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NCT01327612 · OUTCOME

Maximum Change From Baseline in Blood Pressure

Open Label Extension Study of Conatumumab and Ganitumab (AMG 479) · Source last updated 2021-02-21

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 and day 1 of each treatment cycle (every 2, 3, or 4 weeks depending on dosing schedule) up to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.

What was measured

Maximum change from baseline is defined for each participant as the maximum change from baseline value observed across all visits.

Analysis population: Participants who received at least one dose of conatumumab or ganitumab.

Groups in this outcome

20050118: Ganitumab 20 mg/kg

Ganitumab 20 mg/kg once every 4 weeks by intravenous infusion.

20050171: Conatumumab 0.45 mg/kg

Conatumumab 0.45 mg/kg every 2 weeks by intravenous infusion.

20060295: Conatumumab 3 mg/kg

Conatumumab 3 mg/kg every 3 weeks by intravenous infusion.

20060340: Conatumumab 5 mg/kg

Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion.

20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab

Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks.

20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab

Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks.

20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg

Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion.

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

Analysis denominator · Participants

GroupSource count
20050118: Ganitumab 20 mg/kg2
20050171: Conatumumab 0.45 mg/kg1
20060295: Conatumumab 3 mg/kg1
20060340: Conatumumab 5 mg/kg1
20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab2
20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab3
20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg2

Reported measurements

Systolic blood pressure
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
20050118: Ganitumab 20 mg/kg5.59.2Not reportedNot reportedNot reported
20050171: Conatumumab 0.45 mg/kg7.0Not reportedNot reportedNot reportedNot reported
20060295: Conatumumab 3 mg/kg54.0Not reportedNot reportedNot reportedNot reported
20060340: Conatumumab 5 mg/kg37.0Not reportedNot reportedNot reportedNot reported
20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab42.00.0Not reportedNot reportedNot reported
20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab26.017.3Not reportedNot reportedNot reported
20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg32.531.8Not reportedNot reportedNot reported
Diastolic blood pressure
Values in mmHg · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
20050118: Ganitumab 20 mg/kg7.59.2Not reportedNot reportedNot reported
20050171: Conatumumab 0.45 mg/kg1.0Not reportedNot reportedNot reportedNot reported
20060295: Conatumumab 3 mg/kg10.0Not reportedNot reportedNot reportedNot reported
20060340: Conatumumab 5 mg/kg13.0Not reportedNot reportedNot reportedNot reported
20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab27.59.2Not reportedNot reportedNot reported
20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab14.76.4Not reportedNot reportedNot reported
20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg23.56.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.2
        value
        5.5
      2. group Id
        OG001
        value
        7.0
      3. group Id
        OG002
        value
        54.0
      4. group Id
        OG003
        value
        37.0
      5. group Id
        OG004
        spread
        0.0
        value
        42.0
      6. group Id
        OG005
        spread
        17.3
        value
        26.0
      7. group Id
        OG006
        spread
        31.8
        value
        32.5
    title
    Systolic blood pressure
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.2
        value
        7.5
      2. group Id
        OG001
        value
        1.0
      3. group Id
        OG002
        value
        10.0
      4. group Id
        OG003
        value
        13.0
      5. group Id
        OG004
        spread
        9.2
        value
        27.5
      6. group Id
        OG005
        spread
        6.4
        value
        14.7
      7. group Id
        OG006
        spread
        6.4
        value
        23.5
    title
    Diastolic blood pressure
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      2
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      2
    units
    Participants
description
Maximum change from baseline is defined for each participant as the maximum change from baseline value observed across all visits.
dispersion Type
Standard Deviation
groups
  1. description
    Ganitumab 20 mg/kg once every 4 weeks by intravenous infusion.
    id
    OG000
    title
    20050118: Ganitumab 20 mg/kg
  2. description
    Conatumumab 0.45 mg/kg every 2 weeks by intravenous infusion.
    id
    OG001
    title
    20050171: Conatumumab 0.45 mg/kg
  3. description
    Conatumumab 3 mg/kg every 3 weeks by intravenous infusion.
    id
    OG002
    title
    20060295: Conatumumab 3 mg/kg
  4. description
    Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion.
    id
    OG003
    title
    20060340: Conatumumab 5 mg/kg
  5. description
    Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks.
    id
    OG004
    title
    20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab
  6. description
    Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks.
    id
    OG005
    title
    20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab
  7. description
    Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion.
    id
    OG006
    title
    20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg
param Type
MEAN
population Description
Participants who received at least one dose of conatumumab or ganitumab.
reporting Status
POSTED
time Frame
Baseline and day 1 of each treatment cycle (every 2, 3, or 4 weeks depending on dosing schedule) up to 30 days after last dose; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
title
Maximum Change From Baseline in Blood Pressure
type
SECONDARY
unit Of Measure
mmHg

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

Preserved source evidence · Not medical advice