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NCT01096810 · OUTCOME

Time to Progression

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
MEDIAN
Unit
cycles
Interval / dispersion
Full Range
Time frame
From date of treatment until the date of first documented progression

What was measured

To determine the time to progression of asymptomatic multiple myeloma patients receiving TBL 12. The time to progression will be measured in units of a cycle (28 day cycles). Progression is defined using the International Uniform Response Criteria for Multiple Myeloma (Leukemia (2006)20:1467-1473). Which requires one or more of the following: \>25% increase in SPEP (must also be an absolute increase of at least 5 g/dL), \>25% increase in UPEP (must also be an absolute increase of at least 200 mg/24 hours), \>25% increase in bone marrow plasma cells (must also be an absolute increase of at least 10%), new lytic bone lesions or soft tissue plasmacytomas, or development of hypercalcemia (not attributable to any other cause).

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 cycles · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
TBL 1215Not reported254Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2
        upper Limit
        54
        value
        15
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
To determine the time to progression of asymptomatic multiple myeloma patients receiving TBL 12. The time to progression will be measured in units of a cycle (28 day cycles). Progression is defined using the International Uniform Response Criteria for Multiple Myeloma (Leukemia (2006)20:1467-1473). Which requires one or more of the following: \>25% increase in SPEP (must also be an absolute increase of at least 5 g/dL), \>25% increase in UPEP (must also be an absolute increase of at least 200 mg/24 hours), \>25% increase in bone marrow plasma cells (must also be an absolute increase of at least 10%), new lytic bone lesions or soft tissue plasmacytomas, or development of hypercalcemia (not attributable to any other cause).
dispersion Type
Full Range
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
MEDIAN
reporting Status
POSTED
time Frame
From date of treatment until the date of first documented progression
title
Time to Progression
type
PRIMARY
unit Of Measure
cycles

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

Preserved source evidence · Not medical advice