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NCT04770402 · OUTCOME

Adverse Events of Special Interest

Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma Patients · Source last updated 2025-01-27

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
approx. 10 weeks

What was measured

Adverse Events of Special Interest (AESI) will be determined for each subject as binary variables indicating whether or not they experienced a protocol defined AESI, including bleeding, bruising, skin infection, edema, dry skin, urticaria, pruritus, rash, pain or flushing at the acupuncture site, or dizziness, syncope, fatigue, or hyperhidrosis.

Analysis population: Enrolled participants on the acupuncture arm

Groups in this outcome

Acupuncture

Acupuncture: 12 acupuncture sessions over 10 weeks

Standard of Care

Standard of Care CIPN management: Investigator directed standard of care management of CIPN

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

Analysis denominator · Participants

GroupSource count
Acupuncture7
Standard of Care0

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Acupuncture0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Adverse Events of Special Interest (AESI) will be determined for each subject as binary variables indicating whether or not they experienced a protocol defined AESI, including bleeding, bruising, skin infection, edema, dry skin, urticaria, pruritus, rash, pain or flushing at the acupuncture site, or dizziness, syncope, fatigue, or hyperhidrosis.
groups
  1. description
    Acupuncture: 12 acupuncture sessions over 10 weeks
    id
    OG000
    title
    Acupuncture
  2. description
    Standard of Care CIPN management: Investigator directed standard of care management of CIPN
    id
    OG001
    title
    Standard of Care
param Type
COUNT_OF_PARTICIPANTS
population Description
Enrolled participants on the acupuncture arm
reporting Status
POSTED
time Frame
approx. 10 weeks
title
Adverse Events of Special Interest
type
OTHER_PRE_SPECIFIED
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice