NCT02953340 · OUTCOME

Depth of ANC Nadir in Cycle 1

SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide · Source last updated 2022-03-02

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

Measure: MEAN
Unit: 10^9 cells/L
Interval / dispersion: Standard Deviation
Time frame: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)

What was measured

The depth of ANC Nadir was defined as the lowest ANC value after administration of study drug (SPI-2012 or pegfilgrastim) in Cycle 1.

Analysis population: ITT population included all participants who were randomized. Here 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure at the specified timepoint.

Groups in this outcome

(Arm 1): SPI-2012 and TC

At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg/0.6 mL, \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.

(Arm 2): Pegfilgrastim and TC

At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.

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
(Arm 1): SPI-2012 and TC	115
(Arm 2): Pegfilgrastim and TC	116

Reported measurements

Source class 1

Values in 10^9 cells/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
(Arm 1): SPI-2012 and TC	2.67	3.504	Not reported	Not reported	Not reported
(Arm 2): Pegfilgrastim and TC	2.06	2.034	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
3.504
value
2.67
group Id
OG001
spread
2.034
value
2.06

denoms

counts
group Id
OG000
value
115
group Id
OG001
value
116
units
Participants

description

The depth of ANC Nadir was defined as the lowest ANC value after administration of study drug (SPI-2012 or pegfilgrastim) in Cycle 1.

dispersion Type

Standard Deviation

groups

description
At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg/0.6 mL, \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
id
OG000
title
(Arm 1): SPI-2012 and TC
description
At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL G-CSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
id
OG001
title
(Arm 2): Pegfilgrastim and TC

param Type

MEAN

population Description

ITT population included all participants who were randomized. Here 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure at the specified timepoint.

reporting Status

POSTED

time Frame

Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)

title

Depth of ANC Nadir in Cycle 1

type

SECONDARY

unit Of Measure

10^9 cells/L

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

Preserved source evidence · Not medical advice