Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02793544 · OUTCOME

Cumulative Incidences of Viral Reactivations and Infections: Grade 2-3 CMV Reactivation or Infection

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
100 days, 180 days, and 365 days

What was measured

Grade 2: Clinically active CMV infection (e.g. symptoms, cytopenias) or CMV Viremia not decreasing by at least 2/3 of the baseline value after 2 weeks of therapy; Grade 3: CMV end-organ involvement (pneumonitis, enteritis, retinitis). A cumulative incidence will be computed along with a 90% CI. Death from any cause. The time to this event is the time from HCT to death, loss to follow-up, or end of study (whichever comes first). The overall survival probability and 90% CI will be calculated by the Kaplan Meier product limit estimator.

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

100 days
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Myeloablative Conditioning (MAC)10.4Not reported3.819.8Not reported
Reduced Intensity Conditioning (RIC)7.6Not reported2.216Not reported
180 days
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Myeloablative Conditioning (MAC)10.4Not reported3.819.8Not reported
Reduced Intensity Conditioning (RIC)7.6Not reported2.216Not reported
365 days
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Myeloablative Conditioning (MAC)10.4Not reported3.819.8Not reported
Reduced Intensity Conditioning (RIC)7.6Not reported2.216Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.8
        upper Limit
        19.8
        value
        10.4
      2. group Id
        OG001
        lower Limit
        2.2
        upper Limit
        16
        value
        7.6
    title
    100 days
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.8
        upper Limit
        19.8
        value
        10.4
      2. group Id
        OG001
        lower Limit
        2.2
        upper Limit
        16
        value
        7.6
    title
    180 days
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.8
        upper Limit
        19.8
        value
        10.4
      2. group Id
        OG001
        lower Limit
        2.2
        upper Limit
        16
        value
        7.6
    title
    365 days
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    2. group Id
      OG001
      value
      40
    units
    Participants
description
Grade 2: Clinically active CMV infection (e.g. symptoms, cytopenias) or CMV Viremia not decreasing by at least 2/3 of the baseline value after 2 weeks of therapy; Grade 3: CMV end-organ involvement (pneumonitis, enteritis, retinitis). A cumulative incidence will be computed along with a 90% CI. Death from any cause. The time to this event is the time from HCT to death, loss to follow-up, or end of study (whichever comes first). The overall survival probability and 90% CI will be calculated by the Kaplan Meier product limit estimator.
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
100 days, 180 days, and 365 days
title
Cumulative Incidences of Viral Reactivations and Infections: Grade 2-3 CMV Reactivation or Infection
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice