TriangleNCT01459653 · OUTCOME
Incidence of CIN/FN-related Hospitalization Outcomes by EP2006 Practice Patterns (Relative to Guidelines): Patient Level
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
- 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 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents incidences of different outcomes and composite outcome by prophylaxis decision (relative to guidelines). \^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance. CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010).
Analysis population: Evaluable sample by prophylaxis decision (relative to guidelines)
Groups in this outcome
EP2006: Undertreated
Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, undertreated relative to guidelines
EP2006: Correctly Treated
Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, correctly treated relative to guidelines
EP2006: Overtreated
Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, overtreated relative to guidelines.
| Group | Source count |
|---|---|
| EP2006: Undertreated | 251 |
| EP2006: Correctly Treated | 817 |
| EP2006: Overtreated | 376 |
Reported measurements
CIN grade 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EP2006: Undertreated | 12.0 | Not reported | Not reported | Not reported | Not reported |
| EP2006: Correctly Treated | 16.8 | Not reported | Not reported | Not reported | Not reported |
| EP2006: Overtreated | 6.4 | Not reported | Not reported | Not reported | Not reported |
FN
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EP2006: Undertreated | 5.2 | Not reported | Not reported | Not reported | Not reported |
| EP2006: Correctly Treated | 8.0 | Not reported | Not reported | Not reported | Not reported |
| EP2006: Overtreated | 2.1 | Not reported | Not reported | Not reported | Not reported |
CIN/FN-related hospitalization
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EP2006: Undertreated | 8.0 | Not reported | Not reported | Not reported | Not reported |
| EP2006: Correctly Treated | 7.1 | Not reported | Not reported | Not reported | Not reported |
| EP2006: Overtreated | 2.7 | Not reported | Not reported | Not reported | Not reported |
CIN/FN-related chemotherapy disturbance
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EP2006: Undertreated | 14.7 | Not reported | Not reported | Not reported | Not reported |
| EP2006: Correctly Treated | 8.8 | Not reported | Not reported | Not reported | Not reported |
| EP2006: Overtreated | 7.7 | Not reported | Not reported | Not reported | Not reported |
Composite^
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EP2006: Undertreated | 24.7 | Not reported | Not reported | Not reported | Not reported |
| EP2006: Correctly Treated | 26.0 | Not reported | Not reported | Not reported | Not reported |
| EP2006: Overtreated | 13.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 12.0
- group Id
- OG001
- value
- 16.8
- group Id
- OG002
- value
- 6.4
- title
- CIN grade 4
- categories
- measurements
- group Id
- OG000
- value
- 5.2
- group Id
- OG001
- value
- 8.0
- group Id
- OG002
- value
- 2.1
- title
- FN
- categories
- measurements
- group Id
- OG000
- value
- 8.0
- group Id
- OG001
- value
- 7.1
- group Id
- OG002
- value
- 2.7
- title
- CIN/FN-related hospitalization
- categories
- measurements
- group Id
- OG000
- value
- 14.7
- group Id
- OG001
- value
- 8.8
- group Id
- OG002
- value
- 7.7
- title
- CIN/FN-related chemotherapy disturbance
- categories
- measurements
- group Id
- OG000
- value
- 24.7
- group Id
- OG001
- value
- 26.0
- group Id
- OG002
- value
- 13.0
- title
- Composite^
- denoms
- counts
- group Id
- OG000
- value
- 251
- group Id
- OG001
- value
- 817
- group Id
- OG002
- value
- 376
- units
- Participants
- description
- Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents incidences of different outcomes and composite outcome by prophylaxis decision (relative to guidelines). \^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance. CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010).
- groups
- description
- Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, undertreated relative to guidelines
- id
- OG000
- title
- EP2006: Undertreated
- description
- Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, correctly treated relative to guidelines
- id
- OG001
- title
- EP2006: Correctly Treated
- description
- Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, overtreated relative to guidelines.
- id
- OG002
- title
- EP2006: Overtreated
- param Type
- NUMBER
- population Description
- Evaluable sample by prophylaxis decision (relative to guidelines)
- 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
- Incidence of CIN/FN-related Hospitalization Outcomes by EP2006 Practice Patterns (Relative to Guidelines): Patient Level
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice