Study: NCT04316143

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: FATIGUE
Frequency: 1 affected / 29 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: HYPOTENSION
Frequency: 1 affected / 29 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: COLD
Frequency: 1 affected / 29 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: UPPER RESPIRATORY TRACT INFECTION
Frequency: 1 affected / 29 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Notes: TONSILLITIS
Frequency: 1 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: HEADACHE
Frequency: 2 affected / 29 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: ABDOMINAL PAIN
Frequency: 1 affected / 29 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: FEVER
Frequency: 1 affected / 29 at risk

Adverse event: Cardiovascular disorder
Serious: no
Organ System: Cardiac disorders
Notes: CIRCULATORY DYSREGULATION
Frequency: 1 affected / 29 at risk

Adverse event: Temporomandibular pain and dysfunction syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: TEMPOROMANDIBULAR PAIN
Frequency: 1 affected / 29 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Notes: DYSMENORRHEA
Frequency: 1 affected / 29 at risk

Adverse event: Device breakage
Serious: yes
Organ System: Product Issues
Notes: Possible Hickman line fracture
Frequency: 1 affected / 28 at risk

Adverse event: Pulmonary arterial hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Clinical worsening of PAH
Frequency: 1 affected / 28 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Notes: VENTRICULAR EXTRASYSTOLES
Frequency: 2 affected / 28 at risk

Adverse event: Sinus arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: RESPIRATORY ARRHYTHMIA
Frequency: 1 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: FATIGUE
Frequency: 1 affected / 28 at risk

Adverse event: Feeling abnormal
Serious: no
Organ System: General disorders
Notes: FOGGY-HEADEDNESS
Frequency: 1 affected / 28 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: SYNCOPE
Frequency: 1 affected / 28 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: EXANTHEMA
Frequency: 1 affected / 28 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: HYPOTENSION
Frequency: 1 affected / 28 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: COLD
Frequency: 2 affected / 28 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: UPPER RESPIRATORY TRACT INFECTION
Frequency: 1 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: HEADACHE
Frequency: 1 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: DIZZINESS WORSENING LIGHTHEADEDNESS
Frequency: 2 affected / 28 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Notes: DYSMENORRHEA
Frequency: 1 affected / 28 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Notes: PRE-SYNCOPE
Frequency: 1 affected / 28 at risk

Adverse event: Sleep deficit
Serious: no
Organ System: Nervous system disorders
Notes: LACK OF SLEEP
Frequency: 1 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: DIARRHOEA
Frequency: 1 affected / 28 at risk

Adverse event: Diverticulum
Serious: no
Organ System: Gastrointestinal disorders
Notes: WORSENING OF DIVERTICULOSIS
Frequency: 1 affected / 28 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: ALT INCREASE
Frequency: 1 affected / 28 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Notes: GAMMA-GLUTAMYLTRANSFERASE INCREASE
Frequency: 1 affected / 28 at risk

Adverse event: International normalised ratio abnormal
Serious: no
Organ System: Investigations
Notes: ALTERED INR
Frequency: 1 affected / 28 at risk

Adverse event: Pallor
Serious: no
Organ System: Vascular disorders
Notes: PALLOR
Frequency: 1 affected / 28 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: INSOMNIA
Frequency: 2 affected / 28 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: WORSENING OF THE DEPRESSIVE SYNDROME
Frequency: 1 affected / 28 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: THROMBOCYTOPENIA
Frequency: 1 affected / 28 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: HYPERKALAEMIA
Frequency: 1 affected / 28 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: HYPERTRIGLYCERIDEMIA
Frequency: 1 affected / 28 at risk

Adverse event: Pulmonary arterial hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: CLINICAL WORSENING OF PAH
Frequency: 1 affected / 28 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: PAH WORSENING
Frequency: 1 affected / 28 at risk

Adverse event: Device breakage
Serious: no
Organ System: Product Issues
Notes: POSSIBLE HICKMAN LINE FRACTURE
Frequency: 1 affected / 28 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: SWEATING
Frequency: 1 affected / 28 at risk

Adverse event: Sinus arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: RESPIRATORY ARRHYTHMIA
Frequency: 2 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: NAUSEA
Frequency: 2 affected / 27 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: FATIGUE
Frequency: 2 affected / 27 at risk

Adverse event: Feeling abnormal
Serious: no
Organ System: General disorders
Notes: FOGGY-HEADEDNESS
Frequency: 1 affected / 27 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: JAW PAIN
Frequency: 1 affected / 27 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: SYNCOPE
Frequency: 1 affected / 27 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: CUTANEOUS HYPERSENSITIVITY
Frequency: 1 affected / 27 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: HYPOTENSION
Frequency: 1 affected / 27 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Notes: ORTHOSTATIC HYPOTENSION
Frequency: 1 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: HEADACHE
Frequency: 1 affected / 27 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Notes: HERPES SIMPLEX
Frequency: 1 affected / 27 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: ABDOMINAL PAIN
Frequency: 1 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: DIARRHOEA
Frequency: 1 affected / 27 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: WORSENING GASTROESOPHAGEAL REFLUX DISEASE
Frequency: 1 affected / 27 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: VOMITING
Frequency: 1 affected / 27 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: AST INCREASE
Frequency: 1 affected / 27 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Notes: INCREASING OF GLUCOSE
Frequency: 1 affected / 27 at risk

Adverse event: Blood iron decreased
Serious: no
Organ System: Investigations
Notes: FERROPENIA
Frequency: 1 affected / 27 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: PAPULAR RASH
Frequency: 1 affected / 27 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Notes: LOW ATRIAL RHYTHM
Frequency: 1 affected / 27 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: BACK PAIN
Frequency: 1 affected / 27 at risk

Adverse event: Eosinophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: HYPEREOSINOPHILIA
Frequency: 1 affected / 27 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: LYMPHOCYTIC LEUKOPENIA
Frequency: 1 affected / 27 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: INTERMITTENT MICROSCOPIC HAEMATURIA
Frequency: 1 affected / 27 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Notes: RENAL DYSFUNCTION
Frequency: 1 affected / 27 at risk

Adverse event: Sinus arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: RESPIRATORY ARRHYTHMIA
Frequency: 1 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: NAUSEA
Frequency: 1 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: FATIGUE
Frequency: 1 affected / 21 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: SYNCOPE
Frequency: 1 affected / 21 at risk

Adverse event: Gastrointestinal infection
Serious: no
Organ System: Infections and infestations
Notes: GASTROINTESTINAL INFECTION
Frequency: 1 affected / 21 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: VIROSIS
Frequency: 1 affected / 21 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: ALT INCREASE
Frequency: 1 affected / 21 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: INSOMNIA
Frequency: 1 affected / 21 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: BACK PAIN
Frequency: 1 affected / 21 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: EPIGASTRIC PAIN
Frequency: 1 affected / 21 at risk

Adverse event: Irritable bowel syndrome
Serious: no
Organ System: Gastrointestinal disorders
Notes: IRRITABLE COLON WORSENING
Frequency: 1 affected / 21 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: TOOTH PAIN
Frequency: 1 affected / 21 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Notes: CRP VALUE INCREASE
Frequency: 1 affected / 21 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: FACE HEMATOMA
Frequency: 1 affected / 21 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: ANXIETY
Frequency: 1 affected / 21 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: SKIN LESIONS
Frequency: 1 affected / 21 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: LOWER LIMB MUSCULAR PAIN WHILE WALKING
Frequency: 1 affected / 21 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: WORSENING OF DIABETES MELLITUS
Frequency: 1 affected / 21 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: WORSENING SHORTNESS OF BREATH
Frequency: 1 affected / 21 at risk

Adverse event: Gallbladder polyp
Serious: no
Organ System: Hepatobiliary disorders
Notes: GALLBLADDER POLYPS
Frequency: 1 affected / 21 at risk