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NCT03910439 · OUTCOME

Number of Participants With Grade ≥1 Non-serious Adverse Events

Avelumab in Combination With Hypofractionated Radiotherapy in Patients With Relapsed Refractory Multiple Myeloma · Source last updated 2021-05-12

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
Date treatment consent signed to date off study, approximately 14 months and 4 days.

What was measured

Grade ≥1 non-serious adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. Grade 1 is mild, Grade 2 is moderate, and Grade 3 is severe or medically significant.

Groups in this outcome

Grade 1

Grade 1 is mild.

Grade 2

Grade 2 is moderate.

Grade 3

Grade 3 is severe or medically significant.

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 14
Grade 24
Grade 34

Reported measurements

Alanine aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 11Not reportedNot reportedNot reportedNot reported
Grade 21Not reportedNot reportedNot reportedNot reported
Grade 30Not reportedNot reportedNot reportedNot reported
Alkaline aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 11Not reportedNot reportedNot reportedNot reported
Grade 20Not reportedNot reportedNot reportedNot reported
Grade 30Not reportedNot reportedNot reportedNot reported
Arthralgia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 11Not reportedNot reportedNot reportedNot reported
Grade 20Not reportedNot reportedNot reportedNot reported
Grade 30Not reportedNot reportedNot reportedNot reported
Aspartate aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 11Not reportedNot reportedNot reportedNot reported
Grade 21Not reportedNot reportedNot reportedNot reported
Grade 30Not reportedNot reportedNot reportedNot reported
Chest pain - cardiac
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 10Not reportedNot reportedNot reportedNot reported
Grade 21Not reportedNot reportedNot reportedNot reported
Grade 30Not reportedNot reportedNot reportedNot reported
Eye disorders - Other, posterior vitreous detachment
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 11Not reportedNot reportedNot reportedNot reported
Grade 20Not reportedNot reportedNot reportedNot reported
Grade 30Not reportedNot reportedNot reportedNot reported
Nausea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 11Not reportedNot reportedNot reportedNot reported
Grade 20Not reportedNot reportedNot reportedNot reported
Grade 30Not reportedNot reportedNot reportedNot reported
Pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 11Not reportedNot reportedNot reportedNot reported
Grade 21Not reportedNot reportedNot reportedNot reported
Grade 30Not reportedNot reportedNot reportedNot reported
Rash maculo-papular
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 11Not reportedNot reportedNot reportedNot reported
Grade 20Not reportedNot reportedNot reportedNot reported
Grade 30Not reportedNot reportedNot reportedNot reported
Skin infection
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 11Not reportedNot reportedNot reportedNot reported
Grade 20Not reportedNot reportedNot reportedNot reported
Grade 30Not reportedNot reportedNot reportedNot reported
Syncope
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 10Not reportedNot reportedNot reportedNot reported
Grade 20Not reportedNot reportedNot reportedNot reported
Grade 31Not reportedNot reportedNot reportedNot reported
Vomiting
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 10Not reportedNot reportedNot reportedNot reported
Grade 21Not reportedNot reportedNot reportedNot reported
Grade 30Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Alanine aminotransferase increased
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Alkaline aminotransferase increased
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Arthralgia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Aspartate aminotransferase increased
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Chest pain - cardiac
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Eye disorders - Other, posterior vitreous detachment
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Nausea
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Pain
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Rash maculo-papular
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Skin infection
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Syncope
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Vomiting
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      4
    units
    Participants
description
Grade ≥1 non-serious adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. Grade 1 is mild, Grade 2 is moderate, and Grade 3 is severe or medically significant.
groups
  1. description
    Grade 1 is mild.
    id
    OG000
    title
    Grade 1
  2. description
    Grade 2 is moderate.
    id
    OG001
    title
    Grade 2
  3. description
    Grade 3 is severe or medically significant.
    id
    OG002
    title
    Grade 3
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Date treatment consent signed to date off study, approximately 14 months and 4 days.
title
Number of Participants With Grade ≥1 Non-serious Adverse Events
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice