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NCT02643420 · OUTCOME

Duration of Severe Neutropenia (DSN) in Cycle 1

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
MEAN
Unit
days
Interval / dispersion
Standard Deviation
Time frame
Day 1 and Days 4-15 in Cycle 1 (each cycle was 21 days)

What was measured

DSN was defined as the number of days of severe neutropenia (absolute neutrophil count \[ANC\] \<0.5×10\^9/L), after the administration of study drug in Cycle 1.

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

Source class 1
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm 1: SPI-2012 and TC0.200.503Not reportedNot reportedNot reported
Arm 2: Pegfilgrastim and TC0.350.683Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -0.266
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -0.031
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% confidence interval (CI) of the difference in mean DSN between the treatment arms was \<0.62 days.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    <0.0001
    param Type
    Mean Difference (Final Values)
    param Value
    -0.148
    statistical Comment
    The p-values are based on the calculated t-statistics from the bootstrapped sample mean and standard deviation.
    statistical Method
    t-statistics
Complete source fields
analyses
  1. ci Lower Limit
    -0.266
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -0.031
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% confidence interval (CI) of the difference in mean DSN between the treatment arms was \<0.62 days.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    <0.0001
    param Type
    Mean Difference (Final Values)
    param Value
    -0.148
    statistical Comment
    The p-values are based on the calculated t-statistics from the bootstrapped sample mean and standard deviation.
    statistical Method
    t-statistics
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.503
        value
        0.20
      2. group Id
        OG001
        spread
        0.683
        value
        0.35
denoms
  1. counts
    1. group Id
      OG000
      value
      196
    2. group Id
      OG001
      value
      210
    units
    Participants
description
DSN was defined as the number of days of severe neutropenia (absolute neutrophil count \[ANC\] \<0.5×10\^9/L), after the administration of study drug in Cycle 1.
dispersion Type
Standard Deviation
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
MEAN
population Description
The ITT population included all participants who were randomized.
reporting Status
POSTED
time Frame
Day 1 and Days 4-15 in Cycle 1 (each cycle was 21 days)
title
Duration of Severe Neutropenia (DSN) in Cycle 1
type
PRIMARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice