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NCT01637961 · OUTCOME

Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0

Alisertib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus · Source last updated 2019-07-23

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
Every cycle during treatment and 30 days after the last treatment, up to 5 years.

Analysis population: Eligible and treated 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 021
Grade 1 (CTCAE v 4.0)21
Grade 2 (CTCAE v 4.0)21
Grade 3 (CTCAE v 4.0)21
Grade 4 (CTCAE v 4.0)21
Grade 5 (CTCAE v 4.0)21

Reported measurements

Leukopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 09Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)3Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)4Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)5Not 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
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 011Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)9Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)0Not 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
Neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 011Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)3Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)5Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 4.0)2Not 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 05Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)3Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)9Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)3Not 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
Other investigations
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 018Not 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
Other blood/lymphatics
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 019Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 4.0)1Not 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
Cardiac
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 020Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)0Not 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
Nausea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 015Not 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)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
Vomiting
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 018Not 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
Other gastrointestinal
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 04Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)7Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)6Not 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
General and administration site
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 09Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)5Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)7Not 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
Infections/infestations
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 019Not 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)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
Metabolism/nutrition
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 014Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)1Not 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
Musculoskeletal/connective tissue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 016Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)3Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)1Not 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 020Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)1Not 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
Nervous system
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 012Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)5Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)4Not 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
Psychiatric
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 019Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)2Not 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
Renal/urinary
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 019Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)2Not 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
Reproductive/breast
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 019Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)1Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)0Not 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
Respiratory/thoracic/mediastinal
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 016Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)4Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)0Not 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
Skin/subcutaneous
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 07Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)5Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)7Not 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
Vascular disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 019Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 4.0)0Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 4.0)1Not 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
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Leukopenia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Thrombocytopenia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        0
    title
    Neutropenia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
    title
    Anemia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        3
      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
    Other investigations
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
    title
    Other blood/lymphatics
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Cardiac
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Nausea
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        3
      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
    Vomiting
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Other gastrointestinal
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    General and administration site
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        0
      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
    Infections/infestations
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      21
    3. group Id
      OG002
      value
      21
    4. group Id
      OG003
      value
      21
    5. group Id
      OG004
      value
      21
    6. group Id
      OG005
      value
      21
    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 treated patients
reporting Status
POSTED
time Frame
Every cycle during treatment and 30 days after the last treatment, up to 5 years.
title
Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0
type
SECONDARY
unit Of Measure
Participants

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