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NCT00408681 · OUTCOME

Functional Recovery

Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant · Source last updated 2017-03-07

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
at 28 days after starting treatment with the study product

What was measured

Functional recovery was defined as partial or complete resolution of gastrointestinal manifestations of acute graft-versus-host disease. Gastrointestinal manifestations of acute graft-versus-host disease include anorexia, nausea, vomiting, diarrhea, abdominal pain and bleeding. Complete response (CR) of intestinal GVHD was defined as the absence of any symptoms referable to intestinal GVHD. Partial response (PR) was defined as clearing of abdominal pain (or withdrawal of opioid analgesic requirements in patients treated for abdominal pain) and of grossly visible bleeding if present, and resolution of diarrhea or decrease in the three day average stool volume by ≥ 500 mL in patients with stool volumes of ≥ 500 mL. Progression of GVHD was defined as an increase in the three day average stool volume by \> 500 mL, or the development of new abdominal pain (or new opioid analgesic requirements) or new intestinal bleeding.

Groups in this outcome

Treated Patients

Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Treated Patients20

Reported measurements

Source class 1

Complete clinical response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treated Patients10Not reportedNot reportedNot reportedNot reported

Partial clinical response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treated Patients1Not reportedNot reportedNot reportedNot reported

No response or clinical progression

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treated Patients6Not reportedNot reportedNot reportedNot reported

Death before day 28

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treated Patients3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      title
      Complete clinical response
    2. measurements
      1. group Id
        OG000
        value
        1
      title
      Partial clinical response
    3. measurements
      1. group Id
        OG000
        value
        6
      title
      No response or clinical progression
    4. measurements
      1. group Id
        OG000
        value
        3
      title
      Death before day 28
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
Functional recovery was defined as partial or complete resolution of gastrointestinal manifestations of acute graft-versus-host disease. Gastrointestinal manifestations of acute graft-versus-host disease include anorexia, nausea, vomiting, diarrhea, abdominal pain and bleeding. Complete response (CR) of intestinal GVHD was defined as the absence of any symptoms referable to intestinal GVHD. Partial response (PR) was defined as clearing of abdominal pain (or withdrawal of opioid analgesic requirements in patients treated for abdominal pain) and of grossly visible bleeding if present, and resolution of diarrhea or decrease in the three day average stool volume by ≥ 500 mL in patients with stool volumes of ≥ 500 mL. Progression of GVHD was defined as an increase in the three day average stool volume by \> 500 mL, or the development of new abdominal pain (or new opioid analgesic requirements) or new intestinal bleeding.
groups
  1. description
    Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Treated Patients
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
at 28 days after starting treatment with the study product
title
Functional Recovery
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice