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NCT00021255 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer · Source last updated 2016-11-15

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
All Adverse Events (AE) were collected from the time the participant started treatment with study drug until 30 days after the last infusion of study treatment (chemotherapy or Herceptin).
Other-event reporting threshold
5%

Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug until 30 days after the last infusion of study drug). Safety population included all treated participants. Source vocabulary used to define AE term: Pooled NCI-CTC version 2.0 and COSTART version 5.0

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)

Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.

218 / 10181017 / 1018Not reported / Not reported
AC Followed by Docetaxel + Herceptin (AC→TH)

Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.

298 / 11001100 / 1100Not reported / Not reported
Docetaxel + Carboplatin + Herceptin (TCH)

Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.

283 / 10561052 / 1056Not reported / Not reported

Group identifiers: EG000: Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) · EG001: AC Followed by Docetaxel + Herceptin (AC→TH) · EG002: Docetaxel + Carboplatin + Herceptin (TCH)

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
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      1056
    term
    ANEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      1056
    term
    LEUKOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1056
    term
    LYMPHEDEMA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      1056
    term
    PANCYTOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      1056
    term
    THROMBOCYTOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1056
    term
    ANGINA PECTORIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1056
    term
    AORTIC STENOSIS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      1056
    term
    ARRHYTHMIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1056
    term
    ARTERIAL ANOMALY
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1056
    term
    AV BLOCK
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1056
    term
    CARDIOMYOPATHY
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1056
    term
    CARDIOVASCULAR DISORDER

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
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      94
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      107
      num At Risk
      1056
    term
    LYMPHEDEMA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      78
      num At Risk
      1056
    term
    HYPERTENSION
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      1056
    term
    LEFT HEART FAILURE
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      94
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      95
      num At Risk
      1056
    term
    PALPITATION
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      67
      num At Risk
      1056
    term
    TACHYCARDIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      230
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      238
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      252
      num At Risk
      1056
    term
    ANOREXIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      383
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      403
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      351
      num At Risk
      1056
    term
    CONSTIPATION
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      439
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      555
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      658
      num At Risk
      1056
    term
    DIARRHEA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      204
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      273
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      263
      num At Risk
      1056
    term
    DYSPEPSIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      890
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      967
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      863
      num At Risk
      1056
    term
    NAUSEA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      660
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      735
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      564
      num At Risk
      1056
    term
    STOMATITIS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      563
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      628
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      428
      num At Risk
      1056
    term
    VOMITING
Complete source fields
description
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug until 30 days after the last infusion of study drug). Safety population included all treated participants. Source vocabulary used to define AE term: Pooled NCI-CTC version 2.0 and COSTART version 5.0
event Groups
  1. description
    Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
    id
    EG000
    other Num Affected
    1017
    other Num At Risk
    1018
    serious Num Affected
    218
    serious Num At Risk
    1018
    title
    Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)
  2. description
    Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
    id
    EG001
    other Num Affected
    1100
    other Num At Risk
    1100
    serious Num Affected
    298
    serious Num At Risk
    1100
    title
    AC Followed by Docetaxel + Herceptin (AC→TH)
  3. description
    Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
    id
    EG002
    other Num Affected
    1052
    other Num At Risk
    1056
    serious Num Affected
    283
    serious Num At Risk
    1056
    title
    Docetaxel + Carboplatin + Herceptin (TCH)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      94
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      107
      num At Risk
      1056
    term
    LYMPHEDEMA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      78
      num At Risk
      1056
    term
    HYPERTENSION
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      1056
    term
    LEFT HEART FAILURE
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      94
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      95
      num At Risk
      1056
    term
    PALPITATION
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      67
      num At Risk
      1056
    term
    TACHYCARDIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      230
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      238
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      252
      num At Risk
      1056
    term
    ANOREXIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      383
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      403
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      351
      num At Risk
      1056
    term
    CONSTIPATION
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      439
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      555
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      658
      num At Risk
      1056
    term
    DIARRHEA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      204
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      273
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      263
      num At Risk
      1056
    term
    DYSPEPSIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      890
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      967
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      863
      num At Risk
      1056
    term
    NAUSEA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      660
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      735
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      564
      num At Risk
      1056
    term
    STOMATITIS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      563
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      628
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      428
      num At Risk
      1056
    term
    VOMITING
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      1056
    term
    ANEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      1056
    term
    LEUKOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1056
    term
    LYMPHEDEMA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      1056
    term
    PANCYTOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      1056
    term
    THROMBOCYTOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1056
    term
    ANGINA PECTORIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1056
    term
    AORTIC STENOSIS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      1056
    term
    ARRHYTHMIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1056
    term
    ARTERIAL ANOMALY
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1056
    term
    AV BLOCK
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1056
    term
    CARDIOMYOPATHY
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI V2/COSTART V5
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1018
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1100
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1056
    term
    CARDIOVASCULAR DISORDER
time Frame
All Adverse Events (AE) were collected from the time the participant started treatment with study drug until 30 days after the last infusion of study treatment (chemotherapy or Herceptin).

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Preserved source evidence · Not medical advice