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NCT00085735 · ADVERSE EVENTS

Adverse events

Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma · Source last updated 2026-06-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Not reported
Other-event reporting threshold
0%

All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (3-7 Years of Age, LDCSI, IFRT)

See Detailed Description (Arm I) Cisplatin: Given IV Craniospinal Irradiation: Undergo craniospinal Irradiation Cyclophosphamide: Given IV Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy) Laboratory Biomarker Analysis: Correlative studies Lomustine: Given orally Quality-of-Life Assessment: Ancillary studies Vincristine Sulfate: Given IV

7 / 6360 / 63Not reported / Not reported
Arm II (3-7 Years of Age, LDCSI, PFRT)

See Detailed Description (Arm II) Cisplatin: Given IV Craniospinal Irradiation: Undergo craniospinal Irradiation Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies Lomustine: Given orally Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy) Vincristine Sulfate: Given IV

7 / 6461 / 64Not reported / Not reported
Arm III (3-7 Years of Age, SDCSI, IFRT)

See Detailed Description (Arm III) Cisplatin: Given IV Craniospinal Irradiation: Undergo craniospinal Irradiation Cyclophosphamide: Given IV Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy) Laboratory Biomarker Analysis: Correlative studies Lomustine: Given orally Quality-of-Life Assessment: Ancillary studies Vincristine Sulfate: Given IV

6 / 6055 / 60Not reported / Not reported
Arm IV (3-7 Years of Age, SDCSI, PFRT)

See Detailed Description (Arm IV) Craniospinal Irradiation: Undergo craniospinal Irradiation Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies Lomustine: Given orally Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy) Vincristine Sulfate: Given IV

3 / 5853 / 58Not reported / Not reported
Arm V (8-21 Years of Age, SDCSI, IFRT)

See Detailed Description (Arm V) Cisplatin: Given IV Craniospinal Irradiation: Undergo craniospinal Irradiation Cyclophosphamide: Given IV Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy) Laboratory Biomarker Analysis: Correlative studies Lomustine: Given orally Quality-of-Life Assessment: Ancillary studies Vincristine Sulfate: Given IV

16 / 130123 / 130Not reported / Not reported
Arm VI (8-21 Years of Age, SDCSI, PFRT)

See Detailed Description (Arm VI) Cisplatin: Given IV Craniospinal Irradiation: Undergo craniospinal Irradiation Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies Lomustine: Given orally Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy) Vincristine Sulfate: Given IV

18 / 138135 / 138Not reported / Not reported

Group identifiers: EG000: Arm I (3-7 Years of Age, LDCSI, IFRT) · EG001: Arm II (3-7 Years of Age, LDCSI, PFRT) · EG002: Arm III (3-7 Years of Age, SDCSI, IFRT) · EG003: Arm IV (3-7 Years of Age, SDCSI, PFRT) · EG004: Arm V (8-21 Years of Age, SDCSI, IFRT) · EG005: Arm VI (8-21 Years of Age, SDCSI, PFRT)

Serious adverse events

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

  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      130
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      130
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Blood and lymphatic system disorders - Other, specify
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      64
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Febrile neutropenia
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      138
      num Events
      1
    term
    Esophagitis
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      130
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Ileus
  6. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Encephalomyelitis infection
  7. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Sepsis
  8. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      130
      num Events
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      138
      num Events
      3
    term
    Alanine aminotransferase increased
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      63
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      58
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      138
      num Events
      2
    term
    Aspartate aminotransferase increased
  10. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Blood bilirubin increased
  11. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Lymphocyte count decreased
  12. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      64
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      130
      num Events
      5
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      138
      num Events
      3
    term
    Neutrophil count decreased

