Study: NCT03175679

Adverse event: Refractory bile duct infection and toxic megacolon
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not considered relatedto the iNKT cell therapy.
Frequency: 1 affected / 3 at risk

Adverse event: Chills
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 3 at risk

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

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

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

Adverse event: Decreased platelet count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Decreased white blood cell count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Increased blood bilirubin level
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 3 at risk

Adverse event: Increased aspartate transaminase level
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Cirrhosis and upper gastrointestinal bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not considered relatedto the iNKT cell therapy.
Frequency: 1 affected / 3 at risk

Adverse event: Decreased platelet count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Increased blood bilirubin level
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Cirrhosis and upper gastrointestinal bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not considered relatedto the iNKT cell therapy.
Frequency: 2 affected / 3 at risk

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

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

Adverse event: Decreased platelet count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Decreased white blood cell count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Increased blood bilirubin level
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 3 at risk

Adverse event: Increased alanine transaminase level
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Increased aspartate transaminase level
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 3 at risk

Adverse event: Spontaneous rupture of the tumor
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not considered relatedto the iNKT cell therapy.
Frequency: 1 affected / 1 at risk

Adverse event: Decreased platelet count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1 at risk

Adverse event: Decreased neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1 at risk

Adverse event: Decreased white blood cell count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1 at risk

Adverse event: Increased alanine transaminase level
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1 at risk

Adverse event: Increased aspartate transaminase level
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1 at risk