Mean Diastolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 1mg, 3mg, and 10 mg Cohorts - Safety Population
A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies · Source last updated 2015-02-20
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEAN
Unit
mmHg
Interval / dispersion
Standard Deviation
Time frame
Baseline, Day 1
What was measured
Diastolic blood pressures (DBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion DBPs are presented in the 1 mg, 3 mg and 10 mg cohorts at: 15, 30, 45, 60, 75, and 90 minutes post infusion and at 1, 2, 3, 4, 6, 8 hours post infusion. 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. Mean DBP on Day 1 for first dose (cycle 1) are presented below.
Analysis population: All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.
Groups in this outcome
1 mg/kg Nivolumab
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.
3 mg/kg Nivolumab
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.
10 mg/kg Nivolumab
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.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
1 mg/kg Nivolumab
6
3 mg/kg Nivolumab
6
10 mg/kg Nivolumab
21
Reported measurements
Baseline (n=6, 6, 21)
Values in mmHg · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
1 mg/kg Nivolumab
80.3
11.62
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
72.2
10.72
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
74.4
12.19
Not reported
Not reported
Not reported
Infusion (0 minutes) (n=6, 5, 19)
Values in mmHg · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
1 mg/kg Nivolumab
79.2
11.72
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
73.6
10.01
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
74.2
11.31
Not reported
Not reported
Not reported
15 minutes post infusion (n=6,6,21)
Values in mmHg · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
1 mg/kg Nivolumab
74.5
11.41
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
69.5
10.41
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
72.3
11.87
Not reported
Not reported
Not reported
30 minutes post infusion (n=6,6,21)
Values in mmHg · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
1 mg/kg Nivolumab
78.8
11.0
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
70.7
10.29
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
71.1
10.40
Not reported
Not reported
Not reported
45 minutes post infusion (n=6,6,21)
Values in mmHg · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
1 mg/kg Nivolumab
75.7
10.67
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
69.8
12.09
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
72.7
12.69
Not reported
Not reported
Not reported
60 minutes post infusion (n=6,6,21)
Values in mmHg · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
1 mg/kg Nivolumab
78.7
8.78
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
69.5
9.97
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
74.1
10.53
Not reported
Not reported
Not reported
75 minutes post infusion (n=5,3,12)
Values in mmHg · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
1 mg/kg Nivolumab
79.0
11.20
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
71.7
0.58
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
73.7
11.93
Not reported
Not reported
Not reported
90 minutes post infusion (n=4,4,14)
Values in mmHg · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
1 mg/kg Nivolumab
79.8
8.73
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
70.3
8.18
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
74.4
11.09
Not reported
Not reported
Not reported
1 hour post infusion (n= 6,5,21)
Values in mmHg · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
1 mg/kg Nivolumab
78.5
7.58
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
74.4
17.18
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
71.9
10.24
Not reported
Not reported
Not reported
2 hour post infusion (n= 6,6,21)
Values in mmHg · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
1 mg/kg Nivolumab
83.0
10.35
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
70.7
19.04
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
72.0
10.62
Not reported
Not reported
Not reported
3 hour post infusion (n= 6,5,19)
Values in mmHg · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
1 mg/kg Nivolumab
79.5
13.20
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
67.8
24.59
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
72.9
11.98
Not reported
Not reported
Not reported
4 hour post infusion (n= 6,6,21)
Values in mmHg · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
1 mg/kg Nivolumab
75.2
17.68
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
69.2
13.64
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
73.5
9.86
Not reported
Not reported
Not reported
6 hour post infusion (n= 6,6,21)
Values in mmHg · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
1 mg/kg Nivolumab
74.7
7.81
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
77.7
13.35
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
73.1
10.32
Not reported
Not reported
Not reported
8 hour post infusion (n= 5,5,21)
Values in mmHg · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
1 mg/kg Nivolumab
83.8
8.04
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
76.4
15.29
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
74.7
8.33
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
11.62
value
80.3
group Id
OG001
spread
10.72
value
72.2
group Id
OG002
spread
12.19
value
74.4
title
Baseline (n=6, 6, 21)
categories
measurements
group Id
OG000
spread
11.72
value
79.2
group Id
OG001
spread
10.01
value
73.6
group Id
OG002
spread
11.31
value
74.2
title
Infusion (0 minutes) (n=6, 5, 19)
categories
measurements
group Id
OG000
spread
11.41
value
74.5
group Id
OG001
spread
10.41
value
69.5
group Id
OG002
spread
11.87
value
72.3
title
15 minutes post infusion (n=6,6,21)
categories
measurements
group Id
OG000
spread
11.0
value
78.8
group Id
OG001
spread
10.29
value
70.7
group Id
OG002
spread
10.40
value
71.1
title
30 minutes post infusion (n=6,6,21)
categories
measurements
group Id
OG000
spread
10.67
value
75.7
group Id
OG001
spread
12.09
value
69.8
group Id
OG002
spread
12.69
value
72.7
title
45 minutes post infusion (n=6,6,21)
categories
measurements
group Id
OG000
spread
8.78
value
78.7
group Id
OG001
spread
9.97
value
69.5
group Id
OG002
spread
10.53
value
74.1
title
60 minutes post infusion (n=6,6,21)
categories
measurements
group Id
OG000
spread
11.20
value
79.0
group Id
OG001
spread
0.58
value
71.7
group Id
OG002
spread
11.93
value
73.7
title
75 minutes post infusion (n=5,3,12)
categories
measurements
group Id
OG000
spread
8.73
value
79.8
group Id
OG001
spread
8.18
value
70.3
group Id
OG002
spread
11.09
value
74.4
title
90 minutes post infusion (n=4,4,14)
categories
measurements
group Id
OG000
spread
7.58
value
78.5
group Id
OG001
spread
17.18
value
74.4
group Id
OG002
spread
10.24
value
71.9
title
1 hour post infusion (n= 6,5,21)
categories
measurements
group Id
OG000
spread
10.35
value
83.0
group Id
OG001
spread
19.04
value
70.7
group Id
OG002
spread
10.62
value
72.0
title
2 hour post infusion (n= 6,6,21)
categories
measurements
group Id
OG000
spread
13.20
value
79.5
group Id
OG001
spread
24.59
value
67.8
group Id
OG002
spread
11.98
value
72.9
title
3 hour post infusion (n= 6,5,19)
categories
measurements
group Id
OG000
spread
17.68
value
75.2
group Id
OG001
spread
13.64
value
69.2
group Id
OG002
spread
9.86
value
73.5
title
4 hour post infusion (n= 6,6,21)
denoms
counts
group Id
OG000
value
6
group Id
OG001
value
6
group Id
OG002
value
21
units
Participants
description
Diastolic blood pressures (DBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion DBPs are presented in the 1 mg, 3 mg and 10 mg cohorts at: 15, 30, 45, 60, 75, and 90 minutes post infusion and at 1, 2, 3, 4, 6, 8 hours post infusion. 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. Mean DBP on Day 1 for first dose (cycle 1) are presented below.
dispersion Type
Standard Deviation
groups
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
OG000
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
OG001
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
OG002
title
10 mg/kg Nivolumab
param Type
MEAN
population Description
All participants who received at least 1 dose or any partial dose of nivolumab and had available blood pressure at baseline and post-infusion were analyzed.
reporting Status
POSTED
time Frame
Baseline, Day 1
title
Mean Diastolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 1mg, 3mg, and 10 mg Cohorts - Safety Population
Triangle