TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01577186

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 480 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 480 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 480 at risk

Adverse event: Aggression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 480 at risk

Adverse event: Alcohol abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 480 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 480 at risk

Adverse event: Drug abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 480 at risk

Adverse event: Hallucination, auditory
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 480 at risk

Adverse event: Impulsive behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 480 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 480 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 480 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 27 affected / 480 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 480 at risk

Adverse event: Scrotal ulcer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 480 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 480 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 480 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 480 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 480 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 480 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 56 affected / 480 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 480 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 480 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 480 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 480 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 480 at risk
Study: NCT01577238

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk
Study: NCT01577381

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Nephropathy
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk
Study: NCT01577732

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 300 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 300 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 95 affected / 300 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 82 affected / 300 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 52 affected / 300 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 52 affected / 300 at risk

Adverse event: Irritability/fussiness
Serious: no
Organ System: General disorders
Frequency: 108 affected / 300 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 115 affected / 300 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 101 affected / 300 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 48 affected / 300 at risk
Study: NCT01578031

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 129 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 129 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 129 at risk

Adverse event: High blood pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 129 at risk

Adverse event: Claustrophobia during MRI
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 129 at risk

Adverse event: Abnormal finding on MiniScid
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 129 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 69 at risk

Adverse event: Hospitalizaiton
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 69 at risk

Adverse event: High blood pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 69 at risk

Adverse event: High blood pressure
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 12 at risk

Adverse event: Claustrophobia during MRI
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 12 at risk

Adverse event: Abnormal MRI
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Abnormal spirometry
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk
Study: NCT01578278

Adverse event: Mild taste following instillation
Serious: no
Organ System: General disorders
Frequency: 9 affected / 152 at risk

Adverse event: Mild taste following instillation
Serious: no
Organ System: General disorders
Frequency: 8 affected / 152 at risk
Study: NCT01578330

Adverse event: Multiple sclerosis
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 42 at risk

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

Adverse event: Medication taken before pregnancy
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 42 at risk

Adverse event: Middle ear infection surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 42 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 42 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 42 at risk

Adverse event: Increase of hepatic enzymes
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 42 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 42 at risk

Adverse event: Multiple sclerosis
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 42 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 42 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 42 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 42 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 42 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 42 at risk
Study: NCT01578486

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

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

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

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 8 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Bloody urine
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk
Study: NCT01578785

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 13 affected / 119 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 119 at risk
Study: NCT01578902

Adverse event: acute urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 84 at risk

Adverse event: rectalcutaneous fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: acute grade 2 genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 84 at risk

Adverse event: acute grade 2 gastrointestinal toxicity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 84 at risk

Adverse event: late grade 2 gastrointestinal toxicity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 84 at risk

Adverse event: late grade 2 genitourinary toxicity
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 84 at risk

Adverse event: late grade 3+ GI toxicity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: acute grade 3+ GU toxicity
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 84 at risk
Study: NCT01578980

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Notes: Hypoglycemia \<60 mg/dL requiring carbohydrate treatment
Frequency: 6 affected / 20 at risk

Adverse event: Staff Initiated System Shut-dowm
Serious: yes
Organ System: Endocrine disorders
Notes: Hyperglycemia due to site failure or tube occlusion
Frequency: 3 affected / 20 at risk
Study: NCT01578993

Adverse event: Venous thrombosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Symptomatic venous thrombus in upper extremity ( PICC arm); verified via standard ultrasonography procedure.
Frequency: 6 affected / 101 at risk
Study: NCT01579305

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: This event was classified as not related to the anesthesia, study device, or procedure, and resolved without sequelae after treatment with medication and a procedure.
Frequency: 1 affected / 139 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Notes: lumps/bumps
Frequency: 14 affected / 139 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 139 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 139 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: This event was classified as not related to the anesthesia, study device, or procedure, and resolved with sequelae after treatment with a procedure.
Frequency: 1 affected / 141 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Notes: lumps/bumps
Frequency: 12 affected / 141 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 141 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 141 at risk
Study: NCT01579318

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

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

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

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

Adverse event: Temperature intolerance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Actinic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Xerosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk
Study: NCT01579513

Adverse event: Lung assist device therapy
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 81 at risk

Adverse event: Insulin therapy
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 81 at risk

Adverse event: Lung assist device therapy
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 95 at risk

Adverse event: Insulin therapy
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 95 at risk
Study: NCT01579565

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 202 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 202 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 34 affected / 202 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 202 at risk

Adverse event: Posterior capsule opafication
Serious: no
Organ System: Eye disorders
Frequency: 17 affected / 202 at risk

Adverse event: Anterior chamber inflammation
Serious: no
Organ System: Eye disorders
Frequency: 17 affected / 202 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 202 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 202 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 202 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 202 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 202 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 204 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 204 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 204 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 76 affected / 204 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 204 at risk

Adverse event: Posterior capsule opafication
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 204 at risk

Adverse event: Anterior chamber inflammation
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 204 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 204 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 204 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 204 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 204 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 204 at risk
Study: NCT01579916

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 241 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 241 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 241 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 241 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 241 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 241 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 241 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 241 at risk

Adverse event: Post-traumatic headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 241 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 241 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 241 at risk

Adverse event: Increased upper airway secretion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 241 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 241 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 241 at risk

Adverse event: Extradural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 60 at risk

Adverse event: Multiple fractures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 60 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk
Study: NCT01580306

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 8 at risk

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 8 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

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

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 8 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 8 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 8 at risk

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

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

Adverse event: Blood pressure systolic increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk
Study: NCT01580488

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

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 24 at risk
Study: NCT01580592

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 9 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 12 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 12 at risk
Study: NCT01580618

Adverse event: intrapleural hemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: bleeding into the pleural space from infusion of normal saline or TNKase through the existing pleural catheter
Frequency: 1 affected / 13 at risk