Study: NCT00992446

Adverse event: Atrial flutter/atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Transplant toxicity.
Frequency: 2 affected / 27 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Transplant toxicity. One patient had both febrile neutropenia with transplant and pneumonia with maintenance therapy as two separate events.
Frequency: 2 affected / 27 at risk

Adverse event: Abdominal pain/diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Maintenance therapy toxicity.
Frequency: 1 affected / 27 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Maintenance therapy toxicity. One patient had both febrile neutropenia with transplant and pneumonia with maintenance therapy as two separate events.
Frequency: 2 affected / 27 at risk

Adverse event: Nausea, vomiting, and diarrhea requiring hospitalization
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Transplant toxicity.
Frequency: 2 affected / 27 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Transplant toxicity.
Frequency: 1 affected / 27 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Autologous transplant adverse event. No patients died due to transplant therapy.
Frequency: 3 affected / 27 at risk

Adverse event: Auto GVHD
Serious: no
Organ System: General disorders
Notes: Autologous transplant adverse event. No patients died due to transplant therapy.
Frequency: 2 affected / 27 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Autologous transplant adverse event. No patients died due to transplant therapy.
Frequency: 2 affected / 27 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Autologous transplant adverse event. No patients died due to transplant therapy.
Frequency: 3 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Autologous transplant adverse event. No patients died due to transplant therapy.
Frequency: 6 affected / 27 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Autologous transplant adverse event. No patients died due to transplant therapy.
Frequency: 21 affected / 27 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Autologous transplant adverse event. No patients died due to transplant therapy.
Frequency: 2 affected / 27 at risk

Adverse event: Nausea/Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Autologous transplant adverse event. No patients died due to transplant therapy.
Frequency: 7 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Autologous transplant adverse event. No patients died due to transplant therapy.
Frequency: 6 affected / 27 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Autologous transplant adverse event. No patients died due to transplant therapy.
Frequency: 16 affected / 27 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Notes: Autologous transplant adverse event. No patients died due to transplant therapy.
Frequency: 27 affected / 27 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Autologous transplant adverse event. No patients died due to transplant therapy.
Frequency: 2 affected / 27 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Notes: Autologous transplant adverse event. No patients died due to transplant therapy.
Frequency: 27 affected / 27 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: General disorders
Notes: Autologous transplant adverse event. No patients died due to transplant therapy.
Frequency: 2 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Maintenance therapy post-transplant adverse event. No patients died due to maintenance therapy.
Frequency: 1 affected / 19 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Maintenance therapy post-transplant adverse event. No patients died due to maintenance therapy.
Frequency: 1 affected / 19 at risk

Adverse event: Methaemoglobinaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Maintenance therapy post-transplant adverse event. No patients died due to maintenance therapy.
Frequency: 1 affected / 19 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Notes: Maintenance therapy post-transplant adverse event. No patients died due to maintenance therapy.
Frequency: 13 affected / 19 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Maintenance therapy post-transplant adverse event. No patients died due to maintenance therapy.
Frequency: 2 affected / 19 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Notes: Maintenance therapy post-transplant adverse event. No patients died due to maintenance therapy.
Frequency: 2 affected / 19 at risk