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NCT01326702 · ADVERSE EVENTS

Adverse events

Veliparib, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed or Refractory Lymphoma, Multiple Myeloma, or Solid Tumors · Source last updated 2019-12-16

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
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dose Level 1: Bendamustine 70 mg/m2, ABT-888 50 mg

Bendamustine 70 mg/m2, ABT-888 50 mg

1 / 32 / 30 / 3
Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg

Bendamustine 90 mg/m2, ABT-888 50 mg

3 / 31 / 31 / 3
Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID

Bendamustine 90 mg/m2, ABT-888 100 mg BID

3 / 61 / 60 / 6
Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID

Bendamustine 90 mg/m2, ABT-888 150 mg BID

2 / 40 / 40 / 4
Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID

Bendamustine 90 mg/m2, ABT-888 200 mg BID

2 / 50 / 50 / 5
Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID

Bendamustine 90 mg/m2, ABT-888 300 mg BID

5 / 150 / 150 / 15
Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID

Bendamustine 90 mg/m2, ABT-888 400 mg BID

3 / 70 / 70 / 7

Group identifiers: EG000: Dose Level 1: Bendamustine 70 mg/m2, ABT-888 50 mg · EG001: Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg · EG002: Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID · EG003: Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID · EG004: Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID · EG005: Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID · EG006: Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID

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
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Hematuria
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Hypertension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Alanine aminotransferase increased
  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
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Aspartate aminotransferase increased
  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
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Chest pain - cardiac
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Back pain
  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
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Abdominal pain
  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
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Duodenal hemorrhage
  11. 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
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Gastric hemorrhage
  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
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Lung 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
    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
      3
      num Events
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Diarrhea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Hematuria
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Hypoalbuminemia
  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
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Hypocalcemia
  7. 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
      3
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Hypophosphatemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Lymphocyte count decreased
  9. 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
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Platelet count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    White blood cell decreased
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Bendamustine 70 mg/m2, ABT-888 50 mg
    id
    EG000
    other Num Affected
    2
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Dose Level 1: Bendamustine 70 mg/m2, ABT-888 50 mg
  2. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Bendamustine 90 mg/m2, ABT-888 50 mg
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    Dose Level 2: Bendamustine 90 mg/m2, ABT-888 50 mg
  3. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    Bendamustine 90 mg/m2, ABT-888 100 mg BID
    id
    EG002
    other Num Affected
    1
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Dose Level 3: Bendamustine 90 mg/m2, ABT-888 100 mg BID
  4. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Bendamustine 90 mg/m2, ABT-888 150 mg BID
    id
    EG003
    other Num Affected
    0
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Dose Level 4: Bendamustine 90 mg/m2, ABT-888 150 mg BID
  5. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    Bendamustine 90 mg/m2, ABT-888 200 mg BID
    id
    EG004
    other Num Affected
    0
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Dose Level 5: Bendamustine 90 mg/m2, ABT-888 200 mg BID
  6. deaths Num Affected
    0
    deaths Num At Risk
    15
    description
    Bendamustine 90 mg/m2, ABT-888 300 mg BID
    id
    EG005
    other Num Affected
    0
    other Num At Risk
    15
    serious Num Affected
    5
    serious Num At Risk
    15
    title
    Dose Level 6: Bendamustine 90 mg/m2, ABT-888 300 mg BID
  7. deaths Num Affected
    0
    deaths Num At Risk
    7
    description
    Bendamustine 90 mg/m2, ABT-888 400 mg BID
    id
    EG006
    other Num Affected
    0
    other Num At Risk
    7
    serious Num Affected
    3
    serious Num At Risk
    7
    title
    Dose Level 7: Bendamustine 90 mg/m2, ABT-888 400 mg BID
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
      1
      num At Risk
      3
      num Events
      8
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Diarrhea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Hematuria
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Hypoalbuminemia
  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
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Hypocalcemia
  7. 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
      3
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Hypophosphatemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Lymphocyte count decreased
  9. 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
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Platelet count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    White blood cell decreased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Hematuria
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Hypertension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Alanine aminotransferase increased
  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
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Aspartate aminotransferase increased
  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
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Chest pain - cardiac
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Back pain
  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
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Abdominal pain
  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
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Duodenal hemorrhage
  11. 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
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Gastric hemorrhage
  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
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      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
      15
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Lung Infection

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Preserved source evidence · Not medical advice