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NCT00506129 · ADVERSE EVENTS

Adverse events

Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma · Source last updated 2020-12-29

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
Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Fludarabine + Melphalan With PBPC

Fludarabine 25 mg/m\^2 intravenous (IV) daily for 5 days prior to allogeneic peripheral blood progenitor cell (PBPC) , Melphalan 70 mg/m\^2 IV daily for 2 days prior to IV Allogeneic Transplant following Fludarabine \& Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 \& -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.

0 / 3333 / 33Not reported / Not reported

Group identifiers: EG000: Fludarabine + Melphalan With PBPC

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
      Cardiac disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        33
        num Events
        1
      term
      Primary graft failure with autologous reconstitution
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        33
        num Events
        6
      term
      Cardiac Edema
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        33
        num Events
        1
      term
      Cardiac Function
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Vascular disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        7
        num At Risk
        33
        num Events
        7
      term
      Hypertension
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        33
        num Events
        1
      term
      Congestive heart failure
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        33
        num Events
        1
      term
      Chest pain
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        33
        num Events
        1
      term
      pericarditis
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        33
        num Events
        2
      term
      tachycardia
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        8
        num At Risk
        33
        num Events
        8
      term
      fever
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        33
        num Events
        5
      term
      fatigue
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        10
        num At Risk
        33
        num Events
        10
      term
      fluid overload: Edema
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        33
        num Events
        4
      term
      rigors
    Complete source fields
    event Groups
    1. description
      Fludarabine 25 mg/m\^2 intravenous (IV) daily for 5 days prior to allogeneic peripheral blood progenitor cell (PBPC) , Melphalan 70 mg/m\^2 IV daily for 2 days prior to IV Allogeneic Transplant following Fludarabine \& Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 \& -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
      id
      EG000
      other Num Affected
      33
      other Num At Risk
      33
      serious Num Affected
      0
      serious Num At Risk
      33
      title
      Fludarabine + Melphalan With PBPC
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        33
        num Events
        1
      term
      Primary graft failure with autologous reconstitution
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        33
        num Events
        6
      term
      Cardiac Edema
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        33
        num Events
        1
      term
      Cardiac Function
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Vascular disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        7
        num At Risk
        33
        num Events
        7
      term
      Hypertension
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        33
        num Events
        1
      term
      Congestive heart failure
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        33
        num Events
        1
      term
      Chest pain
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        33
        num Events
        1
      term
      pericarditis
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        33
        num Events
        2
      term
      tachycardia
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        8
        num At Risk
        33
        num Events
        8
      term
      fever
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        33
        num Events
        5
      term
      fatigue
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        10
        num At Risk
        33
        num Events
        10
      term
      fluid overload: Edema
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (2.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        33
        num Events
        4
      term
      rigors
    time Frame
    Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).

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

    Preserved source evidence · Not medical advice