Study: NCT00562159

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 213 at risk

Adverse event: Pelvic haematoma
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 213 at risk

Adverse event: Ear Pruritis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 42 affected / 213 at risk

Adverse event: Eye Pruritis
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 213 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 213 at risk

Adverse event: Oedema mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 213 at risk

Adverse event: Oral pruritus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 76 affected / 213 at risk

Adverse event: Parathesia Oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 213 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 213 at risk

Adverse event: Swollen tongue
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 213 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 213 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 213 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 56 affected / 213 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 213 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 213 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 213 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 213 at risk

Adverse event: Pharyngeal oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 213 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 63 affected / 213 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 213 at risk

Adverse event: Viral pericarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 226 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 226 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 226 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 226 at risk

Adverse event: Alcohol abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 226 at risk

Adverse event: Bulimia nervosa
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 226 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 226 at risk

Adverse event: Ear Pruritis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 226 at risk

Adverse event: Eye Pruritis
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 226 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 226 at risk

Adverse event: Oedema mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 226 at risk

Adverse event: Oral pruritus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 226 at risk

Adverse event: Parathesia Oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 226 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 226 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 43 affected / 226 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 226 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 39 affected / 226 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 226 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 226 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 226 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 226 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 226 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 226 at risk