TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01237951

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 74 at risk

Adverse event: Dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 74 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 74 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 74 at risk

Adverse event: Cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 74 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 74 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 74 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 34 affected / 74 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 74 at risk

Adverse event: Infection
Serious: no
Organ System: Immune system disorders
Frequency: 71 affected / 74 at risk

Adverse event: Cardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 54 affected / 74 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 74 at risk

Adverse event: Hand-foot syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 74 at risk
Study: NCT01238120

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 25 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

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

Adverse event: Pain - Postoperative
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 23 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 25 at risk

Adverse event: Puritis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Atrial Thrombus
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Neoplasm benign - Cyst
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 25 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Retinopathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Infection - Urinary Tract
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 24 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 24 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 24 at risk
Study: NCT01238536

Adverse event: Hospitalization or Surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: Any hospitalization or surgery was included as a serious adverse event. this included lumbar spine surgery for failure to improve symptoms or hospitalizations for any reason. None were deemed directly associated with the interventions.
Frequency: 5 affected / 200 at risk

Adverse event: Dural puncture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Dural puncture at time of procedure
Frequency: 1 affected / 200 at risk

Adverse event: All other self reported adverse events
Serious: no
Organ System: General disorders
Notes: Patients were asked an open-ended question about whether they experienced any adverse event or unexpected adverse event. Patients described the AE, but there were no consistent descriptions to clearly separate into rates for each type of AE.
Frequency: 43 affected / 200 at risk

Adverse event: Hospitalization or Surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: Any hospitalization or surgery was included as a serious adverse event. this included lumbar spine surgery for failure to improve symptoms or hospitalizations for any reason. None were deemed directly associated with the interventions.
Frequency: 4 affected / 200 at risk

Adverse event: Dural puncture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Dural puncture at time of procedure
Frequency: 1 affected / 200 at risk

Adverse event: All other self reported adverse events
Serious: no
Organ System: General disorders
Notes: Patients were asked an open-ended question about whether they experienced any adverse event or unexpected adverse event. Patients described the AE, but there were no consistent descriptions to clearly separate into rates for each type of AE.
Frequency: 31 affected / 200 at risk
Study: NCT01238588

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk
Study: NCT01238640

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 84 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 84 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 84 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 84 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 84 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 84 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 84 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 84 at risk
Study: NCT01238900

Adverse event: Device dislocation
Serious: no
Organ System: Gastrointestinal disorders
Notes: 9 subjects (39.1% of participants) had stent migration and required additional endoscopy to remove the stent
Frequency: 9 affected / 23 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk
Study: NCT01239043

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 34 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 9 affected / 34 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 3 affected / 34 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 36 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 36 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 34 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 33 affected / 103 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 8 affected / 103 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 103 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 103 at risk
Study: NCT01239056

Adverse event: pseudocyst infection requiring surgery
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Major complication from transmural drainage
Frequency: 2 affected / 20 at risk

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

Adverse event: post-ERCP pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk
Study: NCT01239121

Adverse event: Hospital Readmission
Serious: yes
Organ System: Investigations
Notes: Outcome not ascertained in the third arm because those participants were not hospitalized.
Frequency: 39 affected / 186 at risk

Adverse event: Medication-related symptoms
Serious: no
Organ System: Investigations
Notes: For this outcome 66 and 87 participants unable to be reached by telephone in first and second arms, respectively.Outcome not ascertained in the third arm because those participants were not hospitalized.
Frequency: 24 affected / 120 at risk

Adverse event: Hospital Readmission
Serious: yes
Organ System: Investigations
Notes: Outcome not ascertained in the third arm because those participants were not hospitalized.
Frequency: 36 affected / 195 at risk

Adverse event: Medication-related symptoms
Serious: no
Organ System: Investigations
Notes: For this outcome 66 and 87 participants unable to be reached by telephone in first and second arms, respectively.Outcome not ascertained in the third arm because those participants were not hospitalized.
Frequency: 21 affected / 108 at risk
Study: NCT01239160

Adverse event: Oedema
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Study leg became markedly swollen (no cellulitis).
Frequency: 1 affected / 64 at risk

Adverse event: Pain
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Extreme shooting pain followed by swelling and hardness of the leg.
Frequency: 1 affected / 64 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Breathlessness and dizziness.
Frequency: 1 affected / 64 at risk

Adverse event: Worsened swelling/Edema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 64 at risk

Adverse event: Vomiting/Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 64 at risk

Adverse event: Pain/Itching
Serious: no
Organ System: General disorders
Frequency: 9 affected / 64 at risk

Adverse event: Cellulitis/Infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 64 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Notes: New diagnosis of lung cancer.
Frequency: 1 affected / 66 at risk

Adverse event: Fractured legs
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Fractured legs from motor vehicle accident.
Frequency: 1 affected / 66 at risk

Adverse event: Discoloration of toes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Worsened swelling/Edema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 66 at risk

Adverse event: Pain/Itching
Serious: no
Organ System: General disorders
Frequency: 7 affected / 66 at risk

Adverse event: Cellulitis/Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 66 at risk
Study: NCT01239472

Adverse event: Transplant failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: biopsy proven acute rejection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk
Study: NCT01239511

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 45 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Hepatitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 47 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 47 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk
Study: NCT01239745

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 46 at risk
Study: NCT01240200

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Blood glucose \<70mg/dL
Frequency: 22 affected / 48 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Blood glucose \<70mg/dL
Frequency: 15 affected / 47 at risk
Study: NCT01240304

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

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk
Study: NCT01240356

Adverse event: Intracranial hemohhrage secondary to bacterial endocarditis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Death
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 20 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 20 at risk

Adverse event: Pneumonia/respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Stroke progression/Nuero-worsening
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Fewer
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 20 at risk

Adverse event: Anemia/decreased hemoglobin and hematocrit
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 20 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 20 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Electrolyze imbalance
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 20 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 20 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 20 at risk

Adverse event: Right lung atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Elevated CK
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Elevated white blood count
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 20 at risk

Adverse event: Utinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: Asymptomatic ICH
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 20 at risk

Adverse event: Elevated Coag lab test
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: New diagnosis of PFO
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Positive sputum culture
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk
Study: NCT01240551

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Urinary tract pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk
Study: NCT01240785

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Fetal death at 39 weeks due to umbilical cord complication
Frequency: 1 affected / 110 at risk
Study: NCT01241240

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 93 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Pyomyositis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Pituitary tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 93 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 22 affected / 93 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 93 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 93 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 93 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 93 at risk

Adverse event: Visual field defect
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 93 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 98 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 98 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 98 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 98 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 98 at risk

Adverse event: Visual field defect
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 98 at risk
Study: NCT01241318

Adverse event: Chlorhexidine-related adverse events
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 18510 at risk

Adverse event: Chlorhexidine ocular exposure
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 18510 at risk