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NCT02761187 · OUTCOME

Number of Participants With Atleast One Treatment-emergent Adverse Events Leading to Treatment Discontinuation

An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Participants · Source last updated 2025-02-24

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
Baseline up to 5 years

What was measured

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Treatment discontinuation includes temporary and permanent discontinuation, drug modification, and second primary malignancies.

Analysis population: Participants who received Takeda products and signed informed consent form were included in the analysis. As pre-specified in SAP, data for treatment-emergent adverse events was planned to be collected and reported for Takeda products only. Participants were counted more than once in each line of therapy towards the total. The data is reported as per the known line of therapies.

Groups in this outcome

1st Line of Therapy

The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

2nd Line of Therapy

The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

3rd Line of Therapy

The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

4th Line of Therapy

The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

>4th Line of Therapy

The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

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

Analysis denominator · Participants

GroupSource count
1st Line of Therapy2261
2nd Line of Therapy1878
3rd Line of Therapy1455
4th Line of Therapy912
>4th Line of Therapy500

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
1st Line of Therapy375Not reportedNot reportedNot reportedNot reported
2nd Line of Therapy275Not reportedNot reportedNot reportedNot reported
3rd Line of Therapy178Not reportedNot reportedNot reportedNot reported
4th Line of Therapy98Not reportedNot reportedNot reportedNot reported
>4th Line of Therapy95Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        375
      2. group Id
        OG001
        value
        275
      3. group Id
        OG002
        value
        178
      4. group Id
        OG003
        value
        98
      5. group Id
        OG004
        value
        95
denoms
  1. counts
    1. group Id
      OG000
      value
      2261
    2. group Id
      OG001
      value
      1878
    3. group Id
      OG002
      value
      1455
    4. group Id
      OG003
      value
      912
    5. group Id
      OG004
      value
      500
    units
    Participants
description
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Treatment discontinuation includes temporary and permanent discontinuation, drug modification, and second primary malignancies.
groups
  1. description
    The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
    id
    OG000
    title
    1st Line of Therapy
  2. description
    The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
    id
    OG001
    title
    2nd Line of Therapy
  3. description
    The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
    id
    OG002
    title
    3rd Line of Therapy
  4. description
    The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
    id
    OG003
    title
    4th Line of Therapy
  5. description
    The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
    id
    OG004
    title
    >4th Line of Therapy
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants who received Takeda products and signed informed consent form were included in the analysis. As pre-specified in SAP, data for treatment-emergent adverse events was planned to be collected and reported for Takeda products only. Participants were counted more than once in each line of therapy towards the total. The data is reported as per the known line of therapies.
reporting Status
POSTED
time Frame
Baseline up to 5 years
title
Number of Participants With Atleast One Treatment-emergent Adverse Events Leading to Treatment Discontinuation
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice