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NCT01059643 · OUTCOME

Pharmacokinetics, Intracycle Accumulation Ratio (Ra) of LY2523355

A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck · Source last updated 2019-09-18

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

Measure
GEOMETRIC_MEAN
Unit
ratio
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Day 1 and Day 3 of Cycle 1 (21-day cycle)

What was measured

Intracycle Ra of LY2523355 is the ratio of LY2523355 maximum plasma concentration (Cmax) on Day 3 of Cycle 1 to the Cmax of LY2523355 on Day 1 of Cycle 1 following daily doses of LY2523355 on Days 1, 2 and 3 of Cycle 1 (21-day cycle) at each dose level.

Analysis population: All enrolled participants who received at least 1 dose of study drug with Ra measure.

Groups in this outcome

5 mg/m²LY2523355

LY2523355: 5 milligrams/square meter/day (mg/m²/day) administered intravenously as a 1-hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.

6 mg/m² LY253355

LY2523355: 6 mg/m²/day administered intravenously as a one hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 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
5 mg/m²LY252335565
6 mg/m² LY25335528

Reported measurements

Source class 1
Values in ratio · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
5 mg/m²LY25233551.0287Not reportedNot reportedNot reported
6 mg/m² LY2533551.0861Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        87
        value
        1.02
      2. group Id
        OG001
        spread
        61
        value
        1.08
denoms
  1. counts
    1. group Id
      OG000
      value
      65
    2. group Id
      OG001
      value
      28
    units
    Participants
description
Intracycle Ra of LY2523355 is the ratio of LY2523355 maximum plasma concentration (Cmax) on Day 3 of Cycle 1 to the Cmax of LY2523355 on Day 1 of Cycle 1 following daily doses of LY2523355 on Days 1, 2 and 3 of Cycle 1 (21-day cycle) at each dose level.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    LY2523355: 5 milligrams/square meter/day (mg/m²/day) administered intravenously as a 1-hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.
    id
    OG000
    title
    5 mg/m²LY2523355
  2. description
    LY2523355: 6 mg/m²/day administered intravenously as a one hour infusion on Days 1, 2, and 3 + pegfilgrastim on Day 4 of each 21-day cycle.
    id
    OG001
    title
    6 mg/m² LY253355
param Type
GEOMETRIC_MEAN
population Description
All enrolled participants who received at least 1 dose of study drug with Ra measure.
reporting Status
POSTED
time Frame
Day 1 and Day 3 of Cycle 1 (21-day cycle)
title
Pharmacokinetics, Intracycle Accumulation Ratio (Ra) of LY2523355
type
SECONDARY
unit Of Measure
ratio

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

Preserved source evidence · Not medical advice