TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04964193

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Breast tenderness or Breast discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 24 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Breast tenderness or Breast discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Frequently Urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Flu like symptoms (Runny rose nose, headache)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk
Study: NCT04970381

Adverse event: Rehospitalization
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 75 at risk

Adverse event: Allergy causing rivaroxaban discontinuation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 75 at risk
Study: NCT04973488

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Cardiac disorders
Notes: 1 patient in the treatment group presented with transient hypotension (systolic blood pressure \<90 mmHg) after the transfusion of convalescent plasma, which resolved upon administration of crystalloid bolus.
Frequency: 1 affected / 19 at risk
Study: NCT04980014

Adverse event: Tendon rupture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 655 at risk
Study: NCT04982874

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 24 at risk

Adverse event: Polyuria
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Frequent urination
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Polyuria
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Frequent urination
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk
Study: NCT04988646

Adverse event: Headache, Dizzines
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Headache, Dizzines
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

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

Adverse event: Headache, Dizzines
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk
Study: NCT04992442

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk
Study: NCT05005351

Adverse event: Post COVID-19 Vaccination Syndrome
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 39 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 39 at risk

Adverse event: Worsening Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 39 at risk

Adverse event: Exacerbation of Gastroparesis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Exacerbation of Fibromyalgia Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Left Side Rib Contusions
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 39 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 28 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

Adverse event: Cellulitis in Face
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk
Study: NCT05007899

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

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

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk
Study: NCT05012579

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: sore/lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: sore/lesion observed in 2 subjects, on the dominant wrist
Frequency: 2 affected / 40 at risk

Adverse event: significant and persistent skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: persistent pain from stimulation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: pain felt in thumb of treatment hand
Frequency: 1 affected / 40 at risk

Adverse event: significant discomfort with stimulation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: twitching of ring finger
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: ring finger on treatment hand
Frequency: 1 affected / 40 at risk

Adverse event: anxiety/insomnia/worsening of tremor at night
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk
Study: NCT05017493

Adverse event: Xagrotin
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Xagrotin is a herbal compound, and it contains flavonoids, phenols, etc., which dilate blood vessels. Therefore, the risk of internal bleeding is higher in people who take high-dose vasodilators and high-dose Xagrotin at the same time.
Frequency: 1 affected / 483 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Participants got Diarrhea
Frequency: 113 affected / 483 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Participants got flatulence
Frequency: 113 affected / 483 at risk

Adverse event: Xagrotin
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Xagrotin is a herbal compound, and it contains flavonoids, phenols, etc., which dilate blood vessels. Therefore, the risk of internal bleeding is higher in people who take high-dose vasodilators and high-dose Xagrotin at the same time.
Frequency: 10 affected / 178 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Participants got Diarrhea
Frequency: 15 affected / 178 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: Participants got flatulence
Frequency: 15 affected / 178 at risk
Study: NCT05045625

Adverse event: intraoperative
Serious: no
Organ System: Surgical and medical procedures
Notes: During optimization of lead placement, we noticed that one contact of the 64 became dislodged. We were able to retrieve it easily with suction.
Frequency: 1 affected / 12 at risk
Study: NCT05054114

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 315 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 315 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 315 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 315 at risk

Adverse event: Increase in blood pressure
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 315 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 315 at risk

Adverse event: Skin hardening
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 315 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 315 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 315 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 315 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 315 at risk

Adverse event: Increase in blood pressure
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 315 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 315 at risk

Adverse event: Rashes on the nasal mucosa (herpetic)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 315 at risk

Adverse event: Frequent urination
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 315 at risk

Adverse event: Increasing PSA levels
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 315 at risk

Adverse event: Pain when urinating (exacerbation of chronic prostatitis)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 315 at risk
Study: NCT05065658

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 83 affected / 83 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 83 affected / 83 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 83 affected / 83 at risk
Study: NCT05076604

Adverse event: Postoperative Acute Kidney Injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Per STS Definition
Frequency: 11 affected / 157 at risk

Adverse event: Postoperative Hemodialysis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 10 affected / 157 at risk

Adverse event: Prolonged Ventilation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: STS Definition
Frequency: 20 affected / 157 at risk

Adverse event: Tracheostomy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 157 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 157 at risk

Adverse event: Postoperative ECMO
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 157 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: STS Definition
Frequency: 10 affected / 157 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 157 at risk

Adverse event: Postoperative Atrial Fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 38 affected / 157 at risk

Adverse event: Postoperative Acute Kidney Injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Per STS Definition
Frequency: 9 affected / 157 at risk

Adverse event: Postoperative Hemodialysis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 157 at risk

Adverse event: Prolonged Ventilation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: STS Definition
Frequency: 14 affected / 157 at risk

Adverse event: Tracheostomy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 157 at risk

Adverse event: Reintervention due to MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 157 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 157 at risk

Adverse event: Postoperative ECMO
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 157 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: STS Definition
Frequency: 5 affected / 157 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 157 at risk

Adverse event: Postoperative Atrial Fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 47 affected / 157 at risk
Study: NCT05088772

Adverse event: Ear Barotrauma
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 17 affected / 86 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 86 at risk

Adverse event: Ocular Changes
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 86 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 18 affected / 86 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 86 at risk
Study: NCT05096312

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk
Study: NCT05097573

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 17 at risk
Study: NCT05113979

Adverse event: Death secondary to kidney failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Death due to natural causes
Frequency: 1 affected / 10 at risk

Adverse event: Unseated haptic tab
Serious: no
Organ System: Eye disorders
Notes: One or more AccuraSee IOPCL haptic tabs not securely attached to the PCIOL
Frequency: 1 affected / 10 at risk

Adverse event: Failure to implant IOPCL
Serious: no
Organ System: Eye disorders
Notes: Failure to implant IOPCL due to intraoperative discovery of phacodonesis (pre-existing)
Frequency: 1 affected / 10 at risk
Study: NCT05119348

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 137 at risk

Adverse event: Pressure in chest
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 137 at risk

Adverse event: Somnolence/ drowsy/ sleepy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 137 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Pressure in chest
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 108 at risk

Adverse event: Confused/ disoriented
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 108 at risk
Study: NCT05127018

Adverse event: Slight lip ptosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: patients felt slight lip ptosis at 1-2 weeks after injection, which disappeared within 4 weeks without further intervention.
Frequency: 5 affected / 33 at risk

Adverse event: Slight lip ptosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: patients felt slight lip ptosis at 1-2 weeks after injection, which disappeared within 4 weeks without further intervention.
Frequency: 4 affected / 33 at risk
Study: NCT05134337

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

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
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: Muscle twitching
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

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

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

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk
Study: NCT05134350

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

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk
Study: NCT05166824

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 68 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 68 at risk

Adverse event: Skin Burn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 68 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 10 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 10 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 10 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 10 at risk

Adverse event: Crusting
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 10 at risk

Adverse event: Hardness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Bruisiing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 10 at risk
Study: NCT05167370

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 2 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2 at risk

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

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

Adverse event: Disease progression
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 2 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk
Study: NCT05175131

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 155 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 155 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 155 at risk

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 155 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 155 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 155 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 155 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 155 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 155 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 155 at risk
Study: NCT05200455

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Subject had post operative wound infection following craniotomy. This was recorded as a serious adverse event that was unrelated to the study procedure.
Frequency: 1 affected / 30 at risk

Adverse event: Chronic Inflammatory Reaction
Serious: yes
Organ System: Infections and infestations
Notes: Study subject had fever of unknown etiology, cerebritis, chronic inflammatory reaction. This was recorded as a serious adverse event that was unrelated to the study procedure.
Frequency: 1 affected / 30 at risk