Efficacy and Safety Evaluating Study of CT-P6 in Her2 Pos... | NCT02162667

ID	Type	Description	Link
2013-004525-84	EudraCT Number

Status Module

Name	Class
Nippon Kayaku Co., Ltd.	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
CT-P6	Experimental		Drug: Trastuzumab
Trastuzumab	Active Comparator		Drug: Trastuzumab

Name	Type	Description	Arm Group Labels	Other Names
Trastuzumab	Drug	Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.	CT-P6 Trastuzumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Percentage of Patients Achieving Pathological Complete Response Defined as the Absence of Invasion Tumor Cells in the Breast and in Axillary Lymph Nodes, Regardless of Ductal Carcinoma in Situ (DCIS)	Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period. The primary endpoint, Pathological complete response, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.	After Neo-adjuvant therapy and Surgery (up to 30 weeks)

Secondary Outcomes

Measure	Description	Time Frame
The Percentage of Patients Achieving Pathological Complete Response (pCR) of the Breast Regardless of DCIS With Positive or Unknown Nodal Status	Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period. The secondary endpoint, other than pCR of breast and axillary nodes ragardless of DCIS which was primary endpoint, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.

Eligibility Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34148205	Derived	Stebbing J, Baranau YV, Baryash V, Manikhas A, Moiseyenko V, Dzagnidze G, Zhavrid E, Boliukh D, Pikiel J, Eniu AE, Li RK, Tiangco B, Lee SJ, Kim S. Long-term efficacy and safety of CT-P6 versus trastuzumab in patients with HER2-positive early breast cancer: final results from a randomized phase III trial. Breast Cancer Res Treat. 2021 Aug;188(3):631-640. doi: 10.1007/s10549-021-06240-5. Epub 2021 Jun 20.
31428820

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	CT-P6	Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study in the neoadjuvant period. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional CT-P6 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	CT-P6	Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study in the neoadjuvant period. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional CT-P6 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery).
BG001	Herceptin	Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study in the neoadjuvant period. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional Herceptin 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery).
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	OG00046.77(40.43 to 53.19) OG00150.39(44.10 to 56.68)

Secondary

The Percentage of Patients Achieving Pathological Complete Response (pCR) of the Breast Regardless of DCIS With Positive or Unknown Nodal Status

Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.

The secondary endpoint, other than pCR of breast and axillary nodes ragardless of DCIS which was primary endpoint, will be assessed using resected bio-specimens collected in breast and axilla during a surgery.

Posted

Number

95% Confidence Interval

percentage of responders

After Neo-adjuvant therapy and Surgery (up to 30 weeks)

ID	Title	Description
OG000	CT-P6	Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
OG001	Herceptin	Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.

Secondary

The Percentage of Patients Achieving Pathological Complete Response of the Breast and Axillary Nodes With Absence of DCIS

Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.

Posted

Number

95% Confidence Interval

percentage of responders

After Neo-adjuvant therapy and Surgery (up to 30 weeks)

ID	Title	Description
OG000	CT-P6	Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
OG001	Herceptin	Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.

Secondary

Overall Response Rate (ORR) From Local Review

The ORR was defined as the proportion of patients with a BOR of CR or PR as assessed by RECIST guideline Version 1.1 during the Nedadjuvant Period.

Posted

Number

95% Confidence Interval

percentage of responders

After Neo-adjuvant therapy (up to 24 weeks)

ID	Title	Description
OG000	CT-P6	Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8.
OG001	Herceptin	Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8.

Secondary

Disease-free Survival

Patients who underwent breast surgery were included in the DFS analysis. Disease-free survival was defined as the interval between the date of breast surgery and disease progression, recurrence, or death from any cause, whichever occurred first. Only a recurrence or progression of disease that occurred before beginning another anticancer therapy was regarded as an event.

Posted

Number

95% Confidence Interval

proportion of participants

Up to 3 years from the day of last patient enrollment (during whole study period)

ID	Title	Description
OG000	CT-P6	Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional CT-P6 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery)
OG001

Secondary

Progression-Free Survival

Progression-free survival was defined as the interval between randomization and disease progression, recurrence, or death from any cause, whichever occurred first. Only a recurrence or progression of disease that occurred before beginning another anticancer therapy was regarded as an event.

Posted

Number

95% Confidence Interval

proportion of participants

Up to 3 years from the day of last patient enrollment (during whole study period)

ID	Title	Description
OG000	CT-P6	Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
OG001	Herceptin	Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.

Secondary

Overall Survival

Overall survival was defined as the interval between randomization and death from any cause.

Posted

Number

95% Confidence Interval

proportion of participants

Up to 3 years from the day of last patient enrollment (during whole study period)

ID	Title	Description
OG000	CT-P6	Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
OG001	Herceptin	Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.

Secondary

The Number of Patients Who Had Progressive Disease or Recurrence

If recurrence or progression of disease occurred at any time during the study, the progressed tumor site was recorded in the "recurrence or progression of disease" eCRF page as local, regional, or distant, with diagnostic method and whether positive cytology or histology or not.

The resulting recurrence or progression of disease information was summarized as secondary endpoint.

Posted

Number

participants

Up to 3 years from the day of last patient enrollment (during whole study period)

ID	Title	Description
OG000	CT-P6	Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
OG001	Herceptin	Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.

Secondary

Maximum Serum Concentration After Administration (Cmax) in Each Cycle

Pharmacokinetic samples were collected before study drug (CT-P6 or US-licensed Herceptin) administration (within 15 minutes prior to the beginning of the study drug infusion) and within 15 minutes after the end of the study drug infusion for each cycle during the Neoadjuvant Period. After the completion of treatment, an additional PK sample was collected at the EOT1.

Safety Analysis Set: All patients randomly assigned to study drug and who receive at least 1 dose (fully or partially) of study drug

Posted

Mean

Standard Deviation

µg/mL

End of each treatment cycles, up to 24 weeks (during neoadjuvant period)

ID	Title	Description
OG000	CT-P6	Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8.
OG001	Herceptin	Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8.

Secondary

Trough Serum Concentration (Ctrough) in Each Cycle

Safety Analysis Set: All patients randomly assigned to study drug and who receive at least 1 dose (fully or partially) of study drug

Posted

Mean

Standard Deviation

µg/mL

Pre-infusion of cycles 1 to 8 during neoadjuvant period

ID	Title	Description
OG000	CT-P6	Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8.
OG001	Herceptin	Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8.

Post-Hoc

The Percentage of Patients Achieving Pathological Complete Response of the Breast and Axillary Nodes Regardless of DCIS

Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.

Posted

Number

95% Confidence Interval

percentage of responders

After Neo-adjuvant therapy and Surgery (up to 30 weeks)

ID	Title	Description
OG000	CT-P6	Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.
OG001	Herceptin	Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CT-P6	Patient received CT-P6 at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional CT-P6 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery)			22	271	263	271
EG001	Herceptin	Patient received Herceptin at an initial dose of 8 mg/kg administered by a single IV infusion on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycles 2 through 8 (3-week cycles). Patients also received docetaxel 75 mg/m^2 during cycles 1 through 4 and FEC (fluorouracil 500mg/m^2, epirubicin 75mg/m^2, and cyclophosphamide 500mg/m^2) during Cycles 5 through 8. After a total of 8 treatment cycles of the neoadjuvant treatment, surgery was performed within 3 to 6 weeks from the last dose of study. Three to 6 weeks after surgery, patients entered the adjuvant period and received additional Herceptin 6 mg/kg (3-week cycles) for up to 1 year from the first day of study drug administration in the Neoadjuvant Period, excluding surgery (or up to 10 cycles after surgery).			36	278	264	278

