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NCT00004228 · ADVERSE EVENTS

Adverse events

Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma · Source last updated 2019-08-06

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%

There were 19 total ineligible patients, 4 for A0, 2 for A1, 4 for A2, 1 for B2 (CNS+), 1 for B2 (Disseminated), 2 for B1 (CNS-), and 5 for B1 (NHL additional enrollment). All ineligible patients excluded from adverse event reporting.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
A0 (Localized Disease Stg I/II) Modified CCG BFM

Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)

8 / 5656 / 56Not reported / Not reported
A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens

Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)

8 / 6464 / 64Not reported / Not reported
A2 (Disseminated, No CNS - CCG Mod BFM w/Intens

Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate).

13 / 6160 / 61Not reported / Not reported
B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy

Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)

0 / 1210 / 12Not reported / Not reported
B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens

Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)

12 / 6666 / 66Not reported / Not reported
B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens

Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)

9 / 6362 / 63Not reported / Not reported
B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment

Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)

1 / 5252 / 52Not reported / Not reported

Group identifiers: EG000: A0 (Localized Disease Stg I/II) Modified CCG BFM · EG001: A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens · EG002: A2 (Disseminated, No CNS - CCG Mod BFM w/Intens · EG003: B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy · EG004: B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens · EG005: B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens · EG006: B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment

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
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      2
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Bilirubin
  2. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    CNS cerebrovascular ischemia
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Cardiovascular/Arrhythmia
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      66
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Cardiovascular/General-Other
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Catheter-related infection
  6. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      66
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Cortical blindness, Anxiety, agitation
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Esophagitis
  8. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      56
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      66
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Febrile neutropenia
  9. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Fever, Increase BP, Back pain
  10. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    GGT
  11. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Headache, Vomiting, Nausea, Pancytopenia, Fever
  12. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      56
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      64
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      61
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      66
      num Events
      4
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      63
      num Events
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Hemoglobin (Hgb)

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
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      56
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      64
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      66
      num Events
      4
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      63
      num Events
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Allergic reaction/hypersensitivity
  2. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      66
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Autoimmune reaction
  3. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      61
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Allergy/Immunology
  4. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Inner ear/hearing
  5. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      66
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Middle ear/hearing
  6. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Auditory/Hearing
  7. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      56
      num Events
      509
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      64
      num Events
      533
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      61
      num Events
      520
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      12
      num Events
      69
    5. group Id
      EG004
      num Affected
      66
      num At Risk
      66
      num Events
      530
    6. group Id
      EG005
      num Affected
      62
      num At Risk
      63
      num Events
      496
    7. group Id
      EG006
      num Affected
      52
      num At Risk
      52
      num Events
      476
    term
    Hemoglobin (Hgb)
  8. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Hemolysis
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      56
      num Events
      532
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      64
      num Events
      552
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      61
      num Events
      536
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      12
      num Events
      72
    5. group Id
      EG004
      num Affected
      66
      num At Risk
      66
      num Events
      556
    6. group Id
      EG005
      num Affected
      62
      num At Risk
      63
      num Events
      505
    7. group Id
      EG006
      num Affected
      52
      num At Risk
      52
      num Events
      476
    term
    Leukocytes (total WBC)
  10. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      56
      num Events
      40
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      64
      num Events
      52
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      61
      num Events
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      5
    5. group Id
      EG004
      num Affected
      15
      num At Risk
      66
      num Events
      39
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      63
      num Events
      26
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      52
      num Events
      29
    term
    Lymphopenia
  11. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      56
      num Events
      86
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      64
      num Events
      139
    3. group Id
      EG002
      num Affected
      40
      num At Risk
      61
      num Events
      116
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      12
      num Events
      14
    5. group Id
      EG004
      num Affected
      36
      num At Risk
      66
      num Events
      114
    6. group Id
      EG005
      num Affected
      37
      num At Risk
      63
      num Events
      98
    7. group Id
      EG006
      num Affected
      27
      num At Risk
      52
      num Events
      79
    term
    Neutrophils/granulocytes (ANC/AGC)
  12. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      56
      num Events
      469
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      64
      num Events
      523
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      61
      num Events
      499
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      12
      num Events
      69
    5. group Id
      EG004
      num Affected
      66
      num At Risk
      66
      num Events
      520
    6. group Id
      EG005
      num Affected
      61
      num At Risk
      63
      num Events
      468
    7. group Id
      EG006
      num Affected
      52
      num At Risk
      52
      num Events
      476
    term
    Platelets
Complete source fields
description
There were 19 total ineligible patients, 4 for A0, 2 for A1, 4 for A2, 1 for B2 (CNS+), 1 for B2 (Disseminated), 2 for B1 (CNS-), and 5 for B1 (NHL additional enrollment). All ineligible patients excluded from adverse event reporting.
event Groups
  1. description
    Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
    id
    EG000
    other Num Affected
    56
    other Num At Risk
    56
    serious Num Affected
    8
    serious Num At Risk
    56
    title
    A0 (Localized Disease Stg I/II) Modified CCG BFM
  2. description
    Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
    id
    EG001
    other Num Affected
    64
    other Num At Risk
    64
    serious Num Affected
    8
    serious Num At Risk
    64
    title
    A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens
  3. description
    Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate).
    id
    EG002
    other Num Affected
    60
    other Num At Risk
    61
    serious Num Affected
    13
    serious Num At Risk
    61
    title
    A2 (Disseminated, No CNS - CCG Mod BFM w/Intens
  4. description
    Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
    id
    EG003
    other Num Affected
    10
    other Num At Risk
    12
    serious Num Affected
    0
    serious Num At Risk
    12
    title
    B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy
  5. description
    Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
    id
    EG004
    other Num Affected
    66
    other Num At Risk
    66
    serious Num Affected
    12
    serious Num At Risk
    66
    title
    B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens
  6. description
    Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
    id
    EG005
    other Num Affected
    62
    other Num At Risk
    63
    serious Num Affected
    9
    serious Num At Risk
    63
    title
    B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens
  7. description
    Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
    id
    EG006
    other Num Affected
    52
    other Num At Risk
    52
    serious Num Affected
    1
    serious Num At Risk
    52
    title
    B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment
frequency Threshold
0
other Events
  1. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      56
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      64
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      66
      num Events
      4
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      63
      num Events
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Allergic reaction/hypersensitivity
  2. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      66
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Autoimmune reaction
  3. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      61
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Allergy/Immunology
  4. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Inner ear/hearing
  5. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      66
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Middle ear/hearing
  6. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Auditory/Hearing
  7. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      56
      num Events
      509
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      64
      num Events
      533
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      61
      num Events
      520
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      12
      num Events
      69
    5. group Id
      EG004
      num Affected
      66
      num At Risk
      66
      num Events
      530
    6. group Id
      EG005
      num Affected
      62
      num At Risk
      63
      num Events
      496
    7. group Id
      EG006
      num Affected
      52
      num At Risk
      52
      num Events
      476
    term
    Hemoglobin (Hgb)
  8. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Hemolysis
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      56
      num Events
      532
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      64
      num Events
      552
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      61
      num Events
      536
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      12
      num Events
      72
    5. group Id
      EG004
      num Affected
      66
      num At Risk
      66
      num Events
      556
    6. group Id
      EG005
      num Affected
      62
      num At Risk
      63
      num Events
      505
    7. group Id
      EG006
      num Affected
      52
      num At Risk
      52
      num Events
      476
    term
    Leukocytes (total WBC)
  10. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      56
      num Events
      40
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      64
      num Events
      52
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      61
      num Events
      40
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      5
    5. group Id
      EG004
      num Affected
      15
      num At Risk
      66
      num Events
      39
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      63
      num Events
      26
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      52
      num Events
      29
    term
    Lymphopenia
  11. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      56
      num Events
      86
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      64
      num Events
      139
    3. group Id
      EG002
      num Affected
      40
      num At Risk
      61
      num Events
      116
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      12
      num Events
      14
    5. group Id
      EG004
      num Affected
      36
      num At Risk
      66
      num Events
      114
    6. group Id
      EG005
      num Affected
      37
      num At Risk
      63
      num Events
      98
    7. group Id
      EG006
      num Affected
      27
      num At Risk
      52
      num Events
      79
    term
    Neutrophils/granulocytes (ANC/AGC)
  12. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      56
      num Events
      469
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      64
      num Events
      523
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      61
      num Events
      499
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      12
      num Events
      69
    5. group Id
      EG004
      num Affected
      66
      num At Risk
      66
      num Events
      520
    6. group Id
      EG005
      num Affected
      61
      num At Risk
      63
      num Events
      468
    7. group Id
      EG006
      num Affected
      52
      num At Risk
      52
      num Events
      476
    term
    Platelets
serious Events
  1. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      2
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    Bilirubin
  2. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    CNS cerebrovascular ischemia
  3. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Cardiovascular/Arrhythmia
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      66
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Cardiovascular/General-Other
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      63
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Catheter-related infection
  6. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      66
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Cortical blindness, Anxiety, agitation
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Esophagitis
  8. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      56
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      64
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      61
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      66
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Febrile neutropenia
  9. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Fever, Increase BP, Back pain
  10. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      52
      num Events
      1
    term
    GGT
  11. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      56
      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
      61
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      66
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      63
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Headache, Vomiting, Nausea, Pancytopenia, Fever
  12. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      56
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      64
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      61
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      66
      num Events
      4
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      63
      num Events
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      52
      num Events
      0
    term
    Hemoglobin (Hgb)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice