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NCT01028716 · ADVERSE EVENTS

Adverse events

Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies · Source last updated 2023-01-23

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
Adverse events were collected for up to 100 days post HCT. Serious Adverse Events were collected until 1 year post-HCT. All cause mortality was assessed up to 3 years post transplant.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Nonmyeloablative HCT, TBI)

Conditioning: Fludarabine IV over 30-60 minutes daily on days -6 through -2 and cyclophosphamide IV over 1-2 hours on days -6, -5, and 3-4. Patients undergo total-body irradiation on day -1. Cell product: Patients undergo donor peripheral blood stem cell transplant on day 0. GVHD Prophylaxis: Patients then receive tacrolimus IV once daily or PO BID on days 5-180 (may be continued if active GvHD is present), mycophenolate mofetil IV or PO TID on days 5-35 (may be continued if GvHD present), and filgrastim IV beginning on day 5 until the ANC is \>= 1,000/mm\^3 for three consecutive days.

4 / 4544 / 4521 / 45

Group identifiers: EG000: Treatment (Nonmyeloablative HCT, TBI)

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
    Rehospitalization for acute hypoxemic respiratory failure
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      2
    term
    ARDS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Worsening dyspnea with drop in EF to 35%
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Heart Failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DAH requiring intubation and ICU admission. Resulted in Death.
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Diffuse Alveolar Hemorrhage
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Acute hypoxemia respiratory failure

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
    notes
    including arrythmia
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      45
      num Events
      13
    term
    Cardiac
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Including episodes of febrile neutropenia, infections and viral reactivations with BK and CMV in the blood.
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      45
      num Events
      115
    term
    Infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      45
      num Events
      9
    term
    Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      45
      num Events
      24
    term
    Metabolic
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      45
      num Events
      10
    term
    Pulmonary
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      45
      num Events
      17
    term
    GI
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      45
      num Events
      10
    term
    Renal
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
      num Events
      4
    term
    Derm
Complete source fields
event Groups
  1. deaths Num Affected
    21
    deaths Num At Risk
    45
    description
    Conditioning: Fludarabine IV over 30-60 minutes daily on days -6 through -2 and cyclophosphamide IV over 1-2 hours on days -6, -5, and 3-4. Patients undergo total-body irradiation on day -1. Cell product: Patients undergo donor peripheral blood stem cell transplant on day 0. GVHD Prophylaxis: Patients then receive tacrolimus IV once daily or PO BID on days 5-180 (may be continued if active GvHD is present), mycophenolate mofetil IV or PO TID on days 5-35 (may be continued if GvHD present), and filgrastim IV beginning on day 5 until the ANC is \>= 1,000/mm\^3 for three consecutive days.
    id
    EG000
    other Num Affected
    44
    other Num At Risk
    45
    serious Num Affected
    4
    serious Num At Risk
    45
    title
    Treatment (Nonmyeloablative HCT, TBI)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    including arrythmia
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      45
      num Events
      13
    term
    Cardiac
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Including episodes of febrile neutropenia, infections and viral reactivations with BK and CMV in the blood.
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      45
      num Events
      115
    term
    Infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      45
      num Events
      9
    term
    Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      45
      num Events
      24
    term
    Metabolic
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      45
      num Events
      10
    term
    Pulmonary
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      45
      num Events
      17
    term
    GI
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      45
      num Events
      10
    term
    Renal
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      45
      num Events
      4
    term
    Derm
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Rehospitalization for acute hypoxemic respiratory failure
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      2
    term
    ARDS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Worsening dyspnea with drop in EF to 35%
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Heart Failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    DAH requiring intubation and ICU admission. Resulted in Death.
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Diffuse Alveolar Hemorrhage
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Acute hypoxemia respiratory failure
time Frame
Adverse events were collected for up to 100 days post HCT. Serious Adverse Events were collected until 1 year post-HCT. All cause mortality was assessed up to 3 years post transplant.

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Preserved source evidence · Not medical advice