Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00357565 · ADVERSE EVENTS

Adverse events

Hematopoietic Stem Cell Transplantation in the Treatment of Infant Leukemia · Source last updated 2025-08-26

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
2 years
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Double Unit UCB Transplantation

Patients that receive 2 units of umbilical cord blood transplantation (UCBT).

8 / 1515 / 158 / 15
Single Unit UCB Transplantation

Patients that receive one unit of umbilical cord blood transplantation (only if 2 adequate size and matched units are not available).

5 / 1515 / 155 / 15
BM Transplantation

Blood and Marrow transplantation

1 / 44 / 41 / 4

Group identifiers: EG000: Double Unit UCB Transplantation · EG001: Single Unit UCB Transplantation · EG002: BM Transplantation

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
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Bacteremia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      15
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Leukemia relapse
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Respiratory failure (any cause)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Multi-organ Failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Chronic Graft versus host disease

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
      4
      num At Risk
      15
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    PERICARDIAL EFFUSION
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      15
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      15
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Renal replacement therapy / dialysis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      15
      num Events
      4
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      15
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Veno-Occlusive Disease
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      15
      num Events
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      15
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Respiratory failure requiring intubation/ventilation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      15
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      15
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Pulmonary Hemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      15
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Cardiopulmonary failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      15
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    term
    Viremia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      15
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      15
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Gram positive bacteremia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      4
      num Events
      3
    term
    Gram negative bacteremia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      15
      num Events
      7
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      15
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      15
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Graft versus host disease grade 1-2
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Chronic Graft versus host disease
Complete source fields
event Groups
  1. deaths Num Affected
    8
    deaths Num At Risk
    15
    description
    Patients that receive 2 units of umbilical cord blood transplantation (UCBT).
    id
    EG000
    other Num Affected
    15
    other Num At Risk
    15
    serious Num Affected
    8
    serious Num At Risk
    15
    title
    Double Unit UCB Transplantation
  2. deaths Num Affected
    5
    deaths Num At Risk
    15
    description
    Patients that receive one unit of umbilical cord blood transplantation (only if 2 adequate size and matched units are not available).
    id
    EG001
    other Num Affected
    15
    other Num At Risk
    15
    serious Num Affected
    5
    serious Num At Risk
    15
    title
    Single Unit UCB Transplantation
  3. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    Blood and Marrow transplantation
    id
    EG002
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    BM Transplantation
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      15
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    PERICARDIAL EFFUSION
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      15
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      15
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Renal replacement therapy / dialysis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      15
      num Events
      4
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      15
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Veno-Occlusive Disease
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      15
      num Events
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      15
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Respiratory failure requiring intubation/ventilation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      15
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      15
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Pulmonary Hemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      15
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Cardiopulmonary failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      15
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      4
      num Events
      2
    term
    Viremia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      15
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      15
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Gram positive bacteremia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      4
      num Events
      3
    term
    Gram negative bacteremia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      15
      num Events
      7
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      15
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      15
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Graft versus host disease grade 1-2
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Chronic Graft versus host disease
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Bacteremia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      15
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
      num Events
      1
    term
    Leukemia relapse
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Respiratory failure (any cause)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Multi-organ Failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
      num Events
      0
    term
    Chronic Graft versus host disease
time Frame
2 years

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

Preserved source evidence · Not medical advice