NCT02728596 · OUTCOME

Incidence of Febrile Neutropenia Among Intermediate Risk Participants

S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER) · Source last updated 2022-10-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: Within 6 months post registration

What was measured

To compare the rate of FN among intermediate risk participants registered at intervention components by component treatment assignment (administer PP-CSF to intermediate risk participants versus not). Febrile neutropenia is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) as an absolute neutrophil count (ANC) \< 1000/µL and a single temperature of \> 38.3°C (101°F) or a sustained temperature of ≥ 38°C (101°F) for more than one hour.

Analysis population: The analysis population includes only participants that are classified as having intermediate risk of FN. Seven participants were deemed as having an unavailable outcome and were excluded from the analysis population.

Groups in this outcome

Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)

CSF prescribing for patients taking anti-cancer drugs is based on existing automated system recommendations: CSF is recommended for drugs with high risk of FN; CSF is not recommended for drugs with low risk of FN.

Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)

CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines.

Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)

CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN.

Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)

CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN.

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
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)	202
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)	205
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)	540
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)	301

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)	5.9	Not reported	Not reported	Not reported	Not reported
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)	2.9	Not reported	Not reported	Not reported	Not reported
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)	3.7	Not reported	Not reported	Not reported	Not reported
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)	3.7	Not reported	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
0.39
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.95
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY
p Value
0.74
param Type
Odds Ratio (OR)
param Value
0.87
statistical Comment
Adjusted for cancer type.
statistical Method
Regression, Logistic
ci Lower Limit
0.41
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.88
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.87
param Type
Odds Ratio (OR)
param Value
1.09
statistical Comment
Adjusted for cancer type.
statistical Method
Regression, Logistic
ci Lower Limit
0.44
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.57
group Description
This is comparing the FN incidence rate in the arm randomized to alert against PP-CSF vs usual care in intermediate risk participants.
group Ids
OG001
OG003
non Inferiority Type
SUPERIORITY
p Value
0.68
param Type
Odds Ratio (OR)
param Value
1.25
statistical Comment
Adjusted for cancer type.
statistical Method
Regression, Logistic

Complete source fields

analyses

ci Lower Limit
0.39
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.95
group Ids
OG002
OG003
non Inferiority Type
SUPERIORITY
p Value
0.74
param Type
Odds Ratio (OR)
param Value
0.87
statistical Comment
Adjusted for cancer type.
statistical Method
Regression, Logistic
ci Lower Limit
0.41
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.88
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.87
param Type
Odds Ratio (OR)
param Value
1.09
statistical Comment
Adjusted for cancer type.
statistical Method
Regression, Logistic
ci Lower Limit
0.44
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.57
group Description
This is comparing the FN incidence rate in the arm randomized to alert against PP-CSF vs usual care in intermediate risk participants.
group Ids
OG001
OG003
non Inferiority Type
SUPERIORITY
p Value
0.68
param Type
Odds Ratio (OR)
param Value
1.25
statistical Comment
Adjusted for cancer type.
statistical Method
Regression, Logistic

classes

categories
measurements
group Id
OG000
value
5.9
group Id
OG001
value
2.9
group Id
OG002
value
3.7
group Id
OG003
value
3.7

denoms

counts
group Id
OG000
value
202
group Id
OG001
value
205
group Id
OG002
value
540
group Id
OG003
value
301
units
Participants

description

groups

description
CSF prescribing for patients taking anti-cancer drugs is based on existing automated system recommendations: CSF is recommended for drugs with high risk of FN; CSF is not recommended for drugs with low risk of FN.
id
OG000
title
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)
description
CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines.
id
OG001
title
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)
description
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN.
id
OG002
title
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)
description
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN.
id
OG003
title
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)

param Type

NUMBER

population Description

The analysis population includes only participants that are classified as having intermediate risk of FN. Seven participants were deemed as having an unavailable outcome and were excluded from the analysis population.

reporting Status

POSTED

time Frame

Within 6 months post registration

title

Incidence of Febrile Neutropenia Among Intermediate Risk Participants

type

PRIMARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice