Study: NCT01651117

Adverse event: Hospitalisation
Serious: yes
Organ System: Nervous system disorders
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 3 affected / 156 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 4 affected / 156 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 3 affected / 156 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Renal and urinary disorders
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 1 affected / 156 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 1 affected / 156 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Endocrine disorders
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 1 affected / 156 at risk

Adverse event: ED visit
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 3 affected / 156 at risk

Adverse event: ED visit
Serious: no
Organ System: Surgical and medical procedures
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 3 affected / 156 at risk

Adverse event: ED visit
Serious: no
Organ System: Cardiac disorders
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 1 affected / 156 at risk

Adverse event: ED visit
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 1 affected / 156 at risk

Adverse event: ED visit
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 2 affected / 156 at risk

Adverse event: ED visit
Serious: no
Organ System: General disorders
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 1 affected / 156 at risk

Adverse event: ED visit
Serious: no
Organ System: Renal and urinary disorders
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 1 affected / 156 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Nervous system disorders
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 3 affected / 205 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 15 affected / 205 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 3 affected / 205 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Renal and urinary disorders
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 5 affected / 205 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 2 affected / 205 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 1 affected / 205 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Immune system disorders
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 3 affected / 205 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 2 affected / 205 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 2 affected / 205 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 1 affected / 205 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 1 affected / 205 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 6 affected / 205 at risk

Adverse event: ED visit
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 7 affected / 205 at risk

Adverse event: ED visit
Serious: no
Organ System: Surgical and medical procedures
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 4 affected / 205 at risk

Adverse event: ED visit
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 1 affected / 205 at risk

Adverse event: ED visit
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 1 affected / 205 at risk

Adverse event: ED visit
Serious: no
Organ System: General disorders
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 21 affected / 205 at risk

Adverse event: ED visit
Serious: no
Organ System: Infections and infestations
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 4 affected / 205 at risk

Adverse event: ED visit
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 3 affected / 205 at risk

Adverse event: ED visit
Serious: no
Organ System: Reproductive system and breast disorders
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 2 affected / 205 at risk

Adverse event: ED visit
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 1 affected / 205 at risk

Adverse event: ED visit
Serious: no
Organ System: Nervous system disorders
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 1 affected / 205 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Nervous system disorders
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 2 affected / 70 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 3 affected / 70 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 1 affected / 70 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 1 affected / 70 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 5 affected / 70 at risk

Adverse event: ED visit
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 3 affected / 70 at risk

Adverse event: ED visit
Serious: no
Organ System: Surgical and medical procedures
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 2 affected / 70 at risk

Adverse event: ED visit
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 1 affected / 70 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 1 affected / 49 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 1 affected / 49 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 1 affected / 49 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 1 affected / 49 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Endocrine disorders
Notes: We considered any hospitalization (any participant who had to stay in the hospital overnight due to their condition) an SAE. Therefore, these numbers represent those who were hospitalized as a result of an SAE.
Frequency: 1 affected / 49 at risk

Adverse event: ED visit
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 1 affected / 49 at risk

Adverse event: ED visit
Serious: no
Organ System: Surgical and medical procedures
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 2 affected / 49 at risk

Adverse event: ED visit
Serious: no
Organ System: General disorders
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 2 affected / 49 at risk

Adverse event: ED visit
Serious: no
Organ System: Infections and infestations
Notes: We considered any ED visit (any participant who went to the emergency room due to their condition) an AE. Therefore, these numbers represent those who went to the emergency room as a result of an AE.
Frequency: 1 affected / 49 at risk