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NCT01852799 · OUTCOME

Safety Evaluation

A Study of PAD Followed by Autologous Stem Cell Transplantation (ASCT) to Treat Newly Diagnosed Multiple Myeloma · Source last updated 2018-08-10

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
Starting with informed consent signature through study completion, an average of 1 year

What was measured

Safety evaluations will be based on scheduled physical examinations, Eastern Cooperative Oncology Group(ECOG) scores, vital signs (blood pressure, heart rate) and clinical laboratory tests.

Groups in this outcome

PAD Followed by ASCT

Drug: Bortezomib, Adriamycin (Doxorubicin) /Epidoxorubicin(EPI), Dexamethasone. After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators. PAD Followed by ASCT: Drug: Bortezomib, Bortezomib (1.3mg/m2, iv, on day 1, 4, 8, 11, of each 28 day cycle) Drug: Adriamycin (Doxorubicin) /EPI, Adriamycin (Doxorubicin) (9 mg/m2, iv, on days 1-4 of each 28 day cycle) or EPI (15mg/m2, iv, on days 1-4 of each 28 day cycle) Drug: Dexamethasone, Dexamethasone (20mg, iv, on days 1-4, 8-11of each 28 day cycle) After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators.

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

Analysis denominator · Participants

GroupSource count
PAD Followed by ASCT18

Reported measurements

AE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT15Not reportedNot reportedNot reportedNot reported
TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT15Not reportedNot reportedNot reportedNot reported
TEAE related to treatment
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT14Not reportedNot reportedNot reportedNot reported
TEAE(CTCAE≥3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT11Not reportedNot reportedNot reportedNot reported
TEAE related to treatment(CTCAE≥3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT10Not reportedNot reportedNot reportedNot reported
SAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PAD Followed by ASCT0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    title
    AE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    title
    TEAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    TEAE related to treatment
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    TEAE(CTCAE≥3)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    TEAE related to treatment(CTCAE≥3)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    SAE
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
Safety evaluations will be based on scheduled physical examinations, Eastern Cooperative Oncology Group(ECOG) scores, vital signs (blood pressure, heart rate) and clinical laboratory tests.
groups
  1. description
    Drug: Bortezomib, Adriamycin (Doxorubicin) /Epidoxorubicin(EPI), Dexamethasone. After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators. PAD Followed by ASCT: Drug: Bortezomib, Bortezomib (1.3mg/m2, iv, on day 1, 4, 8, 11, of each 28 day cycle) Drug: Adriamycin (Doxorubicin) /EPI, Adriamycin (Doxorubicin) (9 mg/m2, iv, on days 1-4 of each 28 day cycle) or EPI (15mg/m2, iv, on days 1-4 of each 28 day cycle) Drug: Dexamethasone, Dexamethasone (20mg, iv, on days 1-4, 8-11of each 28 day cycle) After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators.
    id
    OG000
    title
    PAD Followed by ASCT
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Starting with informed consent signature through study completion, an average of 1 year
title
Safety Evaluation
type
OTHER_PRE_SPECIFIED
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice