Study: NCT01657877

Adverse event: Invasive lobular carcinoma of left breast
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 75 at risk

Adverse event: Gingival erythema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Noninfective gingivitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Glossitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Loose tooth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Gingival injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 75 at risk

Adverse event: Gingival ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 75 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Oral fibroma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 75 at risk

Adverse event: Tooth restoration
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 75 at risk

Adverse event: Eyelid irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 75 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 75 at risk

Adverse event: Gingival erythema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Tooth disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 71 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Nasal ulcer
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Tonsillar inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Gingival injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Tooth fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Gingival ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 71 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 71 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 71 at risk

Adverse event: Unstable angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 70 at risk

Adverse event: Multiple myeloma of bones
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 70 at risk

Adverse event: Gingival erythema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 70 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Dental caries
Serious: no
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Gingival pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Lip blister
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Hyperaesthesia teeth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Tooth deposit
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 70 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 70 at risk

Adverse event: Gingival injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 70 at risk

Adverse event: Nodule
Serious: no
Organ System: General disorders
Frequency: 1 affected / 70 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 70 at risk

Adverse event: Gingival erythema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: Oral mucosal exfoliation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: Tongue ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 69 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 69 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 69 at risk

Adverse event: Gingival injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 69 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 69 at risk

Adverse event: Nodule
Serious: no
Organ System: General disorders
Frequency: 1 affected / 69 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 69 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 69 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 69 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 69 at risk

Adverse event: Gingival erythema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 71 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 71 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 71 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 71 at risk

Adverse event: Tooth restoration
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 71 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 71 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 71 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 71 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 71 at risk