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NCT01810588 · ADVERSE EVENTS

Adverse events

Targeting the IPA and Matching for the Non-Inherited Maternal Antigen for Haplo-Cord Transplantation · Source last updated 2026-08-19

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
Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.
Other-event reporting threshold
0%

Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1 - Minimum Cell Dose 2 x 10^7 TNC/kg

All subjects in this cohort will receive a minimal cell dose of 2 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit. Haplo-cord transplantation: All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past. For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products. In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.

7 / 156 / 156 / 15
Cohort 2 - Minimum Cell Dose 1 x 10^7 TNC/kg

All subjects in this cohort will receive a minimal cell dose of 1 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit. Haplo-cord transplantation: All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past. For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products. In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.

9 / 206 / 206 / 20
Cohort 3 - Minimum Cell Dose 0.5 x 10^7 TNC/kg

All subjects in this cohort will receive a minimal cell dose of 0.5 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit. Haplo-cord transplantation: All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past. For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products. In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.

14 / 2512 / 2511 / 25
Cohort 4

All subjects in this cohort will receive the minimum required cell dose that is determined following the dose de-escalation portion of the study (cohorts 1 through 3) Haplo-cord transplantation: All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past. For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products. In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.

156 / 21093 / 21079 / 210

Group identifiers: EG000: Cohort 1 - Minimum Cell Dose 2 x 10^7 TNC/kg · EG001: Cohort 2 - Minimum Cell Dose 1 x 10^7 TNC/kg · EG002: Cohort 3 - Minimum Cell Dose 0.5 x 10^7 TNC/kg · EG003: Cohort 4

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
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      210
      num Events
      7
    term
    Acute Kidney Injury
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      210
      num Events
      1
    term
    Acute Renal Failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      210
      num Events
      6
    term
    Infectious Colitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      210
      num Events
      9
    term
    Adenovirus Viremia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      210
      num Events
      1
    term
    Adult Respiratory Distress Syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      210
      num Events
      2
    term
    Altered Mental Status
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      210
      num Events
      1
    term
    Anal Fistula
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      210
      num Events
      2
    term
    Anemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      210
      num Events
      3
    term
    Appendicitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      210
      num Events
      0
    term
    Arthritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      210
      num Events
      1
    term
    Asthma Exacerbation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      210
      num Events
      2
    term
    Atrial fibrillation

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
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      25
      num Events
      4
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      210
      num Events
      31
    term
    Cytomegalovirus viremia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      210
      num Events
      1
    term
    Bacteremia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      20
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      25
      num Events
      3
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      210
      num Events
      33
    term
    C. difficile colitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      210
      num Events
      3
    term
    Candida esophagitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      210
      num Events
      1
    term
    Catheter Related Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      210
      num Events
      4
    term
    Cellulitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      210
      num Events
      1
    term
    Cytomegalovirus colitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      210
      num Events
      0
    term
    Fever
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      210
      num Events
      0
    term
    Hepatitis B Reactivation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      210
      num Events
      3
    term
    Human Herpes Virus 6 Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      210
      num Events
      4
    term
    Herpes Simplex Virus Infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      210
      num Events
      14
    term
    Infectious Diarrhea
Complete source fields
description
Per protocol, events reported were grade 2 and higher infection and graft-versus-host disease events, and all other hematopoietic or extramedullary events grade 3 or higher per CTCAE v4.0.
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    15
    description
    All subjects in this cohort will receive a minimal cell dose of 2 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit. Haplo-cord transplantation: All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past. For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products. In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    15
    serious Num Affected
    7
    serious Num At Risk
    15
    title
    Cohort 1 - Minimum Cell Dose 2 x 10^7 TNC/kg
  2. deaths Num Affected
    6
    deaths Num At Risk
    20
    description
    All subjects in this cohort will receive a minimal cell dose of 1 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit. Haplo-cord transplantation: All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past. For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products. In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    20
    serious Num Affected
    9
    serious Num At Risk
    20
    title
    Cohort 2 - Minimum Cell Dose 1 x 10^7 TNC/kg
  3. deaths Num Affected
    11
    deaths Num At Risk
    25
    description
    All subjects in this cohort will receive a minimal cell dose of 0.5 x 10\^7 total nucleated cells (TNC)/kilogram (kg) for the umbilical cord blood unit. Haplo-cord transplantation: All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past. For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products. In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
    id
    EG002
    other Num Affected
    12
    other Num At Risk
    25
    serious Num Affected
    14
    serious Num At Risk
    25
    title
    Cohort 3 - Minimum Cell Dose 0.5 x 10^7 TNC/kg
  4. deaths Num Affected
    79
    deaths Num At Risk
    210
    description
    All subjects in this cohort will receive the minimum required cell dose that is determined following the dose de-escalation portion of the study (cohorts 1 through 3) Haplo-cord transplantation: All subjects will receive a conditioning regimen of chemotherapy prior to stem cell transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past. For the transplant component of treatment, subject will receive umbilical cord blood. The study involves transplantation of unlicensed units of cord blood. Therefore, these are considered investigational products. In addition to the umbilical cord blood unit, recipients will receive stem cells from a family member ( a haplo-identical donor). After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device.
    id
    EG003
    other Num Affected
    93
    other Num At Risk
    210
    serious Num Affected
    156
    serious Num At Risk
    210
    title
    Cohort 4
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      15
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      20
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      25
      num Events
      4
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      210
      num Events
      31
    term
    Cytomegalovirus viremia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      210
      num Events
      1
    term
    Bacteremia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      20
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      25
      num Events
      3
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      210
      num Events
      33
    term
    C. difficile colitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      210
      num Events
      3
    term
    Candida esophagitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      210
      num Events
      1
    term
    Catheter Related Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      15
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      210
      num Events
      4
    term
    Cellulitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      210
      num Events
      1
    term
    Cytomegalovirus colitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      210
      num Events
      0
    term
    Fever
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      210
      num Events
      0
    term
    Hepatitis B Reactivation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      210
      num Events
      3
    term
    Human Herpes Virus 6 Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      210
      num Events
      4
    term
    Herpes Simplex Virus Infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      210
      num Events
      14
    term
    Infectious Diarrhea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      210
      num Events
      7
    term
    Acute Kidney Injury
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      210
      num Events
      1
    term
    Acute Renal Failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      210
      num Events
      6
    term
    Infectious Colitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      210
      num Events
      9
    term
    Adenovirus Viremia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      210
      num Events
      1
    term
    Adult Respiratory Distress Syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      210
      num Events
      2
    term
    Altered Mental Status
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      210
      num Events
      1
    term
    Anal Fistula
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      210
      num Events
      2
    term
    Anemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      210
      num Events
      3
    term
    Appendicitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      20
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      210
      num Events
      0
    term
    Arthritis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      210
      num Events
      1
    term
    Asthma Exacerbation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      15
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      20
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      25
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      210
      num Events
      2
    term
    Atrial fibrillation
time Frame
Adverse events were collected for all patients from start of transplant conditioning regimen through 1 year post-transplant or when the participant was removed from the study, whichever was sooner, assessed up to 1 year.

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