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NCT00574080 · ADVERSE EVENTS

Adverse events

UARK 2006-15: A Study of Tandem Transplants With or Without Bortezomib and Thalidomide · Source last updated 2017-11-20

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
Not reported
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
VTD + DPACE/Melphalan

Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide \& Melphalan

4 / 100 / 10Not reported / Not reported
DPACE/Melphalan

Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide \& Melphalan

3 / 100 / 10Not reported / Not reported

Group identifiers: EG000: VTD + DPACE/Melphalan · EG001: DPACE/Melphalan

Serious 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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    embolus
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    progressive disease
    organ System
    General disorders
    source Vocabulary
    progressive disease
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    death
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    cardiac failure
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    death
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    secondary malignancy
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    death
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    no cause listed
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    death
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    infection
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    death
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    sepsis
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    death

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
    event Groups
    1. description
      Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide \& Melphalan
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      10
      serious Num Affected
      4
      serious Num At Risk
      10
      title
      VTD + DPACE/Melphalan
    2. description
      Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide \& Melphalan
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      10
      serious Num Affected
      3
      serious Num At Risk
      10
      title
      DPACE/Melphalan
    frequency Threshold
    0
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        10
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      embolus
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      progressive disease
      organ System
      General disorders
      source Vocabulary
      progressive disease
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        10
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        10
        num Events
        0
      term
      death
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      cardiac failure
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        10
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      death
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      secondary malignancy
      organ System
      Neoplasms benign, malignant and unspecified (incl cysts and polyps)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        10
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      death
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      no cause listed
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        10
        num Events
        2
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        10
        num Events
        0
      term
      death
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      infection
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        10
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        10
        num Events
        1
      term
      death
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      sepsis
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        10
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        10
        num Events
        0
      term
      death

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    Preserved source evidence · Not medical advice