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NCT02220985 · ADVERSE EVENTS

Adverse events

Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors in Preventing GVHD · Source last updated 2026-06-01

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
Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.
Other-event reporting threshold
5%

Only grades 3-5 non-hematologic adverse events were captured.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (MRD / High Intensity Conditioning)

HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.

21 / 216 / 215 / 21
Arm B (MRD / Low Intensity Conditioning)

LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.

17 / 208 / 204 / 20
Arm C (MUD / High Intensity Conditioning)

HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.

18 / 186 / 184 / 18
Arm D (MUD / Low Intensity Conditioning)

LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.

15 / 188 / 184 / 18

Group identifiers: EG000: Arm A (MRD / High Intensity Conditioning) · EG001: Arm B (MRD / Low Intensity Conditioning) · EG002: Arm C (MUD / High Intensity Conditioning) · EG003: Arm D (MUD / Low Intensity Conditioning)

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
    Cardiac disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Heart Failure
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      18
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Esophagitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Gastrointestinal Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Gastroparesis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      21
      num Events
      17
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      20
      num Events
      4
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      18
      num Events
      18
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      18
      num Events
      8
    term
    Mucositis oral
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      21
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      20
      num Events
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      18
      num Events
      2
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      18
      num Events
      5
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Typhlitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      18
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Fever
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      18
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Pain

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
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      20
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      18
      num Events
      2
    term
    Diarrhea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Cytokine release syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      18
      num Events
      2
    term
    Infections and infestations, other
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    term
    Hyperglycemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Hypermagnesemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      18
      num Events
      2
    term
    Hypokalemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Hyponatremia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Hypophosphatemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      18
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Syncope
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      18
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Rash maculo-papular
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      18
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      18
      num Events
      3
    term
    Hypertension
Complete source fields
description
Only grades 3-5 non-hematologic adverse events were captured.
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    21
    description
    HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    21
    serious Num Affected
    21
    serious Num At Risk
    21
    title
    Arm A (MRD / High Intensity Conditioning)
  2. deaths Num Affected
    4
    deaths Num At Risk
    20
    description
    LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
    id
    EG001
    other Num Affected
    8
    other Num At Risk
    20
    serious Num Affected
    17
    serious Num At Risk
    20
    title
    Arm B (MRD / Low Intensity Conditioning)
  3. deaths Num Affected
    4
    deaths Num At Risk
    18
    description
    HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    18
    serious Num Affected
    18
    serious Num At Risk
    18
    title
    Arm C (MUD / High Intensity Conditioning)
  4. deaths Num Affected
    4
    deaths Num At Risk
    18
    description
    LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
    id
    EG003
    other Num Affected
    8
    other Num At Risk
    18
    serious Num Affected
    15
    serious Num At Risk
    18
    title
    Arm D (MUD / Low Intensity Conditioning)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      20
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      18
      num Events
      2
    term
    Diarrhea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Cytokine release syndrome
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      18
      num Events
      2
    term
    Infections and infestations, other
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
    term
    Hyperglycemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Hypermagnesemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      18
      num Events
      2
    term
    Hypokalemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Hyponatremia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Hypophosphatemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      18
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Syncope
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      18
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Rash maculo-papular
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      21
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      18
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      18
      num Events
      3
    term
    Hypertension
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Heart Failure
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      18
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Esophagitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Gastrointestinal Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      18
      num Events
      1
    term
    Gastroparesis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      21
      num Events
      17
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      20
      num Events
      4
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      18
      num Events
      18
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      18
      num Events
      8
    term
    Mucositis oral
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      21
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      20
      num Events
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      18
      num Events
      2
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      18
      num Events
      5
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      18
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Typhlitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      18
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      21
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      18
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Fever
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      21
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      18
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      18
      num Events
      0
    term
    Pain
time Frame
Serious and other adverse events were reported from pre-transplant conditioning through day 100 post-transplant. All-cause mortality (including both relapse and non-relapse mortality) was assessed for up to 5 years post-transplant.

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Preserved source evidence · Not medical advice