Study: NCT00510692

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Acute small bowel obstruction associated with underlying disease.
Frequency: 2 affected / 29 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not related to study medication.
Frequency: 1 affected / 29 at risk

Adverse event: Endocrine disorders
Serious: no
Organ System: Endocrine disorders
Notes: Hypothyroidism.
Frequency: 1 affected / 29 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: Most common: Abdominal distension. Abdominal pain. Abdominal pain upper. Diarrhoea. Dyspepsia. Faeces discoloured. Flatulence. Nausea. Stomach discomfort. Vomiting.
Frequency: 23 affected / 29 at risk

Adverse event: General disorders
Serious: no
Organ System: General disorders
Notes: Chills. Fatigue. Hemia. Influenza-like illness. Malaise. Pain. Thirst.
Frequency: 7 affected / 29 at risk

Adverse event: Immune system disorders
Serious: no
Organ System: Immune system disorders
Notes: Seasonal allergy
Frequency: 1 affected / 29 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Notes: Ear infection. Gastroenteritis viral. Infected cyst. Infection localised. Influenza. Localised infection. Lower respiratory tract infection. Naso-pharyngitis. Skin infection. Tonsillitis. Tooth abscess. Tracheitis. Baricella
Frequency: 8 affected / 29 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Back injury. Foot fracture. Neck injury. Procedural pain. Whip lash injury.
Frequency: 4 affected / 29 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: Blood cholesterol increase. Blood creatinine increase. Blood potassium decreased. Lipids increased. Weight decreased. Weight increased.
Frequency: 1 affected / 29 at risk

Adverse event: metabolism and nutritional disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Decreased appetite.
Frequency: 1 affected / 29 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Arthralgia. Axillary mass. Back pain. Bone cyst. Groin pain. Limb discomfort. Muscle spasms. Musculoskeletal pain. Myalgia. Neck pain. Pain in extremity. Pain in jaw.
Frequency: 7 affected / 29 at risk

Adverse event: Neoplasms benign, malignant and unspecified
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Breast cancer. Osteoma.
Frequency: 2 affected / 29 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: Dizziness. Dysgeusia. Headache. Migraine
Frequency: 11 affected / 29 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Notes: Pollakiuria.
Frequency: 1 affected / 29 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough. Epistaxis. Increased upper airways secretion. Pharyngolaryngeal pain.
Frequency: 5 affected / 29 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Heal rash. Rash.
Frequency: 1 affected / 29 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Notes: Episcleritis
Frequency: 1 affected / 29 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: Most common: Abdominal distension. Abdominal pain. Abdominal pain upper. Diarrhoea. Dyspepsia. Faeces discoloured. Flatulence. Nausea. Stomach discomfort. Vomiting.
Frequency: 22 affected / 29 at risk

Adverse event: General disorders
Serious: no
Organ System: General disorders
Notes: Chills. Fatigue. Hemia. Influenza-like illness. Malaise. Pain. Thirst.
Frequency: 9 affected / 29 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Notes: Ear infection. Gastroenteritis viral. Infected cyst. Infection localised. Influenza. Localised infection. Lower respiratory tract infection. Naso-pharyngitis. Skin infection. Tonsillitis. Tooth abscess. Tracheitis. Baricella
Frequency: 7 affected / 29 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Back injury. Foot fracture. Neck injury. Procedural pain. Whip lash injury.
Frequency: 1 affected / 29 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: Blood cholesterol increase. Blood creatinine increase. Blood potassium decreased. Lipids increased. Weight decreased. Weight increased.
Frequency: 5 affected / 29 at risk

Adverse event: metabolism and nutritional disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Decreased appetite.
Frequency: 2 affected / 29 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Arthralgia. Axillary mass. Back pain. Bone cyst. Groin pain. Limb discomfort. Muscle spasms. Musculoskeletal pain. Myalgia. Neck pain. Pain in extremity. Pain in jaw.
Frequency: 8 affected / 29 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: Dizziness. Dysgeusia. Headache. Migraine
Frequency: 6 affected / 29 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Notes: Anxiety. Mood swings.
Frequency: 2 affected / 29 at risk

Adverse event: Reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Breast mass. Epididymal cyst. Mensturation irregular.
Frequency: 3 affected / 29 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough. Epistaxis. Increased upper airways secretion. Pharyngolaryngeal pain.
Frequency: 4 affected / 29 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Heal rash. Rash.
Frequency: 3 affected / 29 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Notes: Hot flush.
Frequency: 1 affected / 29 at risk