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NCT01302366 · OUTCOME

Duration of Response (Excluding Patient Choice and Non-compliance)

A Trial of TBL12 Sea Cucumber Extract in Patients With Untreated Asymptomatic Myeloma · Source last updated 2015-02-12

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

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
up to 3 years

What was measured

Response \[complete response (CR), partial response (PR), and stable disease (SD)\] was assessed after approximately 2 months, 6 months and then every 4 months, until progression of disease. Response and progression of disease evaluation is based on the criteria reported by Blade, et al. (1998).

Analysis population: All patients or the patients excluding personal choice or non-compliance

Groups in this outcome

Sea Cucumber Extract (TBL 12)

TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of 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
Sea Cucumber Extract (TBL 12)15

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Sea Cucumber Extract (TBL 12)21.0Not reported8.531.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.5
        upper Limit
        31.0
        value
        21.0
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
Response \[complete response (CR), partial response (PR), and stable disease (SD)\] was assessed after approximately 2 months, 6 months and then every 4 months, until progression of disease. Response and progression of disease evaluation is based on the criteria reported by Blade, et al. (1998).
dispersion Type
Full Range
groups
  1. description
    TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
    id
    OG000
    title
    Sea Cucumber Extract (TBL 12)
param Type
MEDIAN
population Description
All patients or the patients excluding personal choice or non-compliance
reporting Status
POSTED
time Frame
up to 3 years
title
Duration of Response (Excluding Patient Choice and Non-compliance)
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice