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NCT02793544 · OUTCOME

Cumulative Incidences of Thrombotic Microangiopathy (TMA) and Hepatic Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)

HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide · Source last updated 2025-08-06

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
90% Confidence Interval
Time frame
365 days post transplant

What was measured

TMA is defined as (Ho et al., 2005): 1. RBC fragmentation and \>2 schistocytes per high-power field on peripheral smear 2. Concurrent increased serum LDH above institutional baseline 3. Concurrent renal and/or neurologic dysfunction without other explanation 4. Negative direct and indirect Coombs test results A cumulative incidence will be computed along with a 90% CI. VOD/SOS is defined as: In the first 20 days after HCT, the presence of ≥2 of the following: 1. Bilirubin \>2 mg/Dl, 2. Hepatomegaly or pain in right upper quadrant, 3. Weight gain (\>2% basal weight). A cumulative incidence will be computed along with a 90% CI.

Groups in this outcome

Myeloablative Conditioning (MAC)

Participants received one of three regimens: cyclophosphamide and total body irradiation; busulfan and cyclophosphamide; or fludarabine and busulfan

Reduced Intensity Conditioning (RIC)

Participants received one of two regimens: fludarabine, cyclophosphamide, and low-dose total body irradiation

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

Analysis denominator · Participants

GroupSource count
Myeloablative Conditioning (MAC)40
Reduced Intensity Conditioning (RIC)40

Reported measurements

Thrombotic microangiopathy (TMA)
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Myeloablative Conditioning (MAC)5Not reported0.912.2Not reported
Reduced Intensity Conditioning (RIC)0Not reported00Not reported
Hepatic veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS)
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Myeloablative Conditioning (MAC)10Not reported3.619.2Not reported
Reduced Intensity Conditioning (RIC)2.5Not reported0.18.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.9
        upper Limit
        12.2
        value
        5
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        0
        value
        0
    title
    Thrombotic microangiopathy (TMA)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.6
        upper Limit
        19.2
        value
        10
      2. group Id
        OG001
        lower Limit
        0.1
        upper Limit
        8.2
        value
        2.5
    title
    Hepatic veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS)
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    2. group Id
      OG001
      value
      40
    units
    Participants
description
TMA is defined as (Ho et al., 2005): 1. RBC fragmentation and \>2 schistocytes per high-power field on peripheral smear 2. Concurrent increased serum LDH above institutional baseline 3. Concurrent renal and/or neurologic dysfunction without other explanation 4. Negative direct and indirect Coombs test results A cumulative incidence will be computed along with a 90% CI. VOD/SOS is defined as: In the first 20 days after HCT, the presence of ≥2 of the following: 1. Bilirubin \>2 mg/Dl, 2. Hepatomegaly or pain in right upper quadrant, 3. Weight gain (\>2% basal weight). A cumulative incidence will be computed along with a 90% CI.
dispersion Type
90% Confidence Interval
groups
  1. description
    Participants received one of three regimens: cyclophosphamide and total body irradiation; busulfan and cyclophosphamide; or fludarabine and busulfan
    id
    OG000
    title
    Myeloablative Conditioning (MAC)
  2. description
    Participants received one of two regimens: fludarabine, cyclophosphamide, and low-dose total body irradiation
    id
    OG001
    title
    Reduced Intensity Conditioning (RIC)
param Type
NUMBER
reporting Status
POSTED
time Frame
365 days post transplant
title
Cumulative Incidences of Thrombotic Microangiopathy (TMA) and Hepatic Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice