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NCT02132949 · ADVERSE EVENTS

Adverse events

A Study Evaluating Pertuzumab (Perjeta) Combined With Trastuzumab (Herceptin) and Standard Anthracycline-based Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced, Inflammatory, or Early-stage Breast Cancer · Source last updated 2021-09-17

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 first dose of any study drug until the end of treatment-free follow-up (up to 6 years, 1 month)
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab

Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m\^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m\^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams \[mg\] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram \[mg/kg\] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.

56 / 199197 / 1997 / 199
Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab

Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m\^2 intravenously (IV) q3w, epirubicin 100mg/m\^2 IV q3w, and cyclophosphamide 600mg/m\^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m\^2 in Cycle 5, then 100mg/m\^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.

66 / 198198 / 19813 / 198

Group identifiers: EG000: Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab · EG001: Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab

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
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      198
      num Events
      0
    term
    AGRANULOCYTOSIS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      198
      num Events
      0
    term
    ANAEMIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      198
      num Events
      0
    term
    BONE MARROW FAILURE
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      199
      num Events
      11
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      198
      num Events
      28
    term
    FEBRILE NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      198
      num Events
      0
    term
    LEUKOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      198
      num Events
      2
    term
    NEUTROPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      198
      num Events
      1
    term
    PANCYTOPENIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      198
      num Events
      0
    term
    ACUTE MYOCARDIAL INFARCTION
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      198
      num Events
      0
    term
    ATRIAL FLUTTER
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      199
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      198
      num Events
      1
    term
    ATRIAL THROMBOSIS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      199
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      198
      num Events
      4
    term
    CARDIAC FAILURE
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      198
      num Events
      0
    term
    CARDIAC FAILURE CONGESTIVE

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
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      199
      num Events
      65
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      198
      num Events
      78
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      199
      num Events
      3
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      198
      num Events
      10
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      199
      num Events
      5
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      198
      num Events
      16
    term
    LYMPHOPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      199
      num Events
      54
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      198
      num Events
      43
    term
    NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      199
      num Events
      12
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      198
      num Events
      12
    term
    PALPITATIONS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      199
      num Events
      4
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      198
      num Events
      11
    term
    VERTIGO
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      199
      num Events
      13
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      198
      num Events
      13
    term
    DRY EYE
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      199
      num Events
      20
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      198
      num Events
      37
    term
    LACRIMATION INCREASED
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      199
      num Events
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      198
      num Events
      2
    term
    VISION BLURRED
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      199
      num Events
      12
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      198
      num Events
      38
    term
    ABDOMINAL PAIN
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      199
      num Events
      17
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      198
      num Events
      33
    term
    ABDOMINAL PAIN UPPER
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      199
      num Events
      87
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      198
      num Events
      90
    term
    CONSTIPATION
Complete source fields
event Groups
  1. deaths Num Affected
    7
    deaths Num At Risk
    199
    description
    Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m\^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m\^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams \[mg\] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram \[mg/kg\] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
    id
    EG000
    other Num Affected
    197
    other Num At Risk
    199
    serious Num Affected
    56
    serious Num At Risk
    199
    title
    Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab
  2. deaths Num Affected
    13
    deaths Num At Risk
    198
    description
    Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m\^2 intravenously (IV) q3w, epirubicin 100mg/m\^2 IV q3w, and cyclophosphamide 600mg/m\^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m\^2 in Cycle 5, then 100mg/m\^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
    id
    EG001
    other Num Affected
    198
    other Num At Risk
    198
    serious Num Affected
    66
    serious Num At Risk
    198
    title
    Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      199
      num Events
      65
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      198
      num Events
      78
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      199
      num Events
      3
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      198
      num Events
      10
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      199
      num Events
      5
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      198
      num Events
      16
    term
    LYMPHOPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      199
      num Events
      54
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      198
      num Events
      43
    term
    NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      199
      num Events
      12
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      198
      num Events
      12
    term
    PALPITATIONS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      199
      num Events
      4
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      198
      num Events
      11
    term
    VERTIGO
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      199
      num Events
      13
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      198
      num Events
      13
    term
    DRY EYE
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      199
      num Events
      20
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      198
      num Events
      37
    term
    LACRIMATION INCREASED
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      199
      num Events
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      198
      num Events
      2
    term
    VISION BLURRED
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      199
      num Events
      12
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      198
      num Events
      38
    term
    ABDOMINAL PAIN
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      199
      num Events
      17
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      198
      num Events
      33
    term
    ABDOMINAL PAIN UPPER
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      199
      num Events
      87
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      198
      num Events
      90
    term
    CONSTIPATION
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      198
      num Events
      0
    term
    AGRANULOCYTOSIS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      198
      num Events
      0
    term
    ANAEMIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      198
      num Events
      0
    term
    BONE MARROW FAILURE
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      199
      num Events
      11
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      198
      num Events
      28
    term
    FEBRILE NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      198
      num Events
      0
    term
    LEUKOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      198
      num Events
      2
    term
    NEUTROPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      198
      num Events
      1
    term
    PANCYTOPENIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      198
      num Events
      0
    term
    ACUTE MYOCARDIAL INFARCTION
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      198
      num Events
      0
    term
    ATRIAL FLUTTER
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      199
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      198
      num Events
      1
    term
    ATRIAL THROMBOSIS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      199
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      198
      num Events
      4
    term
    CARDIAC FAILURE
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      199
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      198
      num Events
      0
    term
    CARDIAC FAILURE CONGESTIVE
time Frame
From first dose of any study drug until the end of treatment-free follow-up (up to 6 years, 1 month)

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Preserved source evidence · Not medical advice