{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"47","value":"970"},{"groupId":"OG001","spread":"62","value":"3244"},{"groupId":"OG002","spread":"44","value":"13909"},{"groupId":"OG003","spread":"39","value":"55324"}]}],"title":"AUC (0-T); n=6, 6, 5, 21"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16","value":"2343"},{"groupId":"OG001","spread":"30","value":"6014"},{"groupId":"OG002","spread":"44","value":"15813"},{"groupId":"OG003","spread":"27","value":"76541"}]}],"title":"AUC (INF); n=3, 4, 5, 19"}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"21"}],"units":"Participants"}],"description":"AUC(0-T): Area under the concentration-time curve from the time of dosing to the time of the last observation. AUC(INF): Area under the curve from the time of dosing extrapolated to infinity. Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated ELISA method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The PK parameters of AUC(0-T) and AUC (INF) were measured in micrograms\\*hours per milliliter (µg\\*h/mL).","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.","id":"OG000","title":"0.3 mg/kg Nivolumab"},{"description":"1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.","id":"OG001","title":"1 mg/kg Nivolumab"},{"description":"3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.","id":"OG002","title":"3 mg/kg Nivolumab"},{"description":"10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.","id":"OG003","title":"10 mg/kg Nivolumab"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.","reportingStatus":"POSTED","timeFrame":"Day 1 to Day 85","title":"Geometric Mean Area Under the Curve (AUC) From Time of Dosing to Time of Last Observation (0-T) and Extrapolated to Infinity (INF) Observed Post-Single Dose","type":"PRIMARY","unitOfMeasure":"µg*h/mL"}