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NCT03169361 · BASELINE

Baseline characteristics

NINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) "Relapsed/Refractory Multiple Myeloma" · Source last updated 2023-12-07

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

denoms
  1. counts
    1. group Id
      BG000
      value
      742
    units
    Participants
groups
  1. description
    The usual adult dosage for oral administration was 4 mg as ixazomib, in the fasting state, once a day, once a week for 3 weeks (Days 1, 8, and 15), with a 13-day washout period (Days 16 through 28). This 4-week cycle was repeated for 6 cycles. The dose might be reduced appropriately according to the patient's condition. Participants received interventions as part of routine medical care.
    id
    BG000
    title
    Ixazomib 4 mg
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.85
          value
          70.6
      denoms
      1. counts
        1. group Id
          BG000
          value
          742
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          391
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          351
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          742
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. denoms
      1. counts
        1. group Id
          BG000
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          742
      denoms
      1. counts
        1. group Id
          BG000
          value
          742
        units
        Participants
      title
      Japan
    description
    All participants were enrolled in Japan.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.902
          value
          4.49
      denoms
      1. counts
        1. group Id
          BG000
          value
          739
        units
        Participants
    description
    Mean duration between the first diagnosis of relapsed/refractory multiple myeloma and the start of the study was reported.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The number analyzed is the number of participants with data available for analysis.
    title
    Duration of Diagnosis of Relapsed/Refractory Multiple Myeloma
    unit Of Measure
    Years
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          742
      denoms
      1. counts
        1. group Id
          BG000
          value
          742
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Participants with Relapsed/Refractory Multiple Myeloma
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          140
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          260
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          290
        title
        Stage III
      4. measurements
        1. group Id
          BG000
          value
          50
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          740
        units
        Participants
    description
    International Staging System is a staging system for cancer progression. Stages are classified by Stage I to Stage III. Stage I: Serum beta2-microglobulin \<3.5 mg/L and albumin ≥3.5 g/dL; Stage II: Neither Stage I or III, meaning that either: beta2-microglobulin level ≥3.5 and \<5.5 mg/L (with any albumin level), OR albumin \<3.5 g/dL with beta2-microglobulin \<3.5 mg/L; Stage III: Serum beta2-microglobulin ≥5.5 mg/L. Normal serum beta2-microglobulin: \<3.0 mg/L; normal albumin: 3.5-5.0 g/dL.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The number analyzed is the number of participants with data available for analysis.
    title
    International Staging System
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          240
        title
        Scale = 0
      2. measurements
        1. group Id
          BG000
          value
          294
        title
        Scale = 1
      3. measurements
        1. group Id
          BG000
          value
          112
        title
        Scale = 2
      4. measurements
        1. group Id
          BG000
          value
          81
        title
        Scale = 3
      5. measurements
        1. group Id
          BG000
          value
          15
        title
        Scale = 4
      denoms
      1. counts
        1. group Id
          BG000
          value
          742
        units
        Participants
    description
    Eastern Cooperative Oncology Group performance status assess participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than \[\>\] 50 percent \[%\] of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group Performance Status
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          436
        title
        Outpatient
      2. measurements
        1. group Id
          BG000
          value
          306
        title
        Inpatient
      denoms
      1. counts
        1. group Id
          BG000
          value
          742
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Healthcare Category
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          696
        title
        Had No Hepatic Impairment
      2. measurements
        1. group Id
          BG000
          value
          46
        title
        Had Hepatic Impairment
      denoms
      1. counts
        1. group Id
          BG000
          value
          742
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hepatic Impairment
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          448
        title
        Had No Renal Impairment
      2. measurements
        1. group Id
          BG000
          value
          294
        title
        Had Renal Impairment
      denoms
      1. counts
        1. group Id
          BG000
          value
          742
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Renal Impairment
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          307
        title
        Had No Medical Complications
      2. measurements
        1. group Id
          BG000
          value
          434
        title
        Had Medical Complications
      denoms
      1. counts
        1. group Id
          BG000
          value
          741
        units
        Participants
    description
    Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The number analyzed is the number of participants with data available for analysis.
    title
    Medical Complications
    unit Of Measure
    Participants
population Description
Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      742
    units
    Participants
groups
  1. description
    The usual adult dosage for oral administration was 4 mg as ixazomib, in the fasting state, once a day, once a week for 3 weeks (Days 1, 8, and 15), with a 13-day washout period (Days 16 through 28). This 4-week cycle was repeated for 6 cycles. The dose might be reduced appropriately according to the patient's condition. Participants received interventions as part of routine medical care.
    id
    BG000
    title
    Ixazomib 4 mg
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.85
          value
          70.6
      denoms
      1. counts
        1. group Id
          BG000
          value
          742
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          391
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          351
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          742
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. denoms
      1. counts
        1. group Id
          BG000
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          742
      denoms
      1. counts
        1. group Id
          BG000
          value
          742
        units
        Participants
      title
      Japan
    description
    All participants were enrolled in Japan.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.902
          value
          4.49
      denoms
      1. counts
        1. group Id
          BG000
          value
          739
        units
        Participants
    description
    Mean duration between the first diagnosis of relapsed/refractory multiple myeloma and the start of the study was reported.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The number analyzed is the number of participants with data available for analysis.
    title
    Duration of Diagnosis of Relapsed/Refractory Multiple Myeloma
    unit Of Measure
    Years
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          742
      denoms
      1. counts
        1. group Id
          BG000
          value
          742
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Participants with Relapsed/Refractory Multiple Myeloma
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          140
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          260
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          290
        title
        Stage III
      4. measurements
        1. group Id
          BG000
          value
          50
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          740
        units
        Participants
    description
    International Staging System is a staging system for cancer progression. Stages are classified by Stage I to Stage III. Stage I: Serum beta2-microglobulin \<3.5 mg/L and albumin ≥3.5 g/dL; Stage II: Neither Stage I or III, meaning that either: beta2-microglobulin level ≥3.5 and \<5.5 mg/L (with any albumin level), OR albumin \<3.5 g/dL with beta2-microglobulin \<3.5 mg/L; Stage III: Serum beta2-microglobulin ≥5.5 mg/L. Normal serum beta2-microglobulin: \<3.0 mg/L; normal albumin: 3.5-5.0 g/dL.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The number analyzed is the number of participants with data available for analysis.
    title
    International Staging System
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          240
        title
        Scale = 0
      2. measurements
        1. group Id
          BG000
          value
          294
        title
        Scale = 1
      3. measurements
        1. group Id
          BG000
          value
          112
        title
        Scale = 2
      4. measurements
        1. group Id
          BG000
          value
          81
        title
        Scale = 3
      5. measurements
        1. group Id
          BG000
          value
          15
        title
        Scale = 4
      denoms
      1. counts
        1. group Id
          BG000
          value
          742
        units
        Participants
    description
    Eastern Cooperative Oncology Group performance status assess participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than \[\>\] 50 percent \[%\] of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group Performance Status
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          436
        title
        Outpatient
      2. measurements
        1. group Id
          BG000
          value
          306
        title
        Inpatient
      denoms
      1. counts
        1. group Id
          BG000
          value
          742
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Healthcare Category
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          696
        title
        Had No Hepatic Impairment
      2. measurements
        1. group Id
          BG000
          value
          46
        title
        Had Hepatic Impairment
      denoms
      1. counts
        1. group Id
          BG000
          value
          742
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hepatic Impairment
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          448
        title
        Had No Renal Impairment
      2. measurements
        1. group Id
          BG000
          value
          294
        title
        Had Renal Impairment
      denoms
      1. counts
        1. group Id
          BG000
          value
          742
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Renal Impairment
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          307
        title
        Had No Medical Complications
      2. measurements
        1. group Id
          BG000
          value
          434
        title
        Had Medical Complications
      denoms
      1. counts
        1. group Id
          BG000
          value
          741
        units
        Participants
    description
    Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The number analyzed is the number of participants with data available for analysis.
    title
    Medical Complications
    unit Of Measure
    Participants
population Description
Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

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Preserved source evidence · Not medical advice