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NCT00408681 · FLOW

Participant flow

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.

groups
  1. description
    Patients receive oral lithium carbonate once or twice daily orally. Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Treated Patients
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      STARTED
    2. achievements
      1. comment
        Completion was defined as administration of the study product for at least 28 days.
        group Id
        FG000
        num Subjects
        11
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        9
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients were enrolled according to eligibility criteria in the protocol.
recruitment Details
Patients with severe gastrointestinal acute graft-versus-host disease with or without mucosal denudation identified by endoscopy were recruited from a hospitalized population of patients who had recent allogeneic hematopoietic cell transplantation.
Complete source fields
groups
  1. description
    Patients receive oral lithium carbonate once or twice daily orally. Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Treated Patients
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      STARTED
    2. achievements
      1. comment
        Completion was defined as administration of the study product for at least 28 days.
        group Id
        FG000
        num Subjects
        11
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        9
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients were enrolled according to eligibility criteria in the protocol.
recruitment Details
Patients with severe gastrointestinal acute graft-versus-host disease with or without mucosal denudation identified by endoscopy were recruited from a hospitalized population of patients who had recent allogeneic hematopoietic cell transplantation.

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Preserved source evidence · Not medical advice