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NCT00829166 · ADVERSE EVENTS

Adverse events

A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer · Source last updated 2016-10-31

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
Only study-related serious adverse events (SAEs) were reported from randomization to first treatment; all SAEs and non-SAEs were reported from start of treatment until 30 days after treatment; and thereafter only treatment related SAEs were reported until data cut-off date of 21-Sep-2015 (up to 6 years and 7 months). For participants who crossed over from lapatinib + capecitabine to trastuzumab emtansine, data is reported from time of cross-over until 21-Sep-2015 (up to 3 years and 2 months).
Other-event reporting threshold
5%

Safety population included participants who received at least 1 dose of study medication. Safety analyses were based on the actual treatment received.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Trastuzumab Emtansine

Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.

92 / 490474 / 490Not reported / Not reported
Lapatinib + Capecitabine

Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.

99 / 488471 / 488Not reported / Not reported
Lapatinib + Capecitabine/ Trastuzumab Emtansine

Participants of "Lapatinib + Capecitabine" arm were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.

19 / 136115 / 136Not reported / Not reported

Group identifiers: EG000: Trastuzumab Emtansine · EG001: Lapatinib + Capecitabine · EG002: Lapatinib + Capecitabine/ Trastuzumab Emtansine

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Unmapped (Bacteremia due to infected port)
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Anaemia
  3. assessment Type
    NON_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
      490
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Anaemia of malignant disease
  4. assessment Type
    NON_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
      490
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Febrile neutropenia
  5. assessment Type
    NON_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
      490
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      136
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Angina pectoris
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Atrial fibrillation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Cardiomyopathy
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Coronary artery disease
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Pericardial effusion
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Pericarditis

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      136
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      150
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      136
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      136
    term
    Dry eye
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Abdominal pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Abdominal pain upper
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      139
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      136
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      123
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      385
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      136
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      85
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      136
    term
    Dry mouth
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      136
    term
    Dyspepsia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      136
    term
    Gingival bleeding
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      202
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      224
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      35
      num At Risk
      136
    term
    Nausea
Complete source fields
description
Safety population included participants who received at least 1 dose of study medication. Safety analyses were based on the actual treatment received.
event Groups
  1. description
    Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
    id
    EG000
    other Num Affected
    474
    other Num At Risk
    490
    serious Num Affected
    92
    serious Num At Risk
    490
    title
    Trastuzumab Emtansine
  2. description
    Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
    id
    EG001
    other Num Affected
    471
    other Num At Risk
    488
    serious Num Affected
    99
    serious Num At Risk
    488
    title
    Lapatinib + Capecitabine
  3. description
    Participants of "Lapatinib + Capecitabine" arm were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
    id
    EG002
    other Num Affected
    115
    other Num At Risk
    136
    serious Num Affected
    19
    serious Num At Risk
    136
    title
    Lapatinib + Capecitabine/ Trastuzumab Emtansine
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      136
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      150
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      136
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      136
    term
    Dry eye
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Abdominal pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Abdominal pain upper
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      139
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      136
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      123
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      385
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      136
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      85
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      136
    term
    Dry mouth
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      136
    term
    Dyspepsia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      136
    term
    Gingival bleeding
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      202
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      224
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      35
      num At Risk
      136
    term
    Nausea
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Unmapped (Bacteremia due to infected port)
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Anaemia
  3. assessment Type
    NON_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
      490
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Anaemia of malignant disease
  4. assessment Type
    NON_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
      490
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Febrile neutropenia
  5. assessment Type
    NON_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
      490
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      136
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Angina pectoris
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Atrial fibrillation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Cardiomyopathy
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Coronary artery disease
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Pericardial effusion
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      490
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      488
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      136
    term
    Pericarditis
time Frame
Only study-related serious adverse events (SAEs) were reported from randomization to first treatment; all SAEs and non-SAEs were reported from start of treatment until 30 days after treatment; and thereafter only treatment related SAEs were reported until data cut-off date of 21-Sep-2015 (up to 6 years and 7 months). For participants who crossed over from lapatinib + capecitabine to trastuzumab emtansine, data is reported from time of cross-over until 21-Sep-2015 (up to 3 years and 2 months).

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Preserved source evidence · Not medical advice