Study of Oral Vinorelbine Plus Capecitabine Versus Taxane... | NCT03887130

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vinorelbine-Capecitabine (arm A)	Experimental	oral vinorelbine (OV) with capecitabine (CAP)	Drug: oral vinorelbine Drug: Capecitabine
Gemcitabine-Paclitaxel (arm B)	Active Comparator	gemcitabine (GEM) in combination with paclitaxel (PAC)	Drug: Gemcitabine 1250 mg/m² Drug: Paclitaxel
Gemcitabine-Docetaxel (arm C)	Active Comparator	gemcitabine (GEM) in combination with docetaxel (DOC)	Drug: Gemcitabine 1000 mg/m² Drug: Docetaxel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oral vinorelbine	Drug	Oral vinorelbine 60 mg/m² on day 1 & day 8, for cycle 1, and then 80 mg/m² on day 1 & day 8, every 3 weeks for subsequent cycles	Vinorelbine-Capecitabine (arm A)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease Control Rate (DCR)	Disease control rate (DCR) defined as the sum of complete response, partial response and stable disease for at least 3 months according to RECIST criteria version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR)= Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Stable disease: no partial response or progression of the disease	From Baseline to disease progression or death, up to 6 years

Eligibility Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Vinorelbine-Capecitabine (Arm A)	oral vinorelbine (OV) with capecitabine (CAP) oral vinorelbine: Oral vinorelbine 60 mg/m² on day 1 & day 8, for cycle 1, and then 80 mg/m² on day 1 & day 8, every 3 weeks for subsequent cycles Capecitabine: Capecitabine 1000 mg/m² twice a day (2000 mg/m² daily) from day 1 to day 14
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Vinorelbine-Capecitabine (Arm A)	oral vinorelbine (OV) with capecitabine (CAP) oral vinorelbine: Oral vinorelbine 60 mg/m² on day 1 & day 8, for cycle 1, and then 80 mg/m² on day 1 & day 8, every 3 weeks for subsequent cycles Capecitabine: Capecitabine 1000 mg/m² twice a day (2000 mg/m² daily) from day 1 to day 14
BG001	Gemcitabine-Paclitaxel (Arm B)	gemcitabine (GEM) in combination with paclitaxel (PAC) Gemcitabine 1250 mg/m²: Gemcitabine 1250 mg/m² on day 1 & day 8 Paclitaxel: Paclitaxel 175 mg/m² on day 1
BG002	Gemcitabine-Docetaxel (Arm C)	gemcitabine (GEM) in combination with docetaxel (DOC) Gemcitabine 1000 mg/m²: Gemcitabine: 1000 mg/m² on day 1 & 8 Docetaxel: Docetaxel 75 mg/m² on day 1
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00049 BG00150 BG00250 BG003149

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00056.4± 9.7 BG00156.0± 10.8 BG00257.4± 9.7 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00049 BG00150 BG002

Body surface area

Mean

Standard Deviation

mg/m²

Title

Denominators

Categories

Title	Measurements
	BG0001.8± 0.2 BG0011.7± 0.2 BG002

Delay between diagnosis and study entry

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0005.5± 5.7 BG0015.8± 6.3 BG002

Primary tumour site

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Bilateral	BG0003 BG0010 BG002

Delay between first relapse/progression and study entry

Mean

Standard Deviation

months

Title

Denominators

Categories

Title	Measurements
	BG0008.8± 19.1 BG00111.1± 29.8 BG002

Categorized number of organs involved at baseline

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
1 organ	BG0009 BG0013 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Disease Control Rate (DCR)

Disease control rate (DCR) defined as the sum of complete response, partial response and stable disease for at least 3 months according to RECIST criteria version 1.1.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI:

Complete Response (CR)= Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.

Stable disease: no partial response or progression of the disease

Disease control rate was measured in the Intent-to-treat ITT population that consisted of all treated patients.

Posted

Number

95% Confidence Interval

percentage of participants

From Baseline to disease progression or death, up to 6 years

ID	Title	Description
OG000	Vinorelbine-Capecitabine (Arm A)	oral vinorelbine (OV) with capecitabine (CAP) oral vinorelbine: Oral vinorelbine 60 mg/m² on day 1 & day 8, for cycle 1, and then 80 mg/m² on day 1 & day 8, every 3 weeks for subsequent cycles Capecitabine: Capecitabine 1000 mg/m² twice a day (2000 mg/m² daily) from day 1 to day 14
OG001	Gemcitabine-Paclitaxel (Arm B)	gemcitabine (GEM) in combination with paclitaxel (PAC) Gemcitabine 1250 mg/m²: Gemcitabine 1250 mg/m² on day 1 & day 8 Paclitaxel: Paclitaxel 175 mg/m² on day 1
OG002	Gemcitabine-Docetaxel (Arm C)	gemcitabine (GEM) in combination with docetaxel (DOC) Gemcitabine 1000 mg/m²: Gemcitabine: 1000 mg/m² on day 1 & 8 Docetaxel: Docetaxel 75 mg/m² on day 1

Units	Counts
Participants	OG00049 OG00150 OG00250

Title

Denominators

Categories

Title	Measurements
	OG00073.5(58.9 to 85.1) OG00178.0(64.1 to 88.5) OG00280.0(66.3 to 90.0)

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	Vinorelbine-Capecitabine (Arm A)	oral vinorelbine (OV) with capecitabine (CAP) oral vinorelbine: Oral vinorelbine 60 mg/m² on day 1 & day 8, for cycle 1, and then 80 mg/m² on day 1 & day 8, every 3 weeks for subsequent cycles Capecitabine: Capecitabine 1000 mg/m² twice a day (2000 mg/m² daily) from day 1 to day 14	31	49	13	49	49	49
EG001	Gemcitabine-Paclitaxel (Arm B)	gemcitabine (GEM) in combination with paclitaxel (PAC) Gemcitabine 1250 mg/m²: Gemcitabine 1250 mg/m² on day 1 & day 8 Paclitaxel: Paclitaxel 175 mg/m² on day 1	37	50	16	50	50	50
EG002	Gemcitabine-Docetaxel (Arm C)	gemcitabine (GEM) in combination with docetaxel (DOC) Gemcitabine 1000 mg/m²: Gemcitabine: 1000 mg/m² on day 1 & 8 Docetaxel: Docetaxel 75 mg/m² on day 1	35	50	12	50	50	50