Serious Adverse Events

Term	Organ System	Statistical Information
Anemia	Blood and lymphatic system disorders	EG0001 affected271 at risk EG0013 affected278 at risk
Febrile neutropenia	Blood and lymphatic system disorders	EG0006 affected271 at risk EG0013 affected278 at risk
Leukocytosis	Blood and lymphatic system disorders	EG0000 affected271 at risk EG0011 affected278 at risk
Neutropenia	Blood and lymphatic system disorders	EG0002 affected271 at risk EG0013 affected278 at risk
Acute myocardial infarction	Cardiac disorders	EG0000 affected271 at risk EG0011 affected278 at risk
Adams-Stokes syndrome	Cardiac disorders	EG0001 affected271 at risk EG0010 affected278 at risk
Angina pectoris	Cardiac disorders	EG0000 affected271 at risk EG0011 affected278 at risk
Congestive cardiomyopathy	Cardiac disorders	EG0000 affected271 at risk EG0011 affected278 at risk
Myocardial infarction	Cardiac disorders	EG0000 affected271 at risk EG0011 affected278 at risk
Dacryostenosis acquired	Eye disorders	EG0000 affected271 at risk EG0011 affected278 at risk
Abdominal pain	Gastrointestinal disorders	EG0001 affected271 at risk EG0010 affected278 at risk
Gastritis	Gastrointestinal disorders	EG0000 affected271 at risk EG0011 affected278 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	EG0000 affected271 at risk EG0011 affected278 at risk
Pancreatitis acute	Gastrointestinal disorders	EG0001 affected271 at risk EG0010 affected278 at risk
Stomatitis	Gastrointestinal disorders	EG0001 affected271 at risk EG0010 affected278 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	EG0000 affected271 at risk EG0011 affected278 at risk
Implant site extravasation	General disorders	EG0001 affected271 at risk EG0010 affected278 at risk
Incarcerated hernia	General disorders	EG0001 affected271 at risk EG0010 affected278 at risk
Sudden death	General disorders	EG0001 affected271 at risk EG0010 affected278 at risk
Cholecystitis acute	Hepatobiliary disorders	EG0000 affected271 at risk EG0011 affected278 at risk
Drug hypersensitivity	Immune system disorders	EG0001 affected271 at risk EG0010 affected278 at risk
Appendicitis	Infections and infestations	EG0001 affected271 at risk EG0011 affected278 at risk
Bronchitis	Infections and infestations	EG0000 affected271 at risk EG0011 affected278 at risk
Device related infection	Infections and infestations	EG0000 affected271 at risk EG0012 affected278 at risk
Endocarditis	Infections and infestations	EG0000 affected271 at risk EG0011 affected278 at risk
Pneumonia	Infections and infestations	EG0002 affected271 at risk EG0011 affected278 at risk
Postoperative abscess	Infections and infestations	EG0001 affected271 at risk EG0010 affected278 at risk
Septic embolus	Infections and infestations	EG0000 affected271 at risk EG0011 affected278 at risk
Subcutaneous abscess	Infections and infestations	EG0000 affected271 at risk EG0011 affected278 at risk
Complications of transplant surgery	Injury, poisoning and procedural complications	EG0001 affected271 at risk EG0010 affected278 at risk
Humerus fracture	Injury, poisoning and procedural complications	EG0000 affected271 at risk EG0011 affected278 at risk
Infusion related reaction	Injury, poisoning and procedural complications	EG0000 affected271 at risk EG0011 affected278 at risk
Multiple fractures	Injury, poisoning and procedural complications	EG0000 affected271 at risk EG0011 affected278 at risk
Overdose	Injury, poisoning and procedural complications	EG0000 affected271 at risk EG0011 affected278 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	EG0000 affected271 at risk EG0011 affected278 at risk
Scar	Injury, poisoning and procedural complications	EG0000 affected271 at risk EG0011 affected278 at risk
Seroma	Injury, poisoning and procedural complications	EG0000 affected271 at risk EG0011 affected278 at risk
Thermal burn	Injury, poisoning and procedural complications	EG0001 affected271 at risk EG0010 affected278 at risk
Heart rate irregular	Investigations	EG0001 affected271 at risk EG0010 affected278 at risk
Dehydration	Metabolism and nutrition disorders	EG0001 affected271 at risk EG0010 affected278 at risk
Hypokalaemia	Metabolism and nutrition disorders	EG0000 affected271 at risk EG0011 affected278 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected271 at risk EG0012 affected278 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected271 at risk EG0011 affected278 at risk
Ovarian germ cell teratoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected271 at risk EG0011 affected278 at risk
Cerebral infarction	Nervous system disorders	EG0000 affected271 at risk EG0011 affected278 at risk
Calculus urinary	Renal and urinary disorders	EG0000 affected271 at risk EG0011 affected278 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG0001 affected271 at risk EG0010 affected278 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	EG0001 affected271 at risk EG0010 affected278 at risk
Neurodermatitis	Skin and subcutaneous tissue disorders	EG0000 affected271 at risk EG0011 affected278 at risk
Oocyte harvest	Surgical and medical procedures	EG0000 affected271 at risk EG0011 affected278 at risk
Aortic dissection	Vascular disorders	EG0000 affected271 at risk EG0011 affected278 at risk
Deep vein thrombosis	Vascular disorders	EG0000 affected271 at risk EG0011 affected278 at risk

Other Adverse Events

Term	Organ System	Statistical Information
Anaemia	Blood and lymphatic system disorders	EG00059 affected271 at risk EG00167 affected278 at risk
Febrile neutropenia	Blood and lymphatic system disorders	EG00011 affected271 at risk EG00116 affected278 at risk
Leukopenia	Blood and lymphatic system disorders	EG00028 affected271 at risk EG00141 affected278 at risk
Neutropenia	Blood and lymphatic system disorders	EG00095 affected271 at risk EG001116 affected278 at risk
Lacrimation increased	Eye disorders	EG00016 affected271 at risk EG00115 affected278 at risk
Constipation	Gastrointestinal disorders	EG00024 affected271 at risk EG00118 affected278 at risk
Diarrhoea	Gastrointestinal disorders	EG00052 affected271 at risk EG00150 affected278 at risk
Nausea	Gastrointestinal disorders	EG00099 affected271 at risk EG00194 affected278 at risk
Stomatitis	Gastrointestinal disorders	EG00046 affected271 at risk EG00133 affected278 at risk
Vomiting	Gastrointestinal disorders	EG00027 affected271 at risk EG00126 affected278 at risk
Asthenia	General disorders	EG00047 affected271 at risk EG00138 affected278 at risk
Fatigue	General disorders	EG00053 affected271 at risk EG00162 affected278 at risk
Oedema peripheral	General disorders	EG0008 affected271 at risk EG00118 affected278 at risk
Pyrexia	General disorders	EG00031 affected271 at risk EG00130 affected278 at risk
Upper respiratory tract infection	Infections and infestations	EG00017 affected271 at risk EG0018 affected278 at risk
Infusion related reaction	Injury, poisoning and procedural complications	EG00031 affected271 at risk EG00128 affected278 at risk
Radiation skin injury	Injury, poisoning and procedural complications	EG00033 affected271 at risk EG00134 affected278 at risk
Alanine aminotransferase increased	Investigations	EG00018 affected271 at risk EG00130 affected278 at risk
Aspartate aminotransferase increased	Investigations	EG00014 affected271 at risk EG00125 affected278 at risk
Ejection fraction decreased	Investigations	EG00020 affected271 at risk EG0019 affected278 at risk
Neutrophil count decreased	Investigations	EG00014 affected271 at risk EG00113 affected278 at risk
Decreased appetite	Metabolism and nutrition disorders	EG00021 affected271 at risk EG00120 affected278 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	EG00034 affected271 at risk EG00140 affected278 at risk
Bone pain	Musculoskeletal and connective tissue disorders	EG00011 affected271 at risk EG00120 affected278 at risk
Myalgia	Musculoskeletal and connective tissue disorders	EG00027 affected271 at risk EG00128 affected278 at risk
Dizziness	Nervous system disorders	EG00014 affected271 at risk EG0018 affected278 at risk
Headache	Nervous system disorders	EG00025 affected271 at risk EG00121 affected278 at risk
Peripheral sensory neuropathy	Nervous system disorders	EG00014 affected271 at risk EG00120 affected278 at risk
Insomnia	Psychiatric disorders	EG00016 affected271 at risk EG0017 affected278 at risk
Cough	Respiratory, thoracic and mediastinal disorders	EG00014 affected271 at risk EG00114 affected278 at risk
Alopecia	Skin and subcutaneous tissue disorders	EG000196 affected271 at risk EG001213 affected278 at risk
Rash	Skin and subcutaneous tissue disorders	EG00018 affected271 at risk EG00110 affected278 at risk
Hypertension	Vascular disorders	EG00019 affected271 at risk EG00111 affected278 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Buenos Aires		1185	Argentina

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins