TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02665286

Adverse event: Drowsy
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 76 at risk

Adverse event: dizz
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 76 at risk

Adverse event: Stomach irritation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Drowsy
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 78 at risk

Adverse event: dizz
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 78 at risk

Adverse event: Stomach irritation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Drowsy
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 80 at risk

Adverse event: dizz
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 80 at risk

Adverse event: Stomach irritation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 80 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 80 at risk
Study: NCT02665338

Adverse event: discomfort on head
Serious: no
Organ System: Nervous system disorders
Notes: The participant can feel discomfort in the head or headache.
Frequency: 1 affected / 6 at risk
Study: NCT02665455

Adverse event: Pre eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: None of the Serious Adverse Events are device related.
Frequency: 2 affected / 83 at risk

Adverse event: Vomiting & epigastric pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: None of the Serious Adverse Events are device related.
Frequency: 1 affected / 83 at risk

Adverse event: Decreased foetal movements
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: None of the Serious Adverse Events are device related.
Frequency: 1 affected / 83 at risk
Study: NCT02665728

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk
Study: NCT02665741

Adverse event: Haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post polypectomy bleeding
Frequency: 2 affected / 42 at risk
Study: NCT02666352

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

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

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

Adverse event: Hepatic encephalopathy
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: NCT02666768

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 5 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 5 at risk

Adverse event: Flu-like reaction
Serious: no
Organ System: General disorders
Frequency: 5 affected / 5 at risk

Adverse event: Injection site reactions
Serious: no
Organ System: General disorders
Frequency: 3 affected / 5 at risk

Adverse event: Sinusitis/sinus pain/sinus congestion
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 5 at risk

Adverse event: Bone pain - generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 5 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 5 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 5 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 5 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 5 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 5 at risk
Study: NCT02666846

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 20 at risk

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

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Commom Cold
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Frequency of Micturation Increased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Faeces soft
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk
Study: NCT02666950

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 3 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

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

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Gastrointestinal disorders - Other, specify
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 3 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk
Study: NCT02667119

Adverse event: Inpatient substance use treatment
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Suicidal ideation (not life threatening)
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 14 at risk

Adverse event: Emergency room visit
Serious: no
Organ System: General disorders
Frequency: 2 affected / 14 at risk

Adverse event: Inpatient substance use treatment
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 13 at risk

Adverse event: Suicidal ideation (life threatening)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 13 at risk

Adverse event: Suicidal ideation (not life threatening)
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 13 at risk

Adverse event: Emergency room visit
Serious: no
Organ System: General disorders
Frequency: 4 affected / 13 at risk
Study: NCT02667236

Adverse event: Intervertebral disc disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Rotator cuff syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Central nervous system lesion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 223 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 223 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 223 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 223 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Actinic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 223 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 227 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 227 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 227 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 227 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 227 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 227 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 227 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 227 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 227 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 227 at risk
Study: NCT02667275

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 244 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 244 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 244 at risk

Adverse event: Pulmonary contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 244 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 244 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Precerebral artery occlusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 244 at risk

Adverse event: Post traumatic Stress Disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 244 at risk

Adverse event: Coronary arterial stent insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 244 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 244 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 244 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 244 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 243 at risk

Adverse event: Intervertebral disc degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 243 at risk

Adverse event: Breast cancer stage II
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 243 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 243 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 243 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 243 at risk
Study: NCT02667288

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 147 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 147 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 147 at risk

Adverse event: Actinic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 147 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 147 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 147 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 147 at risk
Study: NCT02667301

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Anxiety from procedure.
Frequency: 1 affected / 16 at risk
Study: NCT02667444

Adverse event: Brain neoplasm benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 666 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 666 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 10 affected / 666 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 666 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 666 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 661 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 661 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 661 at risk

Adverse event: Intracranial aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 661 at risk

Adverse event: Subarachnoid haemorhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 661 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 661 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 661 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 661 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 661 at risk
Study: NCT02667457

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 26 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Claustrophobia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 26 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk
Study: NCT02667639

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 25 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 25 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 25 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Frequency: 2 affected / 25 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 25 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

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

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 25 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 10 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 10 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 10 at risk

Adverse event: General disorders and administration site conditions
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Ear and labyrinth disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Reproductive system and breast disorders
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk
Study: NCT02667704

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 13 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk
Study: NCT02667821

Adverse event: Minor aggravation of neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: One patient reported minor aggravation of local neck pain. Attributed to lying on MRI table for prolonged period. Pain no longer present at follow-up 24 hours later.
Frequency: 1 affected / 20 at risk
Study: NCT02667912

Adverse event: Post-punctional pseudoaneuryzm
Serious: yes
Organ System: Surgical and medical procedures
Notes: Hemorrhage from the femoral artery at the punction site after removal of intra-arterial introducer
Frequency: 1 affected / 27 at risk
Study: NCT02668003

Adverse event: Participant expressing thoughts that might be considered suicidal to therapist or on questionnaire
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 501 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 501 at risk
Study: NCT02668185

Adverse event: transaminase elevations by treatment and CTCAE grade
Serious: no
Organ System: Hepatobiliary disorders
Notes: transient transaminase rise (alanine aminotransferase \[ALT\] greater than aspartate aminotransferase \[AST\]) with a normal bilirubin following treatment with MLE4901
Frequency: 3 affected / 28 at risk