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NCT01945775 · ADVERSE EVENTS

Adverse events

A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) · Source last updated 2022-01-20

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
Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
Other-event reporting threshold
5%

Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.

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

Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.

103 / 286282 / 286220 / 286
Physician's Choice Treatment

Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m\^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m\^2 (equivalent to eribulin 1.23 mg/ m\^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m\^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m\^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.

39 / 126123 / 126100 / 126

Group identifiers: EG000: Talazoparib · EG001: Physician's Choice Treatment

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      126
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      126
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      126
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      126
    term
    Febrile neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      126
    term
    Leukopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      126
    term
    Pancytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      126
    term
    Pericardial effusion
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      126
    term
    Atrial flutter
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      126
    term
    Cardiac tamponade
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      126
    term
    Diplopia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      126
    term
    Vomiting
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      126
    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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      153
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      126
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      77
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      126
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      126
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      126
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      126
    term
    Lacrimation increased
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      142
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      126
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      126
    term
    Diarrhoea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      126
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      126
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      126
    term
    Abdominal pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      126
    term
    Dyspepsia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      126
    term
    Stomatitis
Complete source fields
description
Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
event Groups
  1. deaths Num Affected
    220
    deaths Num At Risk
    286
    description
    Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.
    id
    EG000
    other Num Affected
    282
    other Num At Risk
    286
    serious Num Affected
    103
    serious Num At Risk
    286
    title
    Talazoparib
  2. deaths Num Affected
    100
    deaths Num At Risk
    126
    description
    Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m\^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m\^2 (equivalent to eribulin 1.23 mg/ m\^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m\^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m\^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.
    id
    EG001
    other Num Affected
    123
    other Num At Risk
    126
    serious Num Affected
    39
    serious Num At Risk
    126
    title
    Physician's Choice Treatment
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      153
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      126
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      77
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      126
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      126
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      126
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      126
    term
    Lacrimation increased
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      142
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      126
    term
    Nausea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      126
    term
    Diarrhoea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      126
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      126
    term
    Constipation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      126
    term
    Abdominal pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      126
    term
    Dyspepsia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      126
    term
    Stomatitis
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      126
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      126
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      126
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      126
    term
    Febrile neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      126
    term
    Leukopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      126
    term
    Pancytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      126
    term
    Pericardial effusion
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      126
    term
    Atrial flutter
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      126
    term
    Cardiac tamponade
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      126
    term
    Diplopia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      126
    term
    Vomiting
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v.20.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      286
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      126
    term
    Abdominal pain
time Frame
Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months

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