Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02643420 · OUTCOME

Depth of Absolute Neutrophil Count (ANC) Nadir 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
10^9 ANC/L
Interval / dispersion
Standard Deviation
Time frame
Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)

What was measured

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: The ITT population included all participants who were randomized. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

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 TC191
Arm 2: Pegfilgrastim and TC196

Reported measurements

Source class 1
Values in 10^9 ANC/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm 1: SPI-2012 and TC2.563.086Not reportedNot reportedNot reported
Arm 2: Pegfilgrastim and TC2.533.317Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.93
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.56
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.155
    param Type
    Median Difference (Final Values)
    param Value
    1.2
    statistical Comment
    P-value was obtained based upon asymptotic normality assumption on the log10 transformed data.
    statistical Method
    Asymptotic normality assumption
Complete source fields
analyses
  1. ci Lower Limit
    0.93
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.56
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.155
    param Type
    Median Difference (Final Values)
    param Value
    1.2
    statistical Comment
    P-value was obtained based upon asymptotic normality assumption on the log10 transformed data.
    statistical Method
    Asymptotic normality assumption
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.086
        value
        2.56
      2. group Id
        OG001
        spread
        3.317
        value
        2.53
denoms
  1. counts
    1. group Id
      OG000
      value
      191
    2. group Id
      OG001
      value
      196
    units
    Participants
description
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
  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. Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Day 1 and Days 4, 15 in Cycle 1 (each cycle was 21 days)
title
Depth of Absolute Neutrophil Count (ANC) Nadir in Cycle 1
type
SECONDARY
unit Of Measure
10^9 ANC/L

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

Preserved source evidence · Not medical advice