Study: NCT03224624

Adverse event: Hospitalization (surgical, planned)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 59 at risk

Adverse event: Infection requiring hospitalization
Serious: yes
Organ System: Infections and infestations
Notes: 1 dental infection, 1 salmonella infection, 1 viral URI (usual care); 1 osteomyelitis (self-management)
Frequency: 1 affected / 59 at risk

Adverse event: Gastrointestinal disease requiring hospitalization
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 1 GI bleed (UC); 2 GI bleeds, 1 bowel obstruction, 1 Crohn's disease exacerbation (SM)
Frequency: 4 affected / 59 at risk

Adverse event: Diabetic ketoacidosis requiring hospitalization
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 59 at risk

Adverse event: Stroke requiring hospitalization
Serious: yes
Organ System: Cardiac disorders
Notes: One stroke was fatal and is reported in all-cause mortality.
Frequency: 1 affected / 59 at risk

Adverse event: Psychiatric disease requiring hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 59 at risk

Adverse event: drug toxicity requiring hospitalization
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: carbamazepine toxicity
Frequency: 1 affected / 59 at risk

Adverse event: vertigo (BPPV) requiring hospitalization
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 59 at risk

Adverse event: injurious fall requiring hospitalization
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Hypertension evaluted in emergency department
Serious: no
Organ System: Cardiac disorders
Notes: Adverse events of special interest for this study were emergency department visits related to blood pressure or cardiac symptoms.
Frequency: 1 affected / 59 at risk

Adverse event: Chest pain evaluated in emergency department
Serious: no
Organ System: Cardiac disorders
Notes: Includes chest pain deemed non-cardiac after evaluation
Frequency: 2 affected / 59 at risk

Adverse event: Hospitalization (surgical, planned)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 60 at risk

Adverse event: Infection requiring hospitalization
Serious: yes
Organ System: Infections and infestations
Notes: 1 dental infection, 1 salmonella infection, 1 viral URI (usual care); 1 osteomyelitis (self-management)
Frequency: 3 affected / 60 at risk

Adverse event: Gastrointestinal disease requiring hospitalization
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 1 GI bleed (UC); 2 GI bleeds, 1 bowel obstruction, 1 Crohn's disease exacerbation (SM)
Frequency: 1 affected / 60 at risk

Adverse event: pulmonary embolism requiring hospitalization
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: atrial fibrillation requiring hospitalization
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Stroke requiring hospitalization
Serious: yes
Organ System: Cardiac disorders
Notes: One stroke was fatal and is reported in all-cause mortality.
Frequency: 1 affected / 60 at risk

Adverse event: Hypertension evaluted in emergency department
Serious: no
Organ System: Cardiac disorders
Notes: Adverse events of special interest for this study were emergency department visits related to blood pressure or cardiac symptoms.
Frequency: 1 affected / 60 at risk

Adverse event: Chest pain evaluated in emergency department
Serious: no
Organ System: Cardiac disorders
Notes: Includes chest pain deemed non-cardiac after evaluation
Frequency: 2 affected / 60 at risk

Adverse event: syncope evaluated in emergency department
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Drug-associated angioedema, evaluated in emergency department
Serious: no
Organ System: Immune system disorders
Notes: related to lisinopril
Frequency: 1 affected / 60 at risk