TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01770652

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Difficulty urinating
Frequency: 1 affected / 8 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Notes: Metallic taste in mouth
Frequency: 1 affected / 8 at risk

Adverse event: Chills
Serious: no
Organ System: Nervous system disorders
Notes: Shivering
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Abnormal faeces
Serious: no
Organ System: Gastrointestinal disorders
Notes: Soft stool
Frequency: 1 affected / 8 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 8 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Cramp in right calf
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk
Study: NCT01770691

Adverse event: Spotting
Serious: no
Organ System: General disorders
Notes: Six (6) spotting (small blood spots detected on the TIPI cover after removal) events out of 55 usages were recored with the main TIPI SMDs. All adverse events were considered to be mild, minimal and temporary, and resolved with no sequelae.
Frequency: 3 affected / 7 at risk

Adverse event: Spotting
Serious: no
Organ System: General disorders
Notes: Five (5) spotting (small blood spots detected on the TIPI cover after removal) events out of 42 usages were recorded with the cleared TIPI device. All adverse events were considered to be mild, minimal and temporary, and resolved with no sequela.
Frequency: 2 affected / 7 at risk

Adverse event: Discomfort
Serious: no
Organ System: General disorders
Notes: Two (2) discomfort events out of 42 usages of the cleared TIPI device were recorded. All adverse events were considered to be mild, minimal and temporary, and resolved with no sequela.
Frequency: 2 affected / 7 at risk
Study: NCT01770860

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 46 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 46 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 46 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 46 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Upper respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk
Study: NCT01771172

Adverse event: Implant site infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 50 at risk

Adverse event: Post procedural haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 50 at risk

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

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

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

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 50 at risk

Adverse event: Post procedural haematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 50 at risk
Study: NCT01771250

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

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

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Post procedural haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 14 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Nasal discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dermoid cyst
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 14 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 14 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk
Study: NCT01771731

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 23 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 23 at risk

Adverse event: Disorientation
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Paranoia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 23 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 23 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 23 at risk

Adverse event: Disorientation
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 23 at risk

Adverse event: Paranoia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 23 at risk
Study: NCT01771952

Adverse event: Knee pain and/or stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Self reported knee pain and / or knee stiffness
Frequency: 6 affected / 45 at risk

Adverse event: Knee Effusion with or without pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Knee swelling noted on exam during research visits with or without self reported knee pain
Frequency: 3 affected / 45 at risk

Adverse event: Knee pain and/or stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Self reported knee pain and / or knee stiffness
Frequency: 4 affected / 41 at risk

Adverse event: Knee Effusion with or without pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Knee swelling noted on exam during research visits with or without self reported knee pain
Frequency: 2 affected / 41 at risk
Study: NCT01772316

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 47 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 47 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 47 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 47 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 47 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 47 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 47 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 47 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 47 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 47 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 47 at risk
Study: NCT01772368

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 72 at risk
Study: NCT01772550

Adverse event: Extravasation
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 33 at risk
Study: NCT01773109

Adverse event: Treatment-related seconard maligancy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Embolism
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk
Study: NCT01773226

Adverse event: Joint effusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 11 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 11 at risk

Adverse event: Joint stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 11 at risk

Adverse event: Joint instability
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Site Discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Injection site joint pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Tootache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Procedural nausea
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk
Study: NCT01773395

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 30 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 30 at risk

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

Adverse event: Skin induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 30 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 30 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 27 at risk
Study: NCT01773733

Adverse event: Dry mouth
Serious: no
Organ System: Nervous system disorders
Frequency: 906 affected / 56643 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Headache
Frequency: 511 affected / 56643 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: Insomnia
Frequency: 453 affected / 56643 at risk

Adverse event: Hypertension/increased blood pressure
Serious: no
Organ System: Cardiac disorders
Notes: Hypertension/increased blood pressure
Frequency: 170 affected / 56643 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: tachycardia
Frequency: 114 affected / 56643 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Notes: Depression
Frequency: 170 affected / 56643 at risk

Adverse event: Other Adverse Events
Serious: no
Organ System: General disorders
Notes: Other Adverse Events
Frequency: 673 affected / 56643 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Nervous system disorders
Frequency: 210 affected / 13167 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Headache
Frequency: 119 affected / 13167 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Notes: Insomnia
Frequency: 105 affected / 13167 at risk

Adverse event: Hypertension/increased blood pressure
Serious: no
Organ System: Cardiac disorders
Notes: Hypertension/increased blood pressure
Frequency: 39 affected / 13167 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: tachycardia
Frequency: 26 affected / 13167 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Notes: Depression
Frequency: 39 affected / 13167 at risk

Adverse event: Other Adverse Events
Serious: no
Organ System: General disorders
Notes: Other Adverse Events
Frequency: 157 affected / 13167 at risk
Study: NCT01773954

Adverse event: Fatal MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk
Study: NCT01773967

Adverse event: Worsening diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 483 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: febrile
Frequency: 1 affected / 483 at risk

Adverse event: Lethargy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 483 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 483 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 483 at risk

Adverse event: other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 483 at risk

Adverse event: other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 483 at risk

Adverse event: Worsening diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 488 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 488 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: febrile
Frequency: 1 affected / 488 at risk

Adverse event: Lethargy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 488 at risk

Adverse event: lower respiratory infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 488 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 488 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 488 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 488 at risk

Adverse event: other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 488 at risk

Adverse event: other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 488 at risk
Study: NCT01774045

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: This adverse event is mild and 25-50% related to the study drug by principal investigator's judgement. The subjects were recovered during the trial and without treatment intervention.
Frequency: 2 affected / 23 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: This adverse event is mild and 50% related to the study drug by principal investigator's judgement. The subject was recovered during the trial and without treatment intervention.
Frequency: 1 affected / 23 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: The adverse event is mild and 50% related to the study drug by principal investigator's judgement. The subjects were recovered during the trial and without treatment intervention.
Frequency: 1 affected / 23 at risk

Adverse event: Oral ulcer
Serious: no
Organ System: Nervous system disorders
Notes: The adverse event is mild and 25-30% related to the study drug by principal investigator's judgement. The subject was recovered after one week of the end of trial and without treatment intervention.
Frequency: 1 affected / 23 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: This adverse event is mild and 25-50% related to the study drug by principal investigator's judgement. The subjects were recovered during the trial and without treatment intervention.
Frequency: 1 affected / 7 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: The adverse event is mild and 25-30% related to the study drug by principal investigator's judgement. The subject was recovered during the trial and without treatment intervention.
Frequency: 1 affected / 7 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: The adverse event is mild and 50% related to the study drug by principal investigator's judgement. The subjects were recovered during the trial and without treatment intervention.
Frequency: 1 affected / 7 at risk
Study: NCT01774097

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Ischaemic limb pain
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Post operative hip pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 40 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Anginal discomfort (symptomatic)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 42 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 42 at risk

Adverse event: Post procedural hematoma (left popliteal)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 42 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 42 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 42 at risk

Adverse event: Coronary artery bypass
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 42 at risk

Adverse event: Peripheral arterial disease (worsening)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 42 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Facial paralysis (Bell's palsy)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 42 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 42 at risk

Adverse event: Post operative hip pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 42 at risk