Study: NCT03392883

Adverse event: Suicidality
Serious: yes
Organ System: Psychiatric disorders
Frequency: 28 affected / 1264 at risk

Adverse event: Paralysis due to Parkinson's Disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Hospitalization due to Diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1264 at risk

Adverse event: Hospitalization due to Hyperglycemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Spinal Surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1264 at risk

Adverse event: Heart Dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 1264 at risk

Adverse event: Thyroidectomy
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Removal of Gallbladder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1264 at risk

Adverse event: Catheterization
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1264 at risk

Adverse event: Liver Complications
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Renal Procedure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1264 at risk

Adverse event: Broken Limb
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1264 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1264 at risk

Adverse event: Colon Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1264 at risk

Adverse event: Breast Cancer Related Surgery and Treatment
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 1264 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1264 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1264 at risk

Adverse event: Caesarean Section Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1264 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1264 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1264 at risk

Adverse event: Infection in Leg
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1264 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1264 at risk

Adverse event: Curettage Biopsy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1264 at risk

Adverse event: Hernia repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 1264 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 1264 at risk

Adverse event: Worsening Depression without Suicidality
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 1264 at risk

Adverse event: Surgery for Hand Trauma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1264 at risk

Adverse event: Blood Transfusion for Anemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Cysts
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1264 at risk

Adverse event: Endoscopic retrograde cholangiopancreatography
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1264 at risk

Adverse event: Hospitalization due to COVID-19 Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 21 affected / 1264 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Arthroscopy Procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1264 at risk

Adverse event: Appendicectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1264 at risk

Adverse event: Gastritis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Surgical and medical procedures
Notes: Hospitalization for related tests and scans
Frequency: 1 affected / 1264 at risk

Adverse event: Medical appointment due to non-serious diagnosis related symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 403 affected / 1264 at risk

Adverse event: COVID-19 Infection
Serious: no
Organ System: Infections and infestations
Frequency: 84 affected / 1264 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 4 affected / 1264 at risk

Adverse event: Vertigo Episode
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 1264 at risk

Adverse event: Resection of Malignant Mass on Face
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1264 at risk

Adverse event: Displacement and imbalance
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Facial paralysis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Fever and face rash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Complication of chronic venous insufficiency
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Worsening of Depressive Symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 1264 at risk

Adverse event: Panic attack
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 1264 at risk

Adverse event: Suicide ideation with risk of self-harm
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 1264 at risk

Adverse event: Worsening of depression symptoms secondary to autoimmune disease complication
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Parasuicide behavior
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 1264 at risk

Adverse event: Excision of Uterine Fibroid
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1264 at risk

Adverse event: Tubal ligation surgery
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Ovary and thyroid cysts
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Excision of ovarian myoma
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Post-abortion difficulties
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Pregnancy miscarriage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1264 at risk

Adverse event: Bleeding related to pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1264 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Resection of endometrial polyps
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Trauma related to fall injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 1264 at risk

Adverse event: Work accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1264 at risk

Adverse event: Accident under alcohol influence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1264 at risk

Adverse event: Eye Procedure
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 1264 at risk

Adverse event: Eye haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1264 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1264 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Resection of Gastric and Duodenal Polyps
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Liquid stools
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Gastric ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Respiratory problems
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1264 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1264 at risk

Adverse event: Pacemaker procedure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Arrythmia Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Varicose Vein Surgery
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Ankle trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1264 at risk

Adverse event: Mild Carpal Tunnel
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Hyperextension in Spine
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Broken Finger
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Spinal surgery
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Broken arm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Vocal cords surgery
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Diabetes diagnosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Tiroidectomy
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 1264 at risk

Adverse event: Biopsy of thyroid nodules
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 1264 at risk