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NCT01282463 · OUTCOME

Pharmacokinetics (PK) Maximum Concentration (Cmax) 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 1:Predose,1 hour(hr) post End of Infusion (EOI),48hr,72hr,168hr,336hr post-EOI;Cycle2:Predose,1hr post-EOI; Cycle3:Predose,1hr,48hr,72hr,168hr,336hr post-EOI; Cycle4:Predose,1hr post-EOI;Cycle6 and every other cycle thereafter: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 DP8

Reported measurements

Cycle 1

Analysis denominator · Participants

GroupSource count
Docetaxel + Ramucirumab DP8
Values in microgram/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Docetaxel + Ramucirumab DP25827Not reportedNot reportedNot reported
Cycle 2

Analysis denominator · Participants

GroupSource count
Docetaxel + Ramucirumab DP7
Values in microgram/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Docetaxel + Ramucirumab DP30431Not reportedNot reportedNot reported
Cycle 3

Analysis denominator · Participants

GroupSource count
Docetaxel + Ramucirumab DP3
Values in microgram/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Docetaxel + Ramucirumab DP30013Not reportedNot reportedNot reported
Cycle 4

Analysis denominator · Participants

GroupSource count
Docetaxel + Ramucirumab DP5
Values in microgram/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Docetaxel + Ramucirumab DP27940Not reportedNot reportedNot reported
Cycle 6

Analysis denominator · Participants

GroupSource count
Docetaxel + Ramucirumab DP3
Values in microgram/milliliter (ug/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Docetaxel + Ramucirumab DP25257Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        27
        value
        258
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        31
        value
        304
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    Cycle 2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        13
        value
        300
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Cycle 3
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        40
        value
        279
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    Cycle 4
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        57
        value
        252
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Cycle 6
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    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 1:Predose,1 hour(hr) post End of Infusion (EOI),48hr,72hr,168hr,336hr post-EOI;Cycle2:Predose,1hr post-EOI; Cycle3:Predose,1hr,48hr,72hr,168hr,336hr post-EOI; Cycle4:Predose,1hr post-EOI;Cycle6 and every other cycle thereafter:Predose,1hr Post EOI
title
Pharmacokinetics (PK) Maximum Concentration (Cmax) Ramucirumab
type
SECONDARY
unit Of Measure
microgram/milliliter (ug/mL)

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Preserved source evidence · Not medical advice