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
International normalised ratio	Investigations	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected50 at risk EG0020 events0 affected50 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected50 at risk EG0020 events0 affected50 at risk
Haematoma	Vascular disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected50 at risk EG0020 events0 affected50 at risk
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0002 events1 affected49 at risk EG0010 events0 affected50 at risk EG0021 events1 affected50 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0003 events2 affected49 at risk EG0010 events0 affected50 at risk EG0020 events0 affected50 at risk
Oesophagitis	Gastrointestinal disorders	Systematic Assessment	EG0002 events1 affected49 at risk EG0010 events0 affected50 at risk EG0020 events0 affected50 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0005 events5 affected49 at risk EG0011 events1 affected50 at risk EG0022 events1 affected50 at risk
Malignant tumour excision	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected50 at risk EG0020 events0 affected50 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 events3 affected49 at risk EG0010 events0 affected50 at risk EG0021 events1 affected50 at risk
Deep vein thrombosis	Vascular disorders	Systematic Assessment	EG0002 events1 affected49 at risk EG0010 events0 affected50 at risk EG0020 events0 affected50 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected49 at risk EG0011 events1 affected50 at risk EG0023 events3 affected50 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0004 events4 affected49 at risk EG0011 events1 affected50 at risk EG0021 events1 affected50 at risk
Neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected50 at risk EG0020 events0 affected50 at risk
Pyrexia	General disorders	Systematic Assessment	EG0002 events2 affected49 at risk EG0014 events3 affected50 at risk EG0020 events0 affected50 at risk
Hip fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected49 at risk EG0010 events0 affected50 at risk EG0020 events0 affected50 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected49 at risk EG0010 events0 affected50 at risk EG0020 events0 affected50 at risk
Rib fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected50 at risk EG0020 events0 affected50 at risk
Leukopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected50 at risk EG0020 events0 affected50 at risk
Condition aggravated	General disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected50 at risk EG0020 events0 affected50 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0014 events3 affected50 at risk EG0020 events0 affected50 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected50 at risk EG0020 events0 affected50 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0014 events3 affected50 at risk EG0020 events0 affected50 at risk
Ileus	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected49 at risk EG0010 events0 affected50 at risk EG0020 events0 affected50 at risk
Cerebral ischaemia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected50 at risk EG0020 events0 affected50 at risk
Lower respiratory tract infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected50 at risk EG0020 events0 affected50 at risk
Dysarthria	Nervous system disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected50 at risk EG0020 events0 affected50 at risk
Dyskinesia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected50 at risk EG0020 events0 affected50 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected50 at risk EG0020 events0 affected50 at risk
Dislocation of joint prosthesis	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected50 at risk EG0020 events0 affected50 at risk
Soft tissue infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected50 at risk EG0020 events0 affected50 at risk
Gastroenteritis viral	Infections and infestations	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected50 at risk EG0020 events0 affected50 at risk
Fatigue	General disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0013 events3 affected50 at risk EG0021 events1 affected50 at risk
Hepatic pain	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected50 at risk EG0020 events0 affected50 at risk
Pharyngitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected50 at risk EG0020 events0 affected50 at risk
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected50 at risk EG0020 events0 affected50 at risk
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected50 at risk EG0020 events0 affected50 at risk
Thrombocythaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected50 at risk EG0020 events0 affected50 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected50 at risk EG0020 events0 affected50 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected50 at risk EG0020 events0 affected50 at risk
Pain	General disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected50 at risk EG0020 events0 affected50 at risk
Hypovolaemic shock	Vascular disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected50 at risk EG0020 events0 affected50 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected49 at risk EG0013 events2 affected50 at risk EG0020 events0 affected50 at risk
Delirium	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected50 at risk EG0020 events0 affected50 at risk
Intracranial pressure increased	Nervous system disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0010 events0 affected50 at risk EG0021 events1 affected50 at risk
Haematemesis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0010 events0 affected50 at risk EG0021 events1 affected50 at risk
Oesophagitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0010 events0 affected50 at risk EG0021 events1 affected50 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0010 events0 affected50 at risk EG0021 events1 affected50 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Sinus tachycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0010 events0 affected50 at risk EG0024 events4 affected50 at risk
Lacrimation increased	Eye disorders	Systematic Assessment	EG0003 events3 affected49 at risk EG0010 events0 affected50 at risk EG0023 events3 affected50 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG00016 events16 affected49 at risk EG0016 events6 affected50 at risk EG0029 events9 affected50 at risk
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0008 events8 affected49 at risk EG0013 events3 affected50 at risk EG0024 events4 affected50 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0007 events7 affected49 at risk EG0017 events7 affected50 at risk EG00210 events10 affected50 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG00029 events29 affected49 at risk EG00113 events13 affected50 at risk EG00219 events19 affected50 at risk
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0006 events6 affected49 at risk EG0011 events1 affected50 at risk EG0026 events6 affected50 at risk
Dysphagia	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected49 at risk EG0010 events0 affected50 at risk EG0023 events3 affected50 at risk
Haemorrhoids	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0014 events4 affected50 at risk EG0021 events1 affected50 at risk
Ileus	Gastrointestinal disorders	Systematic Assessment	EG0004 events4 affected49 at risk EG0014 events4 affected50 at risk EG0025 events5 affected50 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG00029 events29 affected49 at risk EG00119 events19 affected50 at risk EG00222 events22 affected50 at risk
