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NCT00976989 · ADVERSE EVENTS

Adverse events

A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer · Source last updated 2017-02-06

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
Up to approximately 5 years
Other-event reporting threshold
5%

Safety population included all participants who were randomized and received study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
T+P Concomitant Anthracycline-based Chemotherapy

5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.

23 / 7272 / 72Not reported / Not reported
T+P Sequential Anthracycline-based Chemotherapy

FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.

18 / 7573 / 75Not reported / Not reported
T+P Concomitant Non-Anthracycline Chemotherapy

Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.

31 / 7676 / 76Not reported / Not reported

Group identifiers: EG000: T+P Concomitant Anthracycline-based Chemotherapy · EG001: T+P Sequential Anthracycline-based Chemotherapy · EG002: T+P Concomitant Non-Anthracycline Chemotherapy

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 (18.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      76
    term
    Febrile Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      76
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      76
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Neutropenic infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Wound infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Anal abscess
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Appendicitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Catheter site infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Clostridium difficile colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Clostridium difficile infection

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      55
      num At Risk
      76
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      76
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      76
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      76
    term
    Dyspepsia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      76
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      76
    term
    Stomatitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      76
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      76
    term
    Dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      76
    term
    Haemorrhoids
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      76
    term
    Abdominal distension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      76
    term
    Oral pain
Complete source fields
description
Safety population included all participants who were randomized and received study drug.
event Groups
  1. description
    5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
    id
    EG000
    other Num Affected
    72
    other Num At Risk
    72
    serious Num Affected
    23
    serious Num At Risk
    72
    title
    T+P Concomitant Anthracycline-based Chemotherapy
  2. description
    FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
    id
    EG001
    other Num Affected
    73
    other Num At Risk
    75
    serious Num Affected
    18
    serious Num At Risk
    75
    title
    T+P Sequential Anthracycline-based Chemotherapy
  3. description
    Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
    id
    EG002
    other Num Affected
    76
    other Num At Risk
    76
    serious Num Affected
    31
    serious Num At Risk
    76
    title
    T+P Concomitant Non-Anthracycline Chemotherapy
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      55
      num At Risk
      76
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      76
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      76
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      76
    term
    Dyspepsia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      76
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      76
    term
    Stomatitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      76
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      76
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      76
    term
    Dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      76
    term
    Haemorrhoids
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      76
    term
    Abdominal distension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      76
    term
    Oral pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      76
    term
    Febrile Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      76
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      76
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Neutropenic infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Wound infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Anal abscess
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Appendicitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Catheter site infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      76
    term
    Clostridium difficile colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (18.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      75
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      76
    term
    Clostridium difficile infection
time Frame
Up to approximately 5 years

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Preserved source evidence · Not medical advice