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NCT00176930 · ADVERSE EVENTS

Adverse events

Stem Cell Transplant for Hematological Malignancy · Source last updated 2021-01-22

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
5 years
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
PBSC: No TBI

Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplant

3 / 1212 / 129 / 12
Marrow : No TBI

Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant

0 / 1310 / 134 / 13
UCB : No TBI

Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplant

0 / 11 / 11 / 1
UCB : No TBI/Bu/Cy/ATG

Patients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimen

0 / 11 / 11 / 1
PBSC

Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant

32 / 213183 / 213113 / 213
Marrow

Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant

10 / 8571 / 8531 / 85
Umbilical Cord Blood

Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant

0 / 22 / 20 / 2
Co-Enroll From MT0403

Patients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)

0 / 22 / 20 / 2

Group identifiers: EG000: PBSC: No TBI · EG001: Marrow : No TBI · EG002: UCB : No TBI · EG003: UCB : No TBI/Bu/Cy/ATG · EG004: PBSC · EG005: Marrow · EG006: Umbilical Cord Blood · EG007: Co-Enroll From MT0403

Serious adverse events

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

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      213
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      85
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Graft versus host disease
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      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
      213
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      85
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Primary Graft Failure
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      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
      213
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      85
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Hemorrhage
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      20
      num At Risk
      213
      num Events
      20
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      85
      num Events
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Death
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      213
      num Events
      8
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      85
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Relapse
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      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
      213
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      85
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Syndromes
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      213
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      85
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Death
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      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
      213
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      85
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Death due to accident

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
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      12
      num Events
      37
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      13
      num Events
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      4
    5. group Id
      EG004
      num Affected
      114
      num At Risk
      213
      num Events
      375
    6. group Id
      EG005
      num Affected
      54
      num At Risk
      85
      num Events
      169
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Infection
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      14
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      13
      num Events
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      91
      num At Risk
      213
      num Events
      143
    6. group Id
      EG005
      num Affected
      42
      num At Risk
      85
      num Events
      70
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
      num Events
      1
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      2
      num Events
      7
    term
    Pneumonia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      34
      num At Risk
      213
      num Events
      45
    6. group Id
      EG005
      num Affected
      14
      num At Risk
      85
      num Events
      22
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      2
      num Events
      2
    term
    Intubation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      13
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      26
      num At Risk
      213
      num Events
      27
    6. group Id
      EG005
      num Affected
      21
      num At Risk
      85
      num Events
      23
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Hypertension
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      12
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      25
      num At Risk
      213
      num Events
      25
    6. group Id
      EG005
      num Affected
      11
      num At Risk
      85
      num Events
      11
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Cystitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      25
      num At Risk
      213
      num Events
      26
    6. group Id
      EG005
      num Affected
      10
      num At Risk
      85
      num Events
      11
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Elevated Liver Function Tests
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      24
      num At Risk
      213
      num Events
      26
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      85
      num Events
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    GI Bleeding
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      13
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      213
      num Events
      12
    6. group Id
      EG005
      num Affected
      13
      num At Risk
      85
      num Events
      13
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      2
      num Events
      2
    term
    Pericardial effusion
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      213
      num Events
      16
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      85
      num Events
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Dialysis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      15
      num At Risk
      213
      num Events
      18
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      85
      num Events
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Veno occlusive disease (VOD)
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      213
      num Events
      18
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      85
      num Events
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Pumonary hemorrhage
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      213
      num Events
      16
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      85
      num Events
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Acute renal failure
Complete source fields
event Groups
  1. deaths Num Affected
    9
    deaths Num At Risk
    12
    description
    Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplant
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    3
    serious Num At Risk
    12
    title
    PBSC: No TBI
  2. deaths Num Affected
    4
    deaths Num At Risk
    13
    description
    Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant
    id
    EG001
    other Num Affected
    10
    other Num At Risk
    13
    serious Num Affected
    0
    serious Num At Risk
    13
    title
    Marrow : No TBI
  3. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplant
    id
    EG002
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    UCB : No TBI
  4. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Patients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimen
    id
    EG003
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    UCB : No TBI/Bu/Cy/ATG
  5. deaths Num Affected
    113
    deaths Num At Risk
    213
    description
    Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
    id
    EG004
    other Num Affected
    183
    other Num At Risk
    213
    serious Num Affected
    32
    serious Num At Risk
    213
    title
    PBSC
  6. deaths Num Affected
    31
    deaths Num At Risk
    85
    description
    Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
    id
    EG005
    other Num Affected
    71
    other Num At Risk
    85
    serious Num Affected
    10
    serious Num At Risk
    85
    title
    Marrow
  7. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
    id
    EG006
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Umbilical Cord Blood
  8. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Patients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
    id
    EG007
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Co-Enroll From MT0403
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      12
      num Events
      37
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      13
      num Events
      32
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      4
    5. group Id
      EG004
      num Affected
      114
      num At Risk
      213
      num Events
      375
    6. group Id
      EG005
      num Affected
      54
      num At Risk
      85
      num Events
      169
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Infection
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      12
      num Events
      14
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      13
      num Events
      8
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      91
      num At Risk
      213
      num Events
      143
    6. group Id
      EG005
      num Affected
      42
      num At Risk
      85
      num Events
      70
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
      num Events
      1
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      2
      num Events
      7
    term
    Pneumonia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      34
      num At Risk
      213
      num Events
      45
    6. group Id
      EG005
      num Affected
      14
      num At Risk
      85
      num Events
      22
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      2
      num Events
      2
    term
    Intubation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      13
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      26
      num At Risk
      213
      num Events
      27
    6. group Id
      EG005
      num Affected
      21
      num At Risk
      85
      num Events
      23
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      2
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Hypertension
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      12
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      25
      num At Risk
      213
      num Events
      25
    6. group Id
      EG005
      num Affected
      11
      num At Risk
      85
      num Events
      11
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Cystitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      25
      num At Risk
      213
      num Events
      26
    6. group Id
      EG005
      num Affected
      10
      num At Risk
      85
      num Events
      11
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Elevated Liver Function Tests
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      12
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      24
      num At Risk
      213
      num Events
      26
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      85
      num Events
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    GI Bleeding
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      13
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      1
      num Events
      1
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      213
      num Events
      12
    6. group Id
      EG005
      num Affected
      13
      num At Risk
      85
      num Events
      13
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      2
      num Events
      2
    term
    Pericardial effusion
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      213
      num Events
      16
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      85
      num Events
      12
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Dialysis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      12
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      15
      num At Risk
      213
      num Events
      18
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      85
      num Events
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Veno occlusive disease (VOD)
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      213
      num Events
      18
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      85
      num Events
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Pumonary hemorrhage
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      213
      num Events
      16
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      85
      num Events
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Acute renal failure
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      213
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      85
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Graft versus host disease
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      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
      213
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      85
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Primary Graft Failure
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      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
      213
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      85
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Hemorrhage
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      20
      num At Risk
      213
      num Events
      20
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      85
      num Events
      8
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Death
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      12
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      213
      num Events
      8
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      85
      num Events
      3
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Relapse
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      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
      213
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      85
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Syndromes
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      213
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      85
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Death
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      12
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      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
      213
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      85
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      2
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Death due to accident
time Frame
5 years

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Preserved source evidence · Not medical advice