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NCT02728596 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Other-event reporting threshold
5%

Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
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.

3 / 456146 / 45644 / 707
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.

0 / 350123 / 35042 / 644
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.

0 / 694243 / 694123 / 1281
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.

1 / 448171 / 44868 / 973

Group identifiers: EG000: Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing) · EG001: Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing) · EG002: Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing) · EG003: Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      694
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      448
    term
    Sepsis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      694
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      448
    term
    Neoplasms benign, malignant and unspecified - Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      694
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      448
    term
    Respiratory failure

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      44
      num At Risk
      694
    4. group Id
      EG003
      num Affected
      27
      num At Risk
      448
    term
    Mucositis oral
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      81
      num At Risk
      694
    4. group Id
      EG003
      num Affected
      76
      num At Risk
      448
    term
    Arthralgia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      110
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      101
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      205
      num At Risk
      694
    4. group Id
      EG003
      num Affected
      121
      num At Risk
      448
    term
    Bone pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      694
    4. group Id
      EG003
      num Affected
      23
      num At Risk
      448
    term
    Myositis
Complete source fields
description
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
event Groups
  1. deaths Num Affected
    44
    deaths Num At Risk
    707
    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
    EG000
    other Num Affected
    146
    other Num At Risk
    456
    serious Num Affected
    3
    serious Num At Risk
    456
    title
    Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)
  2. deaths Num Affected
    42
    deaths Num At Risk
    644
    description
    CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines.
    id
    EG001
    other Num Affected
    123
    other Num At Risk
    350
    serious Num Affected
    0
    serious Num At Risk
    350
    title
    Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)
  3. deaths Num Affected
    123
    deaths Num At Risk
    1281
    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
    EG002
    other Num Affected
    243
    other Num At Risk
    694
    serious Num Affected
    0
    serious Num At Risk
    694
    title
    Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)
  4. deaths Num Affected
    68
    deaths Num At Risk
    973
    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
    EG003
    other Num Affected
    171
    other Num At Risk
    448
    serious Num Affected
    1
    serious Num At Risk
    448
    title
    Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      44
      num At Risk
      694
    4. group Id
      EG003
      num Affected
      27
      num At Risk
      448
    term
    Mucositis oral
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      81
      num At Risk
      694
    4. group Id
      EG003
      num Affected
      76
      num At Risk
      448
    term
    Arthralgia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      110
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      101
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      205
      num At Risk
      694
    4. group Id
      EG003
      num Affected
      121
      num At Risk
      448
    term
    Bone pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      694
    4. group Id
      EG003
      num Affected
      23
      num At Risk
      448
    term
    Myositis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      694
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      448
    term
    Sepsis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      694
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      448
    term
    Neoplasms benign, malignant and unspecified - Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      456
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      350
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      694
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      448
    term
    Respiratory failure
time Frame
Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.

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Preserved source evidence · Not medical advice