Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00597714 · ADVERSE EVENTS

Adverse events

Efficacy Study of T Cell Depleted Allogeneic Non-myeloablative Stem Cell Transplant · Source last updated 2014-06-02

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
Participants will be evaluated at a minimum of 2 times per week by physical exam for toxicity following Version 3 of the NCI expanded common toxicity criteria through day 45 following the first infusion.
Other-event reporting threshold
5%

Graft versus Host Disease (GVHD) and other toxicity was graded per NCI's common terminology criteria for adverse events (CTCAE) (3.0).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort A - Lymphoid Disease

Non-myeloablative stem cell transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells \> 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The peripheral blood stem cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.

16 / 8077 / 80Not reported / Not reported
Cohort B - Myeloid Disease

Non-myeloablative stem cell transplant (SCT): Donor will receive granulocyte colony stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells \> 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The peripheral blood stem cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.

10 / 5752 / 57Not reported / Not reported

Group identifiers: EG000: Cohort A - Lymphoid Disease · EG001: Cohort B - Myeloid Disease

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      80
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Supraventricular and nodal arrhythmia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      80
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
      num Events
      1
    term
    Cardiac Ischemia/Infarction
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      80
      num Events
      9
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      57
      num Events
      6
    term
    Death - NOS
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Diarrhea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Nausea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Elevation bilirubin and alkaline phosphate
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Hepatobiliary/Pancreas
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Pancreatitis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
      num Events
      2
    term
    Febrile neutropenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Meningitis; Parainfluenza; Herpes Zoster; Nocardia; Sepsis; Hickman line infection; C-Diff
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      80
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
      num Events
      3
    term
    Infection - Other
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Sepsis; Parainfluenza III; Gram positive cocci (Staph Aureus); Human Herpes Virus 6; Pneumonia; Polyoma virus; Viremia
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      80
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
      num Events
      5
    term
    Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    H. pylori; BK virus; Influenza
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      80
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Infection with grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Fever possibly due to Human Herpes Virus 6
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Infection with unknown ANC

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      80
      num Events
      3
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      57
      num Events
      13
    term
    Failure to Engraft
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      80
      num Events
      20
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      57
      num Events
      4
    term
    Diarrhea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Fever without neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      80
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      57
      num Events
      5
    term
    Rash/desquamation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      80
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      57
      num Events
      2
    term
    Mucositis/Stomatitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      80
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      57
      num Events
      2
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Liver laceration; Retroperitoneal bleed; Ulcerative Colitis; Death (4)
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      80
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
      num Events
      3
    term
    Hemorrhage/Bleeding
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      80
      num Events
      46
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      57
      num Events
      23
    term
    Febrile neutropenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Pneumonia; Sepsis; Viremia; Human Herpes Virus 6; Herpes Simplex Virus; Cytomegalovirus; Fungal Pneumonia
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      80
      num Events
      14
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      57
      num Events
      5
    term
    Infection - Other
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Bacteremia; Polyoma; Cytomegalovirus; Viremia; Varicella Zoster; Human Herpes Virus 6; Parainfluenza; Respiratory syncytial virus; Penicillium; Vancomycin-resistant enterococcus; Nocardia; Strep Viridans; Gram+ cocci; Ecoli; C-Diff; Klebsiella; MRSA
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      80
      num Events
      118
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      57
      num Events
      90
    term
    Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Varicella Zoster; Cytomegalovirus; Viremia; Pneumonia; Stenotrophomonas Maltophilin; Herpes Simplex Virus; Human Herpes Virus 6; Gram+ cocci; Polyoma; Respiratory syncytial virus; C-Diff; Rhizopus; Parainfluenza; BK virus; Staph; MRSA; Gram- rod
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      80
      num Events
      101
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      57
      num Events
      37
    term
    Infection with normal ANC or grade 1 or 2 neutrophils
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Thrush; Polyoma; Gram negative Sepsis; Gram positive cocci; Cytomegalovirus; Human Herpes Virus 6; Parainfluenza
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      80
      num Events
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
      num Events
      1
    term
    Infection with unknown ANC
Complete source fields
description
Graft versus Host Disease (GVHD) and other toxicity was graded per NCI's common terminology criteria for adverse events (CTCAE) (3.0).
event Groups
  1. description
    Non-myeloablative stem cell transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells \> 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The peripheral blood stem cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
    id
    EG000
    other Num Affected
    77
    other Num At Risk
    80
    serious Num Affected
    16
    serious Num At Risk
    80
    title
    Cohort A - Lymphoid Disease
  2. description
    Non-myeloablative stem cell transplant (SCT): Donor will receive granulocyte colony stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells \> 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The peripheral blood stem cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
    id
    EG001
    other Num Affected
    52
    other Num At Risk
    57
    serious Num Affected
    10
    serious Num At Risk
    57
    title
    Cohort B - Myeloid Disease
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      80
      num Events
      3
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      57
      num Events
      13
    term
    Failure to Engraft
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      80
      num Events
      20
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      57
      num Events
      4
    term
    Diarrhea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Fever without neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      80
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      57
      num Events
      5
    term
    Rash/desquamation
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      80
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      57
      num Events
      2
    term
    Mucositis/Stomatitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      80
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      57
      num Events
      2
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Liver laceration; Retroperitoneal bleed; Ulcerative Colitis; Death (4)
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      80
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
      num Events
      3
    term
    Hemorrhage/Bleeding
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      80
      num Events
      46
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      57
      num Events
      23
    term
    Febrile neutropenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Pneumonia; Sepsis; Viremia; Human Herpes Virus 6; Herpes Simplex Virus; Cytomegalovirus; Fungal Pneumonia
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      80
      num Events
      14
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      57
      num Events
      5
    term
    Infection - Other
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Bacteremia; Polyoma; Cytomegalovirus; Viremia; Varicella Zoster; Human Herpes Virus 6; Parainfluenza; Respiratory syncytial virus; Penicillium; Vancomycin-resistant enterococcus; Nocardia; Strep Viridans; Gram+ cocci; Ecoli; C-Diff; Klebsiella; MRSA
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      80
      num Events
      118
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      57
      num Events
      90
    term
    Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Varicella Zoster; Cytomegalovirus; Viremia; Pneumonia; Stenotrophomonas Maltophilin; Herpes Simplex Virus; Human Herpes Virus 6; Gram+ cocci; Polyoma; Respiratory syncytial virus; C-Diff; Rhizopus; Parainfluenza; BK virus; Staph; MRSA; Gram- rod
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      80
      num Events
      101
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      57
      num Events
      37
    term
    Infection with normal ANC or grade 1 or 2 neutrophils
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Thrush; Polyoma; Gram negative Sepsis; Gram positive cocci; Cytomegalovirus; Human Herpes Virus 6; Parainfluenza
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      80
      num Events
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
      num Events
      1
    term
    Infection with unknown ANC
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      80
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Supraventricular and nodal arrhythmia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      80
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
      num Events
      1
    term
    Cardiac Ischemia/Infarction
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      80
      num Events
      9
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      57
      num Events
      6
    term
    Death - NOS
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Diarrhea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Nausea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Elevation bilirubin and alkaline phosphate
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Hepatobiliary/Pancreas
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Pancreatitis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
      num Events
      2
    term
    Febrile neutropenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Meningitis; Parainfluenza; Herpes Zoster; Nocardia; Sepsis; Hickman line infection; C-Diff
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      80
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
      num Events
      3
    term
    Infection - Other
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Sepsis; Parainfluenza III; Gram positive cocci (Staph Aureus); Human Herpes Virus 6; Pneumonia; Polyoma virus; Viremia
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      80
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
      num Events
      5
    term
    Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    H. pylori; BK virus; Influenza
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      80
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Infection with grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Fever possibly due to Human Herpes Virus 6
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Infection with unknown ANC
time Frame
Participants will be evaluated at a minimum of 2 times per week by physical exam for toxicity following Version 3 of the NCI expanded common toxicity criteria through day 45 following the first infusion.

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

Preserved source evidence · Not medical advice