Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01570387 · OUTCOME

Response to the Maximal Tolerated Dose

A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis · Source last updated 2020-09-22

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
one year

What was measured

Number of participants with a response to treatment at that maximal tolerated dose (including partial, very good, or complete responses)

Analysis population: Number of evaluable patients treated at the maximal tolerated dose of 4mg including the Phase I cohort 3 participants and the Phase II expansion participants

Groups in this outcome

Pom Plus Dex

Pomalidomide dexamethasone Pomalidomide: Cohort 1 = 2 mg/day, Cohort 2 = 3 mg/day, Cohort 3 = 4 mg/day: Days 1-28 Dexamethasone: 10-20 mg on days 1, 8, 15, and 22

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

Analysis denominator · Participants

GroupSource count
Pom Plus Dex18

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pom Plus Dex10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
Number of participants with a response to treatment at that maximal tolerated dose (including partial, very good, or complete responses)
groups
  1. description
    Pomalidomide dexamethasone Pomalidomide: Cohort 1 = 2 mg/day, Cohort 2 = 3 mg/day, Cohort 3 = 4 mg/day: Days 1-28 Dexamethasone: 10-20 mg on days 1, 8, 15, and 22
    id
    OG000
    title
    Pom Plus Dex
param Type
COUNT_OF_PARTICIPANTS
population Description
Number of evaluable patients treated at the maximal tolerated dose of 4mg including the Phase I cohort 3 participants and the Phase II expansion participants
reporting Status
POSTED
time Frame
one year
title
Response to the Maximal Tolerated Dose
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice