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NCT03239145 · ADVERSE EVENTS

Adverse events

Pembrolizumab (Anti-PD-1) and AMG386 (Angiopoietin-2 (Ang-2) in Patients With Advanced Solid Tumor · Source last updated 2026-07-01

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
The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months.
Other-event reporting threshold
0%

A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
[Dose Level I] Pembrolizumab + Trebananib

Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 15 mg/kg weekly.

2 / 33 / 32 / 3
[Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Colorectal)

Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.

14 / 4040 / 4022 / 40
Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Ovarian)

Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.

4 / 1111 / 115 / 11
Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma)

Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.

2 / 44 / 44 / 4

Group identifiers: EG000: [Dose Level I] Pembrolizumab + Trebananib · EG001: [Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Colorectal) · EG002: Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Ovarian) · EG003: Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma)

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 (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Pericardial effusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Colitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Edema limbs
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Fever
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Localized edema
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Biliary tract infection
  11. 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
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Lung infection
  12. 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
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Sepsis

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 (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      4
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Lymph node pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Thrombotic thrombocytopenic purpura
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Blood and lymphatic system disorders - Other, specify
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Chest pain - cardiac
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Conduction disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Palpitations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Sinus bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Ear and labyrinth disorders - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Hyperthyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Hypothyroidism
Complete source fields
description
A serious adverse event is any adverse event (AE) occurring at any dose or during use of Merck or Amgen products that results in death, is life-threatening, causes persistent or significant disability, leads to or prolongs hospitalization, is a congenital anomaly or birth defect, or is another important medical event. Some AEs not meeting the ICH definition, such as new cancers, are also considered serious. All remaining events were classified as Other AEs.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    3
    description
    Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 15 mg/kg weekly.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    [Dose Level I] Pembrolizumab + Trebananib
  2. deaths Num Affected
    22
    deaths Num At Risk
    40
    description
    Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
    id
    EG001
    other Num Affected
    40
    other Num At Risk
    40
    serious Num Affected
    14
    serious Num At Risk
    40
    title
    [Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Colorectal)
  3. deaths Num Affected
    5
    deaths Num At Risk
    11
    description
    Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
    id
    EG002
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    4
    serious Num At Risk
    11
    title
    Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Ovarian)
  4. deaths Num Affected
    4
    deaths Num At Risk
    4
    description
    Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
    id
    EG003
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Dose Expansion Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      4
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Lymph node pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Thrombotic thrombocytopenic purpura
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Blood and lymphatic system disorders - Other, specify
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Chest pain - cardiac
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Conduction disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Palpitations
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Sinus bradycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Sinus tachycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Ear and labyrinth disorders - Other, specify
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Hyperthyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Hypothyroidism
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Pericardial effusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Colitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Vomiting
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Edema limbs
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Fever
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders and administration site conditions
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Localized edema
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Biliary tract infection
  11. 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
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Lung infection
  12. 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
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    term
    Sepsis
time Frame
The median is 3.3 months (range: 0.6 to 25.3 months). Survival status was followed up to 60 months.

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Preserved source evidence · Not medical advice