Study: NCT02679287

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 93 at risk

Adverse event: Infections requiring medications or interventions
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 93 at risk

Adverse event: Renal Cell Carcinoma with Surgical Resection
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 93 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Hypoglycemia requiring the assistance of a third party.
Frequency: 3 affected / 93 at risk

Adverse event: Hyperglycemia with ketosis not meeting diabetes ketoacidosis criteria
Serious: no
Organ System: Endocrine disorders
Notes: Significantly elevated ketones requiring intervention without meeting DCCT criteria for diabetic ketoacidosis
Frequency: 2 affected / 93 at risk

Adverse event: Injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 93 at risk

Adverse event: Infections requiring medications or interventions
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 93 at risk

Adverse event: Conditions requiring steroid use
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: e.g. cervical radiculopathy, knee injury, tenosynovitis, dermatitis
Frequency: 3 affected / 93 at risk

Adverse event: Hyperglycemia with ketosis not meeting diabetes ketoacidosis criteria
Serious: no
Organ System: Endocrine disorders
Notes: Significantly elevated ketones requiring intervention without meeting DCCT criteria for diabetic ketoacidosis
Frequency: 1 affected / 93 at risk

Adverse event: Injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 93 at risk

Adverse event: Infections requiring medications or interventions
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 93 at risk

Adverse event: Outpatient surgery or procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 93 at risk

Adverse event: New onset edema requiring medications
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 93 at risk

Adverse event: Hip Replacement Surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 93 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Hypoglycemia requiring the assistance of a third party.
Frequency: 2 affected / 93 at risk

Adverse event: Injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 93 at risk

Adverse event: Infections requiring medications or interventions
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Conditions requiring steroid use
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: e.g. cervical radiculopathy, knee injury, tenosynovitis, dermatitis
Frequency: 2 affected / 93 at risk

Adverse event: Outpatient surgery or procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 93 at risk

Adverse event: New onset Crohn's disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 93 at risk