Study: NCT00295646

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 450 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 450 at risk

Adverse event: Breast inflammation
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 450 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 450 at risk

Adverse event: Cutaneous reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 450 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 450 at risk

Adverse event: Disease of liver / gallbladder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 450 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 450 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 450 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 450 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 450 at risk

Adverse event: Hypertonia
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 450 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 450 at risk

Adverse event: Lymphedema (arm, hand)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 450 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 450 at risk

Adverse event: Other tumors
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 450 at risk

Adverse event: Periodontal disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 450 at risk

Adverse event: Peripheral nerve disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 450 at risk

Adverse event: Mental disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 450 at risk

Adverse event: Sensory disturbance
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 450 at risk

Adverse event: Skin disease
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 450 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 450 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 450 at risk

Adverse event: Tendonitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 450 at risk

Adverse event: Thyroid disease
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 450 at risk

Adverse event: Tinnitus/hearing loss
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 450 at risk

Adverse event: Torn ligament/Meniscus lesion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 450 at risk

Adverse event: Uro-genital tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 450 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 450 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 450 at risk

Adverse event: Vulvovaginal inflammation
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 450 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 150 affected / 450 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 185 affected / 450 at risk

Adverse event: Breast inflammation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 450 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 450 at risk

Adverse event: Cutaneous reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 450 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 450 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 450 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 98 affected / 450 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 46 affected / 450 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 450 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 85 affected / 450 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 25 affected / 450 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 450 at risk

Adverse event: Hypertonia
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 450 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 450 at risk

Adverse event: Impaired vision
Serious: no
Organ System: Eye disorders
Frequency: 29 affected / 450 at risk

Adverse event: Infection of ear, nose, or throat
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 450 at risk

Adverse event: Irregular vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 450 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 450 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 450 at risk

Adverse event: Lymphedema (arm, hand)
Serious: no
Organ System: Vascular disorders
Frequency: 26 affected / 450 at risk

Adverse event: Morning stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 35 affected / 450 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 450 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 450 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 450 at risk

Adverse event: Other/minor (not categorized)
Serious: no
Organ System: General disorders
Frequency: 119 affected / 450 at risk

Adverse event: Ovarian changes
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 450 at risk

Adverse event: Periodontal disease*
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 450 at risk

Adverse event: Peripheral nerve disease
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 450 at risk

Adverse event: Mental disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 80 affected / 450 at risk

Adverse event: Sensory disturbance
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 450 at risk

Adverse event: Skin disease
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 450 at risk

Adverse event: Spinal troubles/pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 450 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 450 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 450 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 450 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 450 at risk

Adverse event: Thyroid disease
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 450 at risk

Adverse event: Tinnitus/hearing loss
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 450 at risk

Adverse event: Uro-genital tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 450 at risk

Adverse event: Uterine polyp
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 450 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 450 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 450 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 450 at risk

Adverse event: Vulvovaginal inflammation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 450 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 450 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 450 at risk

Adverse event: Cutaneous reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 450 at risk

Adverse event: Disease of liver / gallbladder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 450 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 450 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 450 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 450 at risk

Adverse event: Lymphedema (arm, hand)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 450 at risk

Adverse event: Other tumors
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 450 at risk

Adverse event: Periodontal disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 450 at risk

Adverse event: Peripheral nerve disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 450 at risk

Adverse event: Mental disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 450 at risk

Adverse event: Sensory disturbance
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 450 at risk

Adverse event: Skin disease
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 450 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 450 at risk

Adverse event: Tendonitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 450 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 450 at risk

Adverse event: Tinnitus/hearing loss
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 450 at risk

Adverse event: Torn ligament/Meniscus lesion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 450 at risk

Adverse event: Uro-genital tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 450 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 52 affected / 450 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 13 affected / 450 at risk

Adverse event: Vulvovaginal inflammation
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 450 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 65 affected / 450 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 132 affected / 450 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 450 at risk

Adverse event: Cutaneous reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 450 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 450 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 450 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 82 affected / 450 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 34 affected / 450 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 450 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 450 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 59 affected / 450 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 450 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 27 affected / 450 at risk

Adverse event: Hypertonia
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 450 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 450 at risk

Adverse event: Impaired vision
Serious: no
Organ System: Eye disorders
Frequency: 27 affected / 450 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 450 at risk

Adverse event: Infection of ear, nose, or throat
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 450 at risk

Adverse event: Irregular vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 450 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 10 affected / 450 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 450 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 450 at risk

Adverse event: Lymphedema (arm, hand)
Serious: no
Organ System: Vascular disorders
Frequency: 31 affected / 450 at risk

Adverse event: Morning stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 450 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 450 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 450 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 450 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 450 at risk

Adverse event: Other/minor (not categorized)
Serious: no
Organ System: General disorders
Frequency: 112 affected / 450 at risk

Adverse event: Periodontal disease*
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 450 at risk

Adverse event: Peripheral nerve disease
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 450 at risk

Adverse event: Mental disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 74 affected / 450 at risk

Adverse event: Skin disease
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 450 at risk

Adverse event: Spinal troubles/pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 450 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 450 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 450 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 450 at risk

Adverse event: Tinnitus/hearing loss
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 450 at risk

Adverse event: Uro-genital tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 450 at risk

Adverse event: Uterine polyp
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 450 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 450 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 450 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 450 at risk

Adverse event: Vulvovaginal inflammation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 450 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 450 at risk

Adverse event: Breast inflammation
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 453 at risk

Adverse event: Cutaneous reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 453 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 453 at risk

Adverse event: Disease of liver / gallbladder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 453 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 453 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 453 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 453 at risk

Adverse event: Hypertonia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 453 at risk

Adverse event: Incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 453 at risk

Adverse event: Insult / TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 453 at risk

Adverse event: Irregular vaginal discharge
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 453 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 453 at risk

Adverse event: Lymphedema (arm, hand)
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 453 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 453 at risk

Adverse event: Other tumors
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 453 at risk

Adverse event: Peripheral nerve disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 453 at risk

Adverse event: Sensory disturbance
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 453 at risk

Adverse event: Skin disease
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 453 at risk

Adverse event: Spinal troubles/pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 453 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 453 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 453 at risk

Adverse event: Tendonitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 453 at risk

Adverse event: Thyroid disease
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 453 at risk

Adverse event: Torn ligament/Meniscus lesion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 453 at risk

Adverse event: Uro-genital tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 453 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 453 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 453 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 112 affected / 453 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 128 affected / 453 at risk

Adverse event: Breast inflammation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 453 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 453 at risk

Adverse event: Cutaneous reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 453 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 453 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 453 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 93 affected / 453 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 453 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 453 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 453 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 63 affected / 453 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 453 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 25 affected / 453 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 453 at risk

Adverse event: Hypertonia
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 453 at risk

Adverse event: Impaired vision
Serious: no
Organ System: Eye disorders
Frequency: 22 affected / 453 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 453 at risk

Adverse event: Infection of ear, nose, or throat
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 453 at risk

Adverse event: Irregular vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 453 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 453 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 453 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 453 at risk

Adverse event: Lymphedema (arm, hand)
Serious: no
Organ System: Vascular disorders
Frequency: 28 affected / 453 at risk

Adverse event: Morning stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 33 affected / 453 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 453 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 453 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 453 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 453 at risk

Adverse event: Other/minor (not categorized)
Serious: no
Organ System: General disorders
Frequency: 107 affected / 453 at risk

Adverse event: Ovarian changes
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 453 at risk

Adverse event: Peripheral nerve disease
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 453 at risk

Adverse event: Mental disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 97 affected / 453 at risk

Adverse event: Sensory disturbance
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 453 at risk

Adverse event: Skin disease
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 453 at risk

Adverse event: Spinal troubles/pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 453 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 453 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 453 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 453 at risk

Adverse event: Thyroid disease
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 453 at risk

Adverse event: Tinnitus/hearing loss
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 453 at risk

Adverse event: Torn ligament/Meniscus lesion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 453 at risk

Adverse event: Uterine polyp
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 453 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 453 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 453 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 453 at risk

Adverse event: Vulvovaginal inflammation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 453 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 453 at risk

Adverse event: Breast inflammation
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 450 at risk

Adverse event: Cutaneous reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 450 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 450 at risk

Adverse event: Disease of liver / gallbladder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 450 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 450 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 450 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 450 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 450 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 450 at risk

Adverse event: Hypertonia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 450 at risk

Adverse event: Insult / TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 450 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 450 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 450 at risk

Adverse event: Lymphedema (arm, hand)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 450 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 450 at risk

Adverse event: Other tumors
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 450 at risk

Adverse event: Ovarian changes
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 450 at risk

Adverse event: Peripheral nerve disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 450 at risk

Adverse event: Mental disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 450 at risk

Adverse event: Skin disease
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 450 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 450 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 450 at risk

Adverse event: Tendonitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 450 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 450 at risk

Adverse event: Thyroid disease
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 450 at risk

Adverse event: Tinnitus/hearing loss
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 450 at risk

Adverse event: Torn ligament/Meniscus lesion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 450 at risk

Adverse event: Uro-genital tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 450 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 39 affected / 450 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 450 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 52 affected / 450 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 94 affected / 450 at risk

Adverse event: Cutaneous reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 450 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 450 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 450 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 70 affected / 450 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 450 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 450 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 450 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 59 affected / 450 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 28 affected / 450 at risk

Adverse event: Hypertonia
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 450 at risk

Adverse event: Impaired vision
Serious: no
Organ System: Eye disorders
Frequency: 36 affected / 450 at risk

Adverse event: Infection of ear, nose, or throat
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 450 at risk

Adverse event: Irregular vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 450 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 9 affected / 450 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 450 at risk

Adverse event: Lymphedema (arm, hand)
Serious: no
Organ System: Vascular disorders
Frequency: 29 affected / 450 at risk

Adverse event: Morning stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 450 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 450 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 450 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 450 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 450 at risk

Adverse event: Other/minor (not categorized)
Serious: no
Organ System: General disorders
Frequency: 108 affected / 450 at risk

Adverse event: Ovarian changes
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 450 at risk

Adverse event: Periodontal disease*
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 450 at risk

Adverse event: Peripheral nerve disease
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 450 at risk

Adverse event: Mental disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 70 affected / 450 at risk

Adverse event: Sensory disturbance
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 450 at risk

Adverse event: Skin disease
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 450 at risk

Adverse event: Spinal troubles/pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 450 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 450 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 450 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 450 at risk

Adverse event: Thyroid disease
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 450 at risk

Adverse event: Tinnitus/hearing loss
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 450 at risk

Adverse event: Torn ligament/Meniscus lesion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 450 at risk

Adverse event: Uro-genital tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 450 at risk

Adverse event: Uterine polyp
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 450 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 450 at risk

Adverse event: Vulvovaginal dryness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 450 at risk

Adverse event: Vulvovaginal inflammation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 450 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 450 at risk