Study: NCT03232073

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 439 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 439 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Vertigo positional
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 439 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 439 at risk

Adverse event: Anal fissure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 439 at risk

Adverse event: Functional gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 439 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 439 at risk

Adverse event: Papillitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 439 at risk

Adverse event: Hepatic cytolysis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 439 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 439 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 439 at risk

Adverse event: Complicated appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 439 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 439 at risk

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 439 at risk

Adverse event: Furuncle
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 439 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 439 at risk

Adverse event: Hepatitis B
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 439 at risk

Adverse event: Hepatitis E
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 439 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 439 at risk

Adverse event: Periodontitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 439 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 439 at risk

Adverse event: Staphylococcal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 439 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 439 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 439 at risk

Adverse event: Incarcerated incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 439 at risk

Adverse event: Ligament injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 439 at risk

Adverse event: Ligament sprain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 439 at risk

Adverse event: Tendon injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 439 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 439 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 439 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 439 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 439 at risk

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 439 at risk

Adverse event: Joint ankylosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 439 at risk

Adverse event: Joint contracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 439 at risk

Adverse event: Osteochondrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 439 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 439 at risk

Adverse event: Spinal instability
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 439 at risk

Adverse event: Invasive breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 439 at risk

Adverse event: Invasive ductal breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 439 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 439 at risk

Adverse event: Melanocytic naevus
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 439 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 439 at risk

Adverse event: Dysaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 439 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 439 at risk

Adverse event: Hemianopia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 439 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 439 at risk

Adverse event: Migraine with aura
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 439 at risk

Adverse event: Multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 439 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 439 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 439 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 439 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 439 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 439 at risk

Adverse event: Tubulointerstitial nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 439 at risk

Adverse event: Cervical dysplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 439 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 439 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 439 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 439 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 439 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 439 at risk

Adverse event: Abortion induced
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 439 at risk

Adverse event: Inguinal hernia repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 439 at risk

Adverse event: Mastectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 439 at risk

Adverse event: Spinal operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 439 at risk

Adverse event: Uterine dilation and curettage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 439 at risk

Adverse event: Iliac artery embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 439 at risk

Adverse event: Peripheral artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 439 at risk

Adverse event: Varicose vein
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 439 at risk

Adverse event: Peripheral vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 439 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 439 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 66 affected / 439 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 439 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 24 affected / 439 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 115 affected / 439 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 82 affected / 439 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 439 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 439 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 439 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 73 affected / 439 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 439 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 30 affected / 439 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 31 affected / 439 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 45 affected / 439 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 439 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 57 affected / 439 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 37 affected / 439 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 438 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 438 at risk

Adverse event: Hydrocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 438 at risk

Adverse event: Macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 438 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 438 at risk

Adverse event: Chronic gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 438 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 438 at risk

Adverse event: Duodenal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 438 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 438 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 438 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 438 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 438 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 438 at risk

Adverse event: Hypertransaminasaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 438 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 438 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 438 at risk

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 438 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 438 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 438 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 438 at risk

Adverse event: Large intestine infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 438 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 438 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 438 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 438 at risk

Adverse event: Pyelonephritis chronic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 438 at risk

Adverse event: Suspected COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 438 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 438 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 438 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 438 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 438 at risk

Adverse event: Postoperative wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 438 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 438 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 438 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 438 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 438 at risk

Adverse event: Psoriatic arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 438 at risk

Adverse event: Spinal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 438 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 438 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 438 at risk

Adverse event: Invasive ductal breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 438 at risk

Adverse event: Papillary renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 438 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 438 at risk

Adverse event: Amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 438 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 438 at risk

Adverse event: Multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 438 at risk

Adverse event: Partial seizures with secondary generalisation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 438 at risk

Adverse event: Sacral radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 438 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 438 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 438 at risk

Adverse event: Uhthoff's phenomenon
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 438 at risk

Adverse event: Vertigo CNS origin
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 438 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 438 at risk

Adverse event: Unintended pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 438 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 438 at risk

Adverse event: Mental disorder due to a general medical condition
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 438 at risk

Adverse event: Mood disorder due to a general medical condition
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 438 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 438 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 438 at risk

Adverse event: Tubulointerstitial nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 438 at risk

Adverse event: Endometriosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 438 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 438 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 438 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 438 at risk

Adverse event: Nasal septum deviation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 438 at risk

Adverse event: Abdominoplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 438 at risk

Adverse event: Abortion induced
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 438 at risk

Adverse event: Botulinum toxin injection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 438 at risk

Adverse event: Cervical conisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 438 at risk

Adverse event: Hysterosalpingo-oophorectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 438 at risk

Adverse event: Internal fixation of fracture
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 438 at risk

Adverse event: Osteotomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 438 at risk

Adverse event: Uterine dilation and curettage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 438 at risk

Adverse event: Uvulopalatopharyngoplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 438 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 438 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 64 affected / 438 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 438 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 30 affected / 438 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 108 affected / 438 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 74 affected / 438 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 438 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 51 affected / 438 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 438 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 98 affected / 438 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 26 affected / 438 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 30 affected / 438 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 438 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 438 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 438 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 64 affected / 438 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 44 affected / 438 at risk