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NCT01096810 · OUTCOME

Response Rate

Study of TBL 12 Sea Cucumber Extract for Patients With Untreated Asymptomatic Myeloma · Source last updated 2016-07-22

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
from date of start of treatment until the date of best documented response up to date of progression

What was measured

The response rate - percentage of participants with overall response. Overall response for any participants that has achieved at least a PR or better (PR, VGPR, CR, sCR) is defined using the International Uniform Response Criteria for Multiple Myeloma (Leukemia (2006)20:1467-1473) . Which requires the following: at least \>50% reduction in SPEP, at least \>90% reduction or \<200 mg in UPEP, at least \>50% reduction in the size of soft tissue plasmacytomas, no lytic bone lesions or similar definition that is accurate and appropriate.

Groups in this outcome

TBL 12

TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression

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

Analysis denominator · Participants

GroupSource count
TBL 1220

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
TBL 125Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
The response rate - percentage of participants with overall response. Overall response for any participants that has achieved at least a PR or better (PR, VGPR, CR, sCR) is defined using the International Uniform Response Criteria for Multiple Myeloma (Leukemia (2006)20:1467-1473) . Which requires the following: at least \>50% reduction in SPEP, at least \>90% reduction or \<200 mg in UPEP, at least \>50% reduction in the size of soft tissue plasmacytomas, no lytic bone lesions or similar definition that is accurate and appropriate.
groups
  1. description
    TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
    id
    OG000
    title
    TBL 12
param Type
NUMBER
reporting Status
POSTED
time Frame
from date of start of treatment until the date of best documented response up to date of progression
title
Response Rate
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice