Study: NCT01582854

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Notes: One treatment-emergent death occurred during treatment with actovegin and is not related and two treatment-emergent deaths occurred during treatment with placebo (1 of which also had Brain oedema and Hypostatic pneumonia) and are not related.
Frequency: 13 affected / 250 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Notes: One treatment-emergent death occurred during treatment with actovegin and is not related and two treatment-emergent deaths occurred during treatment with placebo (1 participant also had Ischaemic stroke and Hypostatic pneumonia) and are not related.
Frequency: 1 affected / 250 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: One treatment-emergent death occurred during treatment with actovegin and is not related.
Frequency: 1 affected / 250 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with actovegin and is not related.
Frequency: 1 affected / 250 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with actovegin and is not related.
Frequency: 1 affected / 250 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 250 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: One treatment-emergent death occurred during treatment with actovegin and is not related.
Frequency: 1 affected / 250 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Two treatment-emergent deaths occurred during treatment with actovegin and are not related.
Frequency: 2 affected / 250 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 250 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 250 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 250 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 250 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 250 at risk

Adverse event: Dementia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 250 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 250 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 250 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Notes: One treatment-emergent death occurred during treatment with actovegin and is not related and two treatment-emergent deaths occurred during treatment with placebo (1 of which also had Brain oedema and Hypostatic pneumonia) and are not related.
Frequency: 5 affected / 253 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Notes: One treatment-emergent death occurred during treatment with actovegin and is not related and two treatment-emergent deaths occurred during treatment with placebo (1 participant also had Ischaemic stroke and Hypostatic pneumonia) and are not related.
Frequency: 2 affected / 253 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 253 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 253 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: One treatment-emergent death occurred during treatment with actovegin and is not related.
Frequency: 1 affected / 253 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 253 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 253 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 253 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 253 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 253 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 253 at risk

Adverse event: Diverticulum intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Gastritis erosive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Astrocytoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 253 at risk

Adverse event: Metastases to liver
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 253 at risk

Adverse event: Pancreatic carcinoma metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 253 at risk

Adverse event: Endocarditis bacterial
Serious: yes
Organ System: Infections and infestations
Notes: One treatment-emergent death occurred during treatment with placebo and is not related.
Frequency: 1 affected / 253 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Notes: One treatment-emergent death occurred during treatment with placebo and is not related.
Frequency: 1 affected / 253 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: One treatment-emergent death occurred during treatment with placebo and is not related. No specific cause of death was identified or reported by the investigator.
Frequency: 1 affected / 253 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 253 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 253 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 253 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 253 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 253 at risk

Adverse event: Dementia
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 253 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 253 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 253 at risk