Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01782963 · OUTCOME

Number of Participants With Grade 3 or Higher Treatment Related Adverse Events

Lenalidomide/Bortezomib/Dexamethasone for Multiple Myeloma (MM) · Source last updated 2018-10-31

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
2 years

What was measured

A summary of the number of participants with grade 3 or higher treatment related adverse events for adverse events that had an overall incidence of greater than 15% (any grade) as assessed by Common Terminology Criteria for Adverse Events (CTCAE 4).

Groups in this outcome

Treatment Arm

Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age) Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15 Lenalidomide Bortezomib Dexamethasone

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

Analysis denominator · Participants

GroupSource count
Treatment Arm50

Reported measurements

Fatigue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm8Not reportedNot reportedNot reportedNot reported
Peripheral Neuropathy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm1Not reportedNot reportedNot reportedNot reported
Hypophosphatemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm17Not reportedNot reportedNot reportedNot reported
Neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm7Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm0Not reportedNot reportedNot reportedNot reported
Peripheral Edema
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm1Not reportedNot reportedNot reportedNot reported
Insomnia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm1Not reportedNot reportedNot reportedNot reported
Rash
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm5Not reportedNot reportedNot reportedNot reported
Anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm1Not reportedNot reportedNot reportedNot reported
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm1Not reportedNot reportedNot reportedNot reported
Constipation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm0Not reportedNot reportedNot reportedNot reported
Dysgeusia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm0Not reportedNot reportedNot reportedNot reported
Hyperglycemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm2Not reportedNot reportedNot reportedNot reported
Nausea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm0Not reportedNot reportedNot reportedNot reported
Depression
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm0Not reportedNot reportedNot reportedNot reported
Psychiatric Disorder, other
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm2Not reportedNot reportedNot reportedNot reported
Generalized Muscle Weakness
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Arm2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Fatigue
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Peripheral Neuropathy
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    Hypophosphatemia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Neutropenia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Diarrhea
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Peripheral Edema
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Insomnia
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Rash
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Anemia
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Thrombocytopenia
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Constipation
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Dysgeusia
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    units
    Participants
description
A summary of the number of participants with grade 3 or higher treatment related adverse events for adverse events that had an overall incidence of greater than 15% (any grade) as assessed by Common Terminology Criteria for Adverse Events (CTCAE 4).
groups
  1. description
    Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age) Consolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15 Lenalidomide Bortezomib Dexamethasone
    id
    OG000
    title
    Treatment Arm
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
2 years
title
Number of Participants With Grade 3 or Higher Treatment Related Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice