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NCT00245102 · ADVERSE EVENTS

Adverse events

Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma · Source last updated 2014-05-23

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
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Angiosarcoma

Sorafenib 400 mg PO BID

13 / 4436 / 44Not reported / Not reported
MPNST

Sorafenib 400 mg PO BID

7 / 1612 / 16Not reported / Not reported
Leiomyosarcoma

Sorafenib 400 mg PO BID

7 / 4640 / 46Not reported / Not reported
Undifferentiated Pleomorphic Sarcoma

Sorafenib 400 mg PO BID

9 / 1310 / 13Not reported / Not reported
Fibrosarcoma

Sorafenib 400 mg PO BID

0 / 54 / 5Not reported / Not reported
Other Histology

Sorafenib 400 mg PO BID

5 / 2321 / 23Not reported / Not reported

Group identifiers: EG000: Angiosarcoma · EG001: MPNST · EG002: Leiomyosarcoma · EG003: Undifferentiated Pleomorphic Sarcoma · EG004: Fibrosarcoma · EG005: Other Histology

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
    Nervous system disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Ischemia cerebrovascular
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Cardiac disorder
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Confusion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Cough
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      46
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Death-Disease progression
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Dyspnea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Upper gastrointestinal hemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Hypertension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Left ventricular systolic dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Lymphocyte count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Peripheral motor neuropathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Back pain

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
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      46
      num Events
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      13
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      46
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Aspartate aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      44
      num Events
      5
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      16
      num Events
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      46
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      13
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    Hypoalbuminemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Blood bilirubin increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      44
      num Events
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      46
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      23
      num Events
      4
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      3
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      46
      num Events
      7
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      13
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Hyperglycemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      44
      num Events
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      46
      num Events
      24
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      13
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      23
      num Events
      4
    term
    Anemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      44
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      46
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Hypertension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    INR increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      46
      num Events
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      13
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      23
      num Events
      4
    term
    White blood cell decreased
Complete source fields
event Groups
  1. description
    Sorafenib 400 mg PO BID
    id
    EG000
    other Num Affected
    36
    other Num At Risk
    44
    serious Num Affected
    13
    serious Num At Risk
    44
    title
    Angiosarcoma
  2. description
    Sorafenib 400 mg PO BID
    id
    EG001
    other Num Affected
    12
    other Num At Risk
    16
    serious Num Affected
    7
    serious Num At Risk
    16
    title
    MPNST
  3. description
    Sorafenib 400 mg PO BID
    id
    EG002
    other Num Affected
    40
    other Num At Risk
    46
    serious Num Affected
    7
    serious Num At Risk
    46
    title
    Leiomyosarcoma
  4. description
    Sorafenib 400 mg PO BID
    id
    EG003
    other Num Affected
    10
    other Num At Risk
    13
    serious Num Affected
    9
    serious Num At Risk
    13
    title
    Undifferentiated Pleomorphic Sarcoma
  5. description
    Sorafenib 400 mg PO BID
    id
    EG004
    other Num Affected
    4
    other Num At Risk
    5
    serious Num Affected
    0
    serious Num At Risk
    5
    title
    Fibrosarcoma
  6. description
    Sorafenib 400 mg PO BID
    id
    EG005
    other Num Affected
    21
    other Num At Risk
    23
    serious Num Affected
    5
    serious Num At Risk
    23
    title
    Other Histology
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      46
      num Events
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      13
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      46
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      23
      num Events
      1
    term
    Aspartate aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      44
      num Events
      5
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      16
      num Events
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      46
      num Events
      2
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      13
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    Hypoalbuminemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Blood bilirubin increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      44
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      23
      num Events
      3
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      44
      num Events
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      46
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      23
      num Events
      4
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      3
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      46
      num Events
      7
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      13
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Hyperglycemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      44
      num Events
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      46
      num Events
      24
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      13
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      23
      num Events
      4
    term
    Anemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      44
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      46
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      23
      num Events
      2
    term
    Hypertension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    INR increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      46
      num Events
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      13
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      23
      num Events
      4
    term
    White blood cell decreased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Ischemia cerebrovascular
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Cardiac disorder
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Confusion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Cough
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      46
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Death-Disease progression
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      13
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Dyspnea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Upper gastrointestinal hemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Hypertension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Left ventricular systolic dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Lymphocyte count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      44
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Peripheral motor neuropathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE v.3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      44
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      46
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      13
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      23
      num Events
      0
    term
    Back pain

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Preserved source evidence · Not medical advice