NCT02499770 · OUTCOME

Nadir of Absolute Neutrophil Count in Cycle 1, 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: MEAN
Unit: x 10^9 cells/L
Interval / dispersion: Standard Deviation
Time frame: From baseline to the end of Cycle 1

What was measured

Cycle nadir was the lowest value for ANC that occurred between start of cycle and end of cycle and was less than the cycle baseline.

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

Group	Source count
Part 2: Placebo	37
Part 2: Trilaciclib 240 mg/m^2	35

Reported measurements

Source class 1

Values in x 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 2: Placebo	0.815	0.6385	Not reported	Not reported	Not reported
Part 2: Trilaciclib 240 mg/m^2	1.899	1.1930	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.6385
value
0.815
group Id
OG001
spread
1.1930
value
1.899

denoms

counts
group Id
OG000
value
37
group Id
OG001
value
35
units
Participants

description

Cycle nadir was the lowest value for ANC that occurred between start of cycle and end of cycle and was less than the cycle baseline.

dispersion Type

Standard Deviation

groups

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
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

MEAN

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 baseline to the end of Cycle 1

title

Nadir of Absolute Neutrophil Count in Cycle 1, Part 2

type

SECONDARY

unit Of Measure

x 10^9 cells/L

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

Preserved source evidence · Not medical advice