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NCT01282463 · OUTCOME

PK: Minimum Concentration (Cmin) Ramucirumab

Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma · Source last updated 2019-09-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
microgram/milliliter (ug/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 2:Predose,1hr post-EOI;Cycle3:Predose,1hr,48hr,72hr,168hr,336hr, post-EOI;Cycle4:Predose,1hr post-EOI;Cycle6:Predose,1hr Post EOI

Analysis population: All randomized participants who received at least one dose of study drug and had evaluable PK data for Ramucirumab and there was no PK data for Docetaxel arm.

Groups in this outcome

Docetaxel + Ramucirumab DP

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Ramucirumab DP: Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

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

Analysis denominator · Participants

GroupSource count
Docetaxel + Ramucirumab DP46

Reported measurements

Cycle 2

Analysis denominator · Participants

GroupSource count
Docetaxel + Ramucirumab DP28
Values in microgram/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Docetaxel + Ramucirumab DP19.556Not reportedNot reportedNot reported
Cycle 3

Analysis denominator · Participants

GroupSource count
Docetaxel + Ramucirumab DP6
Values in microgram/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Docetaxel + Ramucirumab DP39.934Not reportedNot reportedNot reported
Cycle 4

Analysis denominator · Participants

GroupSource count
Docetaxel + Ramucirumab DP22
Values in microgram/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Docetaxel + Ramucirumab DP35.360Not reportedNot reportedNot reported
Cycle 6

Analysis denominator · Participants

GroupSource count
Docetaxel + Ramucirumab DP4
Values in microgram/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Docetaxel + Ramucirumab DP31.261Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        56
        value
        19.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      units
      Participants
    title
    Cycle 2
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        34
        value
        39.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        60
        value
        35.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      units
      Participants
    title
    Cycle 4
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        61
        value
        31.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 6
denoms
  1. counts
    1. group Id
      OG000
      value
      46
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Ramucirumab DP: Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle
    id
    OG000
    title
    Docetaxel + Ramucirumab DP
param Type
GEOMETRIC_MEAN
population Description
All randomized participants who received at least one dose of study drug and had evaluable PK data for Ramucirumab and there was no PK data for Docetaxel arm.
reporting Status
POSTED
time Frame
Cycle 2:Predose,1hr post-EOI;Cycle3:Predose,1hr,48hr,72hr,168hr,336hr, post-EOI;Cycle4:Predose,1hr post-EOI;Cycle6:Predose,1hr Post EOI
title
PK: Minimum Concentration (Cmin) Ramucirumab
type
SECONDARY
unit Of Measure
microgram/milliliter (ug/mL)

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

Preserved source evidence · Not medical advice