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NCT01536067 · OUTCOME

Frequency and Severity of Toxicity as Graded According to the Cancer Therapeutic Evaluation Program (CTEP) Common Toxicity Criteria (CTC) Version 4.0

Ofatumumab and Bortezomib in Treating Patients With Previously Untreated Waldenstrom Macroglobulinemia · Source last updated 2016-06-10

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
Every 30 days for 2 months

What was measured

Maximum grade per participant of any AE.

Analysis population: All treated and eligible patients

Groups in this outcome

Treatment (Monoclonal Antibody Therapy)

INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. ofatumumab: Given IV bortezomib: Given SC laboratory biomarker analysis: Correlative studies

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

Analysis denominator · Participants

GroupSource count
Treatment (Monoclonal Antibody Therapy)3

Reported measurements

Grade 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Monoclonal Antibody Therapy)0Not reportedNot reportedNot reportedNot reported
Grade 2
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Monoclonal Antibody Therapy)0Not reportedNot reportedNot reportedNot reported
Grade 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Monoclonal Antibody Therapy)3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Grade 3
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    units
    Participants
description
Maximum grade per participant of any AE.
groups
  1. description
    INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. ofatumumab: Given IV bortezomib: Given SC laboratory biomarker analysis: Correlative studies
    id
    OG000
    title
    Treatment (Monoclonal Antibody Therapy)
param Type
NUMBER
population Description
All treated and eligible patients
reporting Status
POSTED
time Frame
Every 30 days for 2 months
title
Frequency and Severity of Toxicity as Graded According to the Cancer Therapeutic Evaluation Program (CTEP) Common Toxicity Criteria (CTC) Version 4.0
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice