Study: NCT03164538

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Notes: Participant reported having been hospitalized due to a leg infection.
Frequency: 1 affected / 35 at risk

Adverse event: Unexpected Atrial Fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Two participants were hospitalized for atrial fibrillation.
Frequency: 2 affected / 35 at risk

Adverse event: Unexpected acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Participant was hospitalized for acute respiratory failure.
Frequency: 1 affected / 35 at risk

Adverse event: Unexpected hypoglycemia
Serious: no
Organ System: Endocrine disorders
Notes: One participant in the PP-MI group reported one episode of hypoglycemia; one participant in the Diabetes Education group reported one episode of hypoglycemia, and another participant in the Diabetes Education reported three episodes of hypoglycemia.
Frequency: 1 affected / 35 at risk

Adverse event: Animal bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Participant went to the ED because of a cat bite.
Frequency: 1 affected / 35 at risk

Adverse event: Unexpected ear fullness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Participant went to the ED due to ear fullness.
Frequency: 1 affected / 35 at risk

Adverse event: Unexpected fall
Serious: no
Organ System: General disorders
Notes: Three participants reported falls. Two participants reported having experienced a fall while going about their daily activities, and one participant reported having experienced three separate falls while going about their daily activities.
Frequency: 3 affected / 35 at risk

Adverse event: Unexpected leg cramps
Serious: no
Organ System: General disorders
Notes: Two participants reported experiencing leg cramps while exercising.
Frequency: 2 affected / 35 at risk

Adverse event: Unexpected kidney stone
Serious: no
Organ System: General disorders
Notes: Participant went to the ED because of a kidney stone.
Frequency: 1 affected / 35 at risk

Adverse event: Unexpected flank pain
Serious: no
Organ System: General disorders
Notes: Participant went to the ED due to flank pain caused by recent kidney stone.
Frequency: 1 affected / 35 at risk

Adverse event: Unexpected shortness of breath
Serious: no
Organ System: General disorders
Notes: Participant went to the ED due to shortness of breath.
Frequency: 1 affected / 35 at risk

Adverse event: Unexpected ankle injury
Serious: no
Organ System: General disorders
Notes: Participant reported having torn a ligament in their ankle.
Frequency: 1 affected / 35 at risk

Adverse event: Unexpected episode of high blood pressure
Serious: no
Organ System: General disorders
Notes: Participant went to the ED due to an episode of high blood pressure.
Frequency: 1 affected / 35 at risk

Adverse event: Unexpected hypoglycemia
Serious: no
Organ System: Endocrine disorders
Notes: One participant in the PP-MI group reported one episode of hypoglycemia; one participant in the Diabetes Education group reported one episode of hypoglycemia, and another participant in the Diabetes Education reported three episodes of hypoglycemia.
Frequency: 2 affected / 35 at risk

Adverse event: Unexpected abdominal pain and diarrhea
Serious: no
Organ System: General disorders
Notes: Participant went to an urgent care clinic due to abdominal pain and diarrhea.
Frequency: 1 affected / 35 at risk

Adverse event: Unexpected nose bleed
Serious: no
Organ System: General disorders
Notes: Participant went to the ED due to a nose bleed that lasted more than 30 minutes.
Frequency: 1 affected / 35 at risk

Adverse event: Unexpected dizziness and abdominal pain
Serious: no
Organ System: General disorders
Notes: Participant went to the ED due to dizziness and abdominal pain.
Frequency: 1 affected / 35 at risk

Adverse event: Unexpected gastrointestinal problems
Serious: no
Organ System: Gastrointestinal disorders
Notes: Participant reported having an upset stomach and loose stools after starting a new medication prescribed by their primary care physician.
Frequency: 1 affected / 35 at risk