Study: NCT01097005

Adverse event: Bile duct cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Causal relationship with the study drug was rated as "possible" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Causal relationship with the study drug was rated as "possible" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Causal relationship with the study drug was rated as "possible" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Causal relationship with the study drug was rated as "possible" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Causal relationship with the study drug was rated as "possible" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Disorientation
Serious: yes
Organ System: Psychiatric disorders
Notes: Causal relationship with the study drug was rated as "possible" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Notes: Causal relationship with the study drug was rated as "possible" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causal relationship with the study drug was rated as "possible" by the investigator.
Frequency: 2 affected / 441 at risk

Adverse event: Drug eruption
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Causal relationship with the study drug was rated as "possible" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Erythema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Causal relationship with the study drug was rated as "possible" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Notes: Causal relationship with the study drug was rated as "possible" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Notes: Causal relationship with the study drug was rated as "possible" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Bronchopulmonary aspergillosis
Serious: yes
Organ System: Infections and infestations
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 3 affected / 441 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 4 affected / 441 at risk

Adverse event: Atypical mycobacterial infection
Serious: yes
Organ System: Infections and infestations
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 2 affected / 441 at risk

Adverse event: Anti-neutrophil cytoplasmic antibody positive vasculitis
Serious: yes
Organ System: Immune system disorders
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Optic neuritis
Serious: yes
Organ System: Nervous system disorders
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Vertigo positional
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Alveoliltis allergic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 2 affected / 441 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 2 affected / 441 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 3 affected / 441 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 2 affected / 441 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 1 affected / 441 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Causal relationship with the study drug was rated as "Not related" by the investigator.
Frequency: 1 affected / 441 at risk