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NCT00450814 · OUTCOME

Overall Toxicity Rate, Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) (Phase II)

Vaccine Therapy With or Without Cyclophosphamide in Treating Patients With Recurrent or Refractory Multiple Myeloma · Source last updated 2019-12-16

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
Not reported
Time frame
Up to 1 year

What was measured

The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below for Phase II patients.

Analysis population: Only phase II patients who completed the study are included in this analysis. Phase II Cohort A and Phase II Cohort B were combined for this analysis due to accrual terminating early in Cohort B and to obtain the overall toxicity rate among Phase II patients.

Groups in this outcome

Phase II (Acetaminophen + Benadryl + MV-NIS)

Patients receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.

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

Analysis denominator · Participants

GroupSource count
Phase II (Acetaminophen + Benadryl + MV-NIS)15

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase II (Acetaminophen + Benadryl + MV-NIS)73.3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        73.3
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below for Phase II patients.
groups
  1. description
    Patients receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.
    id
    OG000
    title
    Phase II (Acetaminophen + Benadryl + MV-NIS)
param Type
NUMBER
population Description
Only phase II patients who completed the study are included in this analysis. Phase II Cohort A and Phase II Cohort B were combined for this analysis due to accrual terminating early in Cohort B and to obtain the overall toxicity rate among Phase II patients.
reporting Status
POSTED
time Frame
Up to 1 year
title
Overall Toxicity Rate, Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) (Phase II)
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice