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NCT02499770 · OUTCOME

Incidence of Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Related AEs, Related SAEs, and AEs Leading to Study Drug Discontinuation 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
TEAEs were any AE that started on or after the first dose of study drug and up to the last dose +30 days (a minimum of 51 days up to a maximum of 374 days)

What was measured

An AE was defined as any untoward medical occurrence in a participant administered a medicinal product that did not necessarily have a causal relationship with this treatment. TEAEs were defined as any AE that started on or after the first dose of study drug and up to the last dose +30 days. SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect. Relatedness to study drug was assessed by the investigator. Related refers to those events that were Possibly, Probably, or Definitely Related. AEs with an unknown/not reported onset date were also included.

Analysis population: Safety analysis set - included all enrolled participants (i.e., signed informed consent) who received at least 1 dose of study drug (etoposide, carboplatin, or trilaciclib). Part 1: Cohort 1 Trilaciclib 200 mg/m\^2 included 1 participant from Part 2 and 1 participant from Part 1 240 mg/m\^2 who received 200 mg/m\^2.

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^212
Part 1: Cohort 2 Trilaciclib 240mg/m^28

Reported measurements

Any TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Cohort 1 Trilaciclib 200 mg/m^212Not reportedNot reportedNot reportedNot reported
Part 1: Cohort 2 Trilaciclib 240mg/m^28Not reportedNot reportedNot reportedNot reported
Any SAE
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^21Not reportedNot reportedNot reportedNot reported
TEAE related to any study drug
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Cohort 1 Trilaciclib 200 mg/m^210Not reportedNot reportedNot reportedNot reported
Part 1: Cohort 2 Trilaciclib 240mg/m^28Not reportedNot reportedNot reportedNot reported
SAE related to any study drug
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Cohort 1 Trilaciclib 200 mg/m^20Not reportedNot reportedNot reportedNot reported
Part 1: Cohort 2 Trilaciclib 240mg/m^20Not reportedNot reportedNot reportedNot reported
TEAE leading to discontinuation of any study drug
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: Cohort 1 Trilaciclib 200 mg/m^20Not reportedNot reportedNot reportedNot reported
Part 1: Cohort 2 Trilaciclib 240mg/m^20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        8
    title
    Any TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        1
    title
    Any SAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        8
    title
    TEAE related to any study drug
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    SAE related to any study drug
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    TEAE leading to discontinuation of any study drug
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      8
    units
    Participants
description
An AE was defined as any untoward medical occurrence in a participant administered a medicinal product that did not necessarily have a causal relationship with this treatment. TEAEs were defined as any AE that started on or after the first dose of study drug and up to the last dose +30 days. SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect. Relatedness to study drug was assessed by the investigator. Related refers to those events that were Possibly, Probably, or Definitely Related. AEs with an unknown/not reported onset date were also included.
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
Safety analysis set - included all enrolled participants (i.e., signed informed consent) who received at least 1 dose of study drug (etoposide, carboplatin, or trilaciclib). Part 1: Cohort 1 Trilaciclib 200 mg/m\^2 included 1 participant from Part 2 and 1 participant from Part 1 240 mg/m\^2 who received 200 mg/m\^2.
reporting Status
POSTED
time Frame
TEAEs were any AE that started on or after the first dose of study drug and up to the last dose +30 days (a minimum of 51 days up to a maximum of 374 days)
title
Incidence of Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Related AEs, Related SAEs, and AEs Leading to Study Drug Discontinuation in Part 1
type
PRIMARY
unit Of Measure
Participants

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