NCT02953340 · OUTCOME

Duration of Severe Neutropenia (DSN) in Cycle 1

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: Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)

What was measured

DSN was defined as the number of days of severe neutropenia (absolute neutrophil count \[ANC\] \<0.5×10\^9 per liter \[L\]) 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

Group	Source count
(Arm 1): SPI-2012 and TC	118
(Arm 2): Pegfilgrastim and TC	119

Reported measurements

Source class 1

Values in Days · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
(Arm 1): SPI-2012 and TC	0.31	0.688	Not reported	Not reported	Not reported
(Arm 2): Pegfilgrastim and TC	0.39	0.949	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
-0.292
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.129
group Ids
OG000
OG001
non Inferiority Comment
The study used non inferiority margin of 0.62 days for the above comparison. 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
param Value
-0.074
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

ci Lower Limit
-0.292
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.129
group Ids
OG000
OG001
non Inferiority Comment
The study used non inferiority margin of 0.62 days for the above comparison. 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
param Value
-0.074
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

categories
measurements
group Id
OG000
spread
0.688
value
0.31
group Id
OG001
spread
0.949
value
0.39

denoms

counts
group Id
OG000
value
118
group Id
OG001
value
119
units
Participants

description

DSN was defined as the number of days of severe neutropenia (absolute neutrophil count \[ANC\] \<0.5×10\^9 per liter \[L\]) from the first occurrence of ANC below the threshold.

dispersion Type

Standard Deviation

groups

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
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

Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)

title

Duration of Severe Neutropenia (DSN) in Cycle 1

type

PRIMARY

unit Of Measure

Days

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Preserved source evidence · Not medical advice