NCT01459653 · OUTCOME
Patient Risk Score (PRS) for Patients Receiving Chemotherapy With 10-20% FN Risk by Tumor Type
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Scores on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
What was measured
Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. Patient risk score (PRS) shows the individual patient risk for FN.The PRS is a sum of eight weighted individual patient risk factors for FN and results in a possible score of 0 to 11 (highest risk for FN). The risk factors were assigned weights based on the level of risk specified by guidelines and SC consensus (age \> 65 years: 3.0; advanced disease: 1.5; history of FN: 3.0; No antibiotic prophylaxis: 0.5; poor performance/nutritional status: 1.5; female gender: 0.5; Hb\<12g/dL: 0.5; Renal, CV or liver disease: 0.5). Advanced disease: Stage IV or Stage III + prior chemotherapy in metastatic setting; CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia
Analysis population: Patients with chemotherapy with 10-20% risk of FN in the evaluable sample by tumor type
Groups in this outcome
EP2006 - All Patients
Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (all patients).
EP2006 - Solid Tumor
Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (Solid tumor).
EP2006 - Hematological Tumor
Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (Hematological tumor).
| Group | Source count |
|---|---|
| EP2006 - All Patients | 650 |
| EP2006 - Solid Tumor | 568 |
| EP2006 - Hematological Tumor | 82 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EP2006 - All Patients | 3.3 | 2.0 | Not reported | Not reported | Not reported |
| EP2006 - Solid Tumor | 3.2 | 1.9 | Not reported | Not reported | Not reported |
| EP2006 - Hematological Tumor | 3.4 | 2.4 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.0
- value
- 3.3
- group Id
- OG001
- spread
- 1.9
- value
- 3.2
- group Id
- OG002
- spread
- 2.4
- value
- 3.4
- denoms
- counts
- group Id
- OG000
- value
- 650
- group Id
- OG001
- value
- 568
- group Id
- OG002
- value
- 82
- units
- Participants
- description
- Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. Patient risk score (PRS) shows the individual patient risk for FN.The PRS is a sum of eight weighted individual patient risk factors for FN and results in a possible score of 0 to 11 (highest risk for FN). The risk factors were assigned weights based on the level of risk specified by guidelines and SC consensus (age \> 65 years: 3.0; advanced disease: 1.5; history of FN: 3.0; No antibiotic prophylaxis: 0.5; poor performance/nutritional status: 1.5; female gender: 0.5; Hb\<12g/dL: 0.5; Renal, CV or liver disease: 0.5). Advanced disease: Stage IV or Stage III + prior chemotherapy in metastatic setting; CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia
- dispersion Type
- Standard Deviation
- groups
- description
- Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (all patients).
- id
- OG000
- title
- EP2006 - All Patients
- description
- Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (Solid tumor).
- id
- OG001
- title
- EP2006 - Solid Tumor
- description
- Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (Hematological tumor).
- id
- OG002
- title
- EP2006 - Hematological Tumor
- param Type
- MEAN
- population Description
- Patients with chemotherapy with 10-20% risk of FN in the evaluable sample by tumor type
- reporting Status
- POSTED
- time Frame
- Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.
- title
- Patient Risk Score (PRS) for Patients Receiving Chemotherapy With 10-20% FN Risk by Tumor Type
- type
- PRIMARY
- unit Of Measure
- Scores on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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