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NCT01484626 · OUTCOME

Number of Patients Experiencing a Toxicity

Bendamustine, Wkly Bortezomib, Lenalidomide and Dexamethasone for Multiple Myeloma · Source last updated 2018-07-10

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
21 days

What was measured

The number of patients experiencing at least one toxicity at the lowest dose of bendamustine. A toxicity is defined as one or more of the following: Upper respiratory infection; anemia; thrombocytopenia; neutropenia; shortness of breath on exertion; decreased appetite; nausea; neuropathy; anxiety; arthritis; and hypercalcemia.

Analysis population: No patients were analyzed as study was terminated early after external sponsor withdrew support. Therefore, data necessary for planned analyses were not collected.

Groups in this outcome

Bendamustine

Bendamustine is combined with standard chemotherapy

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

Analysis denominator · Participants

GroupSource count
Bendamustine3

Reported measurements

Source class 1

Experienced no toxicities

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bendamustine0Not reportedNot reportedNot reportedNot reported

Experienced at least one toxicity

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bendamustine3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      title
      Experienced no toxicities
    2. measurements
      1. group Id
        OG000
        value
        3
      title
      Experienced at least one toxicity
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    units
    Participants
description
The number of patients experiencing at least one toxicity at the lowest dose of bendamustine. A toxicity is defined as one or more of the following: Upper respiratory infection; anemia; thrombocytopenia; neutropenia; shortness of breath on exertion; decreased appetite; nausea; neuropathy; anxiety; arthritis; and hypercalcemia.
groups
  1. description
    Bendamustine is combined with standard chemotherapy
    id
    OG000
    title
    Bendamustine
param Type
COUNT_OF_PARTICIPANTS
population Description
No patients were analyzed as study was terminated early after external sponsor withdrew support. Therefore, data necessary for planned analyses were not collected.
reporting Status
POSTED
time Frame
21 days
title
Number of Patients Experiencing a Toxicity
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice