NCT01358877 · ADVERSE EVENTS

Adverse events

A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer · Source last updated 2025-11-28

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 randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years)
Other-event reporting threshold: 5%

All-cause mortality is reported in the ITT Population. AEs are reported in the Safety Population (Pertuzumab: N=2364 \[2340 pertuzumab arm + 24 placebo arm who received any pertuzumab\]; Placebo: N=2405 \[2367 placebo arm + 38 pertuzumab arm who did not receive any pertuzumab\]). All AEs were collected until 28 days after the last dose (up to 80 weeks). In follow-up, AEs reported were study treatment-related serious AEs, cardiac AEs, SPNBC and myelodysplastic syndrome, and pregnancies.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pertuzumab + Trastuzumab + Chemotherapy Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).	792 / 2364	2353 / 2364	205 / 2400
Placebo + Trastuzumab + Chemotherapy Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).	686 / 2405	2374 / 2405	247 / 2404

Group identifiers: EG000: Pertuzumab + Trastuzumab + Chemotherapy · EG001: Placebo + Trastuzumab + Chemotherapy

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
1
num At Risk
2364
num Events
1
group Id
EG001
num Affected
0
num At Risk
2405
num Events
0
term
AGRANULOCYTOSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
10
num At Risk
2364
num Events
14
group Id
EG001
num Affected
8
num At Risk
2405
num Events
10
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
9
num At Risk
2364
num Events
9
group Id
EG001
num Affected
8
num At Risk
2405
num Events
9
term
FEBRILE BONE MARROW APLASIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
211
num At Risk
2364
num Events
239
group Id
EG001
num Affected
196
num At Risk
2405
num Events
215
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
1
num At Risk
2364
num Events
1
group Id
EG001
num Affected
0
num At Risk
2405
num Events
0
term
HAEMOLYTIC ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
0
num At Risk
2364
num Events
0
group Id
EG001
num Affected
1
num At Risk
2405
num Events
1
term
IDIOPATHIC CYTOPENIA OF UNDETERMINED SIGNIFICANCE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
3
num At Risk
2364
num Events
3
group Id
EG001
num Affected
5
num At Risk
2405
num Events
5
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
1
num At Risk
2364
num Events
1
group Id
EG001
num Affected
1
num At Risk
2405
num Events
1
term
LYMPHADENOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
0
num At Risk
2364
num Events
0
group Id
EG001
num Affected
1
num At Risk
2405
num Events
1
term
MICROANGIOPATHIC HAEMOLYTIC ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
2
num At Risk
2364
num Events
2
group Id
EG001
num Affected
3
num At Risk
2405
num Events
3
term
MYELOSUPPRESSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
25
num At Risk
2364
num Events
30
group Id
EG001
num Affected
34
num At Risk
2405
num Events
39
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
1
num At Risk
2364
num Events
1
group Id
EG001
num Affected
1
num At Risk
2405
num Events
1
term
PANCYTOPENIA

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
667
num At Risk
2364
num Events
833
group Id
EG001
num Affected
567
num At Risk
2405
num Events
717
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
220
num At Risk
2364
num Events
484
group Id
EG001
num Affected
235
num At Risk
2405
num Events
535
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
592
num At Risk
2364
num Events
1039
group Id
EG001
num Affected
556
num At Risk
2405
num Events
1007
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
141
num At Risk
2364
num Events
146
group Id
EG001
num Affected
113
num At Risk
2405
num Events
118
term
DRY EYE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
312
num At Risk
2364
num Events
334
group Id
EG001
num Affected
324
num At Risk
2405
num Events
347
term
LACRIMATION INCREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
285
num At Risk
2364
num Events
369
group Id
EG001
num Affected
261
num At Risk
2405
num Events
337
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
244
num At Risk
2364
num Events
304
group Id
EG001
num Affected
220
num At Risk
2405
num Events
297
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
692
num At Risk
2364
num Events
1028
group Id
EG001
num Affected
762
num At Risk
2405
num Events
1117
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
1667
num At Risk
2364
num Events
3368
group Id
EG001
num Affected
1091
num At Risk
2405
num Events
1791
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
150
num At Risk
2364
num Events
166
group Id
EG001
num Affected
140
num At Risk
2405
num Events
176
term
DRY MOUTH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
328
num At Risk
2364
num Events
378
group Id
EG001
num Affected
341
num At Risk
2405
num Events
406
term
DYSPEPSIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
124
num At Risk
2364
num Events
144
group Id
EG001
num Affected
110
num At Risk
2405
num Events
124
term
GASTROOESOPHAGEAL REFLUX DISEASE

Complete source fields

description

event Groups

deaths Num Affected
205
deaths Num At Risk
2400
description
Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
id
EG000
other Num Affected
2353
other Num At Risk
2364
serious Num Affected
792
serious Num At Risk
2364
title
Pertuzumab + Trastuzumab + Chemotherapy
deaths Num Affected
247
deaths Num At Risk
2404
description
Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
id
EG001
other Num Affected
2374
other Num At Risk
2405
serious Num Affected
686
serious Num At Risk
2405
title
Placebo + Trastuzumab + Chemotherapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
667
num At Risk
2364
num Events
833
group Id
EG001
num Affected
567
num At Risk
2405
num Events
717
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
220
num At Risk
2364
num Events
484
group Id
EG001
num Affected
235
num At Risk
2405
num Events
535
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
592
num At Risk
2364
num Events
1039
group Id
EG001
num Affected
556
num At Risk
2405
num Events
1007
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
141
num At Risk
2364
num Events
146
group Id
EG001
num Affected
113
num At Risk
2405
num Events
118
term
DRY EYE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
312
num At Risk
2364
num Events
334
group Id
EG001
num Affected
324
num At Risk
2405
num Events
347
term
LACRIMATION INCREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
285
num At Risk
2364
num Events
369
group Id
EG001
num Affected
261
num At Risk
2405
num Events
337
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
244
num At Risk
2364
num Events
304
group Id
EG001
num Affected
220
num At Risk
2405
num Events
297
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
692
num At Risk
2364
num Events
1028
group Id
EG001
num Affected
762
num At Risk
2405
num Events
1117
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
1667
num At Risk
2364
num Events
3368
group Id
EG001
num Affected
1091
num At Risk
2405
num Events
1791
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
150
num At Risk
2364
num Events
166
group Id
EG001
num Affected
140
num At Risk
2405
num Events
176
term
DRY MOUTH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
328
num At Risk
2364
num Events
378
group Id
EG001
num Affected
341
num At Risk
2405
num Events
406
term
DYSPEPSIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
124
num At Risk
2364
num Events
144
group Id
EG001
num Affected
110
num At Risk
2405
num Events
124
term
GASTROOESOPHAGEAL REFLUX DISEASE

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
1
num At Risk
2364
num Events
1
group Id
EG001
num Affected
0
num At Risk
2405
num Events
0
term
AGRANULOCYTOSIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
10
num At Risk
2364
num Events
14
group Id
EG001
num Affected
8
num At Risk
2405
num Events
10
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
9
num At Risk
2364
num Events
9
group Id
EG001
num Affected
8
num At Risk
2405
num Events
9
term
FEBRILE BONE MARROW APLASIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
211
num At Risk
2364
num Events
239
group Id
EG001
num Affected
196
num At Risk
2405
num Events
215
term
FEBRILE NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
1
num At Risk
2364
num Events
1
group Id
EG001
num Affected
0
num At Risk
2405
num Events
0
term
HAEMOLYTIC ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
0
num At Risk
2364
num Events
0
group Id
EG001
num Affected
1
num At Risk
2405
num Events
1
term
IDIOPATHIC CYTOPENIA OF UNDETERMINED SIGNIFICANCE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
3
num At Risk
2364
num Events
3
group Id
EG001
num Affected
5
num At Risk
2405
num Events
5
term
LEUKOPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
1
num At Risk
2364
num Events
1
group Id
EG001
num Affected
1
num At Risk
2405
num Events
1
term
LYMPHADENOPATHY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
0
num At Risk
2364
num Events
0
group Id
EG001
num Affected
1
num At Risk
2405
num Events
1
term
MICROANGIOPATHIC HAEMOLYTIC ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
2
num At Risk
2364
num Events
2
group Id
EG001
num Affected
3
num At Risk
2405
num Events
3
term
MYELOSUPPRESSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
25
num At Risk
2364
num Events
30
group Id
EG001
num Affected
34
num At Risk
2405
num Events
39
term
NEUTROPENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 27.1
stats
group Id
EG000
num Affected
1
num At Risk
2364
num Events
1
group Id
EG001
num Affected
1
num At Risk
2405
num Events
1
term
PANCYTOPENIA

time Frame

From randomization (for all-cause mortality) or first study treatment (for adverse events [AEs]) until the end of follow-up (up to 12.9 years)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice