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NCT00167180 · ADVERSE EVENTS

Adverse events

Post Transplant Donor Lymphocyte Infusion · Source last updated 2019-07-30

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
1 Year
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg

Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 IV over 30 minutes DLI Cell Dose 1.0 x 10\^8 CD3+ T-cells/kg

8 / 1512 / 1512 / 15
DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg

Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 DLI Cell Dose 0.5 x 10\^8 CD3+ T-cells/kg

3 / 4211 / 4222 / 42

Group identifiers: EG000: DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg · EG001: DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg

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
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Death, NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Acute Graft vs. Host Disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Infection, NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Acute Sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Pulmonary Failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Graft vs. Host Disease, NOS

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
      6
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Acute Graft vs. Host Disease
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Acute Renal Failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Acute Respiratory Distress Syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Anaphylactic Reaction to Anti-Thymocyte Globulin
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Atrial Flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
    term
    Bacterial Infection, NOS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
    term
    Blood Infection, Bacterial
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
    term
    Blood Infection, Viral
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Bone Marrow Infection, Viral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Bradycardic Arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Brain Infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Cardiac Arrhythmia
Complete source fields
event Groups
  1. deaths Num Affected
    12
    deaths Num At Risk
    15
    description
    Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 IV over 30 minutes DLI Cell Dose 1.0 x 10\^8 CD3+ T-cells/kg
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    15
    serious Num Affected
    8
    serious Num At Risk
    15
    title
    DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg
  2. deaths Num Affected
    22
    deaths Num At Risk
    42
    description
    Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 DLI Cell Dose 0.5 x 10\^8 CD3+ T-cells/kg
    id
    EG001
    other Num Affected
    11
    other Num At Risk
    42
    serious Num Affected
    3
    serious Num At Risk
    42
    title
    DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Acute Graft vs. Host Disease
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Acute Renal Failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Acute Respiratory Distress Syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Anaphylactic Reaction to Anti-Thymocyte Globulin
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Atrial Flutter
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
    term
    Bacterial Infection, NOS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      42
    term
    Blood Infection, Bacterial
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      42
    term
    Blood Infection, Viral
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Bone Marrow Infection, Viral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Bradycardic Arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Brain Infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Cardiac Arrhythmia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Death, NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Acute Graft vs. Host Disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Infection, NOS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      42
    term
    Acute Sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Pulmonary Failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      42
    term
    Graft vs. Host Disease, NOS
time Frame
1 Year

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Preserved source evidence · Not medical advice