TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00545272

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 61 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 68 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 65 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 72 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 62 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 62 at risk
Study: NCT00545298

Adverse event: Pain/ Compression Wrap
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: deterioration of the wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Paronychia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: paronychia was considered severe
Frequency: 1 affected / 1 at risk

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

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

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

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1 at risk

Adverse event: Wound infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1 at risk
Study: NCT00545441

Adverse event: Induration / Redness / Swelling Involving External Opening
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Fistula tract re-opened after closure had been documented
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 43 at risk

Adverse event: Induration / Redness / Swelling involving external opening
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 43 at risk

Adverse event: Infection / Abscess involving fistula
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 43 at risk

Adverse event: Fistula Tract Re-Opened After Closure had been Documented
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Newly apparent fistula opening
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Induration / Redness / Swelling involving external opening
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 39 at risk

Adverse event: Infection / Abscess involving fistula
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 39 at risk

Adverse event: Plug fell out or flap failed
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 39 at risk
Study: NCT00545623

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: abnormal but benign tissue in descending colon
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: kidney problem
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 31 at risk

Adverse event: basal cell CA surgery
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Hip fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: car accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 33 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 34 at risk

Adverse event: sever esophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 34 at risk
Study: NCT00545753

Adverse event: Occular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 294 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 15 affected / 294 at risk

Adverse event: Application site irritation
Serious: no
Organ System: General disorders
Frequency: 5 affected / 294 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 294 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 294 at risk

Adverse event: Application site erythema
Serious: yes
Organ System: General disorders
Notes: Subject randomized to NIX, applied the study medication twice. Day 8 the subject presented with application site erythema. Investigator reported event as a serious AE despite the fact that it did not meet the regulatory definition of a serious event.
Frequency: 1 affected / 246 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: Subject randomized to NIX, applied study medication twice. Day 14 presented with cellulitis. Subject was hospitalized, considered mild severity and unrelated to study medication. The event resolved with no sequelae. Subject didn't have Day 21 visit.
Frequency: 1 affected / 246 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 246 at risk

Adverse event: Occular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 246 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 16 affected / 246 at risk

Adverse event: Application site irritation
Serious: no
Organ System: General disorders
Frequency: 6 affected / 246 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 246 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 246 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 246 at risk
Study: NCT00545779

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 640 at risk

Adverse event: Iridocyclitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 640 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 640 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 640 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 640 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 640 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 640 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 640 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 640 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 640 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 640 at risk
Study: NCT00545844

Adverse event: Allergic reaction Not Otherwise Specified
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 313 at risk

Adverse event: Asthma exacerbation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 313 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 313 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 313 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 313 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 313 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 313 at risk

Adverse event: Swollen tongue
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 313 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 313 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 313 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 313 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 313 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 313 at risk
Study: NCT00546078

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 65 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 65 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 65 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 64 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 33 affected / 64 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 64 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 16 affected / 64 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 32 affected / 65 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 30 affected / 65 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 61 affected / 64 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 24 affected / 64 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 22 affected / 64 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 50 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 48 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 33 affected / 48 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 48 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 16 affected / 48 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 31 affected / 48 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 48 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 45 affected / 48 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 18 affected / 48 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 16 affected / 48 at risk

Adverse event: Chlamydial infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 50 at risk
Study: NCT00546260

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 36 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Vessel puncture site haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Peripheral artery dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 36 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 36 at risk

Adverse event: Vessel puncture site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 36 at risk

Adverse event: Thrombosis in device
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 34 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 34 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 34 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 34 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 34 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 34 at risk

Adverse event: Vessel puncture site haematoma
Serious: no
Organ System: General disorders
Frequency: 2 affected / 34 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 34 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 34 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 34 at risk
Study: NCT00546390

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 27 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 28 at risk

Adverse event: New Atrial Fib
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk
Study: NCT00546429

Adverse event: Bone fracture acetabulum
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 62 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: This subject died and which is also noted as an adverse event in this study.
Frequency: 1 affected / 62 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: This subject suffered from cancer which is also noted as an adverse event in this study.
Frequency: 1 affected / 62 at risk

Adverse event: Medical device removal
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 62 at risk

Adverse event: Respiratory system
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 62 at risk
Study: NCT00546715

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

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

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

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

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Abnormal dreams
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk
Study: NCT00546910

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 63 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 63 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 63 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 63 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 63 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 63 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 63 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 63 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 63 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 63 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 63 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 62 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 62 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 62 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 62 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 62 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 62 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 62 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 62 at risk

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 62 at risk
Study: NCT00547105

Adverse event: Pneumonitis grade 3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: definitely related to radiation
Frequency: 1 affected / 24 at risk

Adverse event: diarrhea grade 4
Serious: yes
Organ System: Gastrointestinal disorders
Notes: definitely related to erlotinib
Frequency: 3 affected / 24 at risk

Adverse event: spinal fraction grade 3
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: back pain definitely related to radiation
Frequency: 1 affected / 24 at risk