TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00807664

Adverse event: Recurrance opposite leg mlum perforans pedis infection
Serious: yes
Organ System: Infections and infestations
Notes: Unlikely related to device
Frequency: 1 affected / 88 at risk

Adverse event: pneumoccal pneumonia hypoxemiante
Serious: yes
Organ System: Infections and infestations
Notes: Unlikely related to device
Frequency: 1 affected / 88 at risk

Adverse event: Arteriopathie left lower limb
Serious: yes
Organ System: Vascular disorders
Notes: Unlikely related to device
Frequency: 1 affected / 88 at risk

Adverse event: Alteration of general state
Serious: yes
Organ System: Social circumstances
Notes: Unlikely related to device
Frequency: 1 affected / 88 at risk

Adverse event: Attack of angina
Serious: yes
Organ System: Cardiac disorders
Notes: Unlikely related to device
Frequency: 1 affected / 88 at risk

Adverse event: Maceration - eczema - redness - pain of wound and peri-wound skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Often AEs in form of maceration of the wound and peri-wound skin are reported together with redness, eczema and pain
Frequency: 4 affected / 88 at risk

Adverse event: Fall
Serious: yes
Organ System: Social circumstances
Notes: Unlikely related to device
Frequency: 1 affected / 94 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unlikely related to device
Frequency: 1 affected / 94 at risk

Adverse event: cardiac decompression
Serious: yes
Organ System: Cardiac disorders
Notes: left-complete arrythmia by artrial fibrillation. Unlikely related to device
Frequency: 1 affected / 94 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unlikely related to device
Frequency: 1 affected / 94 at risk

Adverse event: important pain on right leg
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unlikely related to device
Frequency: 1 affected / 94 at risk

Adverse event: Artheriography planned
Serious: yes
Organ System: Investigations
Notes: Unlikely related to device
Frequency: 1 affected / 94 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Unlikely related to device. The patient died due to the cardiact arrest
Frequency: 1 affected / 94 at risk

Adverse event: Maceration - eczema - redness - pain of wound and peri-wound skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Often AEs in form of maceration of the wound and peri-wound skin are reported together with redness, eczema and pain
Frequency: 2 affected / 94 at risk
Study: NCT00807846

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 100 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 100 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 100 at risk

Adverse event: Hand fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 98 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 98 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 98 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 98 at risk
Study: NCT00808236

Adverse event: Acute Myocardial Infarct
Serious: yes
Organ System: Cardiac disorders
Notes: new; occurring more than 24 hours after hospitalization
Frequency: 2 affected / 27 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Bleeding could occur from any orifice
Frequency: 1 affected / 96 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 96 at risk

Adverse event: Lethal/long-lasting arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 27 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 96 at risk

Adverse event: Nasal discoloration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 96 at risk

Adverse event: Peri-orbital emphysema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 96 at risk

Adverse event: Acute Myocardial Infarct
Serious: yes
Organ System: Cardiac disorders
Notes: new; occurring more than 24 hours after hospitalization
Frequency: 1 affected / 32 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Bleeding could occur from any orifice
Frequency: 1 affected / 104 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 104 at risk

Adverse event: Lethal/long-lasting arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 32 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 32 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 32 at risk

Adverse event: Sepsis/Multi-organ failure
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 32 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 104 at risk
Study: NCT00808470

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: includes any report of stomach ache, upset stomach,
Frequency: 1 affected / 37 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: includes any report of stomach ache, upset stomach,
Frequency: 2 affected / 35 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 35 at risk
Study: NCT00808665

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

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: requiring Intravenous fluids
Frequency: 6 affected / 30 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Surgical and medical procedures
Notes: requiring blood transfusions
Frequency: 9 affected / 30 at risk

Adverse event: Delirium
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Wound infection
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 30 at risk

Adverse event: Return the the Operating Room
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 30 at risk

Adverse event: Device/Hardware Failure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 30 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: EKG Changes
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 30 at risk

Adverse event: Cardiac Arrthymia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: requiring Intravenous fluids
Frequency: 5 affected / 32 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Surgical and medical procedures
Notes: requiring blood transfusions
Frequency: 6 affected / 32 at risk

Adverse event: Delirium
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Wound infection
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 32 at risk

Adverse event: Prolonged Memory loss
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: EKG Changes
Serious: no
Organ System: Cardiac disorders
Frequency: 26 affected / 32 at risk
Study: NCT00809185

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 7 at risk

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

Adverse event: fever/infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 7 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 7 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 7 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 7 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk
Study: NCT00809328

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 102 at risk

Adverse event: Peritonsillar abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 102 at risk

Adverse event: Prothrombin time prolonged
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 102 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 102 at risk

Adverse event: Organising pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 102 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 102 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 102 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 102 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 102 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 102 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 102 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 102 at risk
Study: NCT00809341

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 5 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk
Study: NCT00809445

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 429 at risk

Adverse event: Metastatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 429 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 433 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: unknown cause; "general disorders" selected as default
Frequency: 1 affected / 433 at risk

Adverse event: Overdose
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 419 at risk
Study: NCT00809458

Adverse event: Hypotension (Low blood pressure)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk
Study: NCT00809523

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

Adverse event: Eye strain/glare
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 52 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 52 at risk
Study: NCT00809848

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 36 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 36 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 36 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 36 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 34 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 34 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 34 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 34 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 34 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 34 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 34 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 34 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 34 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 31 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 31 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 31 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 31 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 37 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk
Study: NCT00809926

Adverse event: Lymphocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 232 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 232 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 232 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 232 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 232 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 232 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 232 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 232 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 232 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 232 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 219 at risk

Adverse event: Anaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 219 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 219 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 219 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 219 at risk

Adverse event: Conversion disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 219 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 219 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 219 at risk
Study: NCT00810095

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 40 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 40 at risk

Adverse event: Disorientation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Malignant infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 40 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 40 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 40 at risk
Study: NCT00810342

Adverse event: Intracranial tumor (disorder)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 154 at risk

Adverse event: Cerebrovascular accident (disorder) Blackout (disorder) Spinal cord injury (disorder)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 154 at risk

Adverse event: Fracture elbow
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 154 at risk

Adverse event: suicidal thoughts (finding)
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 154 at risk

Adverse event: Fracture ribs
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 154 at risk

Adverse event: Fracture - Toe
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 154 at risk

Adverse event: Cerebrovascular accident (disorder) Blackout (disorder) Spinal cord injury (disorder)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 157 at risk

Adverse event: Fracture - Toe
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 157 at risk
Study: NCT00810355

Adverse event: psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: suicide ideation
Frequency: 1 affected / 25 at risk

Adverse event: psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: suicide ideation
Frequency: 1 affected / 25 at risk
Study: NCT00810368

Adverse event: Costochondritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: A subject with chronic rib pain and tenderness of costochondritis was sent by his primary care physician to a cardiologist. No cardiac pathology was found. This was considered Grade 1, not related.
Frequency: 1 affected / 12 at risk

Adverse event: Hypergammaglobulinaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: One subject had elevated gamma globulins at week 6 (grade 2 adverse event, not related to study drug). The subjects dropped out of the study and was lost to follow-up.
Frequency: 1 affected / 12 at risk

Adverse event: Elevated CRP Levels
Serious: yes
Organ System: Immune system disorders
Notes: At week 6, one subject showed elevated CRP levels (Grade 1, not related). As per protocol, study drug was discontinued for 2 weeks. Hepatitis A, B, and C serologies were negative, and tests normalized. Study drug was restarted with no sequelae.
Frequency: 1 affected / 13 at risk