Number of Participants With Clinically Significant Laboratory Abnormalities
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
Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
What was measured
The number of participants with clinically significant hematology (including basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, hematocrit, hemoglobin, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils, neutrophils/leukocytes, platelets, and white blood cells) and serum chemistry (including alanine aminotransferase \[ALT\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin, calcium, cholesterol, creatinine, potassium, sodium, and triglycerides) laboratory abnormalities were reported. Clinically significant findings in laboratory parameters were based on investigator's discretion according to Common Technical Criteria for Adverse Events (CTCAE) Version 4.03.
Analysis population: SAF population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim).
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
117
(Arm 2): Pegfilgrastim and TC
118
Reported measurements
Hematology: Basophils
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
0
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
0
Not reported
Not reported
Not reported
Not reported
Hematology: Basophils/Leukocytes
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
0
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
0
Not reported
Not reported
Not reported
Not reported
Hematology: Eosinophils
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
0
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
0
Not reported
Not reported
Not reported
Not reported
Hematology: Eosinophils/Leukocytes
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
0
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
0
Not reported
Not reported
Not reported
Not reported
Hematology: Hematocrit
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
4
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
2
Not reported
Not reported
Not reported
Not reported
Hematology: Hemoglobin
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
6
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
4
Not reported
Not reported
Not reported
Not reported
Hematology: Lymphocytes
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
0
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
0
Not reported
Not reported
Not reported
Not reported
Hematology: Lymphocytes/Leukocytes
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
6
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
13
Not reported
Not reported
Not reported
Not reported
Hematology: Monocytes
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
0
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
0
Not reported
Not reported
Not reported
Not reported
Hematology: Monocytes/Leukocytes
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
0
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
0
Not reported
Not reported
Not reported
Not reported
Hematology: Neutrophils
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
17
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
23
Not reported
Not reported
Not reported
Not reported
Hematology: Neutrophils/Leukocytes
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
12
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
9
Not reported
Not reported
Not reported
Not reported
Hematology: Platelets
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
10
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
2
Not reported
Not reported
Not reported
Not reported
Hematology: White Blood Cells
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
16
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
18
Not reported
Not reported
Not reported
Not reported
Chemistry: Alanine aminotransferase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
2
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
1
Not reported
Not reported
Not reported
Not reported
Chemistry: Alkaline phosphatase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
0
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
1
Not reported
Not reported
Not reported
Not reported
Chemistry: Aspartate aminotransferase
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
1
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
1
Not reported
Not reported
Not reported
Not reported
Chemistry: Bilirubin
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
0
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
0
Not reported
Not reported
Not reported
Not reported
Chemistry: Calcium
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
1
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
1
Not reported
Not reported
Not reported
Not reported
Chemistry: Cholesterol
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
0
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
0
Not reported
Not reported
Not reported
Not reported
Chemistry: Creatinine
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
0
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
0
Not reported
Not reported
Not reported
Not reported
Chemistry: Potassium
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
0
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
1
Not reported
Not reported
Not reported
Not reported
Chemistry: Sodium
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
0
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
2
Not reported
Not reported
Not reported
Not reported
Chemistry: Triglycerides
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
(Arm 1): SPI-2012 and TC
0
Not reported
Not reported
Not reported
Not reported
(Arm 2): Pegfilgrastim and TC
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Hematology: Basophils
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Hematology: Basophils/Leukocytes
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Hematology: Eosinophils
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Hematology: Eosinophils/Leukocytes
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
2
title
Hematology: Hematocrit
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
4
title
Hematology: Hemoglobin
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Hematology: Lymphocytes
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
13
title
Hematology: Lymphocytes/Leukocytes
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Hematology: Monocytes
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Hematology: Monocytes/Leukocytes
categories
measurements
group Id
OG000
value
17
group Id
OG001
value
23
title
Hematology: Neutrophils
categories
measurements
group Id
OG000
value
12
group Id
OG001
value
9
title
Hematology: Neutrophils/Leukocytes
denoms
counts
group Id
OG000
value
117
group Id
OG001
value
118
units
Participants
description
The number of participants with clinically significant hematology (including basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, hematocrit, hemoglobin, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils, neutrophils/leukocytes, platelets, and white blood cells) and serum chemistry (including alanine aminotransferase \[ALT\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin, calcium, cholesterol, creatinine, potassium, sodium, and triglycerides) laboratory abnormalities were reported. Clinically significant findings in laboratory parameters were based on investigator's discretion according to Common Technical Criteria for Adverse Events (CTCAE) Version 4.03.
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
COUNT_OF_PARTICIPANTS
population Description
SAF population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim).
reporting Status
POSTED
time Frame
Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
title
Number of Participants With Clinically Significant Laboratory Abnormalities
Triangle