{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.15","value":"7.3"},{"groupId":"OG001","spread":"10.31","value":"-9.7"},{"groupId":"OG002","spread":"9.75","value":"-1.7"},{"groupId":"OG003","spread":"13.72","value":"-0.3"}]}],"title":"PR at Day 2 (n=6,6,6,21)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.90","value":"5.0"},{"groupId":"OG001","spread":"7.48","value":"-2.0"},{"groupId":"OG002","spread":"19.83","value":"-8.7"},{"groupId":"OG003","spread":"5.57","value":"-1.2"}]}],"title":"QRS at Day 2 (n=6,6,6,21)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"27.86","value":"2.0"},{"groupId":"OG001","spread":"22.89","value":"-15.7"},{"groupId":"OG002","spread":"15.90","value":"-2.0"},{"groupId":"OG003","spread":"20.76","value":"-10.1"}]}],"title":"QT at Day 2 (n=6,6,6,21)"},{"categories":[{"measurements":[{"comment":"no participants with data on this day in this arm","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"no participants with data on this day in this arm","groupId":"OG001","spread":"NA","value":"NA"},{"comment":"no participants with data on this day in this arm","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"24.11","value":"-11.3"}]}],"title":"PR at Day 57 (n=0,0,0,3)"},{"categories":[{"measurements":[{"comment":"no participants with data on this day in this arm","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"no participants with data on this day in this arm","groupId":"OG001","spread":"NA","value":"NA"},{"comment":"no participants with data on this day in this arm","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"5.03","value":"1.3"}]}],"title":"QRS at Day 57 (n=0,0,0,3)"},{"categories":[{"measurements":[{"comment":"no participants with data on this day in this arm","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"no participants with data on this day in this arm","groupId":"OG001","spread":"NA","value":"NA"},{"comment":"no participants with data on this day in this arm","groupId":"OG002","spread":"NA","value":"NA"},{"groupId":"OG003","spread":"33.61","value":"5.3"}]}],"title":"QT at Day 57 (n=0,0,0,3)"},{"categories":[{"measurements":[{"comment":"no participants with data on this day in this arm","groupId":"OG000","spread":"NA","value":"NA"},{"groupId":"OG001","spread":"11.82","value":"-4.5"},{"groupId":"OG002","spread":"17.69","value":"3.5"},{"groupId":"OG003","spread":"17.44","value":"-1.1"}]}],"title":"PR at Day 85 (n=0,4,4,11)"},{"categories":[{"measurements":[{"comment":"no participants with data on this day in this arm","groupId":"OG000","spread":"NA","value":"NA"},{"groupId":"OG001","spread":"9.09","value":"-6.0"},{"groupId":"OG002","spread":"6.73","value":"-4.0"},{"groupId":"OG003","spread":"4.24","value":"0.2"}]}],"title":"QRS at Day 85 (n=0,4,4,11)"},{"categories":[{"measurements":[{"comment":"no participants with data on this day in this arm","groupId":"OG000","spread":"NA","value":"NA"},{"groupId":"OG001","spread":"27.90","value":"-6.0"},{"groupId":"OG002","spread":"33.52","value":"-3.5"},{"groupId":"OG003","spread":"26.40","value":"-0.2"}]}],"title":"QT at Day 85 (n=0,4,4,11)"},{"categories":[{"measurements":[{"comment":"no participants with data on this day in this arm","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"no participants with data on this day in this arm","groupId":"OG001","spread":"NA","value":"NA"},{"groupId":"OG002","spread":"24.04","value":"11.0"},{"groupId":"OG003","spread":"4.62","value":"3.3"}]}],"title":"PR at Day 113 (n=0,0,2,3)"},{"categories":[{"measurements":[{"comment":"no participants with data on this day in this arm","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"no participants with data on this day in this arm","groupId":"OG001","spread":"NA","value":"NA"},{"groupId":"OG002","spread":"2.83","value":"4.0"},{"groupId":"OG003","spread":"6.93","value":"6.0"}]}],"title":"QRS at Day 113 (n=0,0,2,3)"},{"categories":[{"measurements":[{"comment":"no participants with data on this day in this arm","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"no participants with data on this day in this arm","groupId":"OG001","spread":"NA","value":"NA"},{"groupId":"OG002","spread":"50.91","value":"4.0"},{"groupId":"OG003","spread":"28.00","value":"6.0"}]}],"title":"QT at Day 113 (n=0,0,2,3)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"21"}],"units":"Participants"}],"description":"12-lead ECGs were performed at screening, baseline, Day 2 and at completion of the dose cycle (Day 85 in first dose cycle). In those participants undergoing re-treatment, ECG was repeated at the completion of the re-treatment. Baseline was defined as the last measurement before the first dose of study drug, which was calculated from pre-dose or from screening if pre-dose was not available. PR, QRS and QT interval were measured in milliseconds (msec).","dispersionType":"Standard Deviation","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":"MEAN","populationDescription":"All participants who received at least 1 dose or any partial dose of nivolumab and had available ECG at baseline and on the specified post treatment study day were analyzed.","reportingStatus":"POSTED","timeFrame":"Baseline, Day 2, Day 85, Day 113","title":"Mean Change From Baseline in Electrocardiogram Parameters PR, QRS and QT in Safety Population","type":"SECONDARY","unitOfMeasure":"msec"}