Study: NCT00829387

Adverse event: Hyperglycaemia
Serious: yes
Organ System: General disorders
Notes: admission due to hyperglycemia Expected SAE for population
Frequency: 1 affected / 23 at risk

Adverse event: Heart related issues
Serious: yes
Organ System: Cardiac disorders
Notes: Chest pain, dyspnea Unanticipated and unrelated SAE
Frequency: 1 affected / 23 at risk

Adverse event: Biopsy
Serious: no
Organ System: Investigations
Notes: biopsy of various systems (i.e. bladder, skin) - Unanticipated and unrelated AE
Frequency: 2 affected / 23 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Various infections (cellulitis, nausea, vomiting, flu-like symptoms - unanticipate and unrelated AE
Frequency: 2 affected / 23 at risk

Adverse event: Surgery or Procedure
Serious: no
Organ System: Surgical and medical procedures
Notes: Various surgeries or procedures (i.e. colonoscopy, submaxillary gland surgery) - Unanticipated and unrelated AE
Frequency: 1 affected / 23 at risk

Adverse event: ER due to pain
Serious: no
Organ System: General disorders
Notes: Mostly musculoskeletal (neck or leg pain) but also neurological (miagraine) - Unanticipated and unrelated AE
Frequency: 4 affected / 23 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: General disorders
Notes: non-admission, mild hypoglycemia - anticipated AE
Frequency: 2 affected / 23 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: General disorders
Notes: admission due to hyperglycemia Expected SAE for population
Frequency: 1 affected / 24 at risk

Adverse event: Accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Admission due to vehicular accident Unanticipated and unrelated SAE
Frequency: 1 affected / 24 at risk

Adverse event: Diabetic feet complications
Serious: yes
Organ System: Infections and infestations
Notes: Admission due to diabetic feet complications Anticipated SAE for population
Frequency: 1 affected / 24 at risk

Adverse event: Thymectomy
Serious: yes
Organ System: Immune system disorders
Notes: Unanticipated and unrelated SAE
Frequency: 1 affected / 24 at risk

Adverse event: Heart related issues
Serious: yes
Organ System: Cardiac disorders
Notes: Chest pain, dyspnea Unanticipated and unrelated SAE
Frequency: 2 affected / 24 at risk

Adverse event: Biopsy
Serious: no
Organ System: Investigations
Notes: biopsy of various systems (i.e. bladder, skin) - Unanticipated and unrelated AE
Frequency: 1 affected / 24 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Various infections (cellulitis, nausea, vomiting, flu-like symptoms - unanticipate and unrelated AE
Frequency: 1 affected / 24 at risk

Adverse event: Surgery or Procedure
Serious: no
Organ System: Surgical and medical procedures
Notes: Various surgeries or procedures (i.e. colonoscopy, submaxillary gland surgery) - Unanticipated and unrelated AE
Frequency: 1 affected / 24 at risk

Adverse event: Hepatitis C
Serious: no
Organ System: Infections and infestations
Notes: diagnosis of hepatitis C - Unanticipated and unrelated AE
Frequency: 1 affected / 24 at risk

Adverse event: Suicidal Ideation (SI)
Serious: no
Organ System: Psychiatric disorders
Notes: Endorses mild SI but after assessment from clinical psychologist, not deemed to be at risk - Unanticipated and unrelated AE
Frequency: 1 affected / 24 at risk