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NCT02499770 · OUTCOME

Change From Baseline of Lymphocyte Count at the End of Cycle 6, Part 2

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 lymphocyte 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 2: Placebo

Participants received placebo IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.

Part 2: Trilaciclib 240 mg/m^2

Participants received trilaciclib 240 mg/m\^2 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 2: Placebo22
Part 2: Trilaciclib 240 mg/m^220

Reported measurements

Source class 1
Values in x 10^9 cells/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: Placebo-0.2030.4382Not reportedNot reportedNot reported
Part 2: Trilaciclib 240 mg/m^20.1040.6320Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.4382
        value
        -0.203
      2. group Id
        OG001
        spread
        0.6320
        value
        0.104
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    2. group Id
      OG001
      value
      20
    units
    Participants
description
Blood samples were collected for local clinical laboratory assessment of lymphocyte count.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received placebo IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
    id
    OG000
    title
    Part 2: Placebo
  2. description
    Participants received trilaciclib 240 mg/m\^2 IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle.
    id
    OG001
    title
    Part 2: Trilaciclib 240 mg/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 Lymphocyte Count at the End of Cycle 6, Part 2
type
SECONDARY
unit Of Measure
x 10^9 cells/L

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

Preserved source evidence · Not medical advice