Study: NCT04016662

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 105 at risk

Adverse event: Ketosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 105 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 81 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 81 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 81 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 81 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 81 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 81 at risk

Adverse event: Ketosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 81 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 81 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 81 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 1 affected / 81 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 81 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 79 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: General disorders
Notes: The participant was admitted to the hospital for an elective procedure
Frequency: 1 affected / 79 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 79 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 79 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 4 affected / 79 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 79 at risk

Adverse event: Wound
Serious: no
Organ System: General disorders
Frequency: 1 affected / 79 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 79 at risk

Adverse event: Ketosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 79 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 78 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 78 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 78 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 1 affected / 78 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 78 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 78 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 78 at risk