Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03767257 · OUTCOME

Number of Participants With Improvement of Lenalidomide-associated Diarrhea Evaluated by CTCAE 5.0

A Study of Colesevelam for Lenalidomide-Associated Diarrhea · Source last updated 2025-10-21

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
4 weeks

What was measured

To evaluate the ability of colesevelam to improve lenalidomide-associated diarrhea in participants with multiple myeloma treated with lenalidomide maintenance. Diarrhea will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE) grading. The primary end-point is improvement of diarrhea to grade 1 or better according to the CTCAE 5.0 scale by 4 weeks of treatment with colesevelam.

Groups in this outcome

Participants With Myeloma

Individuals with Myeloma on lenalidomide maintenance who experience grade 2 or more diarrhea

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

Analysis denominator · Participants

GroupSource count
Participants With Myeloma25

Reported measurements

Source class 1

Improvement by at least 1 grade per CTCAE scale

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With Myeloma22Not reportedNot reportedNot reportedNot reported

Did not respond to colesevelam treatment

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With Myeloma3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      title
      Improvement by at least 1 grade per CTCAE scale
    2. measurements
      1. group Id
        OG000
        value
        3
      title
      Did not respond to colesevelam treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
To evaluate the ability of colesevelam to improve lenalidomide-associated diarrhea in participants with multiple myeloma treated with lenalidomide maintenance. Diarrhea will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE) grading. The primary end-point is improvement of diarrhea to grade 1 or better according to the CTCAE 5.0 scale by 4 weeks of treatment with colesevelam.
groups
  1. description
    Individuals with Myeloma on lenalidomide maintenance who experience grade 2 or more diarrhea
    id
    OG000
    title
    Participants With Myeloma
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
4 weeks
title
Number of Participants With Improvement of Lenalidomide-associated Diarrhea Evaluated by CTCAE 5.0
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice