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NCT02684162 · ADVERSE EVENTS

Adverse events

Guadecitabine and Donor Lymphocyte Infusion in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Relapsing After Allogeneic Stem Cell Transplant · Source last updated 2025-11-06

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
1 year
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1: Relapsed Leukemia Post-transplant

Patients with morphological relapse for AML and MDS at least 90 days post-transplant. MDS patients: Re-appearance of dysplastic changes in the bone marrow, with or without increase in bone marrow blast count, which is pathologically consistent with myelodysplastic syndrome. AML patients: Bone marrow blast count \>/= 5%.

9 / 133 / 131 / 13
Cohort 2: MRD(Minimal Residual Disease) Post-transplant

Cohort 2: Persistence or reappearance of minimal residual disease by flow cytometry or cytogenetic or molecular testing while being in morphological remission after allogeneic stem cell transplantation.

11 / 188 / 186 / 18
Cohort 3: Maintenance Treatment Post-transplant

Cohort 3: High risk AML and MDS patients who are in complete remission morphologically with no evidence of minimal residual disease by flow cytometry or cytogenetic or molecular testing after allogeneic stem cell transplantation.

12 / 2410 / 2414 / 24

Group identifiers: EG000: Cohort 1: Relapsed Leukemia Post-transplant · EG001: Cohort 2: MRD(Minimal Residual Disease) Post-transplant · EG002: Cohort 3: Maintenance Treatment Post-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
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Diarrhea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      13
      num Events
      10
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      18
      num Events
      41
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      24
      num Events
      50
    term
    Neutrophil count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      13
      num Events
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      18
      num Events
      13
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      24
      num Events
      6
    term
    Platelet count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      13
      num Events
      6
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      18
      num Events
      13
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      24
      num Events
      12
    term
    White blood cell decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Anemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Respiratory failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Upper Respiratory Infection

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
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
      num Events
      7
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
      num Events
      6
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      18
      num Events
      14
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      24
      num Events
      7
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Blood bilirubin increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      18
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
      num Events
      1
    term
    Dyspnea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      18
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      24
      num Events
      3
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      18
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
      num Events
      2
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Gallbladder infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Generalized muscle weakness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Hypotension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Injection site reaction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      24
      num Events
      7
    term
    Lung infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      5
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      18
      num Events
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
      num Events
      2
    term
    Nausea
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    13
    description
    Patients with morphological relapse for AML and MDS at least 90 days post-transplant. MDS patients: Re-appearance of dysplastic changes in the bone marrow, with or without increase in bone marrow blast count, which is pathologically consistent with myelodysplastic syndrome. AML patients: Bone marrow blast count \>/= 5%.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    13
    serious Num Affected
    9
    serious Num At Risk
    13
    title
    Cohort 1: Relapsed Leukemia Post-transplant
  2. deaths Num Affected
    6
    deaths Num At Risk
    18
    description
    Cohort 2: Persistence or reappearance of minimal residual disease by flow cytometry or cytogenetic or molecular testing while being in morphological remission after allogeneic stem cell transplantation.
    id
    EG001
    other Num Affected
    8
    other Num At Risk
    18
    serious Num Affected
    11
    serious Num At Risk
    18
    title
    Cohort 2: MRD(Minimal Residual Disease) Post-transplant
  3. deaths Num Affected
    14
    deaths Num At Risk
    24
    description
    Cohort 3: High risk AML and MDS patients who are in complete remission morphologically with no evidence of minimal residual disease by flow cytometry or cytogenetic or molecular testing after allogeneic stem cell transplantation.
    id
    EG002
    other Num Affected
    10
    other Num At Risk
    24
    serious Num Affected
    12
    serious Num At Risk
    24
    title
    Cohort 3: Maintenance Treatment Post-transplant
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
      num Events
      7
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
      num Events
      6
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      18
      num Events
      14
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      24
      num Events
      7
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Blood bilirubin increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      18
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      24
      num Events
      1
    term
    Dyspnea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      18
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      24
      num Events
      3
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      18
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
      num Events
      2
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Gallbladder infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Generalized muscle weakness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Hypotension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Injection site reaction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      24
      num Events
      7
    term
    Lung infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      5
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      18
      num Events
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      24
      num Events
      2
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Diarrhea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      13
      num Events
      10
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      18
      num Events
      41
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      24
      num Events
      50
    term
    Neutrophil count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      13
      num Events
      6
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      18
      num Events
      13
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      24
      num Events
      6
    term
    Platelet count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      13
      num Events
      6
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      18
      num Events
      13
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      24
      num Events
      12
    term
    White blood cell decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Anemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Respiratory failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      24
      num Events
      0
    term
    Upper Respiratory Infection
time Frame
1 year

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

Preserved source evidence · Not medical advice