Study: NCT00417989

Adverse event: Retinal haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 244 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 244 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 244 at risk

Adverse event: Hypoglycemia (Severe Hypoglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 244 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 244 at risk

Adverse event: Hypoglycemia (Severe Hypoglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 244 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Diabetic Ketoacidosis (Ketoacidosis)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 244 at risk

Adverse event: Gastroenteritis (Acute Gastroenteritis)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 244 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Non-Cardiac (Atypical) Chest Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 244 at risk

Adverse event: Cellulitis (Cellulitis of Left Lower Leg)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 244 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 244 at risk

Adverse event: Syncope Vasovagal (Syncope Vasovagal Response)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 244 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 244 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 244 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Did not meet protocol definition of Severe Hypoglycemia
Frequency: 1 affected / 244 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 244 at risk

Adverse event: Infusion/application site infection/abscess
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 244 at risk

Adverse event: Application site bleeding/bruising/irritation/pain
Serious: no
Organ System: General disorders
Frequency: 20 affected / 244 at risk

Adverse event: Diabetic ketoacidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 244 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 244 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 241 at risk

Adverse event: Hypoglycemia (Severe Hypoglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 241 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 241 at risk

Adverse event: Hypoglycemia (Severe Hypoglycemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 241 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 241 at risk

Adverse event: Diabetic Ketoacidosis (Ketoacidosis)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 241 at risk

Adverse event: Fibula Fracture (Fracture of Left Lower Leg, Fibula at Ankle)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 241 at risk

Adverse event: Gastroenteritis (Acute Gastroenteritis)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 241 at risk

Adverse event: Skin Laceration (Traumatic Laceration to Dorsum of the Right Foot with extensor Hallucis Longus Tear
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 241 at risk

Adverse event: Breast Cancer (Left Breast Cancer: Invasive Ductal Adenocarcinoma)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 241 at risk

Adverse event: Urethral Injury (Urethral Tear)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 241 at risk

Adverse event: Cellulitis (Cellulitis of Left Lower Leg)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 241 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 241 at risk

Adverse event: Limb Crushing Injury (Crush Injury to Right Lateral Thigh)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 241 at risk

Adverse event: Nephrolithiasis (Kidney Stones)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 241 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 241 at risk

Adverse event: Ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Did not meet protocol criteria for DKA
Frequency: 1 affected / 241 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 28 affected / 241 at risk

Adverse event: Infusion/application site infection/abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 241 at risk

Adverse event: Application site bleeding/bruising/irritation/pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 241 at risk

Adverse event: Diabetic ketoacidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 241 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 241 at risk