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NCT00861705 · ADVERSE EVENTS

Adverse events

Paclitaxel With or Without Carboplatin and/or Bevacizumab Followed by Doxorubicin and Cyclophosphamide in Treating Patients With Breast Cancer That Can Be Removed by Surgery · Source last updated 2026-06-29

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
Not reported
Other-event reporting threshold
0%

Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm 1 (Pac --> ddAC)

cyclophosphamide: Given IV

15 / 108107 / 108Not reported / Not reported
Arm 2 (Pac + Bev --> ddAC + Bev)

bevacizumab: Given IV

27 / 108104 / 108Not reported / Not reported
Arm 3 (Pac + Carboplatin --> ddAC)

carboplatin: Given IV

21 / 109106 / 109Not reported / Not reported
Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)

carboplatin: Given IV

39 / 112109 / 112Not reported / Not reported

Group identifiers: EG000: Arm 1 (Pac --> ddAC) · EG001: Arm 2 (Pac + Bev --> ddAC + Bev) · EG002: Arm 3 (Pac + Carboplatin --> ddAC) · EG003: Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)

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 6
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      108
      num Events
      11
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      108
      num Events
      17
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      109
      num Events
      20
    4. group Id
      EG003
      num Affected
      28
      num At Risk
      112
      num Events
      33
    term
    Blood disorder
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      108
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      108
      num Events
      5
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      109
      num Events
      9
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      112
      num Events
      16
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      108
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      109
      num Events
      5
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      112
      num Events
      6
    term
    Hemoglobin decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Atrial tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Myocardial ischemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Palpitations
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      108
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Dry eye syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      112
      num Events
      2
    term
    Eye disorder
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      109
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Vision blurred
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Watering eyes
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      108
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      109
      num Events
      3
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      112
      num Events
      7
    term
    Abdominal pain

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 6
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      108
      num Events
      196
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      108
      num Events
      148
    3. group Id
      EG002
      num Affected
      90
      num At Risk
      109
      num Events
      277
    4. group Id
      EG003
      num Affected
      92
      num At Risk
      112
      num Events
      255
    term
    Blood disorder
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      108
      num Events
      3
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      108
      num Events
      9
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      109
      num Events
      5
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      112
      num Events
      11
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      108
      num Events
      20
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      108
      num Events
      30
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      109
      num Events
      22
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      112
      num Events
      31
    term
    Hemoglobin decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      108
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      109
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Hemolysis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Lymph node pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      108
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Lymphatic disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      112
      num Events
      2
    term
    Cardiac disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Cardiac pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Left ventricular failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      108
      num Events
      5
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      108
      num Events
      10
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      109
      num Events
      10
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      112
      num Events
      4
    term
    Palpitations
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      108
      num Events
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      109
      num Events
      4
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      112
      num Events
      7
    term
    Sinus tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      112
      num Events
      2
    term
    Stokes-Adams syndrome
Complete source fields
description
Out of the 454 participants, 443 began treatment. Six participants were not evaluable for adverse events due to site non-compliance (2 in Arm 2 and 4 in Arm 3). Therefore, adverse events data are available for 437 participants (108 in Arm 1, 108 in Arm 2, 109 in Arm 3, and 112 in Arm 4).
event Groups
  1. description
    cyclophosphamide: Given IV
    id
    EG000
    other Num Affected
    107
    other Num At Risk
    108
    serious Num Affected
    15
    serious Num At Risk
    108
    title
    Arm 1 (Pac --> ddAC)
  2. description
    bevacizumab: Given IV
    id
    EG001
    other Num Affected
    104
    other Num At Risk
    108
    serious Num Affected
    27
    serious Num At Risk
    108
    title
    Arm 2 (Pac + Bev --> ddAC + Bev)
  3. description
    carboplatin: Given IV
    id
    EG002
    other Num Affected
    106
    other Num At Risk
    109
    serious Num Affected
    21
    serious Num At Risk
    109
    title
    Arm 3 (Pac + Carboplatin --> ddAC)
  4. description
    carboplatin: Given IV
    id
    EG003
    other Num Affected
    109
    other Num At Risk
    112
    serious Num Affected
    39
    serious Num At Risk
    112
    title
    Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      108
      num Events
      196
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      108
      num Events
      148
    3. group Id
      EG002
      num Affected
      90
      num At Risk
      109
      num Events
      277
    4. group Id
      EG003
      num Affected
      92
      num At Risk
      112
      num Events
      255
    term
    Blood disorder
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      108
      num Events
      3
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      108
      num Events
      9
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      109
      num Events
      5
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      112
      num Events
      11
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      108
      num Events
      20
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      108
      num Events
      30
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      109
      num Events
      22
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      112
      num Events
      31
    term
    Hemoglobin decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      108
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      109
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Hemolysis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Lymph node pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      108
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Lymphatic disorder
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      112
      num Events
      2
    term
    Cardiac disorder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Cardiac pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Left ventricular failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      108
      num Events
      5
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      108
      num Events
      10
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      109
      num Events
      10
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      112
      num Events
      4
    term
    Palpitations
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      108
      num Events
      5
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      109
      num Events
      4
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      112
      num Events
      7
    term
    Sinus tachycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      112
      num Events
      2
    term
    Stokes-Adams syndrome
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      108
      num Events
      11
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      108
      num Events
      17
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      109
      num Events
      20
    4. group Id
      EG003
      num Affected
      28
      num At Risk
      112
      num Events
      33
    term
    Blood disorder
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      108
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      108
      num Events
      5
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      109
      num Events
      9
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      112
      num Events
      16
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      108
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      109
      num Events
      5
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      112
      num Events
      6
    term
    Hemoglobin decreased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Atrial tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Myocardial ischemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      108
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Palpitations
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      108
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      109
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      112
      num Events
      1
    term
    Dry eye syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      112
      num Events
      2
    term
    Eye disorder
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      109
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Vision blurred
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      108
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      109
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      112
      num Events
      0
    term
    Watering eyes
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 6
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      108
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      109
      num Events
      3
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      112
      num Events
      7
    term
    Abdominal pain

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Preserved source evidence · Not medical advice