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NCT02499770 · OUTCOME

Occurrence of Grade 3/4 Neutropenia in 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From randomization to the end of the treatment period (a minimum of 51 days up to a maximum of 379 days)

What was measured

Grade 3/4 neutropenia was defined as at least 1 ANC value \<1.0 × 10\^9/L during the treatment period.

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: Placebo37
Part 2: Trilaciclib 240 mg/m^238

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Placebo30Not reportedNot reportedNot reportedNot reported
Part 2: Trilaciclib 240 mg/m^214Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        14
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    2. group Id
      OG001
      value
      38
    units
    Participants
description
Grade 3/4 neutropenia was defined as at least 1 ANC value \<1.0 × 10\^9/L during the treatment period.
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
COUNT_OF_PARTICIPANTS
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
From randomization to the end of the treatment period (a minimum of 51 days up to a maximum of 379 days)
title
Occurrence of Grade 3/4 Neutropenia in Part 2
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice