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NCT00441337 · OUTCOME

Mean Systolic 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

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 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 SBP 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 Nivolumab141.815.03Not reportedNot reportedNot reported
Infusion (0 minutes) (n=5)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab144.217.05Not reportedNot reportedNot reported
21 minutes post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab154.322.90Not reportedNot reportedNot reported
36 minutes post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab140.314.71Not reportedNot reportedNot reported
51 minutes post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab147.510.05Not reportedNot reportedNot reported
66 minutes post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab141.015.44Not reportedNot reportedNot reported
82 minutes post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab145.717.60Not reportedNot reportedNot reported
97 minutes post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab141.816.29Not reportedNot reportedNot reported
112 minutes post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab139.811.55Not reportedNot reportedNot reported
127 minutes post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab140.320.47Not reportedNot reportedNot reported
157 minutes post infusion (n=2)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab137.57.78Not reportedNot reportedNot reported
1 hour post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab139.38.04Not reportedNot reportedNot reported
2 hour post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab145.820.85Not reportedNot reportedNot reported
3 hour post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab140.37.92Not reportedNot reportedNot reported
4 hour post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab139.89.89Not reportedNot reportedNot reported
6 hour post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab142.819.06Not reportedNot reportedNot reported
8 hour post infusion (n=6)
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
0.3 mg/kg Nivolumab145.512.77Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.03
        value
        141.8
    title
    Baseline (n=6)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.05
        value
        144.2
    title
    Infusion (0 minutes) (n=5)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.90
        value
        154.3
    title
    21 minutes post infusion (n=6)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.71
        value
        140.3
    title
    36 minutes post infusion (n=6)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.05
        value
        147.5
    title
    51 minutes post infusion (n=6)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.44
        value
        141.0
    title
    66 minutes post infusion (n=6)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.60
        value
        145.7
    title
    82 minutes post infusion (n=6)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.29
        value
        141.8
    title
    97 minutes post infusion (n=6)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.55
        value
        139.8
    title
    112 minutes post infusion (n=6)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.47
        value
        140.3
    title
    127 minutes post infusion (n=6)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.78
        value
        137.5
    title
    157 minutes post infusion (n=2)
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.04
        value
        139.3
    title
    1 hour post infusion (n=6)
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    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 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 SBP 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 Systolic Blood Pressure at Baseline and Post-Infusion Day 1 (Cycle 1) in 0.3 mg Cohort - Safety Population
type
SECONDARY
unit Of Measure
mmHg

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice