Mean Systolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 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
Systolic blood pressures (SBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion SBPs 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 SBPs 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
133.2
2.86
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
121.3
13.11
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
128.8
19.29
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
138.8
10.65
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
116.4
8.56
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
129.5
17.38
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
136.7
12.03
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
117.3
8.64
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
125.5
16.54
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
139.2
6.71
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
119.8
10.82
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
124.0
14.00
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
141.2
12.19
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
111.5
5.79
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
123.5
14.38
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
142.3
3.78
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
115.0
5.69
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
124.8
14.39
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
134.0
8.69
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
119.3
10.21
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
126.2
18.01
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
134.0
7.62
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
119.0
8.76
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
126.1
14.24
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
141.2
5.74
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
120.6
15.69
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
121.2
16.72
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
131.3
9.91
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
119.7
11.04
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
123.4
14.76
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
133.5
9.79
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
122.2
12.24
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
125.4
15.29
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
133.0
9.94
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
128.5
19.61
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
125.9
13.20
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
137.0
11.63
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
130.0
14.21
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
124.6
15.77
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
144.8
13.81
Not reported
Not reported
Not reported
3 mg/kg Nivolumab
130.6
19.36
Not reported
Not reported
Not reported
10 mg/kg Nivolumab
130.6
12.21
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
2.86
value
133.2
group Id
OG001
spread
13.11
value
121.3
group Id
OG002
spread
19.29
value
128.8
title
Baseline (n=6, 6, 21)
categories
measurements
group Id
OG000
spread
10.65
value
138.8
group Id
OG001
spread
8.56
value
116.4
group Id
OG002
spread
17.38
value
129.5
title
Infusion (0 minutes) (n=6, 5, 19)
categories
measurements
group Id
OG000
spread
12.03
value
136.7
group Id
OG001
spread
8.64
value
117.3
group Id
OG002
spread
16.54
value
125.5
title
15 minutes post infusion (n=6,6,21)
categories
measurements
group Id
OG000
spread
6.71
value
139.2
group Id
OG001
spread
10.82
value
119.8
group Id
OG002
spread
14.00
value
124.0
title
30 minutes post infusion (n=6,6,21)
categories
measurements
group Id
OG000
spread
12.19
value
141.2
group Id
OG001
spread
5.79
value
111.5
group Id
OG002
spread
14.38
value
123.5
title
45 minutes post infusion (n=6,6,21)
categories
measurements
group Id
OG000
spread
3.78
value
142.3
group Id
OG001
spread
5.69
value
115.0
group Id
OG002
spread
14.39
value
124.8
title
60 minutes post infusion (n=6,6,21)
categories
measurements
group Id
OG000
spread
8.69
value
134.0
group Id
OG001
spread
10.21
value
119.3
group Id
OG002
spread
18.01
value
126.2
title
75 minutes post infusion (n=5,3,12)
categories
measurements
group Id
OG000
spread
7.62
value
134.0
group Id
OG001
spread
8.76
value
119.0
group Id
OG002
spread
14.24
value
126.1
title
90 minutes post infusion (n=4,4,14)
categories
measurements
group Id
OG000
spread
5.74
value
141.2
group Id
OG001
spread
15.69
value
120.6
group Id
OG002
spread
16.72
value
121.2
title
1 hour post infusion (n= 6,5,21)
categories
measurements
group Id
OG000
spread
9.91
value
131.3
group Id
OG001
spread
11.04
value
119.7
group Id
OG002
spread
14.76
value
123.4
title
2 hour post infusion (n= 6,6,21)
categories
measurements
group Id
OG000
spread
9.79
value
133.5
group Id
OG001
spread
12.24
value
122.2
group Id
OG002
spread
15.29
value
125.4
title
3 hour post infusion (n= 6,5,19)
categories
measurements
group Id
OG000
spread
9.94
value
133.0
group Id
OG001
spread
19.61
value
128.5
group Id
OG002
spread
13.20
value
125.9
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
Systolic blood pressures (SBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Baseline, Infusion (0 minutes) and Post infusion SBPs 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 SBPs 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 Systolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in in 1mg, 3mg, and 10 mg Cohorts - Safety Population
Triangle