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NCT00025506 · OUTCOME

Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0

Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus · Source last updated 2019-07-24

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
Each cycle during treatment and 30 days after the last treatment (average 4 months)

Analysis population: Eligible and evaluable patients

Groups in this outcome

Grade 0

Number of patients who did not experience the adverse event.

Grade 1

Number of patients who experienced a Grade 1 adverse event (Common Toxicity Criteria version 2)

Grade 2

Number of patients who experienced a Grade 2 adverse event (Common Toxicity Criteria version 2)

Grade 3

Number of patients who experienced a Grade 3 adverse event (Common Toxicity Criteria version 2)

Grade 4

Number of patients who experienced a Grade 4 adverse event (Common Toxicity Criteria version 2)

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 045
Grade 145
Grade 245
Grade 345
Grade 445

Reported measurements

Nausea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 031Not reportedNot reportedNot reportedNot reported
Grade 14Not reportedNot reportedNot reportedNot reported
Grade 26Not reportedNot reportedNot reportedNot reported
Grade 34Not reportedNot reportedNot reportedNot reported
Grade 40Not reportedNot reportedNot reportedNot reported
Vomiting
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 036Not reportedNot reportedNot reportedNot reported
Grade 14Not reportedNot reportedNot reportedNot reported
Grade 24Not reportedNot reportedNot reportedNot reported
Grade 31Not reportedNot reportedNot reportedNot reported
Grade 40Not reportedNot reportedNot reportedNot reported
Constipation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 027Not reportedNot reportedNot reportedNot reported
Grade 16Not reportedNot reportedNot reportedNot reported
Grade 29Not reportedNot reportedNot reportedNot reported
Grade 33Not reportedNot reportedNot reportedNot reported
Grade 40Not reportedNot reportedNot reportedNot reported
Anorexia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 042Not reportedNot reportedNot reportedNot reported
Grade 12Not reportedNot reportedNot reportedNot reported
Grade 21Not reportedNot reportedNot reportedNot reported
Grade 30Not reportedNot reportedNot reportedNot reported
Grade 40Not reportedNot reportedNot reportedNot reported
Fatigue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 022Not reportedNot reportedNot reportedNot reported
Grade 15Not reportedNot reportedNot reportedNot reported
Grade 215Not reportedNot reportedNot reportedNot reported
Grade 33Not reportedNot reportedNot reportedNot reported
Grade 40Not reportedNot reportedNot reportedNot reported
Neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 041Not reportedNot reportedNot reportedNot reported
Grade 11Not reportedNot reportedNot reportedNot reported
Grade 23Not reportedNot reportedNot reportedNot reported
Grade 30Not reportedNot reportedNot reportedNot reported
Grade 40Not reportedNot reportedNot reportedNot reported
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 044Not reportedNot reportedNot reportedNot reported
Grade 11Not reportedNot reportedNot reportedNot reported
Grade 20Not reportedNot reportedNot reportedNot reported
Grade 30Not reportedNot reportedNot reportedNot reported
Grade 40Not reportedNot reportedNot reportedNot reported
Anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 022Not reportedNot reportedNot reportedNot reported
Grade 19Not reportedNot reportedNot reportedNot reported
Grade 29Not reportedNot reportedNot reportedNot reported
Grade 34Not reportedNot reportedNot reportedNot reported
Grade 41Not reportedNot reportedNot reportedNot reported
Cardiovascular
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 031Not reportedNot reportedNot reportedNot reported
Grade 19Not reportedNot reportedNot reportedNot reported
Grade 22Not reportedNot reportedNot reportedNot reported
Grade 31Not reportedNot reportedNot reportedNot reported
Grade 42Not reportedNot reportedNot reportedNot reported
Neuropathy (sensory)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 027Not reportedNot reportedNot reportedNot reported
Grade 112Not reportedNot reportedNot reportedNot reported
Grade 25Not reportedNot reportedNot reportedNot reported
Grade 31Not reportedNot reportedNot reportedNot reported
Grade 40Not reportedNot reportedNot reportedNot reported
Other neurologic
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 031Not reportedNot reportedNot reportedNot reported
Grade 12Not reportedNot reportedNot reportedNot reported
Grade 26Not reportedNot reportedNot reportedNot reported
Grade 36Not reportedNot reportedNot reportedNot reported
Grade 40Not reportedNot reportedNot reportedNot reported
Dermatologic
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 039Not reportedNot reportedNot reportedNot reported
Grade 14Not reportedNot reportedNot reportedNot reported
Grade 22Not reportedNot reportedNot reportedNot reported
Grade 30Not reportedNot reportedNot reportedNot reported
Grade 40Not reportedNot reportedNot reportedNot reported
Metabolic
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 040Not reportedNot reportedNot reportedNot reported
Grade 13Not reportedNot reportedNot reportedNot reported
Grade 20Not reportedNot reportedNot reportedNot reported
Grade 32Not reportedNot reportedNot reportedNot reported
Grade 40Not reportedNot reportedNot reportedNot reported
Pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 038Not reportedNot reportedNot reportedNot reported
Grade 14Not reportedNot reportedNot reportedNot reported
Grade 22Not reportedNot reportedNot reportedNot reported
Grade 31Not reportedNot reportedNot reportedNot reported
Grade 40Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        31
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        0
    title
    Nausea
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
    title
    Vomiting
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
    title
    Constipation
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        42
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    title
    Anorexia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        15
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
    title
    Fatigue
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        41
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    title
    Neutropenia
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        44
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    title
    Thrombocytopenia
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        1
    title
    Anemia
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        31
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        2
    title
    Cardiovascular
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
    title
    Neuropathy (sensory)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        31
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        0
    title
    Other neurologic
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        39
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    title
    Dermatologic
denoms
  1. counts
    1. group Id
      OG000
      value
      45
    2. group Id
      OG001
      value
      45
    3. group Id
      OG002
      value
      45
    4. group Id
      OG003
      value
      45
    5. group Id
      OG004
      value
      45
    units
    Participants
groups
  1. description
    Number of patients who did not experience the adverse event.
    id
    OG000
    title
    Grade 0
  2. description
    Number of patients who experienced a Grade 1 adverse event (Common Toxicity Criteria version 2)
    id
    OG001
    title
    Grade 1
  3. description
    Number of patients who experienced a Grade 2 adverse event (Common Toxicity Criteria version 2)
    id
    OG002
    title
    Grade 2
  4. description
    Number of patients who experienced a Grade 3 adverse event (Common Toxicity Criteria version 2)
    id
    OG003
    title
    Grade 3
  5. description
    Number of patients who experienced a Grade 4 adverse event (Common Toxicity Criteria version 2)
    id
    OG004
    title
    Grade 4
param Type
COUNT_OF_PARTICIPANTS
population Description
Eligible and evaluable patients
reporting Status
POSTED
time Frame
Each cycle during treatment and 30 days after the last treatment (average 4 months)
title
Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice