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NCT02633059 · OUTCOME

Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)

Idasanutlin, Ixazomib Citrate, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma · Source last updated 2024-09-19

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
30 days after the last dose of study treatment, up to 3 years

What was measured

Overall toxicity incidence as well as toxicity profiles by dose level, patient and tumor site will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.

Groups in this outcome

Phase 1: Dose Level 0

Phase 1: Ixazomib 4.0 mg, Idasanutlin 100 mg, and Dexamethasone 40 mg

Phase 1: Dose Level 1

Phase 1: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg

Phase 1: Dose Level 2

Phase 1: Ixazomib 4.0 mg, Idasanutlin 250 mg, and Dexamethasone 40 mg

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

Analysis denominator · Participants

GroupSource count
Phase 1: Dose Level 04
Phase 1: Dose Level 17
Phase 1: Dose Level 24

Reported measurements

Grade 3+ Adverse Events, Regardless of Attribution
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Dose Level 03Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 14Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 23Not reportedNot reportedNot reportedNot reported
Grade 3+ Adverse Events, At Least Possibly Related
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Dose Level 02Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 14Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 23Not reportedNot reportedNot reportedNot reported
Grade 4+ Adverse Events, Regardless of Attribution
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Dose Level 00Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 11Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 23Not reportedNot reportedNot reportedNot reported
Grade 4+ Adverse Events, At Least Possibly Related
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Dose Level 00Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 11Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 22Not reportedNot reportedNot reportedNot reported
Grade 5 Adverse Events, Regardless of Attribution
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Dose Level 00Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 20Not reportedNot reportedNot reportedNot reported
Grade 5 Adverse Events, At Least Possibly Related
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Dose Level 00Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 20Not reportedNot reportedNot reportedNot reported
Grade 3+ Heme Adverse Events, Regardless of Attribution
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Dose Level 03Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 14Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 23Not reportedNot reportedNot reportedNot reported
Grade 3+ Heme Adverse Events, At Least Possibly Related
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Dose Level 02Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 14Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 23Not reportedNot reportedNot reportedNot reported
Grade 4+ Heme Adverse Events, Regardless of Attribution
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Dose Level 00Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 11Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 23Not reportedNot reportedNot reportedNot reported
Grade 4+ Heme Adverse Events, At Least Possibly Related
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Dose Level 00Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 11Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 22Not reportedNot reportedNot reportedNot reported
Grade 5 Heme Adverse Events, Regardless of Attribution
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Dose Level 00Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 20Not reportedNot reportedNot reportedNot reported
Grade 5 Heme Adverse Events, At Least Possibly Related
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Dose Level 00Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 20Not reportedNot reportedNot reportedNot reported
Grade 3+ Non-heme Adverse Events, Regardless of Attribution
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Dose Level 01Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 12Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 20Not reportedNot reportedNot reportedNot reported
Grade 3+ Non-heme Adverse Events, At Least Possibly Related
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Dose Level 01Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 11Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 20Not reportedNot reportedNot reportedNot reported
Grade 4+ Non-heme Adverse Events, Regardless of Attribution
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Dose Level 00Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 20Not reportedNot reportedNot reportedNot reported
Grade 4+ Non-heme Adverse Events, At Least Possibly Related
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Dose Level 00Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 20Not reportedNot reportedNot reportedNot reported
Grade 5 Non-heme Adverse Events, Regardless of Attribution
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Dose Level 00Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 20Not reportedNot reportedNot reportedNot reported
Grade 5 Non-heme Adverse Events, At Least Possibly Related
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Dose Level 00Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 10Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Level 20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
    title
    Grade 3+ Adverse Events, Regardless of Attribution
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
    title
    Grade 3+ Adverse Events, At Least Possibly Related
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
    title
    Grade 4+ Adverse Events, Regardless of Attribution
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
    title
    Grade 4+ Adverse Events, At Least Possibly Related
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Grade 5 Adverse Events, Regardless of Attribution
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Grade 5 Adverse Events, At Least Possibly Related
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
    title
    Grade 3+ Heme Adverse Events, Regardless of Attribution
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
    title
    Grade 3+ Heme Adverse Events, At Least Possibly Related
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
    title
    Grade 4+ Heme Adverse Events, Regardless of Attribution
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
    title
    Grade 4+ Heme Adverse Events, At Least Possibly Related
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Grade 5 Heme Adverse Events, Regardless of Attribution
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Grade 5 Heme Adverse Events, At Least Possibly Related
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      4
    units
    Participants
description
Overall toxicity incidence as well as toxicity profiles by dose level, patient and tumor site will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.
groups
  1. description
    Phase 1: Ixazomib 4.0 mg, Idasanutlin 100 mg, and Dexamethasone 40 mg
    id
    OG000
    title
    Phase 1: Dose Level 0
  2. description
    Phase 1: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
    id
    OG001
    title
    Phase 1: Dose Level 1
  3. description
    Phase 1: Ixazomib 4.0 mg, Idasanutlin 250 mg, and Dexamethasone 40 mg
    id
    OG002
    title
    Phase 1: Dose Level 2
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
30 days after the last dose of study treatment, up to 3 years
title
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice