TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02833077

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 144 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 144 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 144 at risk

Adverse event: Uterine haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 144 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 144 at risk

Adverse event: Injection site cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 144 at risk

Adverse event: Injection site inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 144 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 144 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 144 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 144 at risk

Adverse event: Intraductal proliferative breast lesion
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 144 at risk

Adverse event: Invasive papillary breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 144 at risk

Adverse event: Keratoacanthoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 144 at risk

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

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 48 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 48 at risk

Adverse event: Breast cancer stage IV
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 48 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 38 at risk
Study: NCT02833233

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 5 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 5 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 5 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 5 at risk

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

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

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

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 5 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk
Study: NCT02833311

Adverse event: Falls
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 15 at risk

Adverse event: Falls
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 16 at risk

Adverse event: Falls
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 15 at risk
Study: NCT02833415

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk
Study: NCT02833805

Adverse event: Gram negative rods Bacteremia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 21 at risk
Study: NCT02833857

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Calcium ionised decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 11 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Catheter placement
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 11 at risk

Adverse event: Gastrostomy
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 11 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 11 at risk
Study: NCT02833948

Adverse event: Major bleeding event
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 116 at risk

Adverse event: minor bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 116 at risk

Adverse event: Major bleeding event
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 115 at risk

Adverse event: Embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 115 at risk

Adverse event: minor bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 115 at risk
Study: NCT02834806

Adverse event: Peri procedureal MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 58 at risk

Adverse event: Non specific chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 6 affected / 58 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 58 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 58 at risk

Adverse event: eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 58 at risk
Study: NCT02835092

Adverse event: Vertigo and Neck Strain
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 66 at risk

Adverse event: Tonsillectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 65 at risk

Adverse event: Partial Knee Orthoplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 65 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 65 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 67 at risk

Adverse event: Upper Respiratory Tract Infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 67 at risk

Adverse event: Decreased frequency of bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 67 at risk
Study: NCT02835443

Adverse event: Low potassium / hypokalemia (Non Study-Related)
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: The subject went to a nearby Emergency Department for nausea and vomiting and was admitted for Hypokalemia; per definition, hospitalization is reported as an SAE. The subject had a history of Hypokalemia.
Frequency: 1 affected / 12 at risk

Adverse event: Post-anesthesia nausea
Serious: no
Organ System: Surgical and medical procedures
Notes: See published article for details of all AEs:

Baker KB, et al. Cerebellar deep brain stimulation for chronic post-stroke motor rehabilitation: a phase I trial. Nature Medicine. 2023;10.1038. https://doi.org/10.1038/s41591-023-02507-0
Frequency: 3 affected / 12 at risk

Adverse event: Post-surgical incision pain/sensitivity or headache
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 12 at risk

Adverse event: IPG site pain/redness
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 12 at risk

Adverse event: Nausea and vomiting during DBS programming
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 12 at risk
Study: NCT02835820

Adverse event: Hospitalisation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient was admitted due to asthma exacerbation for 23-hour observation.
Frequency: 1 affected / 7 at risk
Study: NCT02836652

Adverse event: Major Bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 31 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 31 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 31 at risk

Adverse event: Suspected Pump Thrombosis
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 31 at risk

Adverse event: Major Bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 22 affected / 34 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 34 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 34 at risk

Adverse event: Suspected Pump Thrombosis
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 34 at risk
Study: NCT02836717

Adverse event: Other: Broken or dislocated lead
Serious: yes
Organ System: Product Issues
Notes: Stimulator lead broken or dislocated. Correct stimulation no longer possible
Frequency: 14 affected / 59 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Notes: A disorder characterized by an infectious process involving the use of a medical device
Frequency: 5 affected / 59 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 59 at risk

Adverse event: Other: Pulse generator dislocation
Serious: yes
Organ System: Product Issues
Frequency: 5 affected / 59 at risk

Adverse event: Other: Device failure
Serious: yes
Organ System: Product Issues
Notes: Loss of function of neural stimulator
Frequency: 5 affected / 59 at risk

Adverse event: Other: Dislocated lead
Serious: no
Organ System: Product Issues
Notes: Stimulator lead dislocated. Correct stimulation no longer possible
Frequency: 3 affected / 59 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Notes: A disorder characterized by an infectious process involving the use of a medical device
Frequency: 5 affected / 59 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Other
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 59 at risk

Adverse event: Other: Broken or dislocated lead
Serious: yes
Organ System: Product Issues
Notes: Stimulator lead broken or dislocated. Correct stimulation no longer possible
Frequency: 3 affected / 8 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Notes: A disorder characterized by an infectious process involving the use of a medical device
Frequency: 1 affected / 8 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 8 at risk

Adverse event: Other: Device failure
Serious: yes
Organ System: Product Issues
Notes: Loss of function of neural stimulator
Frequency: 1 affected / 8 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Other: Broken or dislocated lead
Serious: yes
Organ System: Product Issues
Notes: Stimulator lead broken or dislocated. Correct stimulation no longer possible
Frequency: 4 affected / 12 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Notes: A disorder characterized by an infectious process involving the use of a medical device
Frequency: 2 affected / 12 at risk

Adverse event: Other: Pulse generator dislocation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 12 at risk
Study: NCT02836990

Adverse event: Reoperation for groin complication
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 46 at risk

Adverse event: Reoperation for groin complication
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 55 at risk
Study: NCT02837042

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk
Study: NCT02837237

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Procedural hypotension
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: increased creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk
Study: NCT02837328

Adverse event: Gastrointestinal Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 29 at risk

Adverse event: Gastrointestinal Symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk
Study: NCT02837510

Adverse event: Vertigo
Serious: no
Organ System: General disorders
Frequency: 1 affected / 117 at risk

Adverse event: Accident
Serious: no
Organ System: General disorders
Notes: participant involved in a minor car accident
Frequency: 1 affected / 115 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: Voluntary hospitalization for psychiatric symptoms.
Frequency: 1 affected / 113 at risk

Adverse event: Hypoglycemic event
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 113 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Hospitalization due to knee replacement
Frequency: 1 affected / 113 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Participant hospitalized for respiratory infection
Frequency: 1 affected / 113 at risk
Study: NCT02837731

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 102 at risk

Adverse event: Intubation/respiratory distress
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 102 at risk

Adverse event: Severe septic shock and transition to comfort care
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 102 at risk

Adverse event: Intubation and ards
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Intubation and surgery
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Skin tear and possible infection related to the monitor leads
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 48 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Respiratory distress requiring intubation and transfer to ICU
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 48 at risk
Study: NCT02837783

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Back injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 9 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Anal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk
Study: NCT02837952

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 41 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 41 at risk

Adverse event: Hyperaesthesia teeth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 41 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 41 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Swelling face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 82 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 82 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 82 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 82 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 82 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 82 at risk