Study: NCT03151057

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: CMV viremia
Frequency: 2 affected / 9 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: neutropenia
Frequency: 4 affected / 9 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: increased Alanine transaminase (ALT)
Serious: yes
Organ System: Investigations
Notes: increased Alanine transaminase increased at least 3x upper limit of normal value.
Frequency: 2 affected / 9 at risk

Adverse event: Increased Aspartate Transferase (AST)
Serious: yes
Organ System: Investigations
Notes: Aspartate Transferase (AST) increased at least 3x upper limit of normal value.
Frequency: 2 affected / 9 at risk

Adverse event: Increased bilirubin
Serious: yes
Organ System: Investigations
Notes: Bilirubin increased at least 3x upper limit of normal
Frequency: 1 affected / 9 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Decreased platelet count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: idelalisib or placebo held for >14 days
Serious: no
Organ System: General disorders
Frequency: 5 affected / 9 at risk

Adverse event: Graft versus host disease (GVHD)
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 9 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: neutropenia
Frequency: 1 affected / 7 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: increased Alanine transaminase (ALT)
Serious: yes
Organ System: Investigations
Notes: increased Alanine transaminase increased at least 3x upper limit of normal value.
Frequency: 2 affected / 7 at risk

Adverse event: Increased Aspartate Transferase (AST)
Serious: yes
Organ System: Investigations
Notes: Aspartate Transferase (AST) increased at least 3x upper limit of normal value.
Frequency: 2 affected / 7 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Systemic bacterial infection
Frequency: 1 affected / 7 at risk

Adverse event: Cystitis haemorrhagic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Decreased platelet count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 7 at risk

Adverse event: idelalisib or placebo held for >14 days
Serious: no
Organ System: General disorders
Frequency: 3 affected / 7 at risk

Adverse event: Graft versus host disease (GVHD)
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 7 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk