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NCT01292486 · OUTCOME

Hematocrit of MNC Product

Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure · Source last updated 2013-05-01

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

Measure
MEDIAN
Unit
hematocrit %
Interval / dispersion
Full Range
Time frame
7 days

What was measured

The hematocrit of the collected product was used to quantitate Red Blood Cell (RBC) contamination.

Analysis population: Data was available from 38 MNC collections from 25 of the 26 per protocol patients.

Groups in this outcome

All Per Protocol Patients

Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.

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

Analysis denominator · Participants

GroupSource count
All Per Protocol Patients25

Analysis denominator · MNC collections

GroupSource count
All Per Protocol Patients38

Reported measurements

Source class 1
Values in hematocrit % · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
All Per Protocol Patients1.8Not reported1.14.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.1
        upper Limit
        4.5
        value
        1.8
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      38
    units
    MNC collections
description
The hematocrit of the collected product was used to quantitate Red Blood Cell (RBC) contamination.
dispersion Type
Full Range
groups
  1. description
    Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
    id
    OG000
    title
    All Per Protocol Patients
param Type
MEDIAN
population Description
Data was available from 38 MNC collections from 25 of the 26 per protocol patients.
reporting Status
POSTED
time Frame
7 days
title
Hematocrit of MNC Product
type
SECONDARY
type Units Analyzed
MNC collections
unit Of Measure
hematocrit %

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

Preserved source evidence · Not medical advice