Study: NCT01858558

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 or higher Adverse Events (AEs) from aMILs harvest to 60 days following autologous stem cell transplant (ASCT)
Frequency: 36 affected / 70 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 3 affected / 70 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 70 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 70 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 2 affected / 70 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 3 affected / 70 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 70 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 70 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 8 affected / 70 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 70 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 2 affected / 70 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 4 affected / 70 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 70 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 70 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 4 affected / 70 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 70 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 70 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 3 affected / 70 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 2 affected / 70 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 70 at risk

Adverse event: Mucosal infection
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 11 affected / 70 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 70 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 7 affected / 70 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 3 affected / 70 at risk

Adverse event: Scrotal infection
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 70 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 2 affected / 70 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 2 affected / 70 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 70 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 70 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 70 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 70 at risk

Adverse event: manufacture failure
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 70 at risk

Adverse event: Product contamination
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 70 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: General disorders
Notes: 63 participants in the aMILs Arm had infusions, of those, 8 had record of infusion reaction.
Frequency: 8 affected / 63 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 or higher Adverse Events (AEs) from aMILs harvest to 60 days following autologous stem cell transplant (ASCT)
Frequency: 18 affected / 31 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 31 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 31 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 31 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 31 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 31 at risk

Adverse event: Enterocolitis infection
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 31 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 31 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 31 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 31 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 2 affected / 31 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 31 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 2 affected / 31 at risk

Adverse event: Lymphocyte count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 31 at risk

Adverse event: Mucosal infection
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 5 affected / 31 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 2 affected / 31 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 3 affected / 31 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 4 affected / 31 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 31 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 31 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 2 affected / 31 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 31 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 1 affected / 31 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT
Frequency: 2 affected / 31 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk