Study: NCT02606708

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 314 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 314 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 46 affected / 314 at risk

Adverse event: Hemolitic autoimmune anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 314 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 314 at risk

Adverse event: PAIN lower extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 314 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 314 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 314 at risk

Adverse event: Mastitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 314 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 314 at risk

Adverse event: RASH BOTH BREASTS
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 314 at risk

Adverse event: PAIN Breast Left superior aspect
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 314 at risk

Adverse event: Eczema at right inframammary breast
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 314 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 314 at risk

Adverse event: DERMATITIS HANDS AND FEET
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Second Malignancy Globular ca in situ with Pagetoid spread in controlateral breast
Frequency: 1 affected / 314 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 314 at risk

Adverse event: PAIN RIGHT SHOULDER+ LEFT HIP
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 314 at risk

Adverse event: RASH FUNGAL - LEFT AXILLA
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 314 at risk

Adverse event: SYNCOPAL EPISODE
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 314 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 42 affected / 314 at risk

Adverse event: DERMATITIS HANDS AND FEET
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 314 at risk

Adverse event: RIGHT LEG SURGERY FOR STENT PLACEMENT
Serious: no
Organ System: Cardiac disorders
Notes: Cardiovascular / General Other: RIGHT LEG SURGERY FOR STENT PLACEMENT
Frequency: 1 affected / 314 at risk

Adverse event: Pain ARTHRALGIA
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 314 at risk

Adverse event: ARTHRITIS LEG PAIN
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: ARTHRITIS LEG PAIN+ CLAUDICATIO INTERMITTENS
Frequency: 1 affected / 314 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 314 at risk

Adverse event: Back pain
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 314 at risk

Adverse event: CELLULITIS RIGHT ARM
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 314 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 314 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 314 at risk

Adverse event: MELANOMA IN SITU RIGTH LEG
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: MELANOMA IN SITU RIGTH LEG
Frequency: 1 affected / 314 at risk

Adverse event: ADRENAL CORTICAL ADENOMA
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 314 at risk

Adverse event: Appendicitis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 314 at risk

Adverse event: DEGENERATIVE SPONDILOSIS
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Musculoskeletal Other: DEGENERATIVE SPONDILOSIS
Frequency: 1 affected / 314 at risk

Adverse event: PAIN LEFT BREAST AT INCISION SITE sore
Serious: no
Organ System: Nervous system disorders
Notes: PAIN LEFT BREAST AT INCISION SITE sore
Frequency: 1 affected / 314 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: HEADACHE
Frequency: 1 affected / 314 at risk

Adverse event: PRURITIS AT BREAST
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 314 at risk

Adverse event: Pain ARTHRALGIA GENERALIZED
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 314 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: DIZZINESS
Frequency: 1 affected / 314 at risk

Adverse event: Back pain
Serious: no
Organ System: Nervous system disorders
Notes: PAIN BACK
Frequency: 1 affected / 314 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: NAUSEA
Frequency: 1 affected / 314 at risk

Adverse event: PAIN AXILLA BOTH
Serious: no
Organ System: Nervous system disorders
Notes: PAIN AXILLA BOTH
Frequency: 1 affected / 314 at risk

Adverse event: PAIN LEFT SHOULDER
Serious: no
Organ System: Nervous system disorders
Notes: PAIN LEFT SHOULDER
Frequency: 1 affected / 314 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Nervous system disorders
Notes: Pain ARTHRALGIA
Frequency: 1 affected / 314 at risk

Adverse event: INCREASED LIVER ENZYMES
Serious: no
Organ System: Hepatobiliary disorders
Notes: INCREASED LIVER ENZYMES
Frequency: 1 affected / 314 at risk

Adverse event: FRACTURE 2ND LEFT RIB
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: FRACTURE 2ND LEFT RIB
Frequency: 1 affected / 314 at risk

Adverse event: PAIN RIGHT THIGH
Serious: no
Organ System: Nervous system disorders
Notes: PAIN RIGHT THIGH
Frequency: 1 affected / 314 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: PINS AND NEEDLES /NUMBNESS AT SENTINEL NODES SITE
Frequency: 1 affected / 314 at risk

Adverse event: PAIN LEFT BREAST
Serious: no
Organ System: Nervous system disorders
Notes: PAIN LEFT BREAST ON DEEP PALPATION
Frequency: 1 affected / 314 at risk

Adverse event: Second Malignancy Invasive ductal ca
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Second Malignancy Invasive ductal ca of controlateral breast (RB)
Frequency: 1 affected / 314 at risk

Adverse event: LEFT FRACTURE ARM LEFT
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 314 at risk

Adverse event: Breast pain
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 314 at risk

Adverse event: PAIN BACK LOWER
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 314 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 314 at risk

Adverse event: LYMPHEDEMA ARM LEFT
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 314 at risk

Adverse event: Meningioma
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 314 at risk

Adverse event: Secondary malignancySKIN CANCER (LEG)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 314 at risk

Adverse event: Night sweats
Serious: no
Organ System: Endocrine disorders
Notes: NIGHT SWEATS
Frequency: 1 affected / 314 at risk

Adverse event: MEMORY LOSS/UNSTEADINESS (DUE TO MENINGIOMA)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 314 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 314 at risk

Adverse event: SEBORRHOIC KERATOSIS UNDER RIGHT BREAST
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 314 at risk

Adverse event: Bone pain
Serious: no
Organ System: Endocrine disorders
Notes: Hot flashes
Frequency: 1 affected / 314 at risk

Adverse event: Bone pain
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 314 at risk

Adverse event: Second Malignancy NEW PRIMARY AT LEFT BREAST
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Second Malignancy NEW PRIMARY AT LEFT BREAST
Frequency: 1 affected / 314 at risk

Adverse event: PAIN ARM LEFT
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 314 at risk

Adverse event: PAIN LEFT SHOULDER
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 314 at risk

Adverse event: Pain ARTHRALGIA
Serious: no
Organ System: Nervous system disorders
Notes: Pain ARTHRALGIA
Frequency: 1 affected / 314 at risk

Adverse event: Myalgia
Serious: no
Organ System: Nervous system disorders
Notes: MYALGIA
Frequency: 1 affected / 314 at risk

Adverse event: PAIN SCAR
Serious: no
Organ System: Nervous system disorders
Notes: PAIN SCAR
Frequency: 1 affected / 314 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: PRURITUS
Frequency: 1 affected / 314 at risk

Adverse event: Second Malignancy RIGHT ANKLE MELANOMA
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Second Malignancy RIGHT ANKLE MELANOMA
Frequency: 1 affected / 314 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Notes: WEIGHT GAIN
Frequency: 1 affected / 314 at risk

Adverse event: JOINT STIFFNESS, CARPAL TUNNEL SYNDROME
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: JOINT STIFFNESS, CARPAL TUNNEL SYNDROME
Frequency: 1 affected / 314 at risk

Adverse event: PAIN Arthralgia KNEE B/L
Serious: no
Organ System: Nervous system disorders
Notes: PAIN Arthralgia KNEE B/L
Frequency: 1 affected / 314 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 314 at risk

Adverse event: PARESTHESIA ARM LEFT
Serious: no
Organ System: Nervous system disorders
Notes: PARESTHESIA ARM LEFT
Frequency: 1 affected / 314 at risk

Adverse event: Pain ARTHRALGIA - Occasional
Serious: no
Organ System: Nervous system disorders
Notes: Pain ARTHRALGIA - Occasional
Frequency: 1 affected / 314 at risk

Adverse event: PAIN BACK LOWER
Serious: no
Organ System: Nervous system disorders
Notes: PAIN BACK LOWER
Frequency: 1 affected / 314 at risk

Adverse event: PAIN RIGHT RIB AREA
Serious: no
Organ System: Nervous system disorders
Notes: PAIN RIGHT RIB AREA
Frequency: 1 affected / 314 at risk

Adverse event: Cardiovascular / General Other: SPLENIC HEMANGIOMA
Serious: no
Organ System: Cardiac disorders
Notes: Cardiovascular / General Other: SPLENIC HEMANGIOMA
Frequency: 1 affected / 314 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Notes: HAIR THINNING
Frequency: 1 affected / 314 at risk

Adverse event: PAIN RIGHT THUMB severe
Serious: no
Organ System: Nervous system disorders
Notes: PAIN RIGHT THUMB severe
Frequency: 1 affected / 314 at risk

Adverse event: ARTHRITIS RIGHT WRIST
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: ARTHRITIS RIGHT WRIST
Frequency: 1 affected / 314 at risk