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NCT00748657 · OUTCOME

Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0

Bevacizumab in Treating Patients With Recurrent Sex Cord-Stromal Tumors of the Ovary · 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
Up to 5 years

What was measured

Adverse Events at least possibly related to study agent.

Analysis population: Eligible and evaluable patients

Groups in this outcome

Grade 0

Number of patients who did not experience the specified AE (adverse event).

Grade 1 (CTCAE v 3.0)

Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0

Grade 2 (CTCAE v 3.0)

Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0

Grade 3 (CTCAE v 3.0)

Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0

Grade 4 (CTCAE v 3.0)

Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0

Grade 5 (CTCAE v 3.0)

Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0

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 036
Grade 1 (CTCAE v 3.0)36
Grade 2 (CTCAE v 3.0)36
Grade 3 (CTCAE v 3.0)36
Grade 4 (CTCAE v 3.0)36
Grade 5 (CTCAE v 3.0)36

Reported measurements

Leukopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 032Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)2Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 028Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)8Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 021Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)7Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)7Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Other Hematologic
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 033Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)2Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Allergy/Immunology
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 023Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)11Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)2Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Auditory/Ear
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 029Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)6Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Cardiac
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 015Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)6Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)9Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)5Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Coagulation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 035Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Constitutional
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 012Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)10Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)13Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Dermatologic
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 017Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)14Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)4Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Endocrine
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 033Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)2Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Gastrointestinal
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 06Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)10Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)15Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)5Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Genitourinary/Renal
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 029Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)5Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Hemorrhage
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 017Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)18Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Infection
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 023Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)11Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)2Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Lymphatics
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 031Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)4Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Metabolic
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 013Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)10Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)8Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)3Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)2Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Musculoskeletal
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 030Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)5Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Neurosensory
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 021Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)13Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Other Neurological
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 022Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)12Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Ocular/Visual
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 030Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)6Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 01Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)11Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)16Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)8Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Pulmonary
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 012Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)20Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)3Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Sexual/Reproductive
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 032Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)4Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Syndromes
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 035Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Vascular
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 035Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Death, Not CTC coded
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 035Not reportedNot reportedNot reportedNot reported
Grade 1 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 2 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 3 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 4 (CTCAE v 3.0)0Not reportedNot reportedNot reportedNot reported
Grade 5 (CTCAE v 3.0)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Leukopenia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        8
      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
    Thrombocytopenia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Anemia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        2
      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
    Other Hematologic
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        11
      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
    Allergy/Immunology
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Auditory/Ear
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
    title
    Cardiac
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        35
      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
    Coagulation
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Constitutional
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        14
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Dermatologic
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        2
      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
    Endocrine
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        15
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
    title
    Gastrointestinal
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    2. group Id
      OG001
      value
      36
    3. group Id
      OG002
      value
      36
    4. group Id
      OG003
      value
      36
    5. group Id
      OG004
      value
      36
    6. group Id
      OG005
      value
      36
    units
    Participants
description
Adverse Events at least possibly related to study agent.
groups
  1. description
    Number of patients who did not experience the specified AE (adverse event).
    id
    OG000
    title
    Grade 0
  2. description
    Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
    id
    OG001
    title
    Grade 1 (CTCAE v 3.0)
  3. description
    Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
    id
    OG002
    title
    Grade 2 (CTCAE v 3.0)
  4. description
    Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
    id
    OG003
    title
    Grade 3 (CTCAE v 3.0)
  5. description
    Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
    id
    OG004
    title
    Grade 4 (CTCAE v 3.0)
  6. description
    Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
    id
    OG005
    title
    Grade 5 (CTCAE v 3.0)
param Type
COUNT_OF_PARTICIPANTS
population Description
Eligible and evaluable patients
reporting Status
POSTED
time Frame
Up to 5 years
title
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
type
SECONDARY
unit Of Measure
Participants

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