TriangleNCT01459653 · OUTCOME
Percentage of Patients With Each Chemotherapy Risk Score (CRS) Result by Tumor Type
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of patients
- Interval / dispersion
- Not reported
- Time frame
- All cycles. 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, mean duration of study for 105 days
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. The CRS quantifies whether the decision to initiate EP2006 as either primary or secondary prophylaxis is consistent with the EORTC guideline (2010) recommendation based upon the patient's chemotherapy toxicity (\<10%, 10-20% or \>20% risk of FN) and the PRS. There are three possible results: under-treated, correctly treated, over-treated
Analysis population: Evaluable sample: total and 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.
EP2006: Solid Tumor
Cancer patients (Solid tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
EP2006: Hematological Tumor
Cancer patients (Hematological tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
| Group | Source count |
|---|---|
| EP2006: All Patients | 1444 |
| EP2006: Solid Tumor | 1115 |
| EP2006: Hematological Tumor | 329 |
Reported measurements
Under-treated (%)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EP2006: All Patients | 17.3 | Not reported | Not reported | Not reported | Not reported |
| EP2006: Solid Tumor | 16.3 | Not reported | Not reported | Not reported | Not reported |
| EP2006: Hematological Tumor | 21.0 | Not reported | Not reported | Not reported | Not reported |
Correctly or Over-treated (%)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EP2006: All Patients | 82.5 | Not reported | Not reported | Not reported | Not reported |
| EP2006: Solid Tumor | 83.7 | Not reported | Not reported | Not reported | Not reported |
| EP2006: Hematological Tumor | 79.0 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.4255
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.2698
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.2698
- param Type
- Odds Ratio (OR)
- param Value
- 0.7350
- statistical Method
- Chi-squared
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 0.4255
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.2698
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.2698
- param Type
- Odds Ratio (OR)
- param Value
- 0.7350
- statistical Method
- Chi-squared
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 17.3
- group Id
- OG001
- value
- 16.3
- group Id
- OG002
- value
- 21.0
- title
- Under-treated (%)
- categories
- measurements
- group Id
- OG000
- value
- 82.5
- group Id
- OG001
- value
- 83.7
- group Id
- OG002
- value
- 79.0
- title
- Correctly or Over-treated (%)
- denoms
- counts
- group Id
- OG000
- value
- 1444
- group Id
- OG001
- value
- 1115
- group Id
- OG002
- value
- 329
- 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. The CRS quantifies whether the decision to initiate EP2006 as either primary or secondary prophylaxis is consistent with the EORTC guideline (2010) recommendation based upon the patient's chemotherapy toxicity (\<10%, 10-20% or \>20% risk of FN) and the PRS. There are three possible results: under-treated, correctly treated, over-treated
- groups
- description
- Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
- id
- OG000
- title
- EP2006: All Patients
- description
- Cancer patients (Solid tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
- id
- OG001
- title
- EP2006: Solid Tumor
- description
- Cancer patients (Hematological tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
- id
- OG002
- title
- EP2006: Hematological Tumor
- param Type
- NUMBER
- population Description
- Evaluable sample: total and by tumor type
- reporting Status
- POSTED
- time Frame
- All cycles. 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, mean duration of study for 105 days
- title
- Percentage of Patients With Each Chemotherapy Risk Score (CRS) Result by Tumor Type
- type
- PRIMARY
- unit Of Measure
- percentage of patients
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Preserved source evidence · Not medical advice