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NCT01871727 · OUTCOME

Main Study Part: Volume of Distribution at Steady State (Vdss) of E7777

A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma · Source last updated 2024-11-13

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

Measure
MEAN
Unit
milliliter (mL)
Interval / dispersion
Standard Deviation
Time frame
Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)

What was measured

Participants were not available for analysis at Cycle 3 Day 1, hence no PK data was collected and analyzed for this timepoint.

Analysis population: Main study part PK analysis set included all participants from whom at least one quantifiable concentration of E7777 was observed at 9 mcg/kg dose (both Main Study and Lead-In). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure for given time points.

Groups in this outcome

Main Study Part: E7777 9 mcg/kg

Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.

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

Analysis denominator · Participants

GroupSource count
Main Study Part: E7777 9 mcg/kg20

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Main Study Part: E7777 9 mcg/kg20
Values in milliliter (mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Part: E7777 9 mcg/kg54302210Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Main Study Part: E7777 9 mcg/kg0
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Main Study Part: E7777 9 mcg/kg1
Values in milliliter (mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Main Study Part: E7777 9 mcg/kg10700NANot reportedNot reportedStandard deviation could not be estimated for Cycle 5 Day 1 as insufficient number of participants were available for analysis.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2210
        value
        5430
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      units
      Participants
    title
    Cycle 1 Day 1
  2. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle 3 Day 1
  3. categories
    1. measurements
      1. comment
        Standard deviation could not be estimated for Cycle 5 Day 1 as insufficient number of participants were available for analysis.
        group Id
        OG000
        spread
        NA
        value
        10700
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Cycle 5 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
Participants were not available for analysis at Cycle 3 Day 1, hence no PK data was collected and analyzed for this timepoint.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
    id
    OG000
    title
    Main Study Part: E7777 9 mcg/kg
param Type
MEAN
population Description
Main study part PK analysis set included all participants from whom at least one quantifiable concentration of E7777 was observed at 9 mcg/kg dose (both Main Study and Lead-In). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here "number analyzed" signifies participants who were evaluable for this outcome measure for given time points.
reporting Status
POSTED
time Frame
Cycles 1, 3 and 5 Day 1: Pre-dose up to 300 hours post-dose (Cycle length was 21 days)
title
Main Study Part: Volume of Distribution at Steady State (Vdss) of E7777
type
SECONDARY
unit Of Measure
milliliter (mL)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice