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NCT01716208 · OUTCOME

Percent Reduction in Complement Levels (CH50)

Ofatumumab and Fresh Frozen Plasma in Patients With Chronic Lymphocytic Lymphoma · Source last updated 2021-05-11

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

Measure
MEAN
Unit
Percentage change
Interval / dispersion
Full Range
Time frame
Up to two weeks

What was measured

Complement CH50 is a blood test that helps us determine whether protein abnormalities and deficiencies in the complement system are responsible for any increase in autoimmune activity.

Groups in this outcome

Ofatumumab + Fresh Frozen Plasma

Ofatumumab will be infused intravenously on day 1 (300 mg initial dose), followed one week later by 2000 mg weekly for 7 doses, followed 4 weeks later by 2000 mg every 4 weeks for 4 doses. Two units (approximately 200 or 250 ml) of FFP will be administered prior to ofatumumab(with the exception of the first dose). A unit of fresh frozen plasma is approximately 250ml (or half a pint). Ofatumumab + Fresh Frozen Plasma

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

Analysis denominator · Participants

GroupSource count
Ofatumumab + Fresh Frozen Plasma12

Reported measurements

Source class 1
Values in Percentage change · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Ofatumumab + Fresh Frozen Plasma54Not reported20100Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20
        upper Limit
        100
        value
        54
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
Complement CH50 is a blood test that helps us determine whether protein abnormalities and deficiencies in the complement system are responsible for any increase in autoimmune activity.
dispersion Type
Full Range
groups
  1. description
    Ofatumumab will be infused intravenously on day 1 (300 mg initial dose), followed one week later by 2000 mg weekly for 7 doses, followed 4 weeks later by 2000 mg every 4 weeks for 4 doses. Two units (approximately 200 or 250 ml) of FFP will be administered prior to ofatumumab(with the exception of the first dose). A unit of fresh frozen plasma is approximately 250ml (or half a pint). Ofatumumab + Fresh Frozen Plasma
    id
    OG000
    title
    Ofatumumab + Fresh Frozen Plasma
param Type
MEAN
reporting Status
POSTED
time Frame
Up to two weeks
title
Percent Reduction in Complement Levels (CH50)
type
SECONDARY
unit Of Measure
Percentage change

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

Preserved source evidence · Not medical advice