Study: NCT00290758

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Mood Alteration: Depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 62 at risk

Adverse event: renal - Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 62 at risk

Adverse event: Obstruction, GU: Uterus
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 62 at risk

Adverse event: Pulmonary/Upper Respiratory: Dyspnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Hemorrhage - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Bloody Nipple Discharge
Frequency: 1 affected / 62 at risk

Adverse event: Hemorrhage with Surgery
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Haematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Blood/bone marrow: Blood- Other
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anemia
Frequency: 1 affected / 62 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 62 at risk

Adverse event: Edima: Limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 62 at risk

Adverse event: Coagulation - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Coagulopathy
Frequency: 1 affected / 62 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 62 at risk

Adverse event: Supraventricular Arrythmia - Select Sinus Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 62 at risk

Adverse event: Cardia Ischemia/Infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 62 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 62 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 62 at risk

Adverse event: Auditory/Ear - Other
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Inner Ear Infection
Frequency: 1 affected / 62 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 10 affected / 62 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 62 at risk

Adverse event: Endocrine - Other
Serious: no
Organ System: Endocrine disorders
Notes: Night Sweats
Frequency: 1 affected / 62 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 62 at risk

Adverse event: Other
Serious: no
Organ System: Eye disorders
Notes: Blurred Vision
Frequency: 1 affected / 62 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 62 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 62 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 62 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 62 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 62 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Notes: Axillary Soreness
Frequency: 2 affected / 62 at risk

Adverse event: Pain - Select: Throat/Pharynx/Larynx
Serious: no
Organ System: General disorders
Frequency: 3 affected / 62 at risk

Adverse event: Pain - Select: Back
Serious: no
Organ System: General disorders
Frequency: 4 affected / 62 at risk

Adverse event: Pain - Select: Joint
Serious: no
Organ System: General disorders
Frequency: 3 affected / 62 at risk

Adverse event: Pain - Select: Breast
Serious: no
Organ System: General disorders
Frequency: 4 affected / 62 at risk

Adverse event: Pain - Select: Extremity - Limb
Serious: no
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Pain - Select: Head/Headaches
Serious: no
Organ System: General disorders
Frequency: 6 affected / 62 at risk

Adverse event: Pain - Select: Abdomen Nos
Serious: no
Organ System: General disorders
Frequency: 2 affected / 62 at risk

Adverse event: Pain - Select: Skin
Serious: no
Organ System: General disorders
Frequency: 2 affected / 62 at risk

Adverse event: Pain - Select: Uterus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 62 at risk

Adverse event: Constitutional Symptoms - Other
Serious: no
Organ System: General disorders
Notes: Malaise
Frequency: 3 affected / 62 at risk

Adverse event: Constitutional Symptoms - Weight Gain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 62 at risk

Adverse event: Constitutional Symptoms - Fever
Serious: no
Organ System: General disorders
Frequency: 10 affected / 62 at risk

Adverse event: Constitutional Symptoms - Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Constitutional Symptoms - Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 62 at risk

Adverse event: Constitutional Symptoms - Rigors/Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Infection with Unknown ANC - Select: Bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 62 at risk

Adverse event: Infections - Other
Serious: no
Organ System: Infections and infestations
Notes: Sinus Infection
Frequency: 3 affected / 62 at risk

Adverse event: Infection with Unknwn ANC - Select: Vagina
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 62 at risk

Adverse event: Infection with Unknown ANC - Select: Skin (Cellulitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 62 at risk

Adverse event: Infection (Documented ClinicallY) - Select: Vagina
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 62 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 62 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 62 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 62 at risk

Adverse event: Blood cholesterol
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 62 at risk

Adverse event: Musculoskeletal - Other (Specify)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Right Lateral Side Discomfort
Frequency: 8 affected / 62 at risk

Adverse event: Mood Alteration - Select: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 62 at risk

Adverse event: Mood Alteration - Select: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 62 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 62 at risk

Adverse event: Neurology (Other)
Serious: no
Organ System: Nervous system disorders
Notes: NUMBNESS, TINGLING, PAIN LEFT UPPER ARM
Frequency: 1 affected / 62 at risk

Adverse event: Incontinence, Urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 62 at risk

Adverse event: Obstruction, GU - Select:: Uterus
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 62 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 62 at risk

Adverse event: Renal - Other
Serious: no
Organ System: Renal and urinary disorders
Notes: vaginal itching
Frequency: 2 affected / 62 at risk

Adverse event: Urinary Frequesncy
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 62 at risk

