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NCT02499770 · OUTCOME

Change From Baseline of Platelet Count at the End of Cycle 6, Part 1

Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC) · Source last updated 2020-08-21

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

Measure
MEAN
Unit
x 10^9 cells/L
Interval / dispersion
Standard Deviation
Time frame
Baseline, Day 1, Day 3, Day 8, Day 10, and Day 15 of a 21-day cycle x 6

What was measured

Blood samples were collected for local clinical laboratory assessment of platelet count.

Analysis population: The FAS included all randomized patients who received at least 1 dose of study drug (etoposide, carboplatin, or trilaciclib). Analyses using the FAS were conducted on the basis of the assigned treatment.

Groups in this outcome

Part 1: Cohort 1 Trilaciclib 200 mg/m^2

Participants received trilaciclib 200 mg/m\^2 administered intravenously (IV) once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.

Part 1: Cohort 2 Trilaciclib 240mg/m^2

Participants received trilaciclib 240 mg/m\^2 administered IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy 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
Part 1: Cohort 1 Trilaciclib 200 mg/m^25
Part 1: Cohort 2 Trilaciclib 240mg/m^27

Reported measurements

Source class 1
Values in x 10^9 cells/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cohort 1 Trilaciclib 200 mg/m^2-72.688.38Not reportedNot reportedNot reported
Part 1: Cohort 2 Trilaciclib 240mg/m^2-59.4108.47Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        88.38
        value
        -72.6
      2. group Id
        OG001
        spread
        108.47
        value
        -59.4
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      7
    units
    Participants
description
Blood samples were collected for local clinical laboratory assessment of platelet count.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received trilaciclib 200 mg/m\^2 administered intravenously (IV) once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
    id
    OG000
    title
    Part 1: Cohort 1 Trilaciclib 200 mg/m^2
  2. description
    Participants received trilaciclib 240 mg/m\^2 administered IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
    id
    OG001
    title
    Part 1: Cohort 2 Trilaciclib 240mg/m^2
param Type
MEAN
population Description
The FAS included all randomized patients who received at least 1 dose of study drug (etoposide, carboplatin, or trilaciclib). Analyses using the FAS were conducted on the basis of the assigned treatment.
reporting Status
POSTED
time Frame
Baseline, Day 1, Day 3, Day 8, Day 10, and Day 15 of a 21-day cycle x 6
title
Change From Baseline of Platelet Count at the End of Cycle 6, Part 1
type
SECONDARY
unit Of Measure
x 10^9 cells/L

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

Preserved source evidence · Not medical advice