Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01596257 · ADVERSE EVENTS

Adverse events

Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation · Source last updated 2022-12-29

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%

Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Bulk Stem Cell Transplantation/SCT

Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on day 0. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS

21 / 6138 / 6126 / 61
Fractionated Stem Cell Transplantation/SCT

Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on days 0, 2, 4, and 6. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS

12 / 5536 / 5523 / 55

Group identifiers: EG000: Bulk Stem Cell Transplantation/SCT · EG001: Fractionated Stem Cell Transplantation/SCT

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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Arthritis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Blood and lymphatic system disorders - Other, spec
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Bronchopulmonary hemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Catheter related infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Colitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Confusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Cough
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Cystitis noninfective
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
    term
    Death NOS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Dehydration

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
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      55
    term
    Febrile Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      55
    term
    Infections and infestations - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      55
    term
    Mucositis oral
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      55
    term
    Hypertension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      55
    term
    Hypotension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
    term
    Skin & subcutaneous tissue disorders Other, spec
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      55
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      55
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
    term
    Alkaline phosphatase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
    term
    Allergic reaction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      55
    term
    Anorexia
Complete source fields
description
Data was pre-specified to be collected for aggregate Bulk SCT and Fractionated SCT interventions and not per transplant type stratification. Adverse Events were not collected based on transplant type stratification
event Groups
  1. deaths Num Affected
    26
    deaths Num At Risk
    61
    description
    Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on day 0. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS
    id
    EG000
    other Num Affected
    38
    other Num At Risk
    61
    serious Num Affected
    21
    serious Num At Risk
    61
    title
    Bulk Stem Cell Transplantation/SCT
  2. deaths Num Affected
    23
    deaths Num At Risk
    55
    description
    Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on days 0, 2, 4, and 6. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS
    id
    EG001
    other Num Affected
    36
    other Num At Risk
    55
    serious Num Affected
    12
    serious Num At Risk
    55
    title
    Fractionated Stem Cell Transplantation/SCT
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      55
    term
    Febrile Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      55
    term
    Infections and infestations - Other, specify
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      55
    term
    Mucositis oral
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      55
    term
    Hypertension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      55
    term
    Hypotension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Colitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
    term
    Skin & subcutaneous tissue disorders Other, spec
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      55
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      55
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
    term
    Alkaline phosphatase increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
    term
    Allergic reaction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      55
    term
    Anorexia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Arthritis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Blood and lymphatic system disorders - Other, spec
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Bronchopulmonary hemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Catheter related infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Colitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Confusion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Cough
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    term
    Cystitis noninfective
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      55
    term
    Death NOS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      61
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    term
    Dehydration
time Frame
2 years

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

Preserved source evidence · Not medical advice