Other reported adverse events

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

  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      63
      num Events
      109
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      64
      num Events
      117
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      60
      num Events
      125
    4. group Id
      EG003
      num Affected
      27
      num At Risk
      58
      num Events
      104
    5. group Id
      EG004
      num Affected
      62
      num At Risk
      130
      num Events
      278
    6. group Id
      EG005
      num Affected
      55
      num At Risk
      138
      num Events
      203
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Blood and lymphatic system disorders - Other, specify
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Disseminated intravascular coagulation
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      63
      num Events
      40
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      64
      num Events
      32
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      60
      num Events
      40
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      58
      num Events
      48
    5. group Id
      EG004
      num Affected
      42
      num At Risk
      130
      num Events
      69
    6. group Id
      EG005
      num Affected
      48
      num At Risk
      138
      num Events
      68
    term
    Febrile neutropenia
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Leukocytosis
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      138
      num Events
      1
    term
    Cardiac arrest
  7. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      58
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Cardiac disorders - Other, specify
  8. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      58
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Palpitations
  9. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      58
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      130
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      138
      num Events
      1
    term
    Sinus tachycardia
  10. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Ventricular tachycardia
  11. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      63
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      58
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      130
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      138
      num Events
      2
    term
    Ear and labyrinth disorders - Other, specify
  12. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      130
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      138
      num Events
      1
    term
    Ear pain
Complete source fields
description
All adverse events (grade 1 and higher) for all eligible patients (n=513) were included in this analysis. Serious AE's were based on whether an AdEERS report was filed OR whether the AE was a grade 5 AE (resulting in death). Of note, there was no other variable in the study database to indicate whether an AE was "serious" or not.
event Groups
  1. description
    See Detailed Description (Arm I) Cisplatin: Given IV Craniospinal Irradiation: Undergo craniospinal Irradiation Cyclophosphamide: Given IV Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy) Laboratory Biomarker Analysis: Correlative studies Lomustine: Given orally Quality-of-Life Assessment: Ancillary studies Vincristine Sulfate: Given IV
    id
    EG000
    other Num Affected
    60
    other Num At Risk
    63
    serious Num Affected
    7
    serious Num At Risk
    63
    title
    Arm I (3-7 Years of Age, LDCSI, IFRT)
  2. description
    See Detailed Description (Arm II) Cisplatin: Given IV Craniospinal Irradiation: Undergo craniospinal Irradiation Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies Lomustine: Given orally Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy) Vincristine Sulfate: Given IV
    id
    EG001
    other Num Affected
    61
    other Num At Risk
    64
    serious Num Affected
    7
    serious Num At Risk
    64
    title
    Arm II (3-7 Years of Age, LDCSI, PFRT)
  3. description
    See Detailed Description (Arm III) Cisplatin: Given IV Craniospinal Irradiation: Undergo craniospinal Irradiation Cyclophosphamide: Given IV Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy) Laboratory Biomarker Analysis: Correlative studies Lomustine: Given orally Quality-of-Life Assessment: Ancillary studies Vincristine Sulfate: Given IV
    id
    EG002
    other Num Affected
    55
    other Num At Risk
    60
    serious Num Affected
    6
    serious Num At Risk
    60
    title
    Arm III (3-7 Years of Age, SDCSI, IFRT)
  4. description
    See Detailed Description (Arm IV) Craniospinal Irradiation: Undergo craniospinal Irradiation Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies Lomustine: Given orally Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy) Vincristine Sulfate: Given IV
    id
    EG003
    other Num Affected
    53
    other Num At Risk
    58
    serious Num Affected
    3
    serious Num At Risk
    58
    title
    Arm IV (3-7 Years of Age, SDCSI, PFRT)
  5. description
    See Detailed Description (Arm V) Cisplatin: Given IV Craniospinal Irradiation: Undergo craniospinal Irradiation Cyclophosphamide: Given IV Involved-Field Radiation Therapy: Undergo smaller volume boost (involved-field radiation therapy) Laboratory Biomarker Analysis: Correlative studies Lomustine: Given orally Quality-of-Life Assessment: Ancillary studies Vincristine Sulfate: Given IV
    id
    EG004
    other Num Affected
    123
    other Num At Risk
    130
    serious Num Affected
    16
    serious Num At Risk
    130
    title
    Arm V (8-21 Years of Age, SDCSI, IFRT)
  6. description
    See Detailed Description (Arm VI) Cisplatin: Given IV Craniospinal Irradiation: Undergo craniospinal Irradiation Cyclophosphamide: Given IV Laboratory Biomarker Analysis: Correlative studies Lomustine: Given orally Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo standard volume boost (whole posterior fossa radiation therapy) Vincristine Sulfate: Given IV
    id
    EG005
    other Num Affected
    135
    other Num At Risk
    138
    serious Num Affected
    18
    serious Num At Risk
    138
    title
    Arm VI (8-21 Years of Age, SDCSI, PFRT)
frequency Threshold
0
other Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      63
      num Events
      109
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      64
      num Events
      117
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      60
      num Events
      125
    4. group Id
      EG003
      num Affected
      27
      num At Risk
      58
      num Events
      104
    5. group Id
      EG004
      num Affected
      62
      num At Risk
      130
      num Events
      278
    6. group Id
      EG005
      num Affected
      55
      num At Risk
      138
      num Events
      203
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Blood and lymphatic system disorders - Other, specify
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Disseminated intravascular coagulation
  4. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      63
      num Events
      40
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      64
      num Events
      32
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      60
      num Events
      40
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      58
      num Events
      48
    5. group Id
      EG004
      num Affected
      42
      num At Risk
      130
      num Events
      69
    6. group Id
      EG005
      num Affected
      48
      num At Risk
      138
      num Events
      68
    term
    Febrile neutropenia
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Leukocytosis
  6. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      138
      num Events
      1
    term
    Cardiac arrest
  7. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      58
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Cardiac disorders - Other, specify
  8. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      58
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Palpitations
  9. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      58
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      130
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      138
      num Events
      1
    term
    Sinus tachycardia
  10. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Ventricular tachycardia
  11. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      63
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      58
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      130
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      138
      num Events
      2
    term
    Ear and labyrinth disorders - Other, specify
  12. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      130
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      138
      num Events
      1
    term
    Ear pain
serious Events
  1. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      130
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Anemia
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      130
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Blood and lymphatic system disorders - Other, specify
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      64
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Febrile neutropenia
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      138
      num Events
      1
    term
    Esophagitis
  5. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      130
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Ileus
  6. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Encephalomyelitis infection
  7. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Sepsis
  8. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      130
      num Events
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      138
      num Events
      3
    term
    Alanine aminotransferase increased
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      63
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      58
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      138
      num Events
      2
    term
    Aspartate aminotransferase increased
  10. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      63
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      64
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Blood bilirubin increased
  11. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      60
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      130
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      138
      num Events
      0
    term
    Lymphocyte count decreased
  12. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      63
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      64
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      60
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      58
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      130
      num Events
      5
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      138
      num Events
      3
    term
    Neutrophil count decreased

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Preserved source evidence · Not medical advice