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NCT00003511 · OUTCOME

Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable

Antineoplaston Therapy in Treating Patients With Multiple Myeloma · Source last updated 2021-06-09

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
36 months

What was measured

Objective response rate per The International Working Group response criteria (1999): Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), \>=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least four weeks. Stable Disease (SD), \< 50% change in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least twelve weeks.

Analysis population: All patients enrolled in the study.

Groups in this outcome

Antineoplaston Therapy

Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. Antineoplaston therapy (Atengenal + Astugenal): Patients with Multiple Myeloma will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

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

Analysis denominator · Participants

GroupSource count
Antineoplaston Therapy5

Reported measurements

Objective response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Antineoplaston Therapy0Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Antineoplaston Therapy1Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Antineoplaston Therapy0Not reportedNot reportedNot reportedNot reported
Not evaluable
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Antineoplaston Therapy4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Objective response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Stable Disease
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Progressive Disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Not evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Objective response rate per The International Working Group response criteria (1999): Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), \>=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least four weeks. Stable Disease (SD), \< 50% change in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least twelve weeks.
groups
  1. description
    Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. Antineoplaston therapy (Atengenal + Astugenal): Patients with Multiple Myeloma will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
    id
    OG000
    title
    Antineoplaston Therapy
param Type
NUMBER
population Description
All patients enrolled in the study.
reporting Status
POSTED
time Frame
36 months
title
Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice