Study: NCT02680756

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 127 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 127 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 127 at risk

Adverse event: Cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 127 at risk

Adverse event: Blood and lymphatic system disorders
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 127 at risk

Adverse event: General disorders and administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 127 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 127 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 127 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 127 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 127 at risk

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 127 at risk

Adverse event: Crohns disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 127 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 127 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 127 at risk

Adverse event: Faeces discoloured
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 127 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 127 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 127 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 127 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 127 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 127 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 127 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 127 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 40 affected / 127 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 29 affected / 127 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 9 affected / 127 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 9 affected / 127 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 9 affected / 127 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 11 affected / 127 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 7 affected / 127 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 5 affected / 127 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 4 affected / 127 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 4 affected / 127 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 4 affected / 127 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 2 affected / 127 at risk

Adverse event: Gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 120 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Neoplasms benign, malignant and unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 120 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 15 affected / 120 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 120 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 120 at risk

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 120 at risk

Adverse event: Crohns disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 120 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 120 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 120 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 120 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 120 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 120 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 120 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 15 affected / 120 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 22 affected / 120 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 6 affected / 120 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 4 affected / 120 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 4 affected / 120 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 2 affected / 120 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 2 affected / 120 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 2 affected / 120 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 3 affected / 120 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 1 affected / 120 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Psychiatric disorders
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 1 affected / 120 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Notes: TEAEs in \<2% of Subjects Overall by SOC
Frequency: 2 affected / 120 at risk