Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02722941 · OUTCOME

Relative Dose Intensity (RDI) Per Cohort

Panobinostat (LBH589): Multiple Myeloma - Autologous Hematopoietic Cell Transplantation (HCT) · Source last updated 2022-11-01

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

Measure
MEDIAN
Unit
percentage of dose
Interval / dispersion
Full Range
Time frame
Up to 2 years

What was measured

Investigators will calculate RDI for each cohort. Relative dose intensity (RDI) represents the ratio of the amount of a drug actually delivered \[actual dose intensity (DI)\] to the amount planned (planned DI). The purpose of calculating RDI is to evaluate whether the planned DI of a chemotherapy treatment was actually achieved which may suggest the feasibility of planned treatment regimen. There are multitude of reports demonstrating a correlation between RDI and survival in cancer treatment. RDI = (total dose received by the patient = mg)/(planned full dose of drug = mg).

Groups in this outcome

Cohort A: Maintenance Therapy

Panobinostat (LBH589): 20 mg by mouth three (3) times per week, every other week, of a 28-day schedule. Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B.

Cohort B: Maintenance Therapy

Panobinostat (LBH589): 10 mg by mouth daily for seven (7) days, every other week, of a 28-day schedule. Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B.

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

Analysis denominator · Participants

GroupSource count
Cohort A: Maintenance Therapy15
Cohort B: Maintenance Therapy15

Reported measurements

Source class 1
Values in percentage of dose · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort A: Maintenance Therapy97.9Not reported77.1100Not reported
Cohort B: Maintenance Therapy89.6Not reported63.1100Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        77.1
        upper Limit
        100
        value
        97.9
      2. group Id
        OG001
        lower Limit
        63.1
        upper Limit
        100
        value
        89.6
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      15
    units
    Participants
description
Investigators will calculate RDI for each cohort. Relative dose intensity (RDI) represents the ratio of the amount of a drug actually delivered \[actual dose intensity (DI)\] to the amount planned (planned DI). The purpose of calculating RDI is to evaluate whether the planned DI of a chemotherapy treatment was actually achieved which may suggest the feasibility of planned treatment regimen. There are multitude of reports demonstrating a correlation between RDI and survival in cancer treatment. RDI = (total dose received by the patient = mg)/(planned full dose of drug = mg).
dispersion Type
Full Range
groups
  1. description
    Panobinostat (LBH589): 20 mg by mouth three (3) times per week, every other week, of a 28-day schedule. Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B.
    id
    OG000
    title
    Cohort A: Maintenance Therapy
  2. description
    Panobinostat (LBH589): 10 mg by mouth daily for seven (7) days, every other week, of a 28-day schedule. Panobinostat: Maintenance therapy dosing as outlined in Cohorts A and B.
    id
    OG001
    title
    Cohort B: Maintenance Therapy
param Type
MEDIAN
reporting Status
POSTED
time Frame
Up to 2 years
title
Relative Dose Intensity (RDI) Per Cohort
type
PRIMARY
unit Of Measure
percentage of dose

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

Preserved source evidence · Not medical advice