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NCT02728596 · OUTCOME

Incidence of Febrile Neutropenia

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 febrile neutropenia (FN) among participants, at any risk level, registered at intervention components versus usual care components. 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: There were 18 participants deemed as having an unavailable outcome and were excluded from the analysis population, leaving 3587 analyzable participants.

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

GroupSource count
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)707
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)640
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)1275
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)965

Reported measurements

Low Risk Group

Analysis denominator · Participants

GroupSource count
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)121
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)127
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)245
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)207
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)1.7Not reportedNot reportedNot reportedNot reported
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)0.8Not reportedNot reportedNot reportedNot reported
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)1.6Not reportedNot reportedNot reportedNot reported
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)1.5Not reportedNot reportedNot reportedNot reported
Intermediate Risk Group

Analysis denominator · Participants

GroupSource 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
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)5.9Not reportedNot reportedNot reportedNot reported
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)2.9Not reportedNot reportedNot reportedNot reported
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)3.7Not reportedNot reportedNot reportedNot reported
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)3.7Not reportedNot reportedNot reportedNot reported
High Risk Group

Analysis denominator · Participants

GroupSource count
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)384
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)308
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)490
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)457
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)6.5Not reportedNot reportedNot reportedNot reported
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)4.2Not reportedNot reportedNot reportedNot reported
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)5.7Not reportedNot reportedNot reportedNot reported
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)6.6Not reportedNot reportedNot reportedNot reported
All FN Risk Groups

Analysis denominator · Participants

GroupSource count
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)707
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)640
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)1275
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)965
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)5.5Not reportedNot reportedNot reportedNot reported
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)3.1Not reportedNot reportedNot reportedNot reported
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)4.1Not reportedNot reportedNot reportedNot reported
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)4.6Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.75
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.95
    group Description
    FN incidence rate in the high risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).
    group Ids
    1. OG001
    2. OG002
    3. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    0.26
    param Type
    Odds Ratio (OR)
    param Value
    1.49
    statistical Comment
    Adjusted for age.
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    0.23
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    18.80
    group Description
    FN incidence rate in the low risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).
    group Ids
    1. OG001
    2. OG002
    3. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    0.51
    param Type
    Odds Ratio (OR)
    param Value
    2.00
    statistical Comment
    Adjusted for cancer type.
    statistical Method
    Regression, Logistic
  3. ci Lower Limit
    0.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.88
    group Description
    FN incidence rate in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the SOE for PP-CSF intervention group (Arm 3).
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.87
    param Type
    Odds Ratio (OR)
    param Value
    1.09
    statistical Method
    Regression, Logistic
  4. ci Lower Limit
    0.44
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.57
    group Description
    FN incidence rate in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the alert against PP-CSF intervention group (Arm 4).
    group Ids
    1. OG001
    2. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    0.68
    param Type
    Odds Ratio (OR)
    param Value
    1.25
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. ci Lower Limit
    0.75
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.95
    group Description
    FN incidence rate in the high risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).
    group Ids
    1. OG001
    2. OG002
    3. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    0.26
    param Type
    Odds Ratio (OR)
    param Value
    1.49
    statistical Comment
    Adjusted for age.
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    0.23
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    18.80
    group Description
    FN incidence rate in the low risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).
    group Ids
    1. OG001
    2. OG002
    3. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    0.51
    param Type
    Odds Ratio (OR)
    param Value
    2.00
    statistical Comment
    Adjusted for cancer type.
    statistical Method
    Regression, Logistic
  3. ci Lower Limit
    0.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.88
    group Description
    FN incidence rate in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the SOE for PP-CSF intervention group (Arm 3).
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.87
    param Type
    Odds Ratio (OR)
    param Value
    1.09
    statistical Method
    Regression, Logistic
  4. ci Lower Limit
    0.44
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.57
    group Description
    FN incidence rate in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the alert against PP-CSF intervention group (Arm 4).
    group Ids
    1. OG001
    2. OG003
    non Inferiority Type
    SUPERIORITY
    p Value
    0.68
    param Type
    Odds Ratio (OR)
    param Value
    1.25
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1.7
      2. group Id
        OG001
        value
        0.8
      3. group Id
        OG002
        value
        1.6
      4. group Id
        OG003
        value
        1.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        121
      2. group Id
        OG001
        value
        127
      3. group Id
        OG002
        value
        245
      4. group Id
        OG003
        value
        207
      units
      Participants
    title
    Low Risk Group
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5.9
      2. group Id
        OG001
        value
        2.9
      3. group Id
        OG002
        value
        3.7
      4. group Id
        OG003
        value
        3.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        202
      2. group Id
        OG001
        value
        205
      3. group Id
        OG002
        value
        540
      4. group Id
        OG003
        value
        301
      units
      Participants
    title
    Intermediate Risk Group
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6.5
      2. group Id
        OG001
        value
        4.2
      3. group Id
        OG002
        value
        5.7
      4. group Id
        OG003
        value
        6.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        384
      2. group Id
        OG001
        value
        308
      3. group Id
        OG002
        value
        490
      4. group Id
        OG003
        value
        457
      units
      Participants
    title
    High Risk Group
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5.5
      2. group Id
        OG001
        value
        3.1
      3. group Id
        OG002
        value
        4.1
      4. group Id
        OG003
        value
        4.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        707
      2. group Id
        OG001
        value
        640
      3. group Id
        OG002
        value
        1275
      4. group Id
        OG003
        value
        965
      units
      Participants
    title
    All FN Risk Groups
denoms
  1. counts
    1. group Id
      OG000
      value
      707
    2. group Id
      OG001
      value
      640
    3. group Id
      OG002
      value
      1275
    4. group Id
      OG003
      value
      965
    units
    Participants
description
To compare the rate of febrile neutropenia (FN) among participants, at any risk level, registered at intervention components versus usual care components. 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.
groups
  1. 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)
  2. 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)
  3. 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)
  4. 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
There were 18 participants deemed as having an unavailable outcome and were excluded from the analysis population, leaving 3587 analyzable participants.
reporting Status
POSTED
time Frame
Within 6 months post registration
title
Incidence of Febrile Neutropenia
type
PRIMARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice