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NCT02953340 · OUTCOME

Number of Participants With Febrile Neutropenia 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days)

What was measured

FN was defined as an oral temperature \>38.3°C (101.0°F) or two consecutive readings of \>38.0°C (100.4°F) for 2 hours and ANC \<1.0×10\^9/L.

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 Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
(Arm 1): SPI-2012 and TC0Not reportedNot reportedNot reportedNot reported
(Arm 2): Pegfilgrastim and TC2Not reportedNot reportedNot reportedNot reported
Cycle 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
(Arm 1): SPI-2012 and TC0Not reportedNot reportedNot reportedNot reported
(Arm 2): Pegfilgrastim and TC0Not reportedNot reportedNot reportedNot reported
Cycle 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
(Arm 1): SPI-2012 and TC0Not reportedNot reportedNot reportedNot reported
(Arm 2): Pegfilgrastim and TC0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Cycle 2
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Cycle 4
denoms
  1. counts
    1. group Id
      OG000
      value
      118
    2. group Id
      OG001
      value
      119
    units
    Participants
description
FN was defined as an oral temperature \>38.3°C (101.0°F) or two consecutive readings of \>38.0°C (100.4°F) for 2 hours and ANC \<1.0×10\^9/L.
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
COUNT_OF_PARTICIPANTS
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
Number of Participants With Febrile Neutropenia in Cycles 2, 3 and 4
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice