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NCT02761187 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
From start of study, until death, or the end of the study, whichever comes first (up to 5 years)
Other-event reporting threshold
0%

As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
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).

269 / 1849306 / 1849351 / 1790
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).

101 / 773125 / 773418 / 1331
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).

82 / 45579 / 455420 / 1050
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).

43 / 23939 / 239348 / 739
>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).

38 / 18132 / 181234 / 453
Robustness Concerns: 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). Only participants treated in 1st line of therapy with concerns around the robustness of data were included in this arm.

0 / 00 / 058 / 340
Robustness Concerns: 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). Only participants treated in 2nd line of therapy with concerns around the robustness of data were included in this arm.

0 / 00 / 072 / 303
Robustness Concerns: 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). Only participants treated in 3rd line of therapy with concerns around the robustness of data were included in this arm.

0 / 00 / 065 / 222
Robustness Concerns: 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). Only participants treated in 4th line of therapy with concerns around the robustness of data were included in this arm.

0 / 00 / 032 / 86
Robustness Concerns: >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). Only participants treated in \>4th line of therapy with concerns around the robustness of data were included in this arm.

0 / 00 / 06 / 24
Robustness Concerns: Unknown Line of Therapy

The 'Unknown Line of Therapy' indicates either: 1) participant was on a regimen on or after study entry, but missing line of therapy with respect to that regimen or 2) have not observed any regimen with line of therapy on or after study entry. Only participants in unknown line of therapy with concerns around the robustness of data were included in this arm.

0 / 00 / 028 / 147

Group identifiers: EG000: 1st Line of Therapy · EG001: 2nd Line of Therapy · EG002: 3rd Line of Therapy · EG003: 4th Line of Therapy · EG004: >4th Line of Therapy · EG005: Robustness Concerns: 1st Line of Therapy · EG006: Robustness Concerns: 2nd Line of Therapy · EG007: Robustness Concerns: 3rd Line of Therapy · EG008: Robustness Concerns: 4th Line of Therapy · EG009: Robustness Concerns: >4th Line of Therapy · EG010: Robustness Concerns: Unknown Line of Therapy

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Febrile bone marrow aplasia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Haematotoxicity
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Angina pectoris
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Atrial flutter
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Bradycardia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Anaemia of malignant disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Cytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Haematotoxicity
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Leukopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Angina pectoris
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Bradycardia
Complete source fields
description
As per planned analysis,mortality was collected for all participants; serious/other adverse events were collected only for participants who signed an informed consent form and had robust data. Data was reported per line of therapies and robustness concerns.As pre-specified in SAP,serious and other adverse events were collected and reported for Takeda products only.A participant maybe counted across multiple lines of therapy, allowing same participant to be represented in multiple index regimens.
event Groups
  1. deaths Num Affected
    351
    deaths Num At Risk
    1790
    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
    EG000
    other Num Affected
    306
    other Num At Risk
    1849
    serious Num Affected
    269
    serious Num At Risk
    1849
    title
    1st Line of Therapy
  2. deaths Num Affected
    418
    deaths Num At Risk
    1331
    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
    EG001
    other Num Affected
    125
    other Num At Risk
    773
    serious Num Affected
    101
    serious Num At Risk
    773
    title
    2nd Line of Therapy
  3. deaths Num Affected
    420
    deaths Num At Risk
    1050
    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
    EG002
    other Num Affected
    79
    other Num At Risk
    455
    serious Num Affected
    82
    serious Num At Risk
    455
    title
    3rd Line of Therapy
  4. deaths Num Affected
    348
    deaths Num At Risk
    739
    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
    EG003
    other Num Affected
    39
    other Num At Risk
    239
    serious Num Affected
    43
    serious Num At Risk
    239
    title
    4th Line of Therapy
  5. deaths Num Affected
    234
    deaths Num At Risk
    453
    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
    EG004
    other Num Affected
    32
    other Num At Risk
    181
    serious Num Affected
    38
    serious Num At Risk
    181
    title
    >4th Line of Therapy
  6. deaths Num Affected
    58
    deaths Num At Risk
    340
    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). Only participants treated in 1st line of therapy with concerns around the robustness of data were included in this arm.
    id
    EG005
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Robustness Concerns: 1st Line of Therapy
  7. deaths Num Affected
    72
    deaths Num At Risk
    303
    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). Only participants treated in 2nd line of therapy with concerns around the robustness of data were included in this arm.
    id
    EG006
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Robustness Concerns: 2nd Line of Therapy
  8. deaths Num Affected
    65
    deaths Num At Risk
    222
    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). Only participants treated in 3rd line of therapy with concerns around the robustness of data were included in this arm.
    id
    EG007
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Robustness Concerns: 3rd Line of Therapy
  9. deaths Num Affected
    32
    deaths Num At Risk
    86
    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). Only participants treated in 4th line of therapy with concerns around the robustness of data were included in this arm.
    id
    EG008
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Robustness Concerns: 4th Line of Therapy
  10. deaths Num Affected
    6
    deaths Num At Risk
    24
    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). Only participants treated in \>4th line of therapy with concerns around the robustness of data were included in this arm.
    id
    EG009
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Robustness Concerns: >4th Line of Therapy
  11. deaths Num Affected
    28
    deaths Num At Risk
    147
    description
    The 'Unknown Line of Therapy' indicates either: 1) participant was on a regimen on or after study entry, but missing line of therapy with respect to that regimen or 2) have not observed any regimen with line of therapy on or after study entry. Only participants in unknown line of therapy with concerns around the robustness of data were included in this arm.
    id
    EG010
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Robustness Concerns: Unknown Line of Therapy
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Anaemia of malignant disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Cytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Haematotoxicity
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Leukopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Angina pectoris
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Bradycardia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Febrile bone marrow aplasia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Haematotoxicity
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Angina pectoris
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Atrial flutter
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1849
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      773
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      455
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      239
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      181
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      0
    term
    Bradycardia
time Frame
From start of study, until death, or the end of the study, whichever comes first (up to 5 years)

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Preserved source evidence · Not medical advice