Study: NCT03240406

Adverse event: Hospitalization for COVID-19
Serious: yes
Organ System: Infections and infestations
Notes: Verbatim Term
Frequency: 1 affected / 144 at risk

Adverse event: Hospitalization for Stent Placement
Serious: yes
Organ System: Surgical and medical procedures
Notes: Verbatim Terms
Frequency: 1 affected / 144 at risk

Adverse event: Uterine cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Verbatim Term(s)
Frequency: 1 affected / 144 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Verbatim Term(s)
Frequency: 1 affected / 144 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Verbatim Term
Frequency: 1 affected / 144 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Verbatim Term(s)
Frequency: 1 affected / 144 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: s/p Chronic Kidney Disease
Frequency: 1 affected / 144 at risk

Adverse event: Heart Attack, Heart Surgery
Serious: yes
Organ System: Cardiac disorders
Notes: Verbatim Terms
Frequency: 1 affected / 144 at risk

Adverse event: Gastric Bypass Revision
Serious: yes
Organ System: Surgical and medical procedures
Notes: Verbatim Term(s)
Frequency: 1 affected / 144 at risk

Adverse event: Emergent Visit for Gastric Bypass
Serious: yes
Organ System: Surgical and medical procedures
Notes: Verbatim Term(s). s/p Gastric Bypass Surgery
Frequency: 1 affected / 144 at risk

Adverse event: Respiratory Problems
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Verbatim Term(s)
Frequency: 2 affected / 144 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 144 at risk

Adverse event: High Blood Pressure
Serious: no
Organ System: Vascular disorders
Notes: Verbatim Term(s)
Frequency: 20 affected / 144 at risk

Adverse event: Periodontal disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 144 at risk

Adverse event: Osteoarthritis, Fibromyalgia/Osteoarthritis, muscular or bone problems
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Verbatim Terms
Frequency: 10 affected / 144 at risk

Adverse event: Obesity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 144 at risk

Adverse event: Stomach or Bowel Issues
Serious: no
Organ System: Gastrointestinal disorders
Notes: Verbatim Terms
Frequency: 3 affected / 144 at risk

Adverse event: Hearing or Vision Problems
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Verbatim Terms. Includes Ear and Eye Disorders
Frequency: 15 affected / 144 at risk

Adverse event: Blood Circulation or Blood-Related Problems
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Verbatim Terms
Frequency: 6 affected / 144 at risk

Adverse event: Chest Pain or Irregular Heartbeat
Serious: no
Organ System: Cardiac disorders
Notes: Verbatim Terms
Frequency: 4 affected / 144 at risk

Adverse event: Dermatitis, Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Verbatim Terms
Frequency: 1 affected / 144 at risk

Adverse event: Rheumatoid Arthritis, Immune Deficiency Syndrome, Multiple Sclerosis, Scleroderma,Autoimmune Disease
Serious: no
Organ System: Immune system disorders
Notes: Verbatim Terms
Frequency: 6 affected / 144 at risk

Adverse event: COPD, Asthma, Emphysema, Chronic Bronchitis, Other Respiratory Problem
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Verbatim Terms
Frequency: 6 affected / 144 at risk

Adverse event: Sickle cell disease
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Verbatim Term
Frequency: 1 affected / 144 at risk

Adverse event: Breast cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Verbatim Term
Frequency: 1 affected / 144 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Verbatim Term
Frequency: 2 affected / 144 at risk

Adverse event: Major Surgery
Serious: no
Organ System: Surgical and medical procedures
Notes: Verbatim Term
Frequency: 6 affected / 144 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Notes: Verbatim Term. Not hospitalized
Frequency: 29 affected / 144 at risk

Adverse event: Emotional or Psychiatric Problems
Serious: no
Organ System: Psychiatric disorders
Notes: Verbatim Terms
Frequency: 3 affected / 144 at risk

Adverse event: Human Immunodeficiency Virus (HIV)
Serious: no
Organ System: Immune system disorders
Notes: Verbatim Term
Frequency: 1 affected / 144 at risk

Adverse event: Urinary Tract Infections (frequent)
Serious: no
Organ System: Infections and infestations
Notes: Verbatim Term
Frequency: 1 affected / 144 at risk

Adverse event: Broken Toe
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Verbatim Term
Frequency: 1 affected / 144 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Verbatim Term
Frequency: 1 affected / 144 at risk

Adverse event: Hernia Surgery
Serious: no
Organ System: Surgical and medical procedures
Notes: Verbatim Term
Frequency: 1 affected / 144 at risk

Adverse event: Liver-Related
Serious: no
Organ System: Hepatobiliary disorders
Notes: Fatty liver treated (Usual diet plus Self-Care arm). Fatty liver resolved (Anti-inflammatory dietary intervention arm). Verbatim terms
Frequency: 1 affected / 144 at risk

Adverse event: Concussion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Verbatim Term
Frequency: 1 affected / 144 at risk

Adverse event: Brain Tumor, benign
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Verbatim Term
Frequency: 1 affected / 144 at risk

Adverse event: Gout
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Verbatim Term
Frequency: 1 affected / 144 at risk

Adverse event: Bilateral Vein Procedure
Serious: no
Organ System: Surgical and medical procedures
Notes: Verbatim Term. s/p leg cramps
Frequency: 1 affected / 144 at risk

Adverse event: Hospitalization for COVID-19
Serious: yes
Organ System: Infections and infestations
Notes: Verbatim Term
Frequency: 4 affected / 146 at risk

Adverse event: Breast Cancer, Surgery and Chemotherapy
Serious: yes
Organ System: Surgical and medical procedures
Notes: Verbatim Term
Frequency: 4 affected / 146 at risk

Adverse event: Hospitalization for Stress
Serious: yes
Organ System: Nervous system disorders
Notes: Verbatim Term
Frequency: 1 affected / 146 at risk

Adverse event: Treatment for Brain Cancer
Serious: yes
Organ System: Surgical and medical procedures
Notes: s/p Brain tumor surgery prior to enrollment
Frequency: 1 affected / 146 at risk

Adverse event: Respiratory Problems
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Verbatim Term(s)
Frequency: 2 affected / 146 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 146 at risk

Adverse event: High Blood Pressure
Serious: no
Organ System: Vascular disorders
Notes: Verbatim Term(s)
Frequency: 18 affected / 146 at risk

Adverse event: Periodontal disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 146 at risk

Adverse event: Osteoarthritis, Fibromyalgia/Osteoarthritis, muscular or bone problems
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Verbatim Terms
Frequency: 8 affected / 146 at risk

Adverse event: Stomach or Bowel Issues
Serious: no
Organ System: Gastrointestinal disorders
Notes: Verbatim Terms
Frequency: 7 affected / 146 at risk

Adverse event: Hearing or Vision Problems
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Verbatim Terms. Includes Ear and Eye Disorders
Frequency: 17 affected / 146 at risk

Adverse event: Blood Circulation or Blood-Related Problems
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Verbatim Terms
Frequency: 2 affected / 146 at risk

Adverse event: Chest Pain or Irregular Heartbeat
Serious: no
Organ System: Cardiac disorders
Notes: Verbatim Terms
Frequency: 6 affected / 146 at risk

Adverse event: Carpal Tunnel
Serious: no
Organ System: Nervous system disorders
Notes: Verbatim Term
Frequency: 2 affected / 146 at risk

Adverse event: Knee arthroplasty
Serious: no
Organ System: Surgical and medical procedures
Notes: Verbatim Term
Frequency: 3 affected / 146 at risk

Adverse event: Rheumatoid Arthritis, Immune Deficiency Syndrome, Multiple Sclerosis, Scleroderma,Autoimmune Disease
Serious: no
Organ System: Immune system disorders
Notes: Verbatim Terms
Frequency: 5 affected / 146 at risk

Adverse event: COPD, Asthma, Emphysema, Chronic Bronchitis, Other Respiratory Problem
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Verbatim Terms
Frequency: 7 affected / 146 at risk

Adverse event: Legionnaires' Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Verbatim Terms
Frequency: 1 affected / 146 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Verbatim Term
Frequency: 1 affected / 146 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Verbatim Term
Frequency: 3 affected / 146 at risk

Adverse event: Major Surgery
Serious: no
Organ System: Surgical and medical procedures
Notes: Verbatim Term
Frequency: 6 affected / 146 at risk

Adverse event: Cholesterol, High
Serious: no
Organ System: Investigations
Frequency: 1 affected / 146 at risk

Adverse event: Pituitary Gland Adenoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Verbatim Term
Frequency: 1 affected / 146 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Notes: Verbatim Term. Not hospitalized
Frequency: 29 affected / 146 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 146 at risk

Adverse event: Thyroid Problems
Serious: no
Organ System: Endocrine disorders
Notes: Verbatim Term
Frequency: 2 affected / 146 at risk

Adverse event: Emotional or Psychiatric Problems
Serious: no
Organ System: Psychiatric disorders
Notes: Verbatim Terms
Frequency: 1 affected / 146 at risk

Adverse event: Human Immunodeficiency Virus (HIV)
Serious: no
Organ System: Immune system disorders
Notes: Verbatim Term
Frequency: 2 affected / 146 at risk

Adverse event: Ankle, Knee Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Verbatim Terms
Frequency: 1 affected / 146 at risk

Adverse event: Perimenopause (possible)
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Verbatim Term
Frequency: 1 affected / 146 at risk

Adverse event: Osteopenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Verbatim Term
Frequency: 1 affected / 146 at risk

Adverse event: Liver-Related
Serious: no
Organ System: Hepatobiliary disorders
Notes: Fatty liver treated (Usual diet plus Self-Care arm). Fatty liver resolved (Anti-inflammatory dietary intervention arm). Verbatim terms
Frequency: 1 affected / 146 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Notes: Verbatim Term
Frequency: 2 affected / 146 at risk