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NCT04459416 · ADVERSE EVENTS

Adverse events

Managing Pain and Symptom Burden Caused by Chemotherapy in People With Myeloma or Lymphoma · Source last updated 2025-10-20

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
90 days
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Acupuncture Plus Usual Care

Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. to prevent severe pain. If acupuncture does not prevent severe pain, the participant will receive opioid medication as backup pain relief. Acupuncture: Acupuncture treatments will be scheduled to cover the period of high symptom burden. Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. Electrical stimulation (e-acupuncture) may be applied to the ST36 and SP6 points when appropriate as per standard acupuncture practice. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.

0 / 15139 / 1510 / 151
Usual Care

Will receive only the usual pain management approach, which includes opioid medication when needed for severe pain, according to the routine guidelines for their care. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.

0 / 1470 / 1470 / 147

Group identifiers: EG000: Acupuncture Plus Usual Care · EG001: Usual 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.

    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Injury, poisoning and procedural complications
      stats
      1. group Id
        EG000
        num Affected
        26
        num At Risk
        151
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        147
      term
      Bruising
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        151
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        147
      term
      Burning sensation
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        151
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        147
      term
      Skin discoloration
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        151
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        147
      term
      Foot cramping
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        151
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        147
      term
      Nose bleed
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        7
        num At Risk
        151
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        147
      term
      Pain/Soreness
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        151
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        147
      term
      Throbbing sensation
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        151
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        147
      term
      Tiredness
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      151
      description
      Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. to prevent severe pain. If acupuncture does not prevent severe pain, the participant will receive opioid medication as backup pain relief. Acupuncture: Acupuncture treatments will be scheduled to cover the period of high symptom burden. Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. Electrical stimulation (e-acupuncture) may be applied to the ST36 and SP6 points when appropriate as per standard acupuncture practice. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.
      id
      EG000
      other Num Affected
      39
      other Num At Risk
      151
      serious Num Affected
      0
      serious Num At Risk
      151
      title
      Acupuncture Plus Usual Care
    2. deaths Num Affected
      0
      deaths Num At Risk
      147
      description
      Will receive only the usual pain management approach, which includes opioid medication when needed for severe pain, according to the routine guidelines for their care. opioid: All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution. Assessments: Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      147
      serious Num Affected
      0
      serious Num At Risk
      147
      title
      Usual Care
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Injury, poisoning and procedural complications
      stats
      1. group Id
        EG000
        num Affected
        26
        num At Risk
        151
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        147
      term
      Bruising
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        151
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        147
      term
      Burning sensation
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        151
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        147
      term
      Skin discoloration
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        151
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        147
      term
      Foot cramping
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        151
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        147
      term
      Nose bleed
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        7
        num At Risk
        151
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        147
      term
      Pain/Soreness
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        151
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        147
      term
      Throbbing sensation
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        151
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        147
      term
      Tiredness
    time Frame
    90 days

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