TriangleNCT01459653 · OUTCOME
Incidence of CIN Grade 4 Episodes by EP2006 Dose: 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. 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 study drug dose
Groups in this outcome
EP2006: 30MIU/Day
Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, treated with 30MIU/day
EP2006: 48MIU/Day
Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, treated with 48MIU/day
| Group | Source count |
|---|---|
| EP2006: 30MIU/Day | 815 |
| EP2006: 48MIU/Day | 610 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EP2006: 30MIU/Day | 11.3 | Not reported | Not reported | Not reported | Not reported |
| EP2006: 48MIU/Day | 15.9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 11.3
- group Id
- OG001
- value
- 15.9
- denoms
- counts
- group Id
- OG000
- value
- 815
- group Id
- OG001
- value
- 610
- 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. 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, treated with 30MIU/day
- id
- OG000
- title
- EP2006: 30MIU/Day
- description
- Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, treated with 48MIU/day
- id
- OG001
- title
- EP2006: 48MIU/Day
- param Type
- NUMBER
- population Description
- Evaluable sample by study drug dose
- 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 Grade 4 Episodes by EP2006 Dose: Patient Level
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice