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NCT00429949 · OUTCOME

Safety and Tolerability of Dasatinib (Grade III-IV Toxicities)

A Phase II Study of Dasatinib in the Treatment of Relapsed or Plateau Phase Multiple Myeloma · Source last updated 2014-08-29

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
Up to 30 days following end of treatment (median duration of therapy was 51 days)

What was measured

Toxicities were graded using the NCI Common Toxicity Criteria v3.0.

Groups in this outcome

Dasatinib

Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle. In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.

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

Analysis denominator · Participants

GroupSource count
Dasatinib21

Reported measurements

Grade III anemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib5Not reportedNot reportedNot reportedNot reported
Grade III neutropenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib2Not reportedNot reportedNot reportedNot reported
Grade III thrombocytopenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib2Not reportedNot reportedNot reportedNot reported
Grade IV thrombocytopenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib3Not reportedNot reportedNot reportedNot reported
Grade III epistaxis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib2Not reportedNot reportedNot reportedNot reported
Grade III gastrointestinal bleed
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib1Not reportedNot reportedNot reportedNot reported
Grade III acute renal failure
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib2Not reportedNot reportedNot reportedNot reported
Grade III headache
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib1Not reportedNot reportedNot reportedNot reported
Grade III aphasia due to laryngeal plasmacytoma
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib1Not reportedNot reportedNot reportedNot reported
Grade III neuropathy
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib1Not reportedNot reportedNot reportedNot reported
Grade III fatigue
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib1Not reportedNot reportedNot reportedNot reported
Grade III hypertension
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib1Not reportedNot reportedNot reportedNot reported
Grade III diarrhea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib1Not reportedNot reportedNot reportedNot reported
Grade III leg/hip pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib1Not reportedNot reportedNot reportedNot reported
Grade III generalized pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib3Not reportedNot reportedNot reportedNot reported
Grade III hypercalcemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib1Not reportedNot reportedNot reportedNot reported
Grade IV hypoglycemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib1Not reportedNot reportedNot reportedNot reported
Grade IV hyperglycemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib1Not reportedNot reportedNot reportedNot reported
Grade III pneumonia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib3Not reportedNot reportedNot reportedNot reported
Grade III pulmonary edema
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib1Not reportedNot reportedNot reportedNot reported
Grade III pneumonitis/pulmonary infiltrates
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib2Not reportedNot reportedNot reportedNot reported
Grade III pulmonary hypertension
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib1Not reportedNot reportedNot reportedNot reported
Grade III hypoxia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib1Not reportedNot reportedNot reportedNot reported
Grade III dyspnea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib1Not reportedNot reportedNot reportedNot reported
Grade IV dyspnea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Grade III anemia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Grade III neutropenia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Grade III thrombocytopenia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Grade IV thrombocytopenia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Grade III epistaxis
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade III gastrointestinal bleed
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Grade III acute renal failure
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade III headache
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade III aphasia due to laryngeal plasmacytoma
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade III neuropathy
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade III fatigue
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade III hypertension
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
Toxicities were graded using the NCI Common Toxicity Criteria v3.0.
groups
  1. description
    Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle. In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.
    id
    OG000
    title
    Dasatinib
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 30 days following end of treatment (median duration of therapy was 51 days)
title
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities)
type
SECONDARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice