Study: NCT01880047

Adverse event: Increased liver enzymes >3 times ULN
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 17 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Respiratory infection - Not related to study medication/placebo
Frequency: 10 affected / 17 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Epistaxis
Frequency: 2 affected / 17 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Transaminitis not requiring study intervention
Frequency: 2 affected / 17 at risk

Adverse event: Rectal prolapse
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Respiratory infection - Not related to study medication/placebo
Frequency: 4 affected / 9 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Epistaxis
Frequency: 2 affected / 9 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Transaminitis not requiring study intervention
Frequency: 1 affected / 9 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Respiratory infection - Not related to study medication/placebo
Frequency: 1 affected / 5 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Epistaxis
Frequency: 1 affected / 5 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Transaminitis not requiring study intervention
Frequency: 1 affected / 5 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Respiratory infection - Not related to study medication/placebo
Frequency: 1 affected / 3 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Transaminitis not requiring study intervention
Frequency: 1 affected / 3 at risk

Adverse event: Increased liver enzymes >3 times ULN
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 22 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Respiratory infection - Not related to study medication/placebo
Frequency: 1 affected / 22 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Epistaxis
Frequency: 3 affected / 22 at risk

Adverse event: Rectal prolapse
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Respiratory infection - Not related to study medication/placebo
Frequency: 1 affected / 21 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Epistaxis
Frequency: 2 affected / 21 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Transaminitis not requiring study intervention
Frequency: 2 affected / 21 at risk

Adverse event: Rectal prolapse
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Respiratory infection - Not related to study medication/placebo
Frequency: 3 affected / 19 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Epistaxis
Frequency: 6 affected / 19 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Transaminitis not requiring study intervention
Frequency: 3 affected / 19 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Epistaxis
Frequency: 2 affected / 11 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Respiratory infection - Not related to study medication/placebo
Frequency: 1 affected / 10 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Epistaxis
Frequency: 3 affected / 10 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Transaminitis not requiring study intervention
Frequency: 1 affected / 10 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Respiratory infection - Not related to study medication/placebo
Frequency: 1 affected / 8 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Epistaxis
Frequency: 4 affected / 8 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Transaminitis not requiring study intervention
Frequency: 1 affected / 8 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Respiratory infection - Not related to study medication/placebo
Frequency: 4 affected / 27 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Epistaxis
Frequency: 16 affected / 27 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Notes: Transaminitis not requiring study intervention
Frequency: 2 affected / 27 at risk