NCT02132949 · ADVERSE EVENTS
Adverse events
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
- From first dose of any study drug until the end of treatment-free follow-up (up to 6 years, 1 month)
- Other-event reporting threshold
- 5%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab | 56 / 199 | 197 / 199 | 7 / 199 |
| Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab | 66 / 198 | 198 / 198 | 13 / 198 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 198
- num Events
- 0
- term
- AGRANULOCYTOSIS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 198
- num Events
- 0
- term
- ANAEMIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 198
- num Events
- 0
- term
- BONE MARROW FAILURE
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 11
- num At Risk
- 199
- num Events
- 11
- group Id
- EG001
- num Affected
- 27
- num At Risk
- 198
- num Events
- 28
- term
- FEBRILE NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 198
- num Events
- 0
- term
- LEUKOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- num Events
- 1
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 198
- num Events
- 2
- term
- NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 198
- num Events
- 1
- term
- PANCYTOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 198
- num Events
- 0
- term
- ACUTE MYOCARDIAL INFARCTION
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 198
- num Events
- 0
- term
- ATRIAL FLUTTER
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 199
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 198
- num Events
- 1
- term
- ATRIAL THROMBOSIS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 199
- num Events
- 3
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 198
- num Events
- 4
- term
- CARDIAC FAILURE
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 198
- num Events
- 0
- term
- CARDIAC FAILURE CONGESTIVE
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 56
- num At Risk
- 199
- num Events
- 65
- group Id
- EG001
- num Affected
- 64
- num At Risk
- 198
- num Events
- 78
- term
- ANAEMIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 199
- num Events
- 3
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 198
- num Events
- 10
- term
- FEBRILE NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 199
- num Events
- 5
- group Id
- EG001
- num Affected
- 11
- num At Risk
- 198
- num Events
- 16
- term
- LYMPHOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 43
- num At Risk
- 199
- num Events
- 54
- group Id
- EG001
- num Affected
- 31
- num At Risk
- 198
- num Events
- 43
- term
- NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 199
- num Events
- 12
- group Id
- EG001
- num Affected
- 11
- num At Risk
- 198
- num Events
- 12
- term
- PALPITATIONS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 199
- num Events
- 4
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 198
- num Events
- 11
- term
- VERTIGO
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 199
- num Events
- 13
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 198
- num Events
- 13
- term
- DRY EYE
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 20
- num At Risk
- 199
- num Events
- 20
- group Id
- EG001
- num Affected
- 37
- num At Risk
- 198
- num Events
- 37
- term
- LACRIMATION INCREASED
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 199
- num Events
- 16
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 198
- num Events
- 2
- term
- VISION BLURRED
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 199
- num Events
- 12
- group Id
- EG001
- num Affected
- 27
- num At Risk
- 198
- num Events
- 38
- term
- ABDOMINAL PAIN
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 15
- num At Risk
- 199
- num Events
- 17
- group Id
- EG001
- num Affected
- 31
- num At Risk
- 198
- num Events
- 33
- term
- ABDOMINAL PAIN UPPER
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 73
- num At Risk
- 199
- num Events
- 87
- group Id
- EG001
- num Affected
- 78
- num At Risk
- 198
- num Events
- 90
- term
- CONSTIPATION
Complete source fields
- event Groups
- deaths Num Affected
- 7
- deaths Num At Risk
- 199
- description
- Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m\^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m\^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams \[mg\] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram \[mg/kg\] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
- id
- EG000
- other Num Affected
- 197
- other Num At Risk
- 199
- serious Num Affected
- 56
- serious Num At Risk
- 199
- title
- Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab
- deaths Num Affected
- 13
- deaths Num At Risk
- 198
- description
- Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m\^2 intravenously (IV) q3w, epirubicin 100mg/m\^2 IV q3w, and cyclophosphamide 600mg/m\^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m\^2 in Cycle 5, then 100mg/m\^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
- id
- EG001
- other Num Affected
- 198
- other Num At Risk
- 198
- serious Num Affected
- 66
- serious Num At Risk
- 198
- title
- Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 56
- num At Risk
- 199
- num Events
- 65
- group Id
- EG001
- num Affected
- 64
- num At Risk
- 198
- num Events
- 78
- term
- ANAEMIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 199
- num Events
- 3
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 198
- num Events
- 10
- term
- FEBRILE NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 199
- num Events
- 5
- group Id
- EG001
- num Affected
- 11
- num At Risk
- 198
- num Events
- 16
- term
- LYMPHOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 43
- num At Risk
- 199
- num Events
- 54
- group Id
- EG001
- num Affected
- 31
- num At Risk
- 198
- num Events
- 43
- term
- NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 199
- num Events
- 12
- group Id
- EG001
- num Affected
- 11
- num At Risk
- 198
- num Events
- 12
- term
- PALPITATIONS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 199
- num Events
- 4
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 198
- num Events
- 11
- term
- VERTIGO
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 199
- num Events
- 13
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 198
- num Events
- 13
- term
- DRY EYE
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 20
- num At Risk
- 199
- num Events
- 20
- group Id
- EG001
- num Affected
- 37
- num At Risk
- 198
- num Events
- 37
- term
- LACRIMATION INCREASED
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 199
- num Events
- 16
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 198
- num Events
- 2
- term
- VISION BLURRED
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 199
- num Events
- 12
- group Id
- EG001
- num Affected
- 27
- num At Risk
- 198
- num Events
- 38
- term
- ABDOMINAL PAIN
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 15
- num At Risk
- 199
- num Events
- 17
- group Id
- EG001
- num Affected
- 31
- num At Risk
- 198
- num Events
- 33
- term
- ABDOMINAL PAIN UPPER
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 73
- num At Risk
- 199
- num Events
- 87
- group Id
- EG001
- num Affected
- 78
- num At Risk
- 198
- num Events
- 90
- term
- CONSTIPATION
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 198
- num Events
- 0
- term
- AGRANULOCYTOSIS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 198
- num Events
- 0
- term
- ANAEMIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 198
- num Events
- 0
- term
- BONE MARROW FAILURE
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 11
- num At Risk
- 199
- num Events
- 11
- group Id
- EG001
- num Affected
- 27
- num At Risk
- 198
- num Events
- 28
- term
- FEBRILE NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 198
- num Events
- 0
- term
- LEUKOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- num Events
- 1
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 198
- num Events
- 2
- term
- NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 198
- num Events
- 1
- term
- PANCYTOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 198
- num Events
- 0
- term
- ACUTE MYOCARDIAL INFARCTION
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 198
- num Events
- 0
- term
- ATRIAL FLUTTER
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 199
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 198
- num Events
- 1
- term
- ATRIAL THROMBOSIS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 199
- num Events
- 3
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 198
- num Events
- 4
- term
- CARDIAC FAILURE
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 199
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 198
- num Events
- 0
- term
- CARDIAC FAILURE CONGESTIVE
- time Frame
- From first dose of any study drug until the end of treatment-free follow-up (up to 6 years, 1 month)
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