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NCT00602667 · ADVERSE EVENTS

Adverse events

Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma · Source last updated 2026-05-19

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

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

Collection time frame
All adverse events grades 3, 4, and 5 which occur during treatment and for 30 days after the end of treatment, and events which occur later than 30 days after the end of treatment which are felt to be at least possibly related to treatment, to the time of off study, were collected with some exceptions noted in the additional description section, up to 6 years..
Other-event reporting threshold
5%

Per protocol, some grade 3 and 4 hematologic toxicities, grade 3 elevation in serum ALT or AST, grade 3 and 4 electrolyte abnormalities, and total parenteral nutrition or intravenous fluids administered to prevent significant weight loss/malnutrition were not collected, especially if they occurred from the beginning of induction chemotherapy. The one patient in the high-risk group who did not start therapy due to early disease progression was excluded from adverse event results.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Low-Risk Group

Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.

3 / 5755 / 5710 / 57
Intermediate-Risk Group

Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.

7 / 156145 / 15658 / 156
High-Risk Group

Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.

5 / 7670 / 7649 / 77

Group identifiers: EG000: Low-Risk Group · EG001: Intermediate-Risk Group · EG002: High-Risk Group

Serious adverse events

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

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      156
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
      num Events
      0
    term
    Hearing: patients with/without baseline audiogram and enrolled in a monitoring program
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      156
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
      num Events
      0
    term
    Hemoglobin
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Neutrophils/granulocytes (ANC/AGC)
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      156
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
      num Events
      0
    term
    Platelets
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      156
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
      num Events
      0
    term
    Hypotension
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Fatigue (asthenia, lethargy, malaise)
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      156
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
      num Events
      0
    term
    Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      156
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
      num Events
      0
    term
    Weight loss
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      156
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
      num Events
      0
    term
    Anorexia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Colitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      156
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
      num Events
      0
    term
    Dehydration
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Diarrhea

Other reported adverse events

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

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Fever of unknown origin without clinically or microbiologically documented infection (ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      57
      num Events
      83
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      156
      num Events
      169
    3. group Id
      EG002
      num Affected
      48
      num At Risk
      76
      num Events
      120
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      57
      num Events
      60
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      156
      num Events
      124
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      76
      num Events
      20
    term
    Neutrophils/granulocytes (ANC/AGC)
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      57
      num Events
      38
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      156
      num Events
      83
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      76
      num Events
      11
    term
    Leukocytes (total WBC)
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      57
      num Events
      11
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      156
      num Events
      32
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      76
      num Events
      29
    term
    Vomiting
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      57
      num Events
      15
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      156
      num Events
      20
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      76
      num Events
      3
    term
    Hemoglobin
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      57
      num Events
      14
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      156
      num Events
      19
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      76
      num Events
      9
    term
    Infection, Catheter-related
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      57
      num Events
      7
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      156
      num Events
      16
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      76
      num Events
      13
    term
    Anorexia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      57
      num Events
      8
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      156
      num Events
      26
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
      num Events
      7
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils, Catheter-related
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      57
      num Events
      19
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      156
      num Events
      9
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      76
      num Events
      4
    term
    Platelets
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      156
      num Events
      10
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      76
      num Events
      13
    term
    Hypoxia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      57
      num Events
      7
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      156
      num Events
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      76
      num Events
      2
    term
    Rash/desquamation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      57
      num Events
      7
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      156
      num Events
      14
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      76
      num Events
      11
    term
    Diarrhea
Complete source fields
description
Per protocol, some grade 3 and 4 hematologic toxicities, grade 3 elevation in serum ALT or AST, grade 3 and 4 electrolyte abnormalities, and total parenteral nutrition or intravenous fluids administered to prevent significant weight loss/malnutrition were not collected, especially if they occurred from the beginning of induction chemotherapy. The one patient in the high-risk group who did not start therapy due to early disease progression was excluded from adverse event results.
event Groups
  1. deaths Num Affected
    10
    deaths Num At Risk
    57
    description
    Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic or high grade glioma histology will receive induction chemotherapy and low-risk therapy.
    id
    EG000
    other Num Affected
    55
    other Num At Risk
    57
    serious Num Affected
    3
    serious Num At Risk
    57
    title
    Low-Risk Group
  2. deaths Num Affected
    58
    deaths Num At Risk
    156
    description
    Patients with M0 medulloblastoma or nodular desmoplastic histology with less than a GTR, other histologic diagnoses with no metastatic disease, will receive induction chemotherapy and intermediate-risk therapy.
    id
    EG001
    other Num Affected
    145
    other Num At Risk
    156
    serious Num Affected
    7
    serious Num At Risk
    156
    title
    Intermediate-Risk Group
  3. deaths Num Affected
    49
    deaths Num At Risk
    77
    description
    Patients with central nervous system (CNS) metastatic disease will receive induction chemotherapy and high-risk therapy.
    id
    EG002
    other Num Affected
    70
    other Num At Risk
    76
    serious Num Affected
    5
    serious Num At Risk
    76
    title
    High-Risk Group
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Fever of unknown origin without clinically or microbiologically documented infection (ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      57
      num Events
      83
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      156
      num Events
      169
    3. group Id
      EG002
      num Affected
      48
      num At Risk
      76
      num Events
      120
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      57
      num Events
      60
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      156
      num Events
      124
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      76
      num Events
      20
    term
    Neutrophils/granulocytes (ANC/AGC)
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      57
      num Events
      38
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      156
      num Events
      83
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      76
      num Events
      11
    term
    Leukocytes (total WBC)
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      57
      num Events
      11
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      156
      num Events
      32
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      76
      num Events
      29
    term
    Vomiting
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      57
      num Events
      15
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      156
      num Events
      20
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      76
      num Events
      3
    term
    Hemoglobin
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      57
      num Events
      14
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      156
      num Events
      19
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      76
      num Events
      9
    term
    Infection, Catheter-related
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      57
      num Events
      7
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      156
      num Events
      16
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      76
      num Events
      13
    term
    Anorexia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      57
      num Events
      8
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      156
      num Events
      26
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
      num Events
      7
    term
    Infection with normal ANC or Grade 1 or 2 neutrophils, Catheter-related
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      57
      num Events
      19
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      156
      num Events
      9
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      76
      num Events
      4
    term
    Platelets
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      156
      num Events
      10
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      76
      num Events
      13
    term
    Hypoxia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      57
      num Events
      7
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      156
      num Events
      8
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      76
      num Events
      2
    term
    Rash/desquamation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      57
      num Events
      7
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      156
      num Events
      14
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      76
      num Events
      11
    term
    Diarrhea
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      156
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
      num Events
      0
    term
    Hearing: patients with/without baseline audiogram and enrolled in a monitoring program
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      156
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
      num Events
      0
    term
    Hemoglobin
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Neutrophils/granulocytes (ANC/AGC)
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      156
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
      num Events
      0
    term
    Platelets
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      156
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
      num Events
      0
    term
    Hypotension
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Fatigue (asthenia, lethargy, malaise)
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      156
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
      num Events
      0
    term
    Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      156
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
      num Events
      0
    term
    Weight loss
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      156
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
      num Events
      0
    term
    Anorexia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Colitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      156
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
      num Events
      0
    term
    Dehydration
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      156
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
      num Events
      1
    term
    Diarrhea
time Frame
All adverse events grades 3, 4, and 5 which occur during treatment and for 30 days after the end of treatment, and events which occur later than 30 days after the end of treatment which are felt to be at least possibly related to treatment, to the time of off study, were collected with some exceptions noted in the additional description section, up to 6 years..

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Preserved source evidence · Not medical advice