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NCT01754402 · ADVERSE EVENTS

Adverse events

Bendamustine + Pomalidomide + Dex in R/R Multiple Myeloma · Source last updated 2024-02-20

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
30 days past last day of drug, up to 1 year
Other-event reporting threshold
0%

Adverse Events were not collected per cohort, so they are represented as a whole

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1: 120mg Bendamustine + 3mg Pomalidomide

* Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days

6 / 66 / 66 / 6
Cohort 2: 120mg Bendamustine + 4mg Pomalidomide

* Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days

1 / 22 / 22 / 2
Expansion: 120mg Bendamustine + 3mg Pomalidomide

* Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days

17 / 3030 / 3013 / 30

Group identifiers: EG000: Cohort 1: 120mg Bendamustine + 3mg Pomalidomide · EG001: Cohort 2: 120mg Bendamustine + 4mg Pomalidomide · EG002: Expansion: 120mg Bendamustine + 3mg Pomalidomide

Serious adverse events

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

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      30
      num Events
      4
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Atrial fibrillation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Chest pain - cardiac
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Supraventricular tachycardia
  5. assessment Type
    NON_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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Diarrhea
  6. assessment Type
    NON_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
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Gastrointestinal disorders - Other, specify
  7. assessment Type
    NON_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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Mucositis oral
  8. assessment Type
    NON_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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Nausea
  9. assessment Type
    NON_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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Vomiting
  10. assessment Type
    NON_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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Death NOS
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      30
      num Events
      9
    term
    Fever
  12. assessment Type
    NON_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
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Bronchial infection

Other reported adverse events

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

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2
      num Events
      2
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      30
      num Events
      73
    term
    Anemia
  2. assessment Type
    NON_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
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      30
      num Events
      2
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      30
      num Events
      2
    term
    Atrial Fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Chest pain - cardiac
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Cardiac disorders - Other, specify
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      30
      num Events
      2
    term
    Palpitations
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      30
      num Events
      2
    term
    Sinus bradycardia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Sinus tachycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Ear and labyrinth disorders - Other, specify
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Ear pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      2
    term
    Eye disorders - Other, specify
  12. assessment Type
    NON_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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Abdominal pain
Complete source fields
description
Adverse Events were not collected per cohort, so they are represented as a whole
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    6
    description
    * Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    6
    serious Num At Risk
    6
    title
    Cohort 1: 120mg Bendamustine + 3mg Pomalidomide
  2. deaths Num Affected
    2
    deaths Num At Risk
    2
    description
    * Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
    id
    EG001
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    Cohort 2: 120mg Bendamustine + 4mg Pomalidomide
  3. deaths Num Affected
    13
    deaths Num At Risk
    30
    description
    * Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
    id
    EG002
    other Num Affected
    30
    other Num At Risk
    30
    serious Num Affected
    17
    serious Num At Risk
    30
    title
    Expansion: 120mg Bendamustine + 3mg Pomalidomide
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      6
      num Events
      5
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2
      num Events
      2
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      30
      num Events
      73
    term
    Anemia
  2. assessment Type
    NON_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
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      30
      num Events
      2
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      30
      num Events
      2
    term
    Atrial Fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Chest pain - cardiac
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Cardiac disorders - Other, specify
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      30
      num Events
      2
    term
    Palpitations
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      30
      num Events
      2
    term
    Sinus bradycardia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Sinus tachycardia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Ear and labyrinth disorders - Other, specify
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Ear pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      2
    term
    Eye disorders - Other, specify
  12. assessment Type
    NON_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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Abdominal pain
serious Events
  1. assessment Type
    NON_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
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      30
      num Events
      4
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Atrial fibrillation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Chest pain - cardiac
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac 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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Supraventricular tachycardia
  5. assessment Type
    NON_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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Diarrhea
  6. assessment Type
    NON_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
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Gastrointestinal disorders - Other, specify
  7. assessment Type
    NON_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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Mucositis oral
  8. assessment Type
    NON_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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Nausea
  9. assessment Type
    NON_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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Vomiting
  10. assessment Type
    NON_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
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      30
      num Events
      0
    term
    Death NOS
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      6
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2
      num Events
      1
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      30
      num Events
      9
    term
    Fever
  12. assessment Type
    NON_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
      0
      num At Risk
      2
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      30
      num Events
      1
    term
    Bronchial infection
time Frame
30 days past last day of drug, up to 1 year

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Preserved source evidence · Not medical advice