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NCT02953340 · OUTCOME

Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4

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
Days
Interval / dispersion
Standard Deviation
Time frame
Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days)

What was measured

DSN was defined as the number of days of severe neutropenia (ANC \<0.5×10\^9/L) from the first occurrence of ANC below the threshold.

Analysis population: ITT population included all participants who were randomized.

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

GroupSource count
(Arm 1): SPI-2012 and TC118
(Arm 2): Pegfilgrastim and TC119

Reported measurements

Cycle 2
Values in Days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
(Arm 1): SPI-2012 and TC0.080.267Not reportedNot reportedNot reported
(Arm 2): Pegfilgrastim and TC0.090.432Not reportedNot reportedNot reported
Cycle 3
Values in Days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
(Arm 1): SPI-2012 and TC0.070.252Not reportedNot reportedNot reported
(Arm 2): Pegfilgrastim and TC0.070.283Not reportedNot reportedNot reported
Cycle 4
Values in Days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
(Arm 1): SPI-2012 and TC0.070.252Not reportedNot reportedNot reported
(Arm 2): Pegfilgrastim and TC0.080.266Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.267
        value
        0.08
      2. group Id
        OG001
        spread
        0.432
        value
        0.09
    title
    Cycle 2
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.252
        value
        0.07
      2. group Id
        OG001
        spread
        0.283
        value
        0.07
    title
    Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.252
        value
        0.07
      2. group Id
        OG001
        spread
        0.266
        value
        0.08
    title
    Cycle 4
denoms
  1. counts
    1. group Id
      OG000
      value
      118
    2. group Id
      OG001
      value
      119
    units
    Participants
description
DSN was defined as the number of days of severe neutropenia (ANC \<0.5×10\^9/L) from the first occurrence of ANC below the threshold.
dispersion Type
Standard Deviation
groups
  1. 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
  2. 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.
reporting Status
POSTED
time Frame
Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days)
title
Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice