TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01955733

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 30 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 30 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 29 at risk

Adverse event: Cerebral microangiopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 29 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 29 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 29 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 29 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk
Study: NCT01955954

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 69 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 69 at risk
Study: NCT01955980

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

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

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

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

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

Adverse event: Nasal dryness
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk
Study: NCT01956240

Adverse event: Desistance
Serious: yes
Organ System: Social circumstances
Notes: Forty seven participants left this study because personal reasons.
Frequency: 23 affected / 48 at risk

Adverse event: No shortened pectoralis minor
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Fifteen participants did not present shortening of pectoralis minor.
Frequency: 15 affected / 48 at risk

Adverse event: Desistance
Serious: yes
Organ System: Social circumstances
Notes: Forty seven participants left this study because personal reasons.
Frequency: 24 affected / 49 at risk

Adverse event: No shortened pectoralis minor
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Fifteen participants did not present shortening of pectoralis minor.
Frequency: 7 affected / 49 at risk
Study: NCT01957137

Adverse event: Device stimulation issue
Serious: no
Organ System: Surgical and medical procedures
Notes: Adverse device effects are presented in this table.
Frequency: 1 affected / 29 at risk

Adverse event: Device stimulation issue
Serious: no
Organ System: Surgical and medical procedures
Notes: Adverse device effects are presented in this table.
Frequency: 4 affected / 30 at risk

Adverse event: Device stimulation issue
Serious: no
Organ System: Surgical and medical procedures
Notes: Adverse device effects are presented in this table.
Frequency: 4 affected / 28 at risk

Adverse event: Device stimulation issue
Serious: no
Organ System: Surgical and medical procedures
Notes: Adverse device effects are presented in this table.
Frequency: 4 affected / 28 at risk
Study: NCT01957202

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 34 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 54 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 68 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 68 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 68 at risk
Study: NCT01957215

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 135 at risk

Adverse event: Application site pruritis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 135 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 135 at risk

Adverse event: Upper respiratory tract infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 135 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 135 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 135 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 135 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 135 at risk

Adverse event: Drug eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 135 at risk

Adverse event: Vascular rupture
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 135 at risk

Adverse event: Upper respiratory tract infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 135 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 135 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 135 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 135 at risk

Adverse event: Erythma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 135 at risk
Study: NCT01957384

Adverse event: Gastroenterit
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related to the test product
Frequency: 1 affected / 22 at risk

Adverse event: Peristomal skin problem
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related to the test products
Frequency: 3 affected / 22 at risk

Adverse event: Diarre
Serious: no
Organ System: Gastrointestinal disorders
Notes: not related to the test products
Frequency: 2 affected / 22 at risk

Adverse event: Peristomal skin problem
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related to the test products
Frequency: 1 affected / 22 at risk

Adverse event: Bleeding from stoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related to the test products
Frequency: 1 affected / 22 at risk

Adverse event: respirational tract infection
Serious: no
Organ System: Infections and infestations
Notes: Not related to the test products
Frequency: 1 affected / 22 at risk

Adverse event: infection of the operational wound on the back/ haemtom in operational wound
Serious: no
Organ System: Infections and infestations
Notes: not related to the test products
Frequency: 1 affected / 22 at risk

Adverse event: Diarre
Serious: no
Organ System: Gastrointestinal disorders
Notes: not related to the test products
Frequency: 1 affected / 22 at risk

Adverse event: short term dizziness
Serious: no
Organ System: General disorders
Notes: Not related to test product
Frequency: 1 affected / 22 at risk

Adverse event: inflammation in rectum
Serious: no
Organ System: Gastrointestinal disorders
Notes: not related to the test products
Frequency: 1 affected / 22 at risk

Adverse event: Pain in collapsed forefoot
Serious: no
Organ System: General disorders
Notes: Not relate to the test products
Frequency: 1 affected / 22 at risk

Adverse event: Gastroenterit
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not related to the test products
Frequency: 1 affected / 22 at risk

Adverse event: stinging skin around the stoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: not related to the test products
Frequency: 1 affected / 22 at risk
Study: NCT01957397

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 25 at risk

Adverse event: Itching of peristomal skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 25 at risk

Adverse event: Expantion of rectal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: The Serious adverse event was not related to the test product
Frequency: 1 affected / 24 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 24 at risk

Adverse event: Itching of peristomal skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 24 at risk

Adverse event: Pain in the peristomal skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: Broken skin in peristomal area
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 22 at risk

Adverse event: Itching of peristomal skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 22 at risk

Adverse event: Pain in the peristomal skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 22 at risk

Adverse event: Broken skin in peristomal area
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Heart spams
Serious: yes
Organ System: Cardiac disorders
Notes: The serious adverse event was not related to own product
Frequency: 1 affected / 26 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pain in the peristomal skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Broken skin in peristomal area
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 26 at risk
Study: NCT01957410

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

Adverse event: Infusion site bruising
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 13 at risk

Adverse event: Panic attack
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 13 at risk

Adverse event: Paranasal sinus discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk
Study: NCT01957462

Adverse event: Absess in the bowl ( by a fistel channel 2 mm from stoma)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: peristomal skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: related to device ( AE categorised ad unlikely-, possibly-, probably--and definitely- related are defined as related AEs)
Frequency: 7 affected / 31 at risk

Adverse event: Peristomal Itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: related to the device
Frequency: 5 affected / 31 at risk

Adverse event: Skin wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Petekkie/pressure mark (peristomal)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: related to device
Frequency: 1 affected / 31 at risk

Adverse event: Pain and sorness by stoma and´in bowl
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not related to device
Frequency: 1 affected / 31 at risk

Adverse event: Pain in bowl
Serious: no
Organ System: Gastrointestinal disorders
Notes: not related to device
Frequency: 1 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: not related to device
Frequency: 1 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Notes: not related to device
Frequency: 1 affected / 31 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related to device
Frequency: 1 affected / 29 at risk

Adverse event: peristomal skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: related to device ( AE categorised ad unlikely-, possibly-, probably--and definitely- related are defined as related AEs)
Frequency: 7 affected / 29 at risk

Adverse event: Peristomal Itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: related to the device
Frequency: 1 affected / 29 at risk

Adverse event: Peristomal skin Pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Petekkie/pressure mark (peristomal)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: related to device
Frequency: 2 affected / 29 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not related to device
Frequency: 1 affected / 29 at risk

Adverse event: dehydration due to obstpation
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

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

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Infections and infestations
Notes: not related to device
Frequency: 1 affected / 29 at risk
Study: NCT01957475

Adverse event: Peristomal skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related to device
Frequency: 1 affected / 18 at risk

Adverse event: Peristomal pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: related to device
Frequency: 1 affected / 18 at risk

Adverse event: broken peristomal skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related to device
Frequency: 1 affected / 18 at risk

Adverse event: Pimple in peristomal area
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: related to device
Frequency: 1 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: not related to device
Frequency: 1 affected / 18 at risk

Adverse event: Fainted
Serious: no
Organ System: General disorders
Notes: not related to device
Frequency: 1 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: not related to device
Frequency: 1 affected / 18 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Notes: not related to device
Frequency: 1 affected / 18 at risk

Adverse event: wound on right arm
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: not related to device
Frequency: 1 affected / 18 at risk

Adverse event: Fungus infection in mouth
Serious: no
Organ System: Infections and infestations
Notes: not related to device
Frequency: 1 affected / 18 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: not related to device
Frequency: 1 affected / 18 at risk

Adverse event: Peristomal skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related to device
Frequency: 5 affected / 19 at risk

Adverse event: Peristomal Itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related to device
Frequency: 2 affected / 19 at risk

Adverse event: Peristomal pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: related to device
Frequency: 1 affected / 19 at risk

Adverse event: broken peristomal skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related to device
Frequency: 1 affected / 19 at risk

Adverse event: Vomit
Serious: no
Organ System: Gastrointestinal disorders
Notes: not related to device
Frequency: 1 affected / 19 at risk

Adverse event: chills in left side of bag and leg after applying the bag
Serious: no
Organ System: General disorders
Notes: 12 times
Frequency: 1 affected / 19 at risk

Adverse event: skin irritation on leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: where the bag cover the skin
Frequency: 1 affected / 19 at risk
Study: NCT01957488

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: not related to device
Frequency: 1 affected / 162 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Not related to device
Frequency: 1 affected / 162 at risk

Adverse event: AC Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related to device
Frequency: 1 affected / 162 at risk

Adverse event: Blocked Stoma
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not related to device
Frequency: 1 affected / 162 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 38 affected / 162 at risk

Adverse event: Superficial Abscess - surcically drained
Serious: yes
Organ System: Infections and infestations
Notes: Unlikely related to device
Frequency: 1 affected / 163 at risk

Adverse event: Dehydration after abdominal infection
Serious: yes
Organ System: Infections and infestations
Notes: Not related to device
Frequency: 1 affected / 163 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 163 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device
Frequency: 1 affected / 163 at risk

Adverse event: Nephrolitiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Not related to device
Frequency: 1 affected / 163 at risk

Adverse event: Lung Cancer Complication
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to device
Frequency: 1 affected / 163 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unlikely related to device
Frequency: 1 affected / 163 at risk

Adverse event: Lacerations left hand requiring suturs following dog attack
Serious: yes
Organ System: Social circumstances
Notes: Not related to device
Frequency: 1 affected / 163 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 163 at risk