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NCT04191187 · ADVERSE EVENTS

Adverse events

Reduced Intensity Flu/Mel/TBI Conditioning for HAPLO HCT Patients With Hematologic Malignancies · Source last updated 2025-12-11

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
All events beginning with start of study intervention until 30 days after the last day of study intervention (up to 36 months) will be reported.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Conditioning Regimen + Transplant

All participants will receive a conditioning regimen of Fludarabine, Melphalan and Total Body Irradiation prior to transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) Fludarabine: Fludarabine 30mg/m\^2/day will be administered over 30-60 minutes intravenous infusion on Days -6 through -2 for a total dose of 150 mg/m\^2 Melphalan: Melphalan 70 mg/m\^2 over 45 minutes will be administered Day -6. Melphalan dose will be calculated based on Actual Body Weight. Total Body Irradiation: Total Body Irradiation (TBI) will be delivered at a dose of 200 centigray units (cGy)

21 / 3416 / 349 / 34

Group identifiers: EG000: Conditioning Regimen + Transplant

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
    Immune system disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    GVHD
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    Cytomegalovirus infection reactivation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      34
      num Events
      10
    term
    Sepsis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      3
    term
    Pneumonitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    COVID-19+
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    Hypoxia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    Multi-organ failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Respiratory Failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
      num Events
      3
    term
    Blood and lymphatic system disorders - Other, specify
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Anorexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    Stevens-Johnson syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Thromboembolic event

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
    Infections and infestations
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      34
      num Events
      6
    term
    Sepsis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    Cytomegalovirus infection reactivation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    Infections and infestations - Other, specify
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    Lung Infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Skin Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Viremia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      34
      num Events
      4
    term
    Fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    Multi-organ failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Disease Progression
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    Hypoxia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      3
    term
    Pneumonitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      2
    term
    Respiratory Failure
Complete source fields
event Groups
  1. deaths Num Affected
    9
    deaths Num At Risk
    34
    description
    All participants will receive a conditioning regimen of Fludarabine, Melphalan and Total Body Irradiation prior to transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) Fludarabine: Fludarabine 30mg/m\^2/day will be administered over 30-60 minutes intravenous infusion on Days -6 through -2 for a total dose of 150 mg/m\^2 Melphalan: Melphalan 70 mg/m\^2 over 45 minutes will be administered Day -6. Melphalan dose will be calculated based on Actual Body Weight. Total Body Irradiation: Total Body Irradiation (TBI) will be delivered at a dose of 200 centigray units (cGy)
    id
    EG000
    other Num Affected
    16
    other Num At Risk
    34
    serious Num Affected
    21
    serious Num At Risk
    34
    title
    Conditioning Regimen + Transplant
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      34
      num Events
      6
    term
    Sepsis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    Cytomegalovirus infection reactivation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    Infections and infestations - Other, specify
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    Lung Infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Skin Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Viremia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      34
      num Events
      4
    term
    Fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    Multi-organ failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Disease Progression
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    Hypoxia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      3
    term
    Pneumonitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      2
    term
    Respiratory Failure
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    GVHD
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    Cytomegalovirus infection reactivation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      34
      num Events
      10
    term
    Sepsis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      3
    term
    Pneumonitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    COVID-19+
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    Hypoxia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    Multi-organ failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Respiratory Failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
      num Events
      3
    term
    Blood and lymphatic system disorders - Other, specify
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Anorexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    Stevens-Johnson syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    Thromboembolic event
time Frame
All events beginning with start of study intervention until 30 days after the last day of study intervention (up to 36 months) will be reported.

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Preserved source evidence · Not medical advice