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NCT00083915 · ADVERSE EVENTS

Adverse events

DTPACE Followed by Tandem Transplant With Melphalan (MEL) 200 Versus MEL/Dexamethasone/Thalidomide (DT) Platinol/Adriamycin/Etoposide (PACE) Hybrid and DTPACE Consolidation · 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
High Dose Melphalan

Not reported

6 / 5227 / 52Not reported / Not reported
Mel-DT PACE

Not reported

3 / 4524 / 45Not reported / Not reported

Group identifiers: EG000: High Dose Melphalan · EG001: Mel-DT PACE

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
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      52
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      45
      num Events
      3
    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.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      45
      num Events
      5
    term
    neutropenic fever
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      52
      num Events
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      45
      num Events
      5
    term
    DVT
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Diverticulitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    CVL infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
      num Events
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      45
      num Events
      5
    term
    nausea, vomiting, diarrhea & fever
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      45
      num Events
      2
    term
    pneumonia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    headcache, rhinitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    supraventricular tachycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    difficile colitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    hematoma
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    fracture
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    edema
Complete source fields
event Groups
  1. id
    EG000
    other Num Affected
    27
    other Num At Risk
    52
    serious Num Affected
    6
    serious Num At Risk
    52
    title
    High Dose Melphalan
  2. id
    EG001
    other Num Affected
    24
    other Num At Risk
    45
    serious Num Affected
    3
    serious Num At Risk
    45
    title
    Mel-DT PACE
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      45
      num Events
      5
    term
    neutropenic fever
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      52
      num Events
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      45
      num Events
      5
    term
    DVT
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      52
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Diverticulitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    CVL infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      52
      num Events
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      45
      num Events
      5
    term
    nausea, vomiting, diarrhea & fever
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      52
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      45
      num Events
      2
    term
    pneumonia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    headcache, rhinitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    supraventricular tachycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    difficile colitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    hematoma
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      52
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    fracture
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      52
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    edema
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      52
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      45
      num Events
      3
    term
    death

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Preserved source evidence · Not medical advice