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NCT04770402 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
AESIs were collected for approximately 10 weeks for the duration of the acupuncture treatment (for those on the intervention arm) and collected through 30 days after last acupuncture session. Serious adverse events and all-cause mortality were monitored and collected for both arms throughout the study, approximately 10 weeks.
Other-event reporting threshold
0%

Only All-Cause Mortality, Serious Adverse Events, and Adverse Events of Special Interest (AESI) were collected for this study. All-cause mortality and Serious Adverse Events were collected for both arms as defined in the clinicaltrials.gov definition. AESIs were collected only for subjects on the intervention arm, including bleeding, bruising, skin infection, edema, dry skin, urticaria, pruritus, rash, pain or flushing at the acupuncture site, dizziness, syncope, fatigue, or hyperhidrosis.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Acupuncture

Acupuncture: 12 acupuncture sessions over 10 weeks

0 / 80 / 80 / 8
Standard of Care

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

0 / 40 / 00 / 4

Group identifiers: EG000: Acupuncture · EG001: Standard of Care

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

      Complete source fields
      description
      Only All-Cause Mortality, Serious Adverse Events, and Adverse Events of Special Interest (AESI) were collected for this study. All-cause mortality and Serious Adverse Events were collected for both arms as defined in the clinicaltrials.gov definition. AESIs were collected only for subjects on the intervention arm, including bleeding, bruising, skin infection, edema, dry skin, urticaria, pruritus, rash, pain or flushing at the acupuncture site, dizziness, syncope, fatigue, or hyperhidrosis.
      event Groups
      1. deaths Num Affected
        0
        deaths Num At Risk
        8
        description
        Acupuncture: 12 acupuncture sessions over 10 weeks
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        8
        serious Num Affected
        0
        serious Num At Risk
        8
        title
        Acupuncture
      2. deaths Num Affected
        0
        deaths Num At Risk
        4
        description
        Standard of Care CIPN management: Investigator directed standard of care management of CIPN
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        0
        serious Num Affected
        0
        serious Num At Risk
        4
        title
        Standard of Care
      frequency Threshold
      0
      time Frame
      AESIs were collected for approximately 10 weeks for the duration of the acupuncture treatment (for those on the intervention arm) and collected through 30 days after last acupuncture session. Serious adverse events and all-cause mortality were monitored and collected for both arms throughout the study, approximately 10 weeks.

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

      Preserved source evidence · Not medical advice