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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 II)

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
Up to 6 months

What was measured

The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.

Analysis population: Participants who had adverse events fitting the criteria

Groups in this outcome

Phase 2: Dose Level 1

Phase 2: Ixazomib 4.0 mg, Idasanutlin 200 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 2: Dose Level 117

Reported measurements

Grade 3+ Adverse Events, Regardless of Attribution
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Dose Level 114Not reportedNot reportedNot reportedNot reported
Grade 3+ Adverse Events, At Least Possibly Related
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Dose Level 113Not reportedNot reportedNot reportedNot reported
Grade 4+ Adverse Events, Regardless of Attribution
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Dose Level 110Not reportedNot reportedNot reportedNot reported
Grade 4+ Adverse Events, At Least Possibly Related
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Dose Level 19Not reportedNot reportedNot reportedNot reported
Grade 5 Adverse Events, Regardless of Attribution
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Dose Level 12Not reportedNot reportedNot reportedNot reported
Grade 5 Adverse Events, At Least Possibly Related
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Dose Level 10Not reportedNot reportedNot reportedNot reported
Grade 3+ Heme Adverse Events, Regardless of Attribution
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Dose Level 113Not reportedNot reportedNot reportedNot reported
Grade 3+ Heme Adverse Events, At Least Possibly Related
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Dose Level 113Not reportedNot reportedNot reportedNot reported
Grade 4+ Heme Adverse Events, Regardless of Attribution
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Dose Level 19Not reportedNot reportedNot reportedNot reported
Grade 4+ Heme Adverse Events, At Least Possibly Related
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Dose Level 19Not reportedNot reportedNot reportedNot reported
Grade 5 Heme Adverse Events, Regardless of Attribution
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Dose Level 10Not reportedNot reportedNot reportedNot reported
Grade 5 Heme Adverse Events, At Least Possibly Related
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Dose Level 10Not reportedNot reportedNot reportedNot reported
Grade 3+ Non-heme Adverse Events, Regardless of Attribution
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Dose Level 15Not reportedNot reportedNot reportedNot reported
Grade 3+ Non-heme Adverse Events, At Least Possibly Related
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Dose Level 13Not reportedNot reportedNot reportedNot reported
Grade 4+ Non-heme Adverse Events, Regardless of Attribution
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Dose Level 14Not reportedNot reportedNot reportedNot reported
Grade 4+ Non-heme Adverse Events, At Least Possibly Related
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Dose Level 12Not reportedNot reportedNot reportedNot reported
Grade 5 Non-heme Adverse Events, Regardless of Attribution
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Dose Level 12Not reportedNot reportedNot reportedNot reported
Grade 5 Non-heme Adverse Events, At Least Possibly Related
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Dose Level 10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    Grade 3+ Adverse Events, Regardless of Attribution
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    Grade 3+ Adverse Events, At Least Possibly Related
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    Grade 4+ Adverse Events, Regardless of Attribution
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Grade 4+ Adverse Events, At Least Possibly Related
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Grade 5 Adverse Events, Regardless of Attribution
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Grade 5 Adverse Events, At Least Possibly Related
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    Grade 3+ Heme Adverse Events, Regardless of Attribution
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    Grade 3+ Heme Adverse Events, At Least Possibly Related
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Grade 4+ Heme Adverse Events, Regardless of Attribution
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Grade 4+ Heme Adverse Events, At Least Possibly Related
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Grade 5 Heme Adverse Events, Regardless of Attribution
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Grade 5 Heme Adverse Events, At Least Possibly Related
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
description
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
groups
  1. description
    Phase 2: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
    id
    OG000
    title
    Phase 2: Dose Level 1
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants who had adverse events fitting the criteria
reporting Status
POSTED
time Frame
Up to 6 months
title
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice