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NCT00303719 · ADVERSE EVENTS

Adverse events

Allogeneic Bone Marrow Transplantation Using Less Intensive Therapy · Source last updated 2020-05-12

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
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
High Risk Patients

Patients with refractory leukemia or MDS

1 / 1312 / 136 / 13
Standard Risk Patients

Patients with Disease criteria: Acute myelogenous leukemia , Acute lymphocytic leukemia, Chronic myelogenous leukemia , NHL, Hodgkins, chronic lymphocytic leukemia, multiple myeloma, Acquired bone marrow failure syndromes, Myelodysplastic syndrome, Renal cell cancer,Chronic myeloproliferative disorder

53 / 292272 / 292124 / 292

Group identifiers: EG000: High Risk Patients · EG001: Standard Risk Patients

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 (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      292
    term
    Graft versus Host disease
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      292
    term
    Relapse
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      292
    term
    Infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      292
    term
    Progressive 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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      292
      num Events
      18
    term
    Acute respiratory distress syndrome (ARDS)
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
      num Events
      15
    2. group Id
      EG001
      num Affected
      128
      num At Risk
      292
      num Events
      334
    term
    Bacterial infection
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      4
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      292
      num Events
      56
    term
    Bleeding
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      292
      num Events
      18
    term
    Cystitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      2
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      292
      num Events
      21
    term
    Hemodialysis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
      num Events
      8
    2. group Id
      EG001
      num Affected
      96
      num At Risk
      292
      num Events
      219
    term
    Infection (Etiology unknown)
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      4
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      292
      num Events
      21
    term
    Organ failure
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
      num Events
      15
    2. group Id
      EG001
      num Affected
      122
      num At Risk
      292
      num Events
      269
    term
    Fungal infection
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      292
      num Events
      51
    term
    Neuropathy
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      292
      num Events
      37
    term
    Neurotoxicity
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      292
      num Events
      20
    term
    perihilar opacity
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      13
      num Events
      25
    2. group Id
      EG001
      num Affected
      179
      num At Risk
      292
      num Events
      489
    term
    Other disorders
Complete source fields
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    13
    description
    Patients with refractory leukemia or MDS
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    13
    serious Num Affected
    1
    serious Num At Risk
    13
    title
    High Risk Patients
  2. deaths Num Affected
    124
    deaths Num At Risk
    292
    description
    Patients with Disease criteria: Acute myelogenous leukemia , Acute lymphocytic leukemia, Chronic myelogenous leukemia , NHL, Hodgkins, chronic lymphocytic leukemia, multiple myeloma, Acquired bone marrow failure syndromes, Myelodysplastic syndrome, Renal cell cancer,Chronic myeloproliferative disorder
    id
    EG001
    other Num Affected
    272
    other Num At Risk
    292
    serious Num Affected
    53
    serious Num At Risk
    292
    title
    Standard Risk Patients
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      292
      num Events
      18
    term
    Acute respiratory distress syndrome (ARDS)
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
      num Events
      15
    2. group Id
      EG001
      num Affected
      128
      num At Risk
      292
      num Events
      334
    term
    Bacterial infection
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      4
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      292
      num Events
      56
    term
    Bleeding
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      292
      num Events
      18
    term
    Cystitis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      2
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      292
      num Events
      21
    term
    Hemodialysis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
      num Events
      8
    2. group Id
      EG001
      num Affected
      96
      num At Risk
      292
      num Events
      219
    term
    Infection (Etiology unknown)
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      4
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      292
      num Events
      21
    term
    Organ failure
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
      num Events
      15
    2. group Id
      EG001
      num Affected
      122
      num At Risk
      292
      num Events
      269
    term
    Fungal infection
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      292
      num Events
      51
    term
    Neuropathy
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      292
      num Events
      37
    term
    Neurotoxicity
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      292
      num Events
      20
    term
    perihilar opacity
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      13
      num Events
      25
    2. group Id
      EG001
      num Affected
      179
      num At Risk
      292
      num Events
      489
    term
    Other disorders
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      292
    term
    Graft versus Host disease
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      292
    term
    Relapse
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      292
    term
    Infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE (2.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      292
    term
    Progressive disease
time Frame
2 years

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Preserved source evidence · Not medical advice