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NCT01072773 · OUTCOME

Number of Participants With Treatment Related Adverse Events.

Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Light Chain Amyloidosis · Source last updated 2014-04-02

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
Duration on treatment (up to 12 cycles/months)

What was measured

Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE. Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE Adverse events will be assessed using NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0.

Groups in this outcome

Bortez/Cyc/Dex

Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.

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

Analysis denominator · Participants

GroupSource count
Bortez/Cyc/Dex2

Reported measurements

Grade 1-2
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortez/Cyc/Dex2Not reportedNot reportedNot reportedNot reported
Grade 3-4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortez/Cyc/Dex0Not reportedNot reportedNot reportedNot reported
Grade 5
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortez/Cyc/Dex0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Grade 1-2
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Grade 3-4
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE. Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE Adverse events will be assessed using NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0.
groups
  1. description
    Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
    id
    OG000
    title
    Bortez/Cyc/Dex
param Type
NUMBER
reporting Status
POSTED
time Frame
Duration on treatment (up to 12 cycles/months)
title
Number of Participants With Treatment Related Adverse Events.
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice