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NCT00589316 · ADVERSE EVENTS

Adverse events

Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation and Donor Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or High-Risk Myelodysplastic Syndrome · Source last updated 2023-02-09

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 adverse events and Other (not including serious adverse events) were monitored and recorded from the time of first exposure to the investigational product (i.e. Iodine 131 + BC8 mAB) through day +100 post-transplant or through patient discharge from the Seattle Cancer Care Alliance (SCCA) system to the patient's primary physician. All-Cause Mortality was monitored/assessed for up to 2 years or through participant survival after completing the study regimen and transplant.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody

RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI

1 / 11 / 11 / 1
Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody

RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI

1 / 11 / 10 / 1
Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody

RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI

4 / 55 / 55 / 5
Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody

RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI

1 / 11 / 10 / 1
Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody

RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI

0 / 11 / 10 / 1
Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody

RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI

2 / 22 / 22 / 2
Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody

RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI

5 / 76 / 75 / 7
Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody

RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI

7 / 77 / 77 / 7

Group identifiers: EG000: Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody · EG001: Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody · EG002: Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody · EG003: Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody · EG004: Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody · EG005: Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody · EG006: Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody · EG007: Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody

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 (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Supraventricular and nodal arrhythmia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Asystole
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Ventricular Arrythmia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Hypotension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Skin GVHD
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      7
      num Events
      2
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    GI GVHD
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Gastritis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Mucositis/stomatitis (clinical exam) Anus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Mucositis/stomatitis (clinical exam) Oral cavity
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Hemorrhage, GU Bladder

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
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      7
      num Events
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Allergic Reaction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Chest Tightness
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Allergic Reaction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Face Rash
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Allergic Reaction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Fever
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Allergic Reaction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Hemoglobin decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Lymphopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      2
      num Events
      2
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      2
      num Events
      2
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Platelets decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      2
      num Events
      2
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    WBC decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Atrial Fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Fluid Overload
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody
  2. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody
  3. deaths Num Affected
    5
    deaths Num At Risk
    5
    description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    4
    serious Num At Risk
    5
    title
    Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody
  4. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    EG003
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody
  5. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    EG004
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody
  6. deaths Num Affected
    2
    deaths Num At Risk
    2
    description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    EG005
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    2
    serious Num At Risk
    2
    title
    Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody
  7. deaths Num Affected
    5
    deaths Num At Risk
    7
    description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    EG006
    other Num Affected
    6
    other Num At Risk
    7
    serious Num Affected
    5
    serious Num At Risk
    7
    title
    Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody
  8. deaths Num Affected
    7
    deaths Num At Risk
    7
    description
    RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 via central line on day -14. NONMYELOABLATIVE CONDITIONING: Patients receive FLU IV over 30 minutes on days -6 to -2 and CY IV over 1 hour on days -6 and -5. Patients undergo TBI on day -1. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. POST-TRANSPLATATION IMMUNOSUPPRESSION: Patients receive CY IV over 1-2 hours on day 3, MMF IV or PO TID on days 4 to 35, and tacrolimus IV over 1-2 hours or PO on days 4 to 180 with taper on day 84. Allogeneic Bone Marrow Transplantation: Given via central line Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Iodine I 131 Monoclonal Antibody BC8: Given IV (dosimetry dose) or via central line (therapeutic dose) Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
    id
    EG007
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    7
    serious Num At Risk
    7
    title
    Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      7
      num Events
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Allergic Reaction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Chest Tightness
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Allergic Reaction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Face Rash
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Allergic Reaction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Fever
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Allergic Reaction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Hemoglobin decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Lymphopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      2
      num Events
      2
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      2
      num Events
      2
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Platelets decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      1
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      2
      num Events
      2
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    WBC decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Atrial Fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Fluid Overload
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Supraventricular and nodal arrhythmia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Asystole
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Ventricular Arrythmia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Hypotension
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Skin GVHD
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      7
      num Events
      2
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    GI GVHD
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Gastritis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Mucositis/stomatitis (clinical exam) Anus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Mucositis/stomatitis (clinical exam) Oral cavity
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      2
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Hemorrhage, GU Bladder
time Frame
Serious adverse events and Other (not including serious adverse events) were monitored and recorded from the time of first exposure to the investigational product (i.e. Iodine 131 + BC8 mAB) through day +100 post-transplant or through patient discharge from the Seattle Cancer Care Alliance (SCCA) system to the patient's primary physician. All-Cause Mortality was monitored/assessed for up to 2 years or through participant survival after completing the study regimen and transplant.

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