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NCT01154452 · ADVERSE EVENTS

Adverse events

Vismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma · Source last updated 2018-08-15

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
RO4929097 10mg

RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD

2 / 64 / 6Not reported / Not reported
RO4929097 15 mg

RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD

2 / 44 / 4Not reported / Not reported
ARM 1 - RO4929097: 15 mg PO QD

ARM 1 - RO4929097: 15 mg PO QD

11 / 3526 / 35Not reported / Not reported
ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD

ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD

8 / 3323 / 33Not reported / Not reported

Group identifiers: EG000: RO4929097 10mg · EG001: RO4929097 15 mg · EG002: ARM 1 - RO4929097: 15 mg PO QD · EG003: ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD

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
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Pleuritic pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Death NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Dysphagia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Hypophosphatemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      35
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Lymphocyte count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Neck pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      35
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Small intestinal obstruction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Urinary tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Wound infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      35
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      35
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Alanine aminotransferase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      35
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Alkaline phosphatase increased

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 (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Activated partial thromboplastin time prolonged
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      4
      num Events
      42
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      35
      num Events
      56
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      33
      num Events
      32
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Blurred vision
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Hypercalcemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
      num Events
      4
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      35
      num Events
      34
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      33
      num Events
      10
    term
    Hyperglycemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      11
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      4
      num Events
      18
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      35
      num Events
      21
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      33
      num Events
      16
    term
    Hypoalbuminemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      2
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      35
      num Events
      13
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
      num Events
      3
    term
    Hypocalcemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Hypokalemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      35
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Hyponatremia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      4
      num Events
      26
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      35
      num Events
      50
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      33
      num Events
      26
    term
    Hypophosphatemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      4
      num Events
      12
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      35
      num Events
      32
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      33
      num Events
      5
    term
    Lymphocyte count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      35
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      33
      num Events
      2
    term
    Musculoskeletal & conn tissue disorder Other, spec
Complete source fields
event Groups
  1. description
    RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    RO4929097 10mg
  2. description
    RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
    id
    EG001
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    RO4929097 15 mg
  3. description
    ARM 1 - RO4929097: 15 mg PO QD
    id
    EG002
    other Num Affected
    26
    other Num At Risk
    35
    serious Num Affected
    11
    serious Num At Risk
    35
    title
    ARM 1 - RO4929097: 15 mg PO QD
  4. description
    ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
    id
    EG003
    other Num Affected
    23
    other Num At Risk
    33
    serious Num Affected
    8
    serious Num At Risk
    33
    title
    ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Activated partial thromboplastin time prolonged
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      4
      num Events
      42
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      35
      num Events
      56
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      33
      num Events
      32
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Blurred vision
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Hypercalcemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      4
      num Events
      4
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      35
      num Events
      34
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      33
      num Events
      10
    term
    Hyperglycemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      11
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      4
      num Events
      18
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      35
      num Events
      21
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      33
      num Events
      16
    term
    Hypoalbuminemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      2
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      35
      num Events
      13
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
      num Events
      3
    term
    Hypocalcemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Hypokalemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      35
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Hyponatremia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      4
      num Events
      26
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      35
      num Events
      50
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      33
      num Events
      26
    term
    Hypophosphatemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      4
      num Events
      12
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      35
      num Events
      32
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      33
      num Events
      5
    term
    Lymphocyte count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      35
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      33
      num Events
      2
    term
    Musculoskeletal & conn tissue disorder Other, spec
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Pleuritic pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Death NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Dysphagia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Hypophosphatemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      35
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Lymphocyte count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Neck pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      35
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Small intestinal obstruction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Urinary tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      35
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Wound infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      35
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      35
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Alanine aminotransferase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      35
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      33
      num Events
      0
    term
    Alkaline phosphatase increased

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Preserved source evidence · Not medical advice