TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01094106

Adverse event: Wound dressings becoming unpleasantly wet, resulting in termination of the study drug infusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Wound dressings becoming unpleasantly wet, resulting in termination of the study drug infusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 34 at risk

Adverse event: Smarting of the wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Smarting of the wound, necessitating termination of the study drug infusion
Frequency: 1 affected / 34 at risk
Study: NCT01094171

Adverse event: Body temperature increased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 400 at risk

Adverse event: Respiratory disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 400 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 400 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 400 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 114 affected / 400 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 258 affected / 400 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 152 affected / 400 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 227 affected / 400 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 240 affected / 400 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 133 affected / 400 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 69 affected / 400 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 400 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 400 at risk

Adverse event: Body temperature increased
Serious: no
Organ System: General disorders
Frequency: 20 affected / 400 at risk
Study: NCT01094522

Adverse event: Culture negative sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Left vocal cord paralysis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 20 at risk

Adverse event: Pulmonary edema requiring re-intubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Respiratory failure requiring re-intubation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Apnea requiring re-intubation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Culture negative sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Pulmonary edema requiring re-intubation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Apnea requiring re-intubation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Left pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Duodenal atresia requiring surgery
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Self-extubation
Serious: no
Organ System: Investigations
Frequency: 2 affected / 20 at risk

Adverse event: Acute respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Duodenal atresia requiring surgery
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk
Study: NCT01094717

Adverse event: Lip dry
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Elevated triglycerides
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 3 at risk

Adverse event: Bump on figner
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Seborrhoeic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk
Study: NCT01094782

Adverse event: Feeling of heaviness and muscle spasm at site of acupuncture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 39 at risk
Study: NCT01094808

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 20 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 20 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 19 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 19 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 19 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 21 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk
Study: NCT01094886

Adverse event: Arthritis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 53 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 53 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 53 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 53 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 53 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 53 at risk

Adverse event: Blood iron decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 53 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 53 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 53 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 53 at risk

Adverse event: Transfusion
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 53 at risk
Study: NCT01095497

Adverse event: Hereditary angioedema
Serious: no
Organ System: Congenital, familial and genetic disorders
Notes: 64% mild, 27% moderate, 9% severe
Frequency: 5 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: 25% mild, 75% moderate
Frequency: 1 affected / 26 at risk

Adverse event: Acne cystic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 50% mild, 50% moderate
Frequency: 1 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 50% mild, 50% moderate
Frequency: 1 affected / 26 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: 39% mild, 51% moderate, 10% severe
Frequency: 10 affected / 13 at risk

Adverse event: Hereditary angioedema
Serious: no
Organ System: Congenital, familial and genetic disorders
Notes: 64% mild, 27% moderate, 9% severe
Frequency: 2 affected / 13 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: 75% mild, 25% moderate
Frequency: 4 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: 25% mild, 75% moderate
Frequency: 1 affected / 13 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Notes: 100% mild
Frequency: 1 affected / 13 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Notes: 100% mild
Frequency: 2 affected / 13 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 50% mild, 50% moderate
Frequency: 1 affected / 13 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: 100% mild
Frequency: 1 affected / 13 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: 39% mild, 51% moderate, 10% severe
Frequency: 8 affected / 12 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: 75% mild, 25% moderate
Frequency: 2 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: 25% mild, 75% moderate
Frequency: 2 affected / 12 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Notes: 100% mild
Frequency: 2 affected / 12 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Notes: 100% mild
Frequency: 1 affected / 12 at risk

Adverse event: Acne cystic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 50% mild, 50% moderate
Frequency: 1 affected / 12 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: 100% mild
Frequency: 1 affected / 12 at risk
Study: NCT01095510

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk
Study: NCT01095653

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 132 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 132 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 132 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 132 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 132 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 132 at risk

Adverse event: Goitre
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 128 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 128 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 128 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 128 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 128 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 128 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 128 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 128 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 128 at risk

Adverse event: Pyloric stenosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 133 at risk

Adverse event: Goitre
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 133 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Urethritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 133 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 133 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 133 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 133 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 133 at risk
Study: NCT01095757

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 45 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 45 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 45 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 45 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 45 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 45 at risk

Adverse event: Thrombocytopenia Grade 1/2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 45 at risk

Adverse event: Thrombocytopenia Over Grade 2
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 45 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 45 at risk
Study: NCT01095978

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 2800 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 2800 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 2800 at risk

Adverse event: Disbacteriosis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2800 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2800 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2800 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2800 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2800 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2800 at risk
Study: NCT01096316

Adverse event: Psychiatric ER visits or hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: We assessed at each objective follow-up all psychiatric emergency room visits and psychiatric hospitalizations. These were also spontaneously sent to us via EMR if the ER visit or hospitalization occurred in the University hospitals
Frequency: 1 affected / 102 at risk

Adverse event: Psychiatric ER visits or hospitalization
Serious: yes
Organ System: Psychiatric disorders
Notes: We assessed at each objective follow-up all psychiatric emergency room visits and psychiatric hospitalizations. These were also spontaneously sent to us via EMR if the ER visit or hospitalization occurred in the University hospitals
Frequency: 1 affected / 103 at risk
Study: NCT01096680

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk
Study: NCT01096771

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Patient died after study infusion drug completed. Mortality rate for ARDS is \>25%. While this is a SAE it is not unexpected and could not be directly connected to study experimental or control drug.
Frequency: 1 affected / 7 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: An adverse event was considered a rise in the serum creatinine level while on the study experimental or control drug.
Frequency: 1 affected / 7 at risk

Adverse event: New Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: Patient died after study infusion drug completed. Mortality rate for ARDS is \>25%. While this is a SAE it is not unexpected and could not be directly connected to study experimental or control drug.
Frequency: 1 affected / 7 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: An adverse event was considered a rise in the serum creatinine level while on the study experimental or control drug.
Frequency: 1 affected / 7 at risk
Study: NCT01096810

Adverse event: Pneumonia pneumococcal
Serious: yes
Organ System: General disorders
Notes: Pneumococcal pneumonia requiring admission, which was felt to be unrelated to study treatment
Frequency: 1 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk
Study: NCT01096849

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 22 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 74 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 74 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 74 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 74 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 74 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 74 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 44 at risk
Study: NCT01096875

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

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk