Study: NCT02345850

Adverse event: SUDDEN CARDIAC ARREST
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 114 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 114 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 114 at risk

Adverse event: DISSEMINATED ADENOVIRUS INFECTION
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: WORSENING EYESIGHT DUE TO CATARACT
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 114 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: ELEVATED ENDOTOXIN LEVEL
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 114 at risk

Adverse event: PLATELET COUNT DECREASE
Serious: no
Organ System: Investigations
Frequency: 1 affected / 114 at risk

Adverse event: NEW MALIGNANCY-RECTAL ADENOCARCINOM
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 114 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: HOSPITAL ADMISSION FOR INFECTION
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 114 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 114 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 114 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 114 at risk

Adverse event: ELEVATED FERRITIN
Serious: no
Organ System: Investigations
Frequency: 1 affected / 114 at risk

Adverse event: NON CARDIAC CHEST PAIN
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 118 at risk

Adverse event: Superior vena cava syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 118 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 118 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 118 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: GRADE 3 UNEXPECTED WEIGHT LOSS
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 118 at risk

Adverse event: Follicular lymphoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 118 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 118 at risk