TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01646814

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 121 at risk

Adverse event: Gastric ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 121 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 121 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 121 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 126 at risk

Adverse event: Gastric ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 126 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 126 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 126 at risk
Study: NCT01647581

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 547 at risk

Adverse event: Chest pain / bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 547 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 547 at risk

Adverse event: Cerebrovascular accident / Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 547 at risk

Adverse event: Post-polypectomy bleed
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 547 at risk

Adverse event: Rectal absess
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 547 at risk

Adverse event: Respiratory illnesses and diseases
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 547 at risk

Adverse event: Unimportant bleed
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 547 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 547 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 547 at risk

Adverse event: Multiple falls
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 547 at risk

Adverse event: Unimportant bleed
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 547 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 547 at risk

Adverse event: Elective laminectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 551 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 551 at risk

Adverse event: Post-polypectomy bleed
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 551 at risk

Adverse event: Post-polypectomy coagulation syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 551 at risk

Adverse event: Respiratory illnesses and diseases
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 551 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 551 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 551 at risk
Study: NCT01647737

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: itching and scratchiness in the throat
Frequency: 1 affected / 30 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: itching and scratchiness in the throat
Frequency: 2 affected / 30 at risk
Study: NCT01647945

Adverse event: Nausea/ Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One patient developed hemoptysis during the observation weeks 16 -18, after the study drug had already been stopped (at week 16).

The hemoptysis occured in the setting of a strep throat infection that was treated with antibiotics.
Frequency: 1 affected / 6 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: General disorders
Frequency: 3 affected / 6 at risk

Adverse event: Fluid retention
Serious: no
Organ System: Cardiac disorders
Notes: not requiring increase in diuretics
Frequency: 1 affected / 6 at risk

Adverse event: Nausea/ Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Nausea/ Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 6 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Fluid retention
Serious: no
Organ System: Cardiac disorders
Notes: not requiring increase in diuretics
Frequency: 3 affected / 6 at risk
Study: NCT01647958

Adverse event: Post operative TIF procedure
Serious: no
Organ System: Gastrointestinal disorders
Notes: Overnight hospital stay at Investigator discretion, due to post-op nausea and dizziness related to the TIF procedure.
Frequency: 1 affected / 41 at risk

Adverse event: Post operative TIF procedure
Serious: no
Organ System: General disorders
Notes: Overnight hospital stay due to allergic reaction to pain medication given for TIF post-op pain.
Frequency: 1 affected / 41 at risk
Study: NCT01648205

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Ventricular Fibrillation is a life-threatening ventricular arrhythmia.
Frequency: 2 affected / 25 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Unsteadiness
Frequency: 3 affected / 25 at risk
Study: NCT01648270

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 18 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 12 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 18 at risk

Adverse event: Dizzyness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 18 at risk

Adverse event: Other
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 18 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 14 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 18 at risk

Adverse event: Dizzyness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 18 at risk

Adverse event: Other
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 18 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 8 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 18 at risk

Adverse event: Dizzyness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 18 at risk

Adverse event: Other
Serious: no
Organ System: Product Issues
Frequency: 10 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 18 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 11 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 18 at risk

Adverse event: Dizzyness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Other
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 18 at risk
Study: NCT01648283

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea and/or vomiting
Frequency: 42 affected / 67 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: routinely related to caffeine abstinence prior to study session
Frequency: 15 affected / 67 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 67 at risk

Adverse event: Dizzyness
Serious: no
Organ System: General disorders
Frequency: 26 affected / 67 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Notes: syncopal episodes related to postural hypotension
Frequency: 1 affected / 67 at risk

Adverse event: feeling "hyperactive"
Serious: no
Organ System: General disorders
Notes: self reported by subject, no obvious s/s
Frequency: 1 affected / 67 at risk

Adverse event: light senstivity
Serious: no
Organ System: General disorders
Notes: self reported
Frequency: 1 affected / 67 at risk
Study: NCT01648452

Adverse event: Uveitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5 at risk

Adverse event: Delayed dark adaptation
Serious: no
Organ System: Eye disorders
Notes: The event coded to a MedDRA v16 Preferred Term of Night Blindness but the verbatim Lower Level Terminology is delayed dark adaptation. As the MedDRA term may misrepresent participants as being blind, the verbatim event will be utilized, not MedDRA.
Frequency: 4 affected / 5 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Vitritis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 5 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Shoulder operation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 5 at risk

Adverse event: Lenticular opacities
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 5 at risk

Adverse event: Uterine operation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 5 at risk
Study: NCT01648699

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypehidrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Death due to sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Restlessness
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk
Study: NCT01648790

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Procedural dizziness
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk
Study: NCT01649180

Adverse event: Retinal vascular disorder
Serious: yes
Organ System: Eye disorders
Notes: retinal vein occlusion
Frequency: 1 affected / 3 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 3 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk
Study: NCT01649232

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 30 at risk

Adverse event: headedness / dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 30 at risk

Adverse event: fatigue or nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk
Study: NCT01649557

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 178 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 178 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 178 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 178 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 178 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 178 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 178 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 41 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 41 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 41 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 41 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 23 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 23 at risk
Study: NCT01649609

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: Proteinuria \> 1 gram
Frequency: 1 affected / 20 at risk

Adverse event: Rapa Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumonitis
Frequency: 1 affected / 20 at risk
Study: NCT01649804

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Ranula
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 12 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 12 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Intervertebral disc disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 12 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 12 at risk
Study: NCT01650285

Adverse event: Anaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 5 at risk

Adverse event: anorexia/decreased appetite
Serious: no
Organ System: Investigations
Frequency: 2 affected / 5 at risk

Adverse event: Constipation
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Investigations
Frequency: 3 affected / 5 at risk

Adverse event: Dizziness
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: Investigations
Frequency: 5 affected / 5 at risk

Adverse event: Flatulence
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Blood glucose
Serious: no
Organ System: Investigations
Frequency: 2 affected / 5 at risk

Adverse event: hemmorhoids
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Hot flush
Serious: no
Organ System: Investigations
Frequency: 2 affected / 5 at risk

Adverse event: Hypersensitivity rxn
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Blood potassium
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: myalgia/ malaise
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Investigations
Frequency: 2 affected / 5 at risk

Adverse event: Pain- leg
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: pain-abdominal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Investigations
Frequency: 2 affected / 5 at risk

Adverse event: White blood cell count
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Aches
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk
Study: NCT01650298

Adverse event: Hemorrahagic event
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient With Hematemesis And Epigastric Pain. Gi Consult. Egd With Ulcer In Funders Which Was Endoclipped. Continued On Aspirin And Apixaban. Avoid Nsaid.
Frequency: 1 affected / 16 at risk

Adverse event: DECOMPENSATED HF
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: HEMORRHAGIC EVENT
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: HEMORRHAGIC EVENT
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 16 at risk

Adverse event: LV Thrombus
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 48 at risk

Adverse event: HEMORRHAGIC EVENT
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 48 at risk

Adverse event: HEMORRHAGIC EVENT
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: Oversensing
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 48 at risk

Adverse event: Radius fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 48 at risk