Study: NCT05364671

Adverse event: Worsening of atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Worsening of persistent atrial fibrillation (symptoms of chest pain, palpitations, loss of consciousness from 22.11.2022). Hospitalized.
Frequency: 1 affected / 382 at risk

Adverse event: Complicated fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Closed, fragmented fracture of the fibula in the lower third of the left shin with displacement.
Frequency: 1 affected / 382 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Without further clarification
Frequency: 2 affected / 382 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 382 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Without further clarification
Frequency: 1 affected / 382 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 382 at risk

Adverse event: Exacerbation of hemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 382 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 382 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 382 at risk

Adverse event: Bacterial prostatitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 382 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 382 at risk

Adverse event: Abnormal Physical Examination Results
Serious: no
Organ System: Investigations
Frequency: 1 affected / 382 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Notes: Without further clarification
Frequency: 1 affected / 382 at risk

Adverse event: Increased protein levels in urine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 382 at risk

Adverse event: Increased transaminases
Serious: no
Organ System: Investigations
Frequency: 1 affected / 382 at risk

Adverse event: Increased eosinophil count
Serious: no
Organ System: Investigations
Frequency: 1 affected / 382 at risk

Adverse event: Increased neutrophil levels
Serious: no
Organ System: Investigations
Frequency: 1 affected / 382 at risk

Adverse event: Hypotension
Serious: no
Organ System: Investigations
Frequency: 1 affected / 382 at risk

Adverse event: Haematocrit reduction
Serious: no
Organ System: Investigations
Frequency: 1 affected / 382 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 382 at risk

Adverse event: Increased percentage of lymphocytes
Serious: no
Organ System: Investigations
Frequency: 1 affected / 382 at risk

Adverse event: Decreased percentage of lymphocytes
Serious: no
Organ System: Investigations
Frequency: 1 affected / 382 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 382 at risk

Adverse event: Itchy face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 382 at risk

Adverse event: Itching, cutaneous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 382 at risk

Adverse event: Anemia unspecified
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 382 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Without further clarification
Frequency: 1 affected / 382 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Without further clarification
Frequency: 1 affected / 382 at risk

Adverse event: Monocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 382 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 382 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 382 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 382 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 382 at risk

Adverse event: Headache in the occipital region
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 382 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 382 at risk

Adverse event: Leukocyturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 382 at risk

Adverse event: Balanoposthitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 382 at risk

Adverse event: Bruised finger
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 382 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Without further clarification
Frequency: 1 affected / 389 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 389 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Vomiting urge
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 389 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 389 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 389 at risk

Adverse event: Dermatitis caused by herpes simplex virus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 389 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 389 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 389 at risk

Adverse event: Exacerbation of chronic pyelonephritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 389 at risk

Adverse event: Etmoiditis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 389 at risk

Adverse event: Protein in urine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 389 at risk

Adverse event: Presence of ketone bodies in urine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 389 at risk

Adverse event: Abnormal Physical Examination Results
Serious: no
Organ System: Investigations
Frequency: 1 affected / 389 at risk

Adverse event: Abnormal blood count
Serious: no
Organ System: Investigations
Frequency: 1 affected / 389 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Notes: Without further clarification
Frequency: 2 affected / 389 at risk

Adverse event: Increased ALT
Serious: no
Organ System: Investigations
Frequency: 1 affected / 389 at risk

Adverse event: Increased bilirubin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 389 at risk

Adverse event: Increased urinary glucose
Serious: no
Organ System: Investigations
Frequency: 1 affected / 389 at risk

Adverse event: Increased creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 389 at risk

Adverse event: Increased total bilirubin
Serious: no
Organ System: Investigations
Frequency: 2 affected / 389 at risk

Adverse event: Increased C-reactive protein
Serious: no
Organ System: Investigations
Frequency: 3 affected / 389 at risk

Adverse event: Increased transaminases
Serious: no
Organ System: Investigations
Frequency: 3 affected / 389 at risk

Adverse event: Decrease in general clinical blood test values
Serious: no
Organ System: Investigations
Frequency: 1 affected / 389 at risk

Adverse event: Decrease in general bilirubin levels
Serious: no
Organ System: Investigations
Frequency: 1 affected / 389 at risk

Adverse event: Decreased platelet count
Serious: no
Organ System: Investigations
Frequency: 1 affected / 389 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Without further clarification
Frequency: 1 affected / 389 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 389 at risk

Adverse event: Itching, cutaneous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 389 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 389 at risk

Adverse event: Increased sweating
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 389 at risk

Adverse event: Rash on the face skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 389 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Without further clarification
Frequency: 1 affected / 389 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 389 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 389 at risk

Adverse event: Upper limb myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 389 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 389 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Without further clarification
Frequency: 3 affected / 389 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 389 at risk

Adverse event: Intercostal neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 389 at risk

Adverse event: Tingling sensation in the eyelids
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 389 at risk

Adverse event: Ear congestion
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 389 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 389 at risk

Adverse event: Exacerbation of chronic cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 389 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 389 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 389 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 389 at risk

Adverse event: Hypertensive crisis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 389 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 389 at risk

Adverse event: Bruised finger
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 389 at risk