Study: NCT00297167

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAEs for EUR-1008 occurred during the first open-label dose stabilization period, during which all participants were on EUR-1008.
Frequency: 1 affected / 34 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAEs for EUR-1008 occurred during the first open-label dose stabilization period, during which all participants were on EUR-1008.
Frequency: 1 affected / 34 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 34 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 2 affected / 34 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 4 affected / 34 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 2 affected / 34 at risk

Adverse event: Abnormal faeces
Serious: no
Organ System: Gastrointestinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 34 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 2 affected / 34 at risk

Adverse event: Frequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 34 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 34 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 34 at risk

Adverse event: Early satiety
Serious: no
Organ System: General disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 2 affected / 34 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 2 affected / 34 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 34 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 2 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 5 affected / 34 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 2 affected / 34 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 34 at risk

Adverse event: Abdominal tenderness
Serious: no
Organ System: Gastrointestinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 34 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 34 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 34 at risk

Adverse event: Oedema mucosal
Serious: no
Organ System: General disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 34 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 34 at risk

Adverse event: Anal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 34 at risk

Adverse event: Clubbing
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 34 at risk

Adverse event: Rales
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 34 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 34 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 34 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 3 affected / 32 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 6 affected / 32 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 3 affected / 32 at risk

Adverse event: Abnormal faeces
Serious: no
Organ System: Gastrointestinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 3 affected / 32 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 3 affected / 32 at risk

Adverse event: Frequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 2 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 32 at risk

Adverse event: Steatorrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 4 affected / 32 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 2 affected / 32 at risk

Adverse event: Gastrointestinal sounds abnormal
Serious: no
Organ System: Gastrointestinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 32 at risk

Adverse event: Infrequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 32 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 32 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 32 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 32 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 32 at risk

Adverse event: Vulvovaginal burning sensation
Serious: no
Organ System: Reproductive system and breast disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 32 at risk

Adverse event: Rales
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: These data represent AEs collected during both double blind treatment periods.
Frequency: 1 affected / 32 at risk