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NCT03041311 · OUTCOME

Major Adverse Hematologic Events (MAHE) (Composite Endpoint)

Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK4/6 Inhibitor, in Extensive-Stage SCLC · Source last updated 2025-09-25

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

Measure
NUMBER
Unit
event rate per week
Interval / dispersion
Not reported
Time frame
Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.

What was measured

The composite endpoint "major adverse hematologic events" (MAHE) included the following aspects of myelosuppression: All-cause hospitalizations - Each recorded preferred term (PT) with a unique start date was counted as an event. All-cause dose reductions - Dose reductions were permitted for E/P but not for trilaciclib or atezolizumab. No more than 2 dose reductions were allowed. Each dose reduction was counted as a separate event. Febrile neutropenia-Each febrile neutropenia event with a unique start date during the Induction Period was defined as a separate event. Prolonged severe neutropenia (SN)-Each cycle with a severe neutropenia duration greater than 5 days was counted as an event, with the date of the first Grade 4 laboratory value defined as the start date for the time-to-first event analysis. Red blood cell (RBC) transfusion on/after Week 5-Each RBC transfusion with a unique start date on/after Week 5 on study during the Induction Period was defined as a separate event.

Analysis population: Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.

Groups in this outcome

Trilaciclib+Etoposide/Carboplatin/Atezolizumab

Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.

Placebo+Etoposide/Carboplatin/Atezolizumab

Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Trilaciclib+Etoposide/Carboplatin/Atezolizumab54
Placebo+Etoposide/Carboplatin/Atezolizumab53

Reported measurements

Major adverse hematologic events (MAHE)
Values in event rate per week · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trilaciclib+Etoposide/Carboplatin/Atezolizumab0.132Not reportedNot reportedNot reportedNot reported
Placebo+Etoposide/Carboplatin/Atezolizumab0.058Not reportedNot reportedNot reportedNot reported
All-cause hospitalizations
Values in event rate per week · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trilaciclib+Etoposide/Carboplatin/Atezolizumab0.032Not reportedNot reportedNot reportedNot reported
Placebo+Etoposide/Carboplatin/Atezolizumab0.030Not reportedNot reportedNot reportedNot reported
All-cause dose reductions
Values in event rate per week · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trilaciclib+Etoposide/Carboplatin/Atezolizumab0.021Not reportedNot reportedNot reportedNot reported
Placebo+Etoposide/Carboplatin/Atezolizumab0.085Not reportedNot reportedNot reportedNot reported
Febrile neutropenia TEAEs
Values in event rate per week · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trilaciclib+Etoposide/Carboplatin/Atezolizumab0.002Not reportedNot reportedNot reportedNot reported
Placebo+Etoposide/Carboplatin/Atezolizumab0.004Not reportedNot reportedNot reportedNot reported
RBC transfusions on/after Week 5
Values in event rate per week · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trilaciclib+Etoposide/Carboplatin/Atezolizumab0.017Not reportedNot reportedNot reportedNot reported
Placebo+Etoposide/Carboplatin/Atezolizumab0.026Not reportedNot reportedNot reportedNot reported
Prolonged SN (>5 days)
Values in event rate per week · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trilaciclib+Etoposide/Carboplatin/Atezolizumab0.005Not reportedNot reportedNot reportedNot reported
Placebo+Etoposide/Carboplatin/Atezolizumab0.170Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.132
      2. group Id
        OG001
        value
        0.058
    title
    Major adverse hematologic events (MAHE)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0.032
      2. group Id
        OG001
        value
        0.030
    title
    All-cause hospitalizations
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0.021
      2. group Id
        OG001
        value
        0.085
    title
    All-cause dose reductions
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0.002
      2. group Id
        OG001
        value
        0.004
    title
    Febrile neutropenia TEAEs
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0.017
      2. group Id
        OG001
        value
        0.026
    title
    RBC transfusions on/after Week 5
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0.005
      2. group Id
        OG001
        value
        0.170
    title
    Prolonged SN (>5 days)
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    2. group Id
      OG001
      value
      53
    units
    Participants
description
The composite endpoint "major adverse hematologic events" (MAHE) included the following aspects of myelosuppression: All-cause hospitalizations - Each recorded preferred term (PT) with a unique start date was counted as an event. All-cause dose reductions - Dose reductions were permitted for E/P but not for trilaciclib or atezolizumab. No more than 2 dose reductions were allowed. Each dose reduction was counted as a separate event. Febrile neutropenia-Each febrile neutropenia event with a unique start date during the Induction Period was defined as a separate event. Prolonged severe neutropenia (SN)-Each cycle with a severe neutropenia duration greater than 5 days was counted as an event, with the date of the first Grade 4 laboratory value defined as the start date for the time-to-first event analysis. Red blood cell (RBC) transfusion on/after Week 5-Each RBC transfusion with a unique start date on/after Week 5 on study during the Induction Period was defined as a separate event.
groups
  1. description
    Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.
    id
    OG000
    title
    Trilaciclib+Etoposide/Carboplatin/Atezolizumab
  2. description
    Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle. Maintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.
    id
    OG001
    title
    Placebo+Etoposide/Carboplatin/Atezolizumab
param Type
NUMBER
population Description
Intent-to-treat (ITT) analysis set included all randomized patients. Analysis using the ITT analysis set were conducted on the basis of the randomly assigned treatment.
reporting Status
POSTED
time Frame
Induction Period. From date of randomization, 21 day treatment cycles to a maximum of 4 cycles or until (if earlier) disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 409 days.
title
Major Adverse Hematologic Events (MAHE) (Composite Endpoint)
type
SECONDARY
unit Of Measure
event rate per week

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Preserved source evidence · Not medical advice