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NCT01119066 · ADVERSE EVENTS

Adverse events

HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies · Source last updated 2022-08-05

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
Up to 3 years
Other-event reporting threshold
0%

Please note: participants were not censored from adverse event evaluation if they had a second or third transplant on protocol

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Total Body Irradiation, Thiotepa and Cyclophosphamide

Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated) total body irradiation: dose of 1375-1500 cGy Thiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1 Cyclophosphamide: 60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated). (CliniMACS) T-cell depleted PBSC Transplant

13 / 12516 / 12542 / 120
Busulfan, Melphalan and Fludarabine

Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5) Busulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics Melphalan: 70mg/m2/day x 2 Fludarabine: 25mg/m2/ day x 5 (CliniMACS) T-cell depleted PBSC Transplant

30 / 21331 / 21371 / 210
Clofarabine, Melphalan and Thiotepa

Clofarabine (20mg/m2/ day x 5) (or, for children \<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1) Thiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1 Melphalan: 70mg/m2/day x 2 Clofarabine: 20mg/m2/ day x 5 (or, for children \<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval) (CliniMACS) T-cell depleted PBSC Transplant

9 / 529 / 5218 / 47
Melphalan, Fludarabine and Thiotepa

Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1) Thiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1 Melphalan: 70mg/m2/day x 2 (CliniMACS) T-cell depleted PBSC Transplant

3 / 113 / 113 / 11

Group identifiers: EG000: Total Body Irradiation, Thiotepa and Cyclophosphamide · EG001: Busulfan, Melphalan and Fludarabine · EG002: Clofarabine, Melphalan and Thiotepa · EG003: Melphalan, Fludarabine and Thiotepa

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
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Acidosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Appendicitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Cardiac arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
    term
    Death NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Gen disorders & admin site conditions Other, spec
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Hepatobiliary disorders - Other, specify
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Hypotension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Hypoxia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    term
    Infections and infestations - Other, specify
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Meningitis

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
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Acidosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Altered Mental Status
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Appendicitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Cardiac arrest
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    CMV Viremia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
    term
    Death NOS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Epistaxis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Febrile neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Gen disorders & admin site conditions Other, spec
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Hepatobiliary disorders - Other, specify
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Hypotension
Complete source fields
description
Please note: participants were not censored from adverse event evaluation if they had a second or third transplant on protocol
event Groups
  1. deaths Num Affected
    42
    deaths Num At Risk
    120
    description
    Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated) total body irradiation: dose of 1375-1500 cGy Thiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1 Cyclophosphamide: 60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated). (CliniMACS) T-cell depleted PBSC Transplant
    id
    EG000
    other Num Affected
    16
    other Num At Risk
    125
    serious Num Affected
    13
    serious Num At Risk
    125
    title
    Total Body Irradiation, Thiotepa and Cyclophosphamide
  2. deaths Num Affected
    71
    deaths Num At Risk
    210
    description
    Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5) Busulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics Melphalan: 70mg/m2/day x 2 Fludarabine: 25mg/m2/ day x 5 (CliniMACS) T-cell depleted PBSC Transplant
    id
    EG001
    other Num Affected
    31
    other Num At Risk
    213
    serious Num Affected
    30
    serious Num At Risk
    213
    title
    Busulfan, Melphalan and Fludarabine
  3. deaths Num Affected
    18
    deaths Num At Risk
    47
    description
    Clofarabine (20mg/m2/ day x 5) (or, for children \<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1) Thiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1 Melphalan: 70mg/m2/day x 2 Clofarabine: 20mg/m2/ day x 5 (or, for children \<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval) (CliniMACS) T-cell depleted PBSC Transplant
    id
    EG002
    other Num Affected
    9
    other Num At Risk
    52
    serious Num Affected
    9
    serious Num At Risk
    52
    title
    Clofarabine, Melphalan and Thiotepa
  4. deaths Num Affected
    3
    deaths Num At Risk
    11
    description
    Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1) Thiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1 Melphalan: 70mg/m2/day x 2 (CliniMACS) T-cell depleted PBSC Transplant
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    11
    serious Num Affected
    3
    serious Num At Risk
    11
    title
    Melphalan, Fludarabine and Thiotepa
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Acidosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Altered Mental Status
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Appendicitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Cardiac arrest
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    CMV Viremia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
    term
    Death NOS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Epistaxis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Febrile neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Gen disorders & admin site conditions Other, spec
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Hepatobiliary disorders - Other, specify
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Hypotension
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Acidosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Acute kidney injury
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Appendicitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Cardiac arrest
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
    term
    Death NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Gen disorders & admin site conditions Other, spec
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Hepatobiliary disorders - Other, specify
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Hypotension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Hypoxia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
    term
    Infections and infestations - Other, specify
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      213
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      52
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
    term
    Meningitis
time Frame
Up to 3 years

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Preserved source evidence · Not medical advice