Study: NCT01823198

Adverse event: Viral Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Bacterial Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Chronic Liver GvHD
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Chronic ocular GvHD
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 6 at risk

Adverse event: Chronic oral GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Chronic Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 6 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Elevated bilirubin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Elevated transminitis
Serious: no
Organ System: Investigations
Frequency: 2 affected / 6 at risk

Adverse event: Flu like syndrome
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 6 at risk

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

Adverse event: Neutropenic fevers
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 6 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 6 at risk

Adverse event: Upper GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 6 at risk

Adverse event: Chronic lung GvHD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Secondary graft failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: ABO incompatibility
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 6 at risk

Adverse event: BK virus associated hemorrhagic cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Chronic ocular GvHD
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Chronic oral GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Chronic Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 6 at risk

Adverse event: Chronic vaginal GvHD
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Elevated bilirubin
Serious: no
Organ System: Investigations
Frequency: 3 affected / 6 at risk

Adverse event: Elevated transminitis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Fevers
Serious: no
Organ System: General disorders
Frequency: 3 affected / 6 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 6 at risk

Adverse event: Neutropenic fevers
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 6 at risk

Adverse event: Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 6 at risk

Adverse event: Upper GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Fungal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Bacterial Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 4 at risk

Adverse event: Organising pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Chronic ocular GvHD
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

Adverse event: Chronic Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Fevers
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 4 at risk

Adverse event: GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 4 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4 at risk

Adverse event: Neutropenic fevers
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 4 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4 at risk

Adverse event: Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 4 at risk

Adverse event: Upper GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 4 at risk

Adverse event: ABO incompatibility
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Bacterial Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 4 at risk

Adverse event: Chronic ocular GvHD
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4 at risk

Adverse event: Elevated bilirubin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Elevated transminitis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Fevers
Serious: no
Organ System: General disorders
Frequency: 3 affected / 4 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Liver GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4 at risk

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

Adverse event: Neutropenic fevers
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4 at risk

Adverse event: Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 4 at risk

Adverse event: Liver GvHD
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1 at risk

Adverse event: Bacterial Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1 at risk

Adverse event: Elevated bilirubin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk

Adverse event: Fungal Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk

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

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1 at risk

Adverse event: Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1 at risk

Adverse event: Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1 at risk

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

Adverse event: Chronic Skin GvHD
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Liver GvHD
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 21 at risk

Adverse event: Bacterial Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Bacterial Infections
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 21 at risk

Adverse event: BK virus associated hemorrhagic cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 21 at risk

Adverse event: Chronic ocular GvHD
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 21 at risk

Adverse event: Chronic oral GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 21 at risk

Adverse event: Chronic Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Chronic vaginal GvHD
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 21 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 21 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 21 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 21 at risk

Adverse event: Ejection fraction decreased
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Elevated bilirubin
Serious: no
Organ System: Investigations
Frequency: 8 affected / 21 at risk

Adverse event: Elevated transminitis
Serious: no
Organ System: Investigations
Frequency: 6 affected / 21 at risk

Adverse event: Fevers
Serious: no
Organ System: General disorders
Frequency: 4 affected / 21 at risk

Adverse event: Flu like syndrome
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 21 at risk

Adverse event: Fungal Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 21 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 21 at risk

Adverse event: Idiopathic thrombocytopenic purpura (ITP)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Liver GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 21 at risk

Adverse event: Neutropenic fevers
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 21 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 21 at risk

Adverse event: Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 21 at risk

Adverse event: Upper GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 21 at risk