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NCT02700841 · OUTCOME

Number of Safely Treated Participants (Feasibility and Safety)

Enhancing Anti--Tetanus Vaccine Response After Autologous Stem Cell Transplantation · Source last updated 2024-03-12

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
Through 180 days post-transplant

What was measured

Determine safety of outcomes based on the number of safely treated participants by CTCAE version 5.0 tool

Groups in this outcome

Arm I (Vaccine, CD34 Transplant, DLI)

ARM I: Patients receive 3 doses of tetanus before transplant and on days 15, and 60 post transplant. Melphalan: Given IV Peripheral Blood Stem Cell Transplantation--CD34 HSCT: Undergo autologous CD34 HSCT Peripheral Blood Stem Cell Transplantation--AHSCT: Undergo AHSCT T Cell-Depleted Hematopoietic Stem Cell Transplantation: Undergo autologous CD34 HSCT Tetanus Toxoid Vaccine: Given IM

Arm II (Vaccine, Stem Cell Transplant)

Patients receive 3 doses of tetanus as in Arm I. Patients receive high-dose melphalan IV on day -2 and undergo AHSCT on day 0. Melphalan: Given IV Peripheral Blood Stem Cell Transplantation--AHSCT: Undergo AHSCT Tetanus Toxoid Vaccine: Given IM

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

Analysis denominator · Participants

GroupSource count
Arm I (Vaccine, CD34 Transplant, DLI)4
Arm II (Vaccine, Stem Cell Transplant)4

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Vaccine, CD34 Transplant, DLI)4Not reportedNot reportedNot reportedNot reported
Arm II (Vaccine, Stem Cell Transplant)4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    units
    Participants
description
Determine safety of outcomes based on the number of safely treated participants by CTCAE version 5.0 tool
groups
  1. description
    ARM I: Patients receive 3 doses of tetanus before transplant and on days 15, and 60 post transplant. Melphalan: Given IV Peripheral Blood Stem Cell Transplantation--CD34 HSCT: Undergo autologous CD34 HSCT Peripheral Blood Stem Cell Transplantation--AHSCT: Undergo AHSCT T Cell-Depleted Hematopoietic Stem Cell Transplantation: Undergo autologous CD34 HSCT Tetanus Toxoid Vaccine: Given IM
    id
    OG000
    title
    Arm I (Vaccine, CD34 Transplant, DLI)
  2. description
    Patients receive 3 doses of tetanus as in Arm I. Patients receive high-dose melphalan IV on day -2 and undergo AHSCT on day 0. Melphalan: Given IV Peripheral Blood Stem Cell Transplantation--AHSCT: Undergo AHSCT Tetanus Toxoid Vaccine: Given IM
    id
    OG001
    title
    Arm II (Vaccine, Stem Cell Transplant)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Through 180 days post-transplant
title
Number of Safely Treated Participants (Feasibility and Safety)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice