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NCT01645930 · OUTCOME

Number of Participants With Clinically Significant Laboratory Abnormalities Reported as Adverse Events of ≥Grade 3 Intensity

Phase 1 Pharmacokinetic Study of Oral Ixazomib Plus Lenalidomide and Dexamethasone in Adult Asian Participants With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2018-11-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From the first dose of study drug through 30 days after the last dose of study drug (up to 577 days)

What was measured

Clinically significant laboratory abnormalities were defined as any test results which were observed beyond the clinically acceptable limits as per the discretion of investigator. Clinical laboratory tests included chemistry, hematology and urinalysis tests.

Analysis population: Safety population was defined as all participants who received at least 1 dose of study drug.

Groups in this outcome

Ixazomib+Lenalidomide+Dexamethasone

Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)

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

Analysis denominator · Participants

GroupSource count
Ixazomib+Lenalidomide+Dexamethasone43

Reported measurements

Alanine Aminotransferase Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib+Lenalidomide+Dexamethasone2Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib+Lenalidomide+Dexamethasone1Not reportedNot reportedNot reportedNot reported
Blood Creatinine Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib+Lenalidomide+Dexamethasone1Not reportedNot reportedNot reportedNot reported
Haemoglobin Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib+Lenalidomide+Dexamethasone1Not reportedNot reportedNot reportedNot reported
Neutrophil Count Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib+Lenalidomide+Dexamethasone2Not reportedNot reportedNot reportedNot reported
Platelet Count Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib+Lenalidomide+Dexamethasone4Not reportedNot reportedNot reportedNot reported
Anaemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib+Lenalidomide+Dexamethasone6Not reportedNot reportedNot reportedNot reported
Febrile Neutropenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib+Lenalidomide+Dexamethasone1Not reportedNot reportedNot reportedNot reported
Neutropenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib+Lenalidomide+Dexamethasone12Not reportedNot reportedNot reportedNot reported
Thrombocytopenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib+Lenalidomide+Dexamethasone8Not reportedNot reportedNot reportedNot reported
Hyperglycaemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib+Lenalidomide+Dexamethasone1Not reportedNot reportedNot reportedNot reported
Hypocalcaemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib+Lenalidomide+Dexamethasone3Not reportedNot reportedNot reportedNot reported
Hypokalaemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib+Lenalidomide+Dexamethasone5Not reportedNot reportedNot reportedNot reported
Hypomagnesaemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib+Lenalidomide+Dexamethasone1Not reportedNot reportedNot reportedNot reported
Hyponatraemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib+Lenalidomide+Dexamethasone1Not reportedNot reportedNot reportedNot reported
Hypophosphataemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib+Lenalidomide+Dexamethasone2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Alanine Aminotransferase Increased
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Aspartate Aminotransferase Increased
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Blood Creatinine Increased
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Haemoglobin Decreased
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Neutrophil Count Decreased
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Platelet Count Decreased
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Anaemia
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Febrile Neutropenia
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    title
    Neutropenia
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Thrombocytopenia
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hyperglycaemia
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Hypocalcaemia
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    units
    Participants
description
Clinically significant laboratory abnormalities were defined as any test results which were observed beyond the clinically acceptable limits as per the discretion of investigator. Clinical laboratory tests included chemistry, hematology and urinalysis tests.
groups
  1. description
    Ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15; lenalidomide 25 mg, capsules, orally, once on Days 1 through 21; and dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15, and 22 of a 28-day treatment cycle until progressive disease (PD) or unacceptable toxicity (up to 20 cycles)
    id
    OG000
    title
    Ixazomib+Lenalidomide+Dexamethasone
param Type
NUMBER
population Description
Safety population was defined as all participants who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
From the first dose of study drug through 30 days after the last dose of study drug (up to 577 days)
title
Number of Participants With Clinically Significant Laboratory Abnormalities Reported as Adverse Events of ≥Grade 3 Intensity
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice