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NCT00085709 · ADVERSE EVENTS

Adverse events

S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML · Source last updated 2015-09-30

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
While the patient is on treatment until resolution of acute toxicities with maximum grade reported.
Other-event reporting threshold
5%

Regular investigator assessments are reported after each cycle of protocol treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Induction 7 + 3 + G.O.

A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment

47 / 293277 / 293Not reported / Not reported
Induction 7 + 3

A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment

9 / 293279 / 293Not reported / Not reported
Ara-C Consolidation

For patients who achieved a CR during induction, patients may receive up to 3 28 day cycles of treatment with Ara-C consolidation. Patients who relapse from CR are taken off protocol consolidation treatment.

13 / 375356 / 375Not reported / Not reported
Post-consolidation G.O.

For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.

19 / 7877 / 78Not reported / Not reported

Group identifiers: EG000: Induction 7 + 3 + G.O. · EG001: Induction 7 + 3 · EG002: Ara-C Consolidation · EG003: Post-consolidation G.O.

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      293
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    DIC (disseminated intravascular coagulation)
  2. assessment Type
    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
      293
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      293
      num Events
      1
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      375
      num Events
      4
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      78
      num Events
      9
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      293
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Hemoglobin
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      293
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Cardiac-ischemia/infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      293
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Pericardial effusion (non-malignant)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      293
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Pericarditis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      293
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      293
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Colitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      293
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      78
      num Events
      1
    term
    Mucositis/stomatitis (clinical exam) - Oral cavity
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      293
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      78
      num Events
      1
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      293
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      78
      num Events
      1
    term
    Pain - Rectum
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      293
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      293
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Perforation, GI - Colon
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      293
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      293
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Typhlitis (cecal inflammation)

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      172
      num At Risk
      293
      num Events
      172
    2. group Id
      EG001
      num Affected
      194
      num At Risk
      293
      num Events
      194
    3. group Id
      EG002
      num Affected
      178
      num At Risk
      375
      num Events
      178
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      78
      num Events
      14
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      116
      num At Risk
      293
      num Events
      116
    2. group Id
      EG001
      num Affected
      109
      num At Risk
      293
      num Events
      109
    3. group Id
      EG002
      num Affected
      201
      num At Risk
      375
      num Events
      201
    4. group Id
      EG003
      num Affected
      27
      num At Risk
      78
      num Events
      27
    term
    Hemoglobin
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      293
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
      num Events
      0
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      375
      num Events
      19
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Vision-blurred vision
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      293
      num Events
      36
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      293
      num Events
      32
    3. group Id
      EG002
      num Affected
      46
      num At Risk
      375
      num Events
      46
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      78
      num Events
      5
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      115
      num At Risk
      293
      num Events
      115
    2. group Id
      EG001
      num Affected
      130
      num At Risk
      293
      num Events
      130
    3. group Id
      EG002
      num Affected
      76
      num At Risk
      375
      num Events
      76
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      78
      num Events
      9
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      293
      num Events
      0
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      293
      num Events
      25
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      375
      num Events
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Heartburn/dyspepsia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      293
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
      num Events
      0
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      375
      num Events
      19
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Hemorrhage, GI - Oral cavity
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      293
      num Events
      76
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      293
      num Events
      64
    3. group Id
      EG002
      num Affected
      63
      num At Risk
      375
      num Events
      63
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      78
      num Events
      8
    term
    Mucositis/stomatitis (clinical exam) - Oral cavity
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      293
      num Events
      33
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      293
      num Events
      37
    3. group Id
      EG002
      num Affected
      35
      num At Risk
      375
      num Events
      35
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Mucositis/stomatitis (functional/symptomatic) - Oral cavity
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      165
      num At Risk
      293
      num Events
      165
    2. group Id
      EG001
      num Affected
      159
      num At Risk
      293
      num Events
      159
    3. group Id
      EG002
      num Affected
      182
      num At Risk
      375
      num Events
      182
    4. group Id
      EG003
      num Affected
      40
      num At Risk
      78
      num Events
      40
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      293
      num Events
      51
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      293
      num Events
      35
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      375
      num Events
      31
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      78
      num Events
      8
    term
    Pain - Abdomen NOS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      293
      num Events
      93
    2. group Id
      EG001
      num Affected
      75
      num At Risk
      293
      num Events
      75
    3. group Id
      EG002
      num Affected
      97
      num At Risk
      375
      num Events
      97
    4. group Id
      EG003
      num Affected
      22
      num At Risk
      78
      num Events
      22
    term
    Vomiting
Complete source fields
description
Regular investigator assessments are reported after each cycle of protocol treatment.
event Groups
  1. description
    A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment
    id
    EG000
    other Num Affected
    277
    other Num At Risk
    293
    serious Num Affected
    47
    serious Num At Risk
    293
    title
    Induction 7 + 3 + G.O.
  2. description
    A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment
    id
    EG001
    other Num Affected
    279
    other Num At Risk
    293
    serious Num Affected
    9
    serious Num At Risk
    293
    title
    Induction 7 + 3
  3. description
    For patients who achieved a CR during induction, patients may receive up to 3 28 day cycles of treatment with Ara-C consolidation. Patients who relapse from CR are taken off protocol consolidation treatment.
    id
    EG002
    other Num Affected
    356
    other Num At Risk
    375
    serious Num Affected
    13
    serious Num At Risk
    375
    title
    Ara-C Consolidation
  4. description
    For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
    id
    EG003
    other Num Affected
    77
    other Num At Risk
    78
    serious Num Affected
    19
    serious Num At Risk
    78
    title
    Post-consolidation G.O.
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      172
      num At Risk
      293
      num Events
      172
    2. group Id
      EG001
      num Affected
      194
      num At Risk
      293
      num Events
      194
    3. group Id
      EG002
      num Affected
      178
      num At Risk
      375
      num Events
      178
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      78
      num Events
      14
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      116
      num At Risk
      293
      num Events
      116
    2. group Id
      EG001
      num Affected
      109
      num At Risk
      293
      num Events
      109
    3. group Id
      EG002
      num Affected
      201
      num At Risk
      375
      num Events
      201
    4. group Id
      EG003
      num Affected
      27
      num At Risk
      78
      num Events
      27
    term
    Hemoglobin
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      293
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
      num Events
      0
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      375
      num Events
      19
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Vision-blurred vision
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      293
      num Events
      36
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      293
      num Events
      32
    3. group Id
      EG002
      num Affected
      46
      num At Risk
      375
      num Events
      46
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      78
      num Events
      5
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      115
      num At Risk
      293
      num Events
      115
    2. group Id
      EG001
      num Affected
      130
      num At Risk
      293
      num Events
      130
    3. group Id
      EG002
      num Affected
      76
      num At Risk
      375
      num Events
      76
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      78
      num Events
      9
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      293
      num Events
      0
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      293
      num Events
      25
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      375
      num Events
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Heartburn/dyspepsia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      293
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
      num Events
      0
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      375
      num Events
      19
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Hemorrhage, GI - Oral cavity
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      293
      num Events
      76
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      293
      num Events
      64
    3. group Id
      EG002
      num Affected
      63
      num At Risk
      375
      num Events
      63
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      78
      num Events
      8
    term
    Mucositis/stomatitis (clinical exam) - Oral cavity
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      293
      num Events
      33
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      293
      num Events
      37
    3. group Id
      EG002
      num Affected
      35
      num At Risk
      375
      num Events
      35
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Mucositis/stomatitis (functional/symptomatic) - Oral cavity
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      165
      num At Risk
      293
      num Events
      165
    2. group Id
      EG001
      num Affected
      159
      num At Risk
      293
      num Events
      159
    3. group Id
      EG002
      num Affected
      182
      num At Risk
      375
      num Events
      182
    4. group Id
      EG003
      num Affected
      40
      num At Risk
      78
      num Events
      40
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      293
      num Events
      51
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      293
      num Events
      35
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      375
      num Events
      31
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      78
      num Events
      8
    term
    Pain - Abdomen NOS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      293
      num Events
      93
    2. group Id
      EG001
      num Affected
      75
      num At Risk
      293
      num Events
      75
    3. group Id
      EG002
      num Affected
      97
      num At Risk
      375
      num Events
      97
    4. group Id
      EG003
      num Affected
      22
      num At Risk
      78
      num Events
      22
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      293
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    DIC (disseminated intravascular coagulation)
  2. assessment Type
    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
      293
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      293
      num Events
      1
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      375
      num Events
      4
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      78
      num Events
      9
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      293
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Hemoglobin
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      293
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Cardiac-ischemia/infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      293
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Pericardial effusion (non-malignant)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      293
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Pericarditis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      293
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      293
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Colitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      293
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      78
      num Events
      1
    term
    Mucositis/stomatitis (clinical exam) - Oral cavity
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      293
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      78
      num Events
      1
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      293
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      293
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      78
      num Events
      1
    term
    Pain - Rectum
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      293
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      293
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Perforation, GI - Colon
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      293
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      293
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      375
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      78
      num Events
      0
    term
    Typhlitis (cecal inflammation)
time Frame
While the patient is on treatment until resolution of acute toxicities with maximum grade reported.

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Preserved source evidence · Not medical advice