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NCT01716208 · OUTCOME

Response to Therapy

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 37 months.

What was measured

Defined as complete, or partial response, and progression-free survival. Measured by National Cancer Institute - Working Group and International Workshop on Chronic Lymphocytic Leukemia

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

PR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ofatumumab + Fresh Frozen Plasma10Not reportedNot reportedNot reportedNot reported

CR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ofatumumab + Fresh Frozen Plasma2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      title
      PR
    2. measurements
      1. group Id
        OG000
        value
        2
      title
      CR
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
Defined as complete, or partial response, and progression-free survival. Measured by National Cancer Institute - Working Group and International Workshop on Chronic Lymphocytic Leukemia
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 37 months.
title
Response to Therapy
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice