Study: NCT01904136

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

Adverse event: Viral Infections
Serious: yes
Organ System: Infections and infestations
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: Flu like syndrome
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1 at risk

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

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

Adverse event: Bacterial Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Neutropenic fevers
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 2 at risk

Adverse event: Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Fevers
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Elevated bilirubin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Viral Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Bacterial Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: GI GvHD
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Bacterial Infections
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 3 at risk

Adverse event: Neutropenic fevers
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

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

Adverse event: Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 3 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Elevated bilirubin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Fungal Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: HSCT related microangiopathy (TA-TMA)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Liver GvHD
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Upper GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Cystitis haemorrhagic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Bacterial Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3 at risk

Adverse event: Neutropenic fevers
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

Adverse event: Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3 at risk

Adverse event: Fevers
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Liver GvHD
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Upper GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: BK virus associated hemorrhagic cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3 at risk

Adverse event: Elevated transminitis
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

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

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

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

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

Adverse event: Hypervolaemia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Upper GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Neutropenic colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Cytoxan induced Hemorrhagic Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Bacterial Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

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

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

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

Adverse event: Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

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

Adverse event: Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Upper GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: BK virus associated hemorrhagic cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Delayed engraftment
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Bacterial Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3 at risk

Adverse event: Flu like syndrome
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Neutropenic fevers
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

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

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

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

Adverse event: Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 3 at risk

Adverse event: Fevers
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Elevated bilirubin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Upper GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: BK virus associated hemorrhagic cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Elevated transminitis
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Cytoxan induced Hemorrhagic Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Secondary graft failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: GI GvHD
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Delayed engraftment
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Liver GvHD
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 10 at risk

Adverse event: CNS hemorrahge due to DSA/PLT Refractory
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Bacterial Infections
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 10 at risk

Adverse event: Neutropenic fevers
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 10 at risk

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

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

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 10 at risk

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

Adverse event: Fevers
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 10 at risk

Adverse event: Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 10 at risk

Adverse event: GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Elevated bilirubin
Serious: no
Organ System: Investigations
Frequency: 3 affected / 10 at risk

Adverse event: Fungal Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Upper GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 10 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 10 at risk

Adverse event: BK virus associated hemorrhagic cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 10 at risk

Adverse event: Elevated transminitis
Serious: no
Organ System: Investigations
Frequency: 6 affected / 10 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Cytoxan induced Hemorrhagic Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk