Study: NCT01828567

Adverse event: Study Safety Protocol
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Study Safety Protocol
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 208 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 208 at risk

Adverse event: Important Medical Event
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 208 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 208 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 208 at risk

Adverse event: Protocol Deviation
Serious: yes
Organ System: Investigations
Frequency: 45 affected / 208 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Important Medical Event
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Important Medical Event
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 208 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 208 at risk

Adverse event: Important Medical Event
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 208 at risk

Adverse event: Emergency Room Visit
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 208 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 208 at risk

Adverse event: Important Medical Event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 208 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 208 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 209 at risk

Adverse event: Study Safety Protocol
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 209 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 209 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 209 at risk

Adverse event: Protocol Deviation
Serious: yes
Organ System: Investigations
Frequency: 36 affected / 209 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 209 at risk

Adverse event: Emergency Room Visit
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 209 at risk

Adverse event: Important Medical Event
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 209 at risk

Adverse event: Important Medical Event
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 209 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 209 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 209 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 209 at risk