TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT05215054

Adverse event: Femoral fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Eye disorder
Serious: no
Organ System: Eye disorders
Notes: Glaucoma / conjunctivitis
Frequency: 2 affected / 55 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastroenteritis, bloating, reflux
Frequency: 5 affected / 55 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 29 affected / 55 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 55 at risk

Adverse event: Muskulokeletal disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 55 at risk

Adverse event: Headache / Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 55 at risk

Adverse event: Pneumonia / Tracheitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Acne, seborrheic dermatitis, burn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 55 at risk

Adverse event: Femoral fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Eye disorder
Serious: no
Organ System: Eye disorders
Notes: Glaucoma / conjunctivitis
Frequency: 2 affected / 55 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastroenteritis, bloating, reflux
Frequency: 5 affected / 55 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 30 affected / 55 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 55 at risk

Adverse event: Muskulokeletal disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 55 at risk

Adverse event: Headache / Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 55 at risk

Adverse event: Pneumonia / Tracheitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Acne, seborrheic dermatitis, burn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 55 at risk
Study: NCT05215418

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 190 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 190 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 190 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 190 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 190 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: chest pain or discomfort due to coronary heart disease
Frequency: 1 affected / 191 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 191 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 191 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 191 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 191 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 191 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 184 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 184 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 184 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 184 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 184 at risk
Study: NCT05215600

Adverse event: Infection >6 weeks
Serious: yes
Organ System: Infections and infestations
Notes: Revision surgery due to infection. Symptoms started 359 days after implantation.
Frequency: 1 affected / 20 at risk

Adverse event: Urinary disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Intraoperative humeral bone fissure
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Traumatic Injury (Not study shoulder)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Instability - Luxation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk
Study: NCT05215613

Adverse event: Pseudarthrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Development of pseudarthrosis after surgery with consequent reoperation with removal of fixation device and consequent new fixation.
Frequency: 1 affected / 30 at risk

Adverse event: Failure of device and new fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Bone fractured again at previous synthesis site, which required a revision surgery with consequent fracture healing.
Frequency: 1 affected / 30 at risk

Adverse event: Valgus knee deviation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Development of Valgus knee deviation after surgery, probably due to the localization of the fracture at the lateral hemiplate of the tibia. It required a distal femur varus osteotomy.
Frequency: 1 affected / 26 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Postoperative infections that had to be reoperated with removal of the devices.
Frequency: 2 affected / 26 at risk

Adverse event: New accident with a multifragmented fracture of the proximal tibia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Accident with a multifragmented fracture of the proximal tibia that required a reoperation with placement of a total knee prosthesis. The plate remained implanted, the proximal screws were removed.
Frequency: 1 affected / 26 at risk

Adverse event: Continued postoperative blood loss from the surgical wound
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Continuous postoperative blood loss from the surgical wound with consequent arteriography and embolization as treatment.
Frequency: 1 affected / 26 at risk

Adverse event: Postoperative anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Postoperative anemia that required treatment (iron supplementation/blood transfusion).
Frequency: 2 affected / 26 at risk
Study: NCT05215847

Adverse event: Mild Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related, no action was taken, resolved without sequelae
Frequency: 2 affected / 12 at risk

Adverse event: Mild Emesis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related, no action was taken, resolved without sequelae
Frequency: 1 affected / 12 at risk

Adverse event: Mild Common Cold
Serious: no
Organ System: Infections and infestations
Notes: No related, concomitant therapy intervention, resolved without sequelae
Frequency: 1 affected / 12 at risk

Adverse event: Mild Headache
Serious: no
Organ System: Nervous system disorders
Notes: Related, no action was taken, resolved without sequelae
Frequency: 1 affected / 12 at risk

Adverse event: Mild Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related, no action was taken, resolved without sequelae
Frequency: 1 affected / 12 at risk

Adverse event: Mild Heart Burn
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related, no action was taken, resolved without sequelae
Frequency: 1 affected / 12 at risk

Adverse event: Mild Hypoglycemia
Serious: no
Organ System: Endocrine disorders
Notes: Not related, no action was taken, resolved without sequelae
Frequency: 1 affected / 12 at risk

Adverse event: Mild COVID-19
Serious: no
Organ System: Infections and infestations
Notes: Not related, concomitant therapy intervention, resolved without sequelae
Frequency: 1 affected / 12 at risk

Adverse event: Mild Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related, no action was taken, resolved without sequelae
Frequency: 1 affected / 12 at risk
Study: NCT05216406

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: a disorder of digestive function characterized by discomfort or heartburn or nausea. dyspepsia, indigestion, stomach upset
Frequency: 3 affected / 31 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: a disorder of digestive function characterized by discomfort or heartburn or nausea. dyspepsia, indigestion, stomach upset
Frequency: 2 affected / 17 at risk
Study: NCT05216510

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

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

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

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 7 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 3 affected / 7 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 7 at risk
Study: NCT05216952

Adverse event: Vaginal Bleeding Requiring Hospitalization
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3 at risk

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

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

Adverse event: Chills
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Severe cramping
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk
Study: NCT05218109

Adverse event: Uncomfortable variation in stimulation intensity at stimulation site
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 20 at risk
Study: NCT05218434

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

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Nose Bleed
Frequency: 1 affected / 9 at risk

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

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Notes: Hayfever
Frequency: 1 affected / 8 at risk

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

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Anxiousness
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: Abdominal Bloating
Frequency: 1 affected / 6 at risk

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

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

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Blocked Nose
Frequency: 1 affected / 5 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough
Frequency: 1 affected / 5 at risk
Study: NCT05219448

Adverse event: [child] Upset stomach (possible relation)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Child participants reported experiencing mild side-effects of having an upset stomach that they believe was possibly due to consumption or over-consumption of the sugar-free Kool-Aid water enhancers.
Frequency: 1 affected / 242 at risk

Adverse event: [child] Upset stomach (probable relation)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Child participants reported experiencing mild side-effects of having an upset stomach that they believe was probably due to consumption or over-consumption of the sugar-free Kool-Aid water enhancers.
Frequency: 2 affected / 242 at risk

Adverse event: [child] Diarrhea (possible relation)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Child participants reported experiencing mild side-effects of having diarrhea that they believe was possibly due to consumption or over-consumption of the sugar-free Kool-Aid water enhancers.
Frequency: 2 affected / 242 at risk

Adverse event: [child] Diarrhea (probable relation)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Child participants reported experiencing mild side-effects of having diarrhea that they believe was probably due to consumption or over-consumption of the sugar-free Kool-Aid water enhancers.
Frequency: 2 affected / 242 at risk

Adverse event: [caregiver] Diarrhea (probable relation)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adult participants reported experiencing mild side-effects of having diarrhea that they believe was probably due to consumption or over-consumption of the sugar-free Kool-Aid water enhancers.
Frequency: 1 affected / 242 at risk
Study: NCT05219669

Adverse event: Rhinalgia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 23 at risk

Adverse event: Rhinalgia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 24 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 24 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 24 at risk

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

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Rhinalgia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk
Study: NCT05219877

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: Patient experienced hematuria two days after urodynamic study
Frequency: 1 affected / 67 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Five patients reported that they experience nausea after consuming the antibiotics prescribed
Frequency: 5 affected / 67 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: Patient experienced hematuria two days after urodynamic study
Frequency: 1 affected / 67 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Five patients reported that they experience nausea after consuming the antibiotics prescribed
Frequency: 5 affected / 67 at risk
Study: NCT05220254

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 20 at risk

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

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

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk
Study: NCT05223335

Adverse event: Possible Stent Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 69 at risk

Adverse event: BARC 3 bleeding event
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 69 at risk
Study: NCT05224544

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Hematuria either pre- or post-catheterization
Frequency: 7 affected / 19 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Renal and urinary disorders
Notes: Burning sensation during normal micturition
Frequency: 1 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea due to antibiotic
Frequency: 1 affected / 19 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Hematuria either pre- or post-catheterization
Frequency: 1 affected / 21 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk
Study: NCT05225389

Adverse event: COVID 19
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk
Study: NCT05225805

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 13 at risk

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

Adverse event: Tooth fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

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

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

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

Adverse event: Cystic fibrosis gastrointestinal disease
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 13 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 13 at risk

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

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

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

Adverse event: Cystic fibrosis gastrointestinal disease
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 13 at risk

Adverse event: Tooth fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk
Study: NCT05226104

Adverse event: Ligament sprain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk
Study: NCT05227027

Adverse event: Anxious or depressed
Serious: no
Organ System: Psychiatric disorders
Notes: Reported being anxious or depressed
Frequency: 1 affected / 241 at risk

Adverse event: Feelings of withdrawal, craving, or irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Reported feelings of withdrawal, craving, or irritability
Frequency: 1 affected / 241 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Reported constipation
Frequency: 1 affected / 241 at risk

Adverse event: Anxious or depressed
Serious: no
Organ System: Psychiatric disorders
Notes: Reported being anxious or depressed
Frequency: 3 affected / 239 at risk

Adverse event: Feelings of withdrawal, craving, or irritability
Serious: no
Organ System: Psychiatric disorders
Notes: Reported feelings of withdrawal, craving, or irritability
Frequency: 4 affected / 239 at risk