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NCT01210222 · OUTCOME

Adverse Events as Assessed by NCI CTCAE v 4.0

Trebananib in Treating Patients With Persistent or Recurrent Endometrial Cancer · Source last updated 2018-02-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 5 years

Analysis population: Eligible and evaluable patients

Groups in this outcome

Grade 0

Number of patients who did not experience the specified AE.

Grade 1 (CTCAE v 4.0)

Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0

Grade 2 (CTCAE v 4.0)

Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0

Grade 3 (CTCAE v 4.0)

Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0

Grade 4 (CTCAE v 4.0)

Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0

Grade 5 (CTCAE v 4.0)

Number of patients who experienced a grade 5 event using common terminology criteria version 4.0

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Grade 032
Grade 1 (CTCAE v 4.0)32
Grade 2 (CTCAE v 4.0)32
Grade 3 (CTCAE v 4.0)32
Grade 4 (CTCAE v 4.0)32
Grade 5 (CTCAE v 4.0)32

Reported measurements

Fatigue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 010Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)11Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)9Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)2Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 015Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)15Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)2Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Constipation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 016Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)10Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)6Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Hypertension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 020Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)1Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)7Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)4Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Nausea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 020Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)6Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)2Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)4Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Abdominal Pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 020Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)1Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)3Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)8Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Edema Limbs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 021Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)4Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)5Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)2Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Anorexia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 022Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)6Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)3Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)1Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Peripheral Sensory Neuropathy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 022Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)10Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Cough
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 024Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)7Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)1Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 024Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)6Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)2Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Hyperglycemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 024Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)6Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)2Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Hyponatremia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 024Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)5Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)2Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)1Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Hypoalbuminemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 024Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)3Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)3Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)2Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Dyspnea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 025Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)4Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)1Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)2Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Vomiting
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 025Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)2Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)3Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)2Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Ascites
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 027Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)2Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)3Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Bloating
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 028Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)1Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)3Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Lymphedema
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 028Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)1Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)1Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)2Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Thromboembolic Event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 028Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)2Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)2Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Localized Edema
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 029Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)3Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Fatigue
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        15
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Anemia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Constipation
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Hypertension
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Nausea
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Abdominal Pain
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Edema Limbs
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Anorexia
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Peripheral Sensory Neuropathy
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Cough
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Diarrhea
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Hyperglycemia
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    2. group Id
      OG001
      value
      32
    3. group Id
      OG002
      value
      32
    4. group Id
      OG003
      value
      32
    5. group Id
      OG004
      value
      32
    6. group Id
      OG005
      value
      32
    units
    Participants
groups
  1. description
    Number of patients who did not experience the specified AE.
    id
    OG000
    title
    Grade 0
  2. description
    Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
    id
    OG001
    title
    Grade 1 (CTCAE v 4.0)
  3. description
    Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
    id
    OG002
    title
    Grade 2 (CTCAE v 4.0)
  4. description
    Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
    id
    OG003
    title
    Grade 3 (CTCAE v 4.0)
  5. description
    Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
    id
    OG004
    title
    Grade 4 (CTCAE v 4.0)
  6. description
    Number of patients who experienced a grade 5 event using common terminology criteria version 4.0
    id
    OG005
    title
    Grade 5 (CTCAE v 4.0)
param Type
COUNT_OF_PARTICIPANTS
population Description
Eligible and evaluable patients
reporting Status
POSTED
time Frame
Up to 5 years
title
Adverse Events as Assessed by NCI CTCAE v 4.0
type
PRIMARY
unit Of Measure
Participants

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