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NCT02793544 · ADVERSE EVENTS

Adverse events

HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide · Source last updated 2025-08-06

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
Up to 1 year post transplant
Other-event reporting threshold
0%

Evaluation of toxicities will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTCAE version 4.03. The protocol pre-specifies that Adverse Events on this study are reported and evaluated by conditioning regimen arm (MAC or RIC).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Myeloablative Conditioning (MAC)

Participants received one of three regimens: cyclophosphamide and total body irradiation; busulfan and cyclophosphamide; or fludarabine and busulfan

12 / 405 / 4011 / 40
Reduced Intensity Conditioning (RIC)

Participants received one of two regimens: fludarabine, cyclophosphamide, and low-dose total body irradiation

13 / 400 / 408 / 40

Group identifiers: EG000: Myeloablative Conditioning (MAC) · EG001: Reduced Intensity Conditioning (RIC)

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
    notes
    Recurrence, persistence, or progression of disease
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Other
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    term
    Multi-organ failure
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Lower gastrointestinal hemorrhage
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Obstruction gastric
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Lung infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Sepsis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Sinusitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Other
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Other
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Leukemia secondary to oncology chemotherapy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    One case of Acute Myeloid Leukemia under MAC, two cases of recurrence, persistence, or progression of disease under MAC, and two cases of recurrence, persistence, or progression of disease under RIC.
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    term
    Other

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
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Myocardial infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Sepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Fall
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Hypoxia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Respiratory failure
Complete source fields
description
Evaluation of toxicities will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTCAE version 4.03. The protocol pre-specifies that Adverse Events on this study are reported and evaluated by conditioning regimen arm (MAC or RIC).
event Groups
  1. deaths Num Affected
    11
    deaths Num At Risk
    40
    description
    Participants received one of three regimens: cyclophosphamide and total body irradiation; busulfan and cyclophosphamide; or fludarabine and busulfan
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    40
    serious Num Affected
    12
    serious Num At Risk
    40
    title
    Myeloablative Conditioning (MAC)
  2. deaths Num Affected
    8
    deaths Num At Risk
    40
    description
    Participants received one of two regimens: fludarabine, cyclophosphamide, and low-dose total body irradiation
    id
    EG001
    other Num Affected
    0
    other Num At Risk
    40
    serious Num Affected
    13
    serious Num At Risk
    40
    title
    Reduced Intensity Conditioning (RIC)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Myocardial infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Sepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Fall
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Hypoxia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Respiratory failure
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Recurrence, persistence, or progression of disease
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Other
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    term
    Multi-organ failure
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Lower gastrointestinal hemorrhage
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Obstruction gastric
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Lung infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    term
    Sepsis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Sinusitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Other
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    term
    Other
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    term
    Leukemia secondary to oncology chemotherapy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    One case of Acute Myeloid Leukemia under MAC, two cases of recurrence, persistence, or progression of disease under MAC, and two cases of recurrence, persistence, or progression of disease under RIC.
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      40
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    term
    Other
time Frame
Up to 1 year post transplant

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Preserved source evidence · Not medical advice