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NCT00914940 · ADVERSE EVENTS

Adverse events

Selective Depletion of CD45RA+T Cells From Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD · Source last updated 2020-08-20

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
AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
Other-event reporting threshold
5%

No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Overall Study Participants

CD34+ enriched allogeneic peripheral blood stem cells (PBSC) followed by CD45RA+ T-cell-depleted allogeneic PBSC and tacrolimus for GVHD prophylaxis

39 / 4141 / 4113 / 41

Group identifiers: EG000: Overall Study Participants

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
    Grade 3
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
      num Events
      2
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grades 2-4
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      41
      num Events
      4
    term
    Acute Kidney Injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
      num Events
      3
    term
    Anorexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Arthralgia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Back Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
      num Events
      2
    term
    Bladder infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 4
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
      num Events
      3
    term
    Bronchopulmonary hemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      41
      num Events
      9
    term
    Catheter related infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
      num Events
      3
    term
    Dehydration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Duodenal 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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      41
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      41
    term
    Lymphocyte count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      41
    term
    Neutrophil count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      41
    term
    Platelet count decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      41
    term
    White blood cell decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      41
    term
    Hyperglycemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      41
    term
    Hyponatremia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      41
    term
    Hypophosphatemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      41
    term
    CD4 lymphocytes decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      41
    term
    Diarrhea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      41
    term
    Hypertenstion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      41
    term
    Rash maculo-papular
Complete source fields
description
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
event Groups
  1. deaths Num Affected
    13
    deaths Num At Risk
    41
    description
    CD34+ enriched allogeneic peripheral blood stem cells (PBSC) followed by CD45RA+ T-cell-depleted allogeneic PBSC and tacrolimus for GVHD prophylaxis
    id
    EG000
    other Num Affected
    41
    other Num At Risk
    41
    serious Num Affected
    39
    serious Num At Risk
    41
    title
    Overall Study Participants
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      41
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      41
    term
    Lymphocyte count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      41
    term
    Neutrophil count decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      41
    term
    Platelet count decreased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      41
    term
    White blood cell decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      41
    term
    Hyperglycemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      41
    term
    Hyponatremia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      41
    term
    Hypophosphatemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      41
    term
    CD4 lymphocytes decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      41
    term
    Diarrhea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      41
    term
    Hypertenstion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      41
    term
    Rash maculo-papular
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
      num Events
      2
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grades 2-4
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      41
      num Events
      4
    term
    Acute Kidney Injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
      num Events
      3
    term
    Anorexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Arthralgia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Back Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
      num Events
      2
    term
    Bladder infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 4
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      41
      num Events
      3
    term
    Bronchopulmonary hemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      41
      num Events
      9
    term
    Catheter related infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      41
      num Events
      3
    term
    Dehydration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v.4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      41
      num Events
      1
    term
    Duodenal infection
time Frame
AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year

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Preserved source evidence · Not medical advice