Adverse event: Sexual - Other
Serious: no
Organ System: Reproductive system and breast disorders
Notes: MENORRHAGIA
Frequency: 6 affected / 62 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 62 at risk

Adverse event: Pulmonary - Other (Specify)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Sneezing
Frequency: 13 affected / 62 at risk

Adverse event: Voice Changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 62 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 62 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Dermatology/Skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MOLE REMOVED ON ABDOMEN - SHOWED DYSPLASIA
Frequency: 6 affected / 62 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Wound Compilation - Non-Infectious
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Sexual
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 64 at risk

Adverse event: Haematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Blood/bone marrow: Blood- Other
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anemia
Frequency: 1 affected / 64 at risk

Adverse event: Edima: Limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Cardia Ischemia/Infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 8 affected / 64 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 64 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 64 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 64 at risk

Adverse event: Ocular - Other
Serious: no
Organ System: Eye disorders
Notes: BILATERAL EYE ITCHING/IRRITATION
Frequency: 2 affected / 64 at risk

Adverse event: Photopsia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 64 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 64 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 64 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 64 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 64 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: GI - Other
Serious: no
Organ System: Gastrointestinal disorders
Notes: Colon Polyps
Frequency: 1 affected / 64 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Pain - Select: Throat/Pharynx/Larynx
Serious: no
Organ System: General disorders
Frequency: 4 affected / 64 at risk

Adverse event: Pain - Select: Larynx
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Pain - Select: Back
Serious: no
Organ System: General disorders
Frequency: 3 affected / 64 at risk

Adverse event: Pain - Select: Joint
Serious: no
Organ System: General disorders
Frequency: 6 affected / 64 at risk

Adverse event: Pain - Select: Breast
Serious: no
Organ System: General disorders
Frequency: 5 affected / 64 at risk

Adverse event: Pain - Select: Extremity - Limb
Serious: no
Organ System: General disorders
Frequency: 4 affected / 64 at risk

Adverse event: Pain - Select: Head/Headaches
Serious: no
Organ System: General disorders
Frequency: 6 affected / 64 at risk

Adverse event: Pain - Select: Cardiac/Heart
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Pain - Select: Neuralgia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Pain - Select: Eye
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Pain - Select: Bone
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Pain - Select: Dental/Teeth/Peridontal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Constitutional Symptoms - Other
Serious: no
Organ System: General disorders
Notes: Malaise
Frequency: 4 affected / 64 at risk

Adverse event: Constitutional Symptoms - Fever
Serious: no
Organ System: General disorders
Frequency: 2 affected / 64 at risk

Adverse event: Constitutional Symptoms - Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 64 at risk

Adverse event: Constitutional Symptoms - Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 64 at risk

Adverse event: Constitutional Symptoms - Sweating
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Allergic Reastion
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Infection (documented clinically) Select: Bladder (Urinary)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Infection with Unknown ANC - Select: Bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Infections - Other
Serious: no
Organ System: Infections and infestations
Notes: Sinus Infection
Frequency: 5 affected / 64 at risk

Adverse event: Infection with Unknwn ANC - Select: Vagina
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 64 at risk

Adverse event: Infection With Unknown ANC - Select: Upper Airways Nose
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Infection With Unknown ANC - Select: Sinus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Infection With Unknown ANC - Select: Urinary Tract Nos
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 64 at risk

Adverse event: Infection (Documented Clinically) - Select: Sinus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Infection With Unknown ANC - Select: Conjunctiva
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Infection (Documented Clinically) - Select: Urinary Tract Nos
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Infection (Documented Clinically) - Select: Pleura (Empyema)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Musculoskeletal - Other (Specify)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Right Lateral Side Discomfort
Frequency: 5 affected / 64 at risk

Adverse event: Joint - Function
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: Mood Alteration - Select: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 64 at risk

Adverse event: Mood Alteration - Select: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 64 at risk

Adverse event: Renal - Other
Serious: no
Organ System: Renal and urinary disorders
Notes: vaginal itching
Frequency: 1 affected / 64 at risk

Adverse event: Sexual - Other
Serious: no
Organ System: Reproductive system and breast disorders
Notes: MENORRHAGIA
Frequency: 8 affected / 64 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 64 at risk

Adverse event: Pulmonary/Upper Respiratory - Other (Specify)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Sinus Congestion
Frequency: 15 affected / 64 at risk

Adverse event: Voice Changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 64 at risk

Adverse event: Dermatology/Skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MOLE REMOVED ON ABDOMEN - SHOWED DYSPLASIA
Frequency: 4 affected / 64 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 64 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 64 at risk