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NCT02499770 · OUTCOME

Time to First Major Adverse Hematologic Event (MAHE) 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
MEDIAN
Unit
Months
Interval / dispersion
Inter-Quartile Range
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

MAHE was a composite endpoint incorporating the measurement of several clinically meaningful aspects of myelopreservation into a single endpoint. The individual components for MAHE were hospitalization for a hematologic event, febrile neutropenia, death related to treatment, dose delay/reduction due to ANC or platelet counts, prolonged severe neutropenia (duration \>5 days), RBC transfusion (actual or eligible) and platelet transfusion (actual or eligible). Time to first occurrence of a MAHE event was defined as the first time to observe an interested event among all the components, starting from the first dose date of study drug administration.

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 Months · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Part 1: Cohort 1 Trilaciclib 200 mg/m^22.6Not reported0.8NANot evaluable
Part 1: Cohort 2 Trilaciclib 240mg/m^23.0Not reported1.0NANot evaluable
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not evaluable
        group Id
        OG000
        lower Limit
        0.8
        upper Limit
        NA
        value
        2.6
      2. comment
        Not evaluable
        group Id
        OG001
        lower Limit
        1.0
        upper Limit
        NA
        value
        3.0
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      9
    units
    Participants
description
MAHE was a composite endpoint incorporating the measurement of several clinically meaningful aspects of myelopreservation into a single endpoint. The individual components for MAHE were hospitalization for a hematologic event, febrile neutropenia, death related to treatment, dose delay/reduction due to ANC or platelet counts, prolonged severe neutropenia (duration \>5 days), RBC transfusion (actual or eligible) and platelet transfusion (actual or eligible). Time to first occurrence of a MAHE event was defined as the first time to observe an interested event among all the components, starting from the first dose date of study drug administration.
dispersion Type
Inter-Quartile Range
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
MEDIAN
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
Time to First Major Adverse Hematologic Event (MAHE) in Part 1
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice