TriangleNCT02728596 · OUTCOME
Incidence of Febrile Neutropenia Among Low Risk Participants
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 of registration
What was measured
To compare the rate of FN among low-risk participants 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: The analysis population includes only participants deemed 'low-risk' within each of the clinic groups.
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. Preventive Intervention: Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
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. Preventive Intervention: Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
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. Preventive Intervention: Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
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. Preventive Intervention: Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
| Group | Source count |
|---|---|
| Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing) | 111 |
| Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing) | 120 |
| Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing) | 229 |
| Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing) | 196 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing) | 1.8 | Not reported | Not reported | Not reported | Not reported |
| Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing) | 0.8 | Not reported | Not reported | Not reported | Not reported |
| Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing) | 1.8 | Not reported | Not reported | Not reported | Not reported |
| Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing) | 1.5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1.8
- group Id
- OG001
- value
- 0.8
- group Id
- OG002
- value
- 1.8
- group Id
- OG003
- value
- 1.5
- denoms
- counts
- group Id
- OG000
- value
- 111
- group Id
- OG001
- value
- 120
- group Id
- OG002
- value
- 229
- group Id
- OG003
- value
- 196
- units
- Participants
- description
- To compare the rate of FN among low-risk participants 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
- 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. Preventive Intervention: Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
- 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. Preventive Intervention: Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
- 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. Preventive Intervention: Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
- 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. Preventive Intervention: Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies
- 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 deemed 'low-risk' within each of the clinic groups.
- reporting Status
- POSTED
- time Frame
- Within 6 months of registration
- title
- Incidence of Febrile Neutropenia Among Low Risk Participants
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice