TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03616977

Adverse event: Catheter site swelling
Serious: no
Organ System: General disorders
Frequency: 4 affected / 68 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 68 at risk

Adverse event: Infusion site swelling
Serious: no
Organ System: General disorders
Frequency: 10 affected / 68 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 68 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 68 at risk

Adverse event: Infusion site swelling
Serious: no
Organ System: General disorders
Frequency: 10 affected / 68 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 68 at risk
Study: NCT03617588

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

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 29 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Sensory loss
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Catheter site rash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 49 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Sensory loss
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Catheter site rash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 49 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 49 at risk
Study: NCT03617692

Adverse event: Increased heart rate (over 100 beats per minute)
Serious: no
Organ System: Cardiac disorders
Notes: Heart rate observed to be over 100 beats per minute during a study visit
Frequency: 1 affected / 27 at risk
Study: NCT03617783

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk
Study: NCT03617861

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

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

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 10 at risk

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

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

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 10 at risk
Study: NCT03617913

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

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

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

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

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

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

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

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

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 2 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 2 at risk
Study: NCT03618056

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1 at risk
Study: NCT03618420

Adverse event: Vasovagal syncope
Serious: no
Organ System: Vascular disorders
Notes: Participant experienced vasovagal syncope as a result of anxiety and peripheral intravenous line (PIV) placement at the beginning of study visit; known risk which is included in the consent form.
Frequency: 1 affected / 50 at risk

Adverse event: Headache/lightheadedness/nausea
Serious: no
Organ System: Nervous system disorders
Notes: Participant experienced headache and lightheadedness during screening visit when blood draw to obtain screening labs was attempted. This is a known risk which is included in the consent form.
Frequency: 1 affected / 50 at risk
Study: NCT03618823

Adverse event: Post-Tonsillectomy Hemorrhage Requiring Operative Intervention
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 7 affected / 149 at risk

Adverse event: Dehydration Requiring Inpatient Admission
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 149 at risk

Adverse event: Post-Tonsillectomy Hemorrhage Not Requiring Operative Intervention
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 149 at risk

Adverse event: Emergency Department Visit for Pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 149 at risk

Adverse event: Nursing Phone Call for Pain
Serious: no
Organ System: General disorders
Frequency: 23 affected / 149 at risk

Adverse event: Nausea or Vomiting
Serious: no
Organ System: General disorders
Frequency: 10 affected / 149 at risk

Adverse event: Post-Tonsillectomy Hemorrhage Requiring Operative Intervention
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 119 at risk

Adverse event: Oxygen Desaturation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Oxygen desaturation requiring prolongation of hospitalization for tonsillectomy and adenoidectomy
Frequency: 1 affected / 119 at risk

Adverse event: Post-Tonsillectomy Hemorrhage Not Requiring Operative Intervention
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 119 at risk

Adverse event: Nursing Phone Call for Pain
Serious: no
Organ System: General disorders
Frequency: 15 affected / 119 at risk

Adverse event: Nausea or Vomiting
Serious: no
Organ System: General disorders
Frequency: 3 affected / 119 at risk
Study: NCT03619174

Adverse event: Right Ankle Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Subject received active treatment. Experienced a right ankle fracture 50 days after treatment that resulted in hospitalization. The event was coded as unrelated.
Frequency: 1 affected / 66 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: Subject received active treatment. Experienced Angina Pectoris 108 days after treatment which resulted in hospitalization. Event coded as not related.
Frequency: 1 affected / 66 at risk

Adverse event: Freeman-Sheldon syndrome
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Subject was treated with Sham. Became pregnant during the trial and delivered a child with Freeman-Sheldon Syndrome. Pregnancy occurred approximately 60 days post treatment and was coded as not related.
Frequency: 1 affected / 33 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk
Study: NCT03619811

Adverse event: Discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Collar bone discomfort reported.
Frequency: 1 affected / 43 at risk
Study: NCT03619876

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2 at risk

Adverse event: Breast cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Incidental finding
Frequency: 1 affected / 2 at risk
Study: NCT03619902

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Nosocomial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Blood folate decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Skin haemorrhage
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Mitral valve prolapse
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Myxomatous mitral valve degeneration
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

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

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

Adverse event: Humerus fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 8 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk
Study: NCT03620747

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 393 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 393 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Pudendal canal syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 393 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 393 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Tracheal stenosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Enterovesical fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 393 at risk

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 393 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 393 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 393 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 393 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 52 affected / 393 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 393 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 393 at risk
Study: NCT03620890

Adverse event: First trimester miscarriage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 57 at risk

Adverse event: Major fetal anomaly (holoprosencephaly) with termination of pregnancy in 2nd trimester
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 57 at risk

Adverse event: Major fetal anomalies (hypoplastic left heart and sacral agenesis) with stillbirth in 2nd trimester
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 57 at risk

Adverse event: Maternal admission to the hospital during pregnancy, other than admission for labor
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 57 at risk

Adverse event: Maternal readmission to hospital after delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 57 at risk

Adverse event: First trimester miscarriage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 51 at risk

Adverse event: Maternal admission to the hospital during pregnancy, other than admission for labor
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 8 affected / 51 at risk

Adverse event: Maternal readmission to hospital after delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 51 at risk
Study: NCT03621189

Adverse event: Pain at application site
Serious: no
Organ System: Nervous system disorders
Notes: Phase 1
Frequency: 4 affected / 40 at risk

Adverse event: Pain at application site
Serious: no
Organ System: Nervous system disorders
Notes: Phase 2
Frequency: 4 affected / 40 at risk

Adverse event: Pain at application site
Serious: no
Organ System: Nervous system disorders
Notes: Phase 2
Frequency: 10 affected / 35 at risk
Study: NCT03621657

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Basal cell carcinoma, unrelated to study procedures, resolved without sequelae
Frequency: 1 affected / 1 at risk
Study: NCT03621735

Adverse event: medical infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

Adverse event: worsened tinnitus
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

Adverse event: medical infections
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 86 at risk

Adverse event: ent - head
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 86 at risk

Adverse event: worsened tinnitus
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 86 at risk

Adverse event: medical infections
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 80 at risk

Adverse event: ent - head
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 80 at risk

Adverse event: worsened tinnitus
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 80 at risk

Adverse event: medical infections
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 89 at risk

Adverse event: ent - head
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 89 at risk

Adverse event: worsened tinnitus
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 89 at risk

Adverse event: medical infections
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 82 at risk

Adverse event: ent - head
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 82 at risk

Adverse event: medical infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk
Study: NCT03621761

Adverse event: MS relapse/exacerbation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 114 at risk

Adverse event: Benign paroxysmal vertigo
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 114 at risk

Adverse event: Cerebrospinal fluid leakage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 114 at risk

Adverse event: Surgical/Medical procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 114 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 114 at risk

Adverse event: MS relapse/exacerbation
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 114 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Surgical/Medical procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 114 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 114 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 114 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 114 at risk

Adverse event: MS relapse/exacerbation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 108 at risk

Adverse event: Localised oedema
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 108 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 108 at risk

Adverse event: Trigeminal neuralgia pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 108 at risk

Adverse event: Surgical/Medical procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 108 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 108 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 108 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 108 at risk
Study: NCT03621787

Adverse event: Difficulty removing implant
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 9 at risk
Study: NCT03622619

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Stinging sensation of the eye
Frequency: 1 affected / 21 at risk