Stomatitis	Gastrointestinal disorders	Systematic Assessment	EG00011 events11 affected49 at risk EG0014 events4 affected50 at risk EG00215 events15 affected50 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG00027 events27 affected49 at risk EG00112 events12 affected50 at risk EG00219 events19 affected50 at risk
Chest pain	General disorders	Systematic Assessment	EG0003 events3 affected49 at risk EG0016 events6 affected50 at risk EG0024 events4 affected50 at risk
Chills	General disorders	Systematic Assessment	EG0003 events3 affected49 at risk EG0012 events2 affected50 at risk EG0020 events0 affected50 at risk
Fatigue	General disorders	Systematic Assessment	EG00038 events38 affected49 at risk EG00135 events35 affected50 at risk EG00242 events42 affected50 at risk
Influenza like illness	General disorders	Systematic Assessment	EG0003 events3 affected49 at risk EG0011 events1 affected50 at risk EG0023 events3 affected50 at risk
Oedema peripheral	General disorders	Systematic Assessment	EG0006 events6 affected49 at risk EG0013 events3 affected50 at risk EG00213 events13 affected50 at risk
Pain	General disorders	Systematic Assessment	EG0003 events3 affected49 at risk EG0012 events2 affected50 at risk EG0023 events3 affected50 at risk
Pyrexia	General disorders	Systematic Assessment	EG0006 events6 affected49 at risk EG0018 events8 affected50 at risk EG00213 events13 affected50 at risk
Hypersensitivity	Immune system disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0015 events5 affected50 at risk EG0026 events6 affected50 at risk
Bronchitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected49 at risk EG0013 events3 affected50 at risk EG0023 events3 affected50 at risk
Neutropenic infection	Infections and infestations	Systematic Assessment	EG0002 events2 affected49 at risk EG0010 events0 affected50 at risk EG0023 events3 affected50 at risk
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0004 events4 affected49 at risk EG0016 events6 affected50 at risk EG0024 events4 affected50 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0004 events4 affected49 at risk EG0011 events1 affected50 at risk EG0021 events1 affected50 at risk
Weight decreased	Investigations	Systematic Assessment	EG00014 events14 affected49 at risk EG0017 events7 affected50 at risk EG00210 events10 affected50 at risk
Weight increased	Investigations	Systematic Assessment	EG0003 events3 affected49 at risk EG0013 events3 affected50 at risk EG0024 events4 affected50 at risk
Anorexia	Metabolism and nutrition disorders	Systematic Assessment	EG00019 events19 affected49 at risk EG00113 events13 affected50 at risk EG00217 events17 affected50 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected49 at risk EG00115 events15 affected50 at risk EG0029 events9 affected50 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0007 events7 affected49 at risk EG0013 events3 affected50 at risk EG0025 events5 affected50 at risk
Bone pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 events3 affected49 at risk EG0012 events2 affected50 at risk EG0024 events4 affected50 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 events3 affected49 at risk EG0012 events2 affected50 at risk EG0024 events4 affected50 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0005 events5 affected49 at risk EG0016 events6 affected50 at risk EG0022 events2 affected50 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0006 events6 affected49 at risk EG0012 events2 affected50 at risk EG0024 events4 affected50 at risk
Dysgeusia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0015 events5 affected50 at risk EG00211 events11 affected50 at risk
Headache	Nervous system disorders	Systematic Assessment	EG00010 events10 affected49 at risk EG0018 events8 affected50 at risk EG0028 events8 affected50 at risk
Paraesthesia	Nervous system disorders	Systematic Assessment	EG0005 events5 affected49 at risk EG00116 events16 affected50 at risk EG0024 events4 affected50 at risk
Peripheral motor neuropathy	Nervous system disorders	Systematic Assessment	EG0003 events3 affected49 at risk EG0010 events0 affected50 at risk EG0020 events0 affected50 at risk
Peripheral sensory neuropathy	Nervous system disorders	Systematic Assessment	EG00012 events12 affected49 at risk EG00118 events18 affected50 at risk EG0028 events8 affected50 at risk
Anxiety	Psychiatric disorders	Systematic Assessment	EG0003 events3 affected49 at risk EG0014 events4 affected50 at risk EG0023 events3 affected50 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0007 events7 affected49 at risk EG0014 events4 affected50 at risk EG0023 events3 affected50 at risk
Insomnia	Psychiatric disorders	Systematic Assessment	EG0006 events6 affected49 at risk EG0013 events3 affected50 at risk EG0023 events3 affected50 at risk
Pelvic pain	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0010 events0 affected50 at risk EG0023 events3 affected50 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0009 events9 affected49 at risk EG0018 events8 affected50 at risk EG0029 events9 affected50 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00018 events18 affected49 at risk EG00113 events13 affected50 at risk EG00217 events17 affected50 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected50 at risk EG0024 events4 affected50 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0010 events0 affected50 at risk EG0023 events3 affected50 at risk
Alopecia	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00012 events12 affected49 at risk EG00138 events38 affected50 at risk EG00240 events40 affected50 at risk
Nail disorder	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0004 events4 affected49 at risk EG0011 events1 affected50 at risk EG0026 events6 affected50 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00024 events24 affected49 at risk EG0014 events4 affected50 at risk EG0026 events6 affected50 at risk
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0004 events4 affected49 at risk EG00111 events11 affected50 at risk EG00213 events13 affected50 at risk
Deep vein thrombosis	Vascular disorders	Systematic Assessment	EG0003 events3 affected49 at risk EG0010 events0 affected50 at risk EG0022 events2 affected50 at risk
Hot flush	Vascular disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0012 events2 affected50 at risk EG0023 events3 affected50 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0002 events2 affected49 at risk EG0012 events2 affected50 at risk EG0025 events5 affected50 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0004 events4 affected49 at risk EG0012 events2 affected50 at risk EG0027 events7 affected50 at risk
Lymphoedema	Vascular disorders	Systematic Assessment	EG0004 events4 affected49 at risk EG0012 events2 affected50 at risk EG00211 events11 affected50 at risk

Title	Organization	Phone	Extension	Email
Gustavo Villanova M.D	Pierre Fabre	+33149108265		gustavo.villanova@pierre-fabre.com

ID	Term
D001943	Breast Neoplasms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D000077235	Vinorelbine
D000069287	Capecitabine
D000093542	Gemcitabine
D017239	Paclitaxel
D000077143	Docetaxel

Ancestor Terms

ID	Term
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids
D026121	Indole Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D054836	Indolizidines
D007212	Indolizines
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D005472	Fluorouracil
D014498	Uracil
D011744	Pyrimidinones
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes