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NCT00441337 · OUTCOME

Mean Diastolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 0.3 mg Cohort - 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. Post infusion DBPs are presented in the 0.3 mg cohort at: 21, 36, 51, 66, 82, 97, 112, 127, 157 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

0.3 mg/kg Nivolumab

0.3 mg of nivolumab per kg of body weight (mg/kg) 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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
0.3 mg/kg Nivolumab6

Reported measurements

Baseline (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab80.318.16Not reportedNot reportedNot reported
Infusion (0 minutes) (n=5)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab82.410.01Not reportedNot reportedNot reported
21 minutes post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab87.010.28Not reportedNot reportedNot reported
36 minutes post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab81.010.88Not reportedNot reportedNot reported
51 minutes post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab79.89.20Not reportedNot reportedNot reported
66 minutes post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab80.38.71Not reportedNot reportedNot reported
82 minutes post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab81.78.69Not reportedNot reportedNot reported
97 minutes post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab80.310.56Not reportedNot reportedNot reported
112 minutes post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab78.78.14Not reportedNot reportedNot reported
127 minutes post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab81.011.14Not reportedNot reportedNot reported
157 minutes post infusion (n=2)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab72.56.36Not reportedNot reportedNot reported
1 hour post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab80.58.96Not reportedNot reportedNot reported
2 hour post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab82.211.02Not reportedNot reportedNot reported
3 hour post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab74.56.35Not reportedNot reportedNot reported
4 hour post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab73.86.08Not reportedNot reportedNot reported
6 hour post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab78.210.44Not reportedNot reportedNot reported
8 hour post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab76.25.67Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.16
        value
        80.3
    title
    Baseline (n=6)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.01
        value
        82.4
    title
    Infusion (0 minutes) (n=5)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.28
        value
        87.0
    title
    21 minutes post infusion (n=6)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.88
        value
        81.0
    title
    36 minutes post infusion (n=6)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.20
        value
        79.8
    title
    51 minutes post infusion (n=6)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.71
        value
        80.3
    title
    66 minutes post infusion (n=6)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.69
        value
        81.7
    title
    82 minutes post infusion (n=6)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.56
        value
        80.3
    title
    97 minutes post infusion (n=6)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.14
        value
        78.7
    title
    112 minutes post infusion (n=6)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.14
        value
        81.0
    title
    127 minutes post infusion (n=6)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.36
        value
        72.5
    title
    157 minutes post infusion (n=2)
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.96
        value
        80.5
    title
    1 hour post infusion (n=6)
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Diastolic blood pressures (DBPs) measured in millimeters of mercury (mmHg) were obtained while the participant was seated. Post infusion DBPs are presented in the 0.3 mg cohort at: 21, 36, 51, 66, 82, 97, 112, 127, 157 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
  1. description
    0.3 mg of nivolumab per kg of body weight (mg/kg) 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
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 0.3 mg Cohort - Safety Population
type
SECONDARY
unit Of Measure
mmHg

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Preserved source evidence · Not medical advice