TriangleNCT01459653 · OUTCOME
Fever and Infections Ever During the Study
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- 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 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;
Analysis population: Evaluable consists of all patients who received at least one dose of study drug, who had no major protocol violations and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e. ANC or completed CIN/FN data).
Groups in this outcome
EP2006
Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
| Group | Source count |
|---|---|
| EP2006 | 1447 |
Reported measurements
Fever ever during study
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EP2006 | 76 | Not reported | Not reported | Not reported | Not reported |
Infections ever during study
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EP2006 | 231 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 76
- title
- Fever ever during study
- categories
- measurements
- group Id
- OG000
- value
- 231
- title
- Infections ever during study
- denoms
- counts
- group Id
- OG000
- value
- 1447
- units
- Participants
- description
- Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;
- 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
- param Type
- NUMBER
- population Description
- Evaluable consists of all patients who received at least one dose of study drug, who had no major protocol violations and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e. ANC or completed CIN/FN data).
- 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
- Fever and Infections Ever During the Study
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice