Study: NCT02921555

Adverse event: Malignant neoplasm of the ampulla of Vater
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 36 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 36 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anaemia
Frequency: 4 affected / 36 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: sleeplessness
Frequency: 7 affected / 36 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Notes: Excitability
Frequency: 4 affected / 36 at risk

Adverse event: Hyperglucemia
Serious: no
Organ System: Endocrine disorders
Notes: Hyperglucemia
Frequency: 3 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 2 affected / 36 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Arterial hypertension
Frequency: 1 affected / 36 at risk

Adverse event: infections
Serious: no
Organ System: Infections and infestations
Notes: infections
Frequency: 3 affected / 36 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Heartburn
Frequency: 2 affected / 36 at risk

Adverse event: Hypertransaminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypertransaminaemia
Frequency: 1 affected / 36 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Arthromyalgia
Frequency: 1 affected / 36 at risk

Adverse event: Tumours
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Tumours
Frequency: 1 affected / 36 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough
Frequency: 1 affected / 36 at risk

Adverse event: Transient diplopia
Serious: no
Organ System: Eye disorders
Notes: Transient diplopia
Frequency: 1 affected / 36 at risk

Adverse event: Limb oedema
Serious: no
Organ System: Vascular disorders
Notes: Limb oedema
Frequency: 1 affected / 36 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hyponatraemia
Frequency: 1 affected / 36 at risk

Adverse event: Acne
Serious: no
Organ System: Endocrine disorders
Notes: Acne
Frequency: 1 affected / 36 at risk

Adverse event: Acute renal dysfunction
Serious: no
Organ System: Renal and urinary disorders
Notes: Acute renal dysfunction
Frequency: 1 affected / 36 at risk

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 39 at risk

Adverse event: Neurogenic tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 39 at risk

Adverse event: Epstein Barr virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 39 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anaemia
Frequency: 6 affected / 39 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: sleeplessness
Frequency: 3 affected / 39 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Notes: Excitability
Frequency: 7 affected / 39 at risk

Adverse event: Hyperglucemia
Serious: no
Organ System: Endocrine disorders
Notes: Hyperglucemia
Frequency: 3 affected / 39 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 2 affected / 39 at risk

Adverse event: Hypertension
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Arterial hypertension
Frequency: 3 affected / 39 at risk

Adverse event: infections
Serious: no
Organ System: Infections and infestations
Notes: infections
Frequency: 1 affected / 39 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Heartburn
Frequency: 2 affected / 39 at risk

Adverse event: Dizziness
Serious: no
Organ System: Vascular disorders
Notes: dizziness
Frequency: 3 affected / 39 at risk

Adverse event: Hypertransaminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypertransaminaemia
Frequency: 2 affected / 39 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Arthromyalgia
Frequency: 2 affected / 39 at risk

Adverse event: Tumours
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Tumours
Frequency: 1 affected / 39 at risk