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NCT01459653 · OUTCOME

Absolute Neutrophil Count (ANC) Across All Cycles

Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor · Source last updated 2016-01-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Per mm^3
Interval / dispersion
Standard Deviation
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 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.

Groups in this outcome

EP2006 Cycles

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
EP2006 Cycles1447

Analysis denominator · cycles

GroupSource count
EP2006 Cycles7792

Reported measurements

Source class 1
Values in Per mm^3 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
EP2006 Cycles4585.63889.8Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        3889.8
        value
        4585.6
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      1447
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      7792
    units
    cycles
description
Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.
dispersion Type
Standard Deviation
groups
  1. 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 Cycles
param Type
MEAN
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
Absolute Neutrophil Count (ANC) Across All Cycles
type
PRIMARY
type Units Analyzed
cycles
unit Of Measure
Per mm^3

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice