TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01860573

Adverse event: Death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 10 affected / 83 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 31 affected / 83 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 83 at risk

Adverse event: Intaventricular Hemorrhage Grade III/IV
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 83 at risk

Adverse event: Periventricular leukomalacia
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 83 at risk

Adverse event: Retinopathy of prematurity
Serious: no
Organ System: Eye disorders
Frequency: 35 affected / 73 at risk

Adverse event: Bronchopulmonary dysplasia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 73 at risk

Adverse event: Death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 85 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 19 affected / 85 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 85 at risk

Adverse event: Intaventricular Hemorrhage Grade III/IV
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 85 at risk

Adverse event: Periventricular leukomalacia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 85 at risk

Adverse event: Retinopathy of prematurity
Serious: no
Organ System: Eye disorders
Frequency: 29 affected / 74 at risk

Adverse event: Bronchopulmonary dysplasia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 74 at risk
Study: NCT01860651

Adverse event: Infusion-related allergic reactions
Serious: no
Organ System: Immune system disorders
Notes: Infliximab infusion-related allergic reactions was only collected in the web group in study 2 (Patients in treatment with biologicals). Data regarding infusion-related allergic reactions was not collected in the control group in study 2.
Frequency: 3 affected / 29 at risk
Study: NCT01860807

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 64 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 64 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 64 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 64 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 64 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 61 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 61 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 61 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 61 at risk
Study: NCT01860846

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 106 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 106 at risk
Study: NCT01861522

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 240 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 240 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 232 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 232 at risk
Study: NCT01861704

Adverse event: Sound Quality -> Fine tuning
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Complaint in follow up or on the phone No removal, only fine tuning the settings
Frequency: 1 affected / 70 at risk

Adverse event: Acoustic Feedback -> Removal
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Complaint in follow up or on the phone, device got removed
Frequency: 1 affected / 70 at risk

Adverse event: Discomfort / Pain -> Removal
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Complaint in follow up or on the phone, device got removed
Frequency: 1 affected / 70 at risk

Adverse event: Handling -> Fine tuning
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Issue with handling of the device that could be resolved by retraining the patient
Frequency: 1 affected / 70 at risk

Adverse event: Acoustic Feedback -> Removal
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Complaint in follow up or on the phone, device got removed
Frequency: 1 affected / 107 at risk

Adverse event: Discomfort / Pain -> Removal
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Complaint in follow up or on the phone, device got removed
Frequency: 2 affected / 107 at risk

Adverse event: Handling -> Removal
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Handling issues, patient removed the device himself not knowing that it cannot be reinserted
Frequency: 1 affected / 107 at risk

Adverse event: Sound Quality -> Removal
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Sound quality issues with the device leading to a removal and exchange of the hearing aid
Frequency: 2 affected / 107 at risk
Study: NCT01861717

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

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
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: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 2 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Ear and labyrinth disorders - Other, specify
Serious: no
Organ System: Ear and labyrinth disorders
Notes: ears feel full of water
Frequency: 1 affected / 2 at risk

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

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: due to blood loss during surgery
Frequency: 1 affected / 2 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

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

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

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Notes: anosmia
Frequency: 1 affected / 2 at risk
Study: NCT01862029

Adverse event: Changes in appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Increased or decreased appetite
Frequency: 4 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 9 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 9 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 9 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 2 affected / 9 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

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

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Early satiety
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk
Study: NCT01862159

Adverse event: Serious adverse event
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Any postoperative complication resulting in intervention under general anesthesia, organ failure or mortality (that is Clavien-Dindo 3b or more)
Frequency: 630 affected / 18737 at risk

Adverse event: Any postoperative complication
Serious: no
Organ System: Gastrointestinal disorders
Notes: Any deviation from a normal postoperative course (that is Clavien-Dindo grade 1 or more)
Frequency: 2180 affected / 25038 at risk
Study: NCT01862484

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Acid Reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Streptococcus Throat Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk
Study: NCT01862536

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: not related to intervention
Frequency: 4 affected / 13 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: not related to intervention
Frequency: 1 affected / 13 at risk

Adverse event: heartburn, dizziness, inability to swallow
Serious: yes
Organ System: General disorders
Notes: not related to intervention
Frequency: 1 affected / 13 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: not related to intervention
Frequency: 4 affected / 23 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: not related to intervention
Frequency: 2 affected / 23 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: not related to intervention
Frequency: 1 affected / 23 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: not related to intervention
Frequency: 1 affected / 23 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: not related to intervention
Frequency: 1 affected / 23 at risk

Adverse event: heartburn, dizziness, inability to swallow
Serious: yes
Organ System: General disorders
Notes: not related to intervention
Frequency: 4 affected / 23 at risk

Adverse event: Vitreous floaters
Serious: yes
Organ System: Eye disorders
Notes: not related to intervention
Frequency: 1 affected / 23 at risk
Study: NCT01862874

Adverse event: Injection-site erythema
Serious: no
Organ System: General disorders
Frequency: 137 affected / 554 at risk

Adverse event: Injection-site pain
Serious: no
Organ System: General disorders
Frequency: 304 affected / 554 at risk

Adverse event: Injection-site swelling
Serious: no
Organ System: General disorders
Frequency: 118 affected / 554 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 559 at risk

Adverse event: Injection-site erythema
Serious: no
Organ System: General disorders
Frequency: 122 affected / 559 at risk

Adverse event: Injection-site pain
Serious: no
Organ System: General disorders
Frequency: 271 affected / 559 at risk

Adverse event: Injection-site swelling
Serious: no
Organ System: General disorders
Frequency: 82 affected / 559 at risk
Study: NCT01862991

Adverse event: Uterine cervical laceration
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 21 at risk

Adverse event: Uterine perforation
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 27 at risk

Adverse event: Uterine perforation
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 27 at risk

Adverse event: Uterine cervical laceration
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 27 at risk
Study: NCT01863030

Adverse event: Seroma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 31 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 31 at risk

Adverse event: Soft tissue necrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk
Study: NCT01863043

Adverse event: necrotizing enterocolits or spontaneous intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 74 at risk

Adverse event: necrotizing enterocolits or spontaneous intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 69 at risk
Study: NCT01863134

Adverse event: Death up to 12 Months
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 72 at risk

Adverse event: Pulmonary infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 72 at risk

Adverse event: Death up to 12 Months
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 68 at risk

Adverse event: Pulmonary infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 68 at risk

Adverse event: Delirium
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 68 at risk
Study: NCT01863368

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 105 at risk

Adverse event: Spinal column injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 46 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 46 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 47 at risk
Study: NCT01863433

Adverse event: Chills
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 120 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 62 affected / 120 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 21 affected / 120 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 12 affected / 120 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 10 affected / 120 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unsolicited adverse event
Frequency: 32 affected / 120 at risk
Study: NCT01863667

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk
Study: NCT01863758

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Fracture of Lower Leg
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 66 at risk

Adverse event: Tenotomy of muculus gastrocnemius medialis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 66 at risk

Adverse event: Appendicitis Acuta
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: wound inflammation due to surgery
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Pain of lumbar spine
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 66 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 66 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 66 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 66 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 66 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 66 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 66 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 66 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 66 at risk
Study: NCT01863849

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Notes: pain at vaccination site
Frequency: 19 affected / 59 at risk

Adverse event: Vaccination site swelling
Serious: no
Organ System: General disorders
Notes: swelling at vaccination site
Frequency: 9 affected / 59 at risk

Adverse event: Vaccination site erythema
Serious: no
Organ System: General disorders
Notes: erythema at vaccination site
Frequency: 13 affected / 59 at risk

Adverse event: Vaccination site induration
Serious: no
Organ System: General disorders
Notes: induration at vaccination site
Frequency: 11 affected / 59 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Gastrointestinal disorders
Notes: fever
Frequency: 2 affected / 59 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 59 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 59 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: muscle pain
Frequency: 3 affected / 59 at risk

Adverse event: Vaccination site haematoma
Serious: no
Organ System: General disorders
Notes: haematoma at vaccination site
Frequency: 2 affected / 59 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Notes: pain at vaccination site
Frequency: 4 affected / 60 at risk

Adverse event: Vaccination site swelling
Serious: no
Organ System: General disorders
Notes: swelling at vaccination site
Frequency: 5 affected / 60 at risk

Adverse event: Vaccination site erythema
Serious: no
Organ System: General disorders
Notes: erythema at vaccination site
Frequency: 3 affected / 60 at risk

Adverse event: Vaccination site induration
Serious: no
Organ System: General disorders
Notes: induration at vaccination site
Frequency: 1 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: sweat
Frequency: 1 affected / 60 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: muscle pain
Frequency: 1 affected / 60 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: joint pain
Frequency: 1 affected / 60 at risk
Study: NCT01863901

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 19 at risk

Adverse event: Cellulitis right side of scrotum and groin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Soreness at triceps, left elbow
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: temporary increase in spasticity of treated extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: edema left clavicular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk