Study: NCT01572662

Adverse event: Skin GvHD
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 49 at risk

Adverse event: Bacterial Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 49 at risk

Adverse event: Viral Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 49 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Transcient Secondary graft failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Delayed engraftment
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Primary graft failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: ABO incompatibility
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 49 at risk

Adverse event: Low Platelet
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 49 at risk

Adverse event: GI GvHD
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 49 at risk

Adverse event: Liver GvHD
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 49 at risk

Adverse event: Autoimmune haemolytic anaemia
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Bacterial Infections
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 49 at risk

Adverse event: Parasite Infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Fungal Infections
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 49 at risk

Adverse event: Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 49 at risk

Adverse event: Fevers
Serious: no
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: Flu like syndrome
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: General disorders
Frequency: 25 affected / 49 at risk

Adverse event: ABO incompatibility
Serious: no
Organ System: Investigations
Frequency: 2 affected / 49 at risk

Adverse event: GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 49 at risk

Adverse event: Liver GvGHD
Serious: no
Organ System: Investigations
Frequency: 10 affected / 49 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 49 at risk

Adverse event: Upper GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 49 at risk

Adverse event: Liver GvHD
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 49 at risk

Adverse event: Chronic GI GvHD
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 49 at risk

Adverse event: Chronic ocular GvHD
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 49 at risk

Adverse event: Chronic oral GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 49 at risk

Adverse event: Chronic lung GvGHD
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 49 at risk

Adverse event: Neutropenic fevers
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 49 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 49 at risk

Adverse event: Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 49 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 49 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 49 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 49 at risk

Adverse event: Cystitis haemorrhagic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 49 at risk

Adverse event: BK virus assoiated Hemorrhagic cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 49 at risk

Adverse event: Elevated transminitis
Serious: no
Organ System: Investigations
Frequency: 22 affected / 49 at risk

Adverse event: Elevated bilirubin
Serious: no
Organ System: Investigations
Frequency: 16 affected / 49 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 49 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 49 at risk

Adverse event: Ejection fraction decreased
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 25 affected / 49 at risk

Adverse event: Chronic Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 49 at risk

Adverse event: Chronic GvHD
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 49 at risk

Adverse event: Chronic vaginal GvHD
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 49 at risk

Adverse event: Chronic GvHD_Serositis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Organising pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Dysrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 49 at risk

Adverse event: Ejection fraction decreased
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 49 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 49 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Diverticulits/colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: PRES
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 49 at risk

Adverse event: Confusions
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 49 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 49 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 49 at risk

Adverse event: Palmar-plantar erythrodysesthesia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: VOD/SOS
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 49 at risk

Adverse event: Autoimmune haemolytic anaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 49 at risk

Adverse event: Red cell dysplasia due to major ABO incompatibility
Serious: no
Organ System: Investigations
Frequency: 3 affected / 49 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: Idiopathic thrombocytopenic purpura (ITP)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 49 at risk

Adverse event: Skin GvHD
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 150 at risk

Adverse event: Bacterial Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 150 at risk

Adverse event: Viral Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 150 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 150 at risk

Adverse event: Transcient Secondary graft failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 150 at risk

Adverse event: ABO incompatibility
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 150 at risk

Adverse event: GI GvHD
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 150 at risk

Adverse event: Liver GvHD
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 150 at risk

Adverse event: Fungal Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 150 at risk

Adverse event: Parasite Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 150 at risk

Adverse event: Sepsis like syndrome
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 150 at risk

Adverse event: HSCT related microangiopathy (TA-TMA)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 150 at risk

Adverse event: Oral mucositis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Polyneuropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 150 at risk

Adverse event: Elevated bilirubin
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 150 at risk

Adverse event: VOD/SOS
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 150 at risk

Adverse event: Chronic lung GvHD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 150 at risk

Adverse event: Diverticulitis/neutropenic colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Bacterial Infections
Serious: no
Organ System: Infections and infestations
Frequency: 82 affected / 150 at risk

Adverse event: Fungal Infections
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 150 at risk

Adverse event: Viral Infections
Serious: no
Organ System: Infections and infestations
Frequency: 75 affected / 150 at risk

Adverse event: Fevers
Serious: no
Organ System: General disorders
Frequency: 4 affected / 150 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: General disorders
Frequency: 81 affected / 150 at risk

Adverse event: GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 150 at risk

Adverse event: Liver GvGHD
Serious: no
Organ System: Investigations
Frequency: 38 affected / 150 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 141 affected / 150 at risk

Adverse event: Upper GI GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 150 at risk

Adverse event: Liver GvHD
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 38 affected / 150 at risk

Adverse event: Chronic ocular GvHD
Serious: no
Organ System: Eye disorders
Frequency: 25 affected / 150 at risk

Adverse event: Chronic oral GvHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 150 at risk

Adverse event: Chronic lung GvGHD
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 150 at risk

Adverse event: Neutropenic fevers
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 41 affected / 150 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 150 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 51 affected / 150 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 150 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 119 affected / 150 at risk

Adverse event: Cystitis haemorrhagic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 150 at risk

Adverse event: BK virus assoiated Hemorrhagic cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 150 at risk

Adverse event: Elevated transminitis
Serious: no
Organ System: Investigations
Frequency: 42 affected / 150 at risk

Adverse event: Elevated bilirubin
Serious: no
Organ System: Investigations
Frequency: 57 affected / 150 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 150 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 150 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 25 affected / 150 at risk

Adverse event: Chronic Skin GvHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 150 at risk

Adverse event: Chronic GvHD
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 150 at risk

Adverse event: Chronic vaginal GvHD
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 150 at risk

Adverse event: Chronic GvHD_Serositis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 150 at risk

Adverse event: Organising pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 150 at risk

Adverse event: Dysrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 150 at risk

Adverse event: Ejection fraction decreased
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 150 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Diverticulits/colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 150 at risk

Adverse event: PRES
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 150 at risk

Adverse event: Confusions
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 150 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 150 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 150 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 150 at risk

Adverse event: Palmar-plantar erythrodysesthesia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 150 at risk

Adverse event: VOD/SOS
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 150 at risk

Adverse event: Autoimmune haemolytic anaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 150 at risk

Adverse event: Red cell dysplasia due to major ABO incompatibility
Serious: no
Organ System: Investigations
Frequency: 3 affected / 150 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 150 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 150 at risk

Adverse event: Idiopathic thrombocytopenic purpura (ITP)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 150 at risk