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NCT00079391 · ADVERSE EVENTS

Adverse events

Stem Cell Transplantation and T-Cell Add-Back to Treat Bone Marrow Malignancies · Source last updated 2015-10-26

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
Overall study
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Bone Marrow Transplantation Using Nexell Isolex 300i

Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.

25 / 4949 / 49Not reported / Not reported

Group identifiers: EG000: Bone Marrow Transplantation Using Nexell Isolex 300i

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      49
      num Events
      9
    term
    Transplant Related Death
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    Hospitalization
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
      num Events
      2
    term
    Hospitalization
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      49
      num Events
      12
    term
    Death
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    Life threatening

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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      49
      num Events
      10
    term
    Acute GVHD before day 60
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      49
      num Events
      22
    term
    Chronic GVHD
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
      num Events
      4
    term
    Hemorrhagic cystitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      49
      num Events
      37
    term
    Cytomegalovirus disease
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      49
      num Events
      18
    term
    Disease Relapse
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      49
      num Events
      19
    term
    Acute GVHD after day 60
Complete source fields
event Groups
  1. description
    Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
    id
    EG000
    other Num Affected
    49
    other Num At Risk
    49
    serious Num Affected
    25
    serious Num At Risk
    49
    title
    Bone Marrow Transplantation Using Nexell Isolex 300i
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      49
      num Events
      10
    term
    Acute GVHD before day 60
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      49
      num Events
      22
    term
    Chronic GVHD
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
      num Events
      4
    term
    Hemorrhagic cystitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      49
      num Events
      37
    term
    Cytomegalovirus disease
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      49
      num Events
      18
    term
    Disease Relapse
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      49
      num Events
      19
    term
    Acute GVHD after day 60
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      49
      num Events
      9
    term
    Transplant Related Death
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    Hospitalization
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      49
      num Events
      2
    term
    Hospitalization
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      49
      num Events
      12
    term
    Death
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
      num Events
      1
    term
    Life threatening
time Frame
Overall study

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Preserved source evidence · Not medical advice