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NCT02499770 · OUTCOME

Occurrence of Severe (Grade 4) Neutropenia in 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
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

Severe (Grade 4) neutropenia was defined as at least 1 ANC value \<0.5 × 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 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^210
Part 1: Cohort 2 Trilaciclib 240mg/m^29

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Cohort 1 Trilaciclib 200 mg/m^24Not reportedNot reportedNot reportedNot reported
Part 1: Cohort 2 Trilaciclib 240mg/m^20Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      9
    units
    Participants
description
Severe (Grade 4) neutropenia was defined as at least 1 ANC value \<0.5 × 10\^9/L during the treatment period.
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
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 Severe (Grade 4) Neutropenia in Part 1
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice