Study: NCT04079218

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Secondary to drug use. Determined by autopsy. Patient expired.
Frequency: 1 affected / 33 at risk

Adverse event: Hospitalization for Gastrointestinal Bleed (GIB)
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 4
Frequency: 1 affected / 33 at risk

Adverse event: Liver Cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 33 at risk

Adverse event: Hospitalization for Chest Pain
Serious: yes
Organ System: Cardiac disorders
Notes: Admit for pulmonary edema and hypertensive emergency in setting of end stage renal disease and known underlying cardiac disease
Frequency: 1 affected / 33 at risk

Adverse event: Pigmentation loss
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Verbatim Term. Pigmentation loss of bilateral internal labia/complete vulvar area. Grade 3
Frequency: 1 affected / 33 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Verbatim Term: Hemoglobin levels 9.8 g/dL (chronic anemia), 10.0 g/dL and 10.3 g/dL. All Grade 1
Frequency: 1 affected / 33 at risk

Adverse event: Leg weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Groin pain
Serious: no
Organ System: Renal and urinary disorders
Notes: Worsening of chronic condition. Secondary to non-obstructing kidney stone and myomatous uterus. Grade 1
Frequency: 1 affected / 33 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Both Grade 1
Frequency: 1 affected / 33 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Verbatim Term: More frequent urination at night. Grade 1
Frequency: 1 affected / 33 at risk

Adverse event: Brown (Vaginal) Discharge
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Both Grade 1
Frequency: 2 affected / 33 at risk

Adverse event: Vaginal Cramping
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Grade 1
Frequency: 1 affected / 33 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 33 at risk

Adverse event: Rash maculopapular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pruritic rash on left forearm. Grade 1
Frequency: 1 affected / 33 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Verbatim Term: Lower extremity edema. Grade 1; Edema to medial/lateral foot after surgery. Grade 2
Frequency: 1 affected / 33 at risk

Adverse event: Trichomonas
Serious: no
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 1 affected / 33 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Notes: Both Grade 1
Frequency: 1 affected / 33 at risk

Adverse event: Healing Biopsy Sites
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Grade 1
Frequency: 1 affected / 33 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Grade 1
Frequency: 1 affected / 33 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: One Grade 1 and one Grade 2
Frequency: 3 affected / 33 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1
Frequency: 1 affected / 33 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 1 affected / 33 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Secondary to GIB
Frequency: 1 affected / 33 at risk

Adverse event: Dark Stools
Serious: no
Organ System: Gastrointestinal disorders
Notes: Secondary to GIB
Frequency: 1 affected / 33 at risk

Adverse event: Hemoglobin decreased 8.7
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hemoglobin decreased from 10.1 to 8.7 in setting of heavy nose bleeds, grade 2
Frequency: 1 affected / 33 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: ED visit for epigastric pain, symptoms treated and sent home. Grade 2
Frequency: 1 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Seen in ED for worsening migraines, treated and sent home from ED. Grade 2
Frequency: 1 affected / 33 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: See in ED for bronchitis symptoms, treated and send home from ED. Grade 2
Frequency: 1 affected / 33 at risk

Adverse event: Diarrhea and abdominal cramping
Serious: no
Organ System: Gastrointestinal disorders
Notes: In setting of new medications including metformin and jardiance as well as a viral illness. Grade 2
Frequency: 1 affected / 33 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Notes: Tooth extraction under local anesthesia, grade 1
Frequency: 1 affected / 33 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Seen in ED for COPD exacerbation, treated and send home from ED. Grade 2; Hospitalized for COPD exacerbation. Grade 3
Frequency: 2 affected / 33 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Verbatim Term: Blood Sugar dropped. Patient was hospitalized. Grade 4
Frequency: 1 affected / 27 at risk

Adverse event: Fractured Right Distal Fibula
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Grade 3
Frequency: 1 affected / 27 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Verbatim Term: Hemoglobin levels 9.8 g/dL (chronic anemia), 10.0 g/dL and 10.3 g/dL. All Grade 1
Frequency: 2 affected / 27 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Both Grade 1
Frequency: 1 affected / 27 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Verbatim Term: Lower extremity edema. Grade 1; Edema to medial/lateral foot after surgery. Grade 2
Frequency: 1 affected / 27 at risk

Adverse event: Vulvar Erythema
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Bilateral. Grade 2
Frequency: 1 affected / 27 at risk

Adverse event: Trichomonas
Serious: no
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 1 affected / 27 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Notes: Both Grade 1
Frequency: 1 affected / 27 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Infections and infestations
Notes: Grade 2
Frequency: 1 affected / 27 at risk

Adverse event: Chest pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Seen in ED for chest pain, attributed to acid reflux, treated and send home from ED. Grade 2
Frequency: 1 affected / 27 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Sinus infection treated with antibiotics. Grade 1
Frequency: 1 affected / 27 at risk