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NCT02643420 · OUTCOME

Number of Participants With Febrile Neutropenia in Cycles 2, 3, and 4

SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE) · 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 was 21 days)

What was measured

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

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

Groups in this outcome

Arm 1: SPI-2012 and TC

Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.

Arm 2: Pegfilgrastim and TC

Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.

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 TC196
Arm 2: Pegfilgrastim and TC210

Reported measurements

Cycle 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1: SPI-2012 and TC1Not reportedNot reportedNot reportedNot reported
Arm 2: Pegfilgrastim and TC1Not reportedNot reportedNot reportedNot reported
Cycle 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1: SPI-2012 and TC4Not reportedNot reportedNot reportedNot reported
Arm 2: Pegfilgrastim and TC1Not reportedNot reportedNot reportedNot reported
Cycle 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1: SPI-2012 and TC2Not reportedNot reportedNot reportedNot reported
Arm 2: Pegfilgrastim and TC0Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -9.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    9.8
    group Description
    FN in Cycle 2
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    1.000
    param Type
    Percent Difference
    param Value
    0.0
    statistical Method
    Fisher Exact
  2. ci Lower Limit
    -8.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    11.3
    group Description
    FN in Cycle 3
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.201
    param Type
    Percent Difference
    param Value
    1.6
    statistical Method
    Fisher Exact
  3. ci Lower Limit
    -8.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    10.8
    group Description
    FN in Cycle 4
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.232
    param Type
    Percent Difference
    param Value
    1.0
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. ci Lower Limit
    -9.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    9.8
    group Description
    FN in Cycle 2
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    1.000
    param Type
    Percent Difference
    param Value
    0.0
    statistical Method
    Fisher Exact
  2. ci Lower Limit
    -8.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    11.3
    group Description
    FN in Cycle 3
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.201
    param Type
    Percent Difference
    param Value
    1.6
    statistical Method
    Fisher Exact
  3. ci Lower Limit
    -8.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    10.8
    group Description
    FN in Cycle 4
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.232
    param Type
    Percent Difference
    param Value
    1.0
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Cycle 2
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        1
    title
    Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Cycle 4
denoms
  1. counts
    1. group Id
      OG000
      value
      196
    2. group Id
      OG001
      value
      210
    units
    Participants
description
FN was defined as an oral temperature \> 38.3 degrees C (101.0 degrees Fahrenheit \[F\]) or two consecutive readings of \>=38.0 degrees C (100.4 degrees F) for 2 hours and ANC \<1.0×10\^9/L.
groups
  1. description
    Participants received SPI-2012 13.2 mg/0.6mL (3.6 mg G-CSF) fixed-dose SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.
    id
    OG000
    title
    Arm 1: SPI-2012 and TC
  2. description
    Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\^2 IV infusion and Cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care.
    id
    OG001
    title
    Arm 2: Pegfilgrastim and TC
param Type
COUNT_OF_PARTICIPANTS
population Description
The 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 was 21 days)
title
Number of Participants With Febrile Neutropenia in Cycles 2, 3, and 4
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice