Study: NCT02551094

Adverse event: Gastro-intestinal SAE
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 2346 at risk

Adverse event: Infection SAE
Serious: yes
Organ System: Infections and infestations
Frequency: 38 affected / 2346 at risk

Adverse event: Pneumonia SAE
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 2346 at risk

Adverse event: Septic Shock SAE
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2346 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 319 affected / 2346 at risk

Adverse event: HF hospitalization SAE
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 2346 at risk

Adverse event: Diarrhea AE
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 208 affected / 2346 at risk

Adverse event: Nauseau AE
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 2346 at risk

Adverse event: Flatulence AE
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 2346 at risk

Adverse event: GI Haemorrhage AE
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 2346 at risk

Adverse event: Anaemia AE
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 2346 at risk

Adverse event: Leukopenia AE
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 2346 at risk

Adverse event: Thrombocytopenia AE
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 2346 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 109 affected / 2346 at risk

Adverse event: Gastro-intestinal SAE
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 2330 at risk

Adverse event: Infection SAE
Serious: yes
Organ System: Infections and infestations
Frequency: 51 affected / 2330 at risk

Adverse event: Pneumonia SAE
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 2330 at risk

Adverse event: Septic Shock SAE
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2330 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 263 affected / 2330 at risk

Adverse event: HF hospitalization SAE
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 2330 at risk

Adverse event: Diarrhea AE
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 225 affected / 2330 at risk

Adverse event: Nauseau AE
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 2330 at risk

Adverse event: Flatulence AE
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 2330 at risk

Adverse event: GI Haemorrhage AE
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 2330 at risk

Adverse event: Anaemia AE
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 2330 at risk

Adverse event: Leukopenia AE
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2330 at risk

Adverse event: Thrombocytopenia AE
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 2330 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 63 affected / 2330 at risk