are presented as minimum and maximum with the other summary statistics as not calculated.","groupId":"OG003","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"90"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"2"}],"units":"Participants"}],"title":"Day 85, pre-dose (Trough concentration)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"39.6","value":"265.575840"},{"groupId":"OG001","spread":"38.0","value":"236.315365"},{"comment":"As pre-specified in the Statistical Analysis Plan, three observations above the lower limit of quantification (LLOQ) are required as a minimum for a serum concentration to be summarised. Two observations above the LLOQ are presented as minimum and maximum with the other summary statistics as not calculated.","groupId":"OG003","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"35"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}],"units":"Participants"}],"title":"Day 183, pre-dose (Trough concentration)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"104.4","value":"27.977227"},{"groupId":"OG001","spread":"206.8","value":"14.031316"},{"groupId":"OG002","spread":"43.0","value":"33.310921"},{"groupId":"OG003","spread":"1429.7","value":"11.252155"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"8"}],"units":"Participants"}],"title":"Follow-up 3-months (Last valid dose + 3 months)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"204"},{"groupId":"OG001","value":"213"},{"groupId":"OG002","value":"36"},{"groupId":"OG003","value":"35"}],"units":"Participants"}],"description":"To characterise the pharmacokinetics (PK) of durvalumab and durvalumab in combination with olaparib","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.\n\nFollowing completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.","id":"OG000","title":"Global Cohort - SoC + Durvalumab"},{"description":"Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.\n\nFollowing completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.","id":"OG001","title":"Global Cohort - SoC + Durvalumab + Olaparib"},{"description":"Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.\n\nFollowing completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.","id":"OG002","title":"China Cohort - SoC + Durvalumab"},{"description":"Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.\n\nFollowing completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.","id":"OG003","title":"China Cohort - SoC + Durvalumab + Olaparib"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"The Overall Number of Participants Analyzed reflects the total number of patients included in the PK Analysis Set, which comprises those treated with durvalumab per protocol and with valid PK data. However, PK concentrations were excluded at the sample level if they do not meet protocol-defined criteria. While some patients may not have any valid samples due to these exclusions, they remain part of the analysis population set by definition.","reportingStatus":"POSTED","timeFrame":"PK sampling performed on Day 85 pre-dose, Day 183 pre-dose, and 3 months after study treatment discontinuation (up to 36 months)","title":"Serum Concentration of Durvalumab","type":"SECONDARY","unitOfMeasure":"μg/mL"}