Study: NCT02161406

Adverse event: Cellulitis of right elbow
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Left side mastoiditis/ abrythnitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Dysphagia from myositis and prolonged hospitalization
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pseudo obstruction of the small bowel, paralytic ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Squamous Cell Carcinoma In-situ Left Anterior Ear
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 44 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Renal crisis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: General disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 13 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Infections and infestations
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 17 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 18 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Nervous system disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 7 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 5 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 7 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Renal and urinary disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 1 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Cardiac disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 3 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Endocrine disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 3 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 2 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Gastrointestinal disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 11 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Hepatobiliary disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 1 affected / 44 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 44 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 44 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 44 at risk

Adverse event: Vomiting (Emesis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 3 affected / 44 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 44 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 44 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pruritis (Itching)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 44 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 44 at risk

Adverse event: Healthcare associated pneumonia (HCAP)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Paronychia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Digital Ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: NSTEMI Myocardial Infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pulmonary arterial hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pulmonary Arterial Hypertension and Pericardial Effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Worsening AV block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Dysphagia due to GI dysmotility
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Erosive oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: GAVE; Severe anemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: GAVE
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Depression with Suicidal Ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 44 at risk

Adverse event: Basal cell carcinoma (BCC)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 44 at risk

Adverse event: Renal crisis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: General disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 12 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 3 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Infections and infestations
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 22 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 17 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Nervous system disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 7 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 13 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 7 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Renal and urinary disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 5 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Cardiac disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 5 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Endocrine disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 1 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 1 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Gastrointestinal disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 13 affected / 44 at risk

Adverse event: Other Non-serious Adverse Events
Serious: no
Organ System: Hepatobiliary disorders
Notes: Specific adverse event terms that occurred in \< 5% of subjects were pooled.
Frequency: 4 affected / 44 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 44 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 44 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 44 at risk

Adverse event: Vomiting (Emesis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 44 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 44 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 44 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 44 at risk

Adverse event: Pruritis (Itching)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 44 at risk