TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02709395

Adverse event: Broke left leg
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 28 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Skin infection elbow
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 28 at risk
Study: NCT02710045

Adverse event: Hospital admission with fever and rash
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 106 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Notes: Fever of unknown cause
Frequency: 19 affected / 106 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 61 affected / 106 at risk

Adverse event: Rash, sores
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 34 affected / 106 at risk

Adverse event: Diarrhoea and / or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 106 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Notes: Fever of unknown cause
Frequency: 24 affected / 115 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 76 affected / 115 at risk

Adverse event: Rash, sores
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 36 affected / 115 at risk

Adverse event: Diarrhoea and / or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 64 affected / 115 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Notes: Fever of unknown cause
Frequency: 12 affected / 81 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 48 affected / 81 at risk

Adverse event: Rash, sores
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 81 at risk

Adverse event: Diarrhoea and / or vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 81 at risk
Study: NCT02710136

Adverse event: Herpes simplex
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Anaphylactic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Peak expiratory flow rate decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

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

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Concussion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

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

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

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk
Study: NCT02710240

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Notes: 1. patient experienced hypertension pre-infusion.
2. patients experienced from hypertension during infusion and infusion was discontinued. These events were classified as SAEs as the patients were taken to the ED for treatment.
Frequency: 3 affected / 336 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 patient experienced respiratory distress during infusion and infusion was discontinued.
Frequency: 1 affected / 336 at risk

Adverse event: IV Site Reactions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 4 patients experienced IV site reactions during infusion. No treatment was deemed necessary and patients recovered upon observation.
Frequency: 4 affected / 336 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: 3 patients experienced hypertension during infusion. Infusion was stopped for 1 patient. Infusion was slowed and completed for 1 patient. No action was taken for 1 patient. Hypertension resolved for all 3 patients upon observation.
Frequency: 3 affected / 336 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 patient experienced hypoxia post-infusion. No treatment was deemed necessary. O2 levels recovered in time upon observation.
Frequency: 1 affected / 336 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 2 patients experienced itching during infusion. Both patients received Benadryl, after which the itching resolved.
Frequency: 2 affected / 336 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 patient experienced hives during infusion. The patient received Benadryl, after which the hives resolved.
Frequency: 1 affected / 336 at risk

Adverse event: Peroneal nerve palsy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1 patient experienced foot drop, presumed secondary to brain tumor. AE was determined to be unrelated and unexpected by the study investigator.
Frequency: 1 affected / 336 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 patient reported nausea during infusion. Infusion was discontinued and the symptoms resolved.
Frequency: 1 affected / 336 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 patient began to vomit during infusion. Infusion was discontinued and the symptoms resolved.
Frequency: 1 affected / 336 at risk

Adverse event: Unilateral Upper Extremity Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 2 patients reported upper extremity pain on the side of the IV placement and infusion. Infusion was discontinued for 1 patient and symptoms resolved. No action was taken for 1 patient and symptoms resolved upon observation.
Frequency: 2 affected / 336 at risk
Study: NCT02710292

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 96 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 96 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 98 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 98 at risk
Study: NCT02710890

Adverse event: Functional gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 55 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk
Study: NCT02710981

Adverse event: Vasodilatory headache
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 36 at risk
Study: NCT02711826

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Coronavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 8 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Superficial vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Coronavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

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

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

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 8 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Major depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 8 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Swelling face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 8 at risk

Adverse event: Transplant rejection
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk
Study: NCT02712047

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 27 at risk

Adverse event: Orchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

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

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 27 at risk

Adverse event: Viral pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

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

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

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

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 27 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk
Study: NCT02712320

Adverse event: Perforated ulcer
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 30 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 30 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 30 at risk
Study: NCT02712424

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Notes: Active TB was defined as an SAE for purpose of this study
Frequency: 3 affected / 315 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 315 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 315 at risk

Adverse event: HIV infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 315 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 73 affected / 315 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 53 affected / 315 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Notes: Active TB was defined as an SAE for purpose of this study
Frequency: 2 affected / 310 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 310 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 69 affected / 310 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 73 affected / 310 at risk
Study: NCT02712788

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2 at risk

Adverse event: Gastroduodenal Artery Bleed
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2 at risk

Adverse event: Thalamic and basal ganglia infarcts
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2 at risk

Adverse event: Fever (neurogenic)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Acute Deep Venous Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 2 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Incontinence associated dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk
Study: NCT02712996

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Notes: Increased anxiety, including panic-like symptoms,
Frequency: 1 affected / 17 at risk
Study: NCT02713347

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Hospitalizations were determined at 6 months and not adjudicated as to organ-specific cause.
Frequency: 33 affected / 154 at risk

Adverse event: Mortality
Serious: yes
Organ System: General disorders
Notes: Mortality was determined at 1 year and was not adjudicated as to organ-specific cause.
Frequency: 6 affected / 154 at risk

Adverse event: All other AEs (not SAE)
Serious: no
Organ System: General disorders
Notes: Anticipated and unanticipated events within any arm of the study were reported. AEs were more likely to be reported by intervention arm subjects due to more exposure to intervention staff. Hospitalizations, deaths, emergency room visits reported
Frequency: 70 affected / 154 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Hospitalizations were determined at 6 months and not adjudicated as to organ-specific cause.
Frequency: 26 affected / 152 at risk

Adverse event: Mortality
Serious: yes
Organ System: General disorders
Notes: Mortality was determined at 1 year and was not adjudicated as to organ-specific cause.
Frequency: 5 affected / 152 at risk

Adverse event: All other AEs (not SAE)
Serious: no
Organ System: General disorders
Notes: Anticipated and unanticipated events within any arm of the study were reported. AEs were more likely to be reported by intervention arm subjects due to more exposure to intervention staff. Hospitalizations, deaths, emergency room visits reported
Frequency: 34 affected / 152 at risk
Study: NCT02713659

Adverse event: Mortality
Serious: yes
Organ System: General disorders
Notes: 1 participant in the ELP arm died of presumed SIDS.
Frequency: 1 affected / 60 at risk
Study: NCT02713698

Adverse event: Mean arterial pressure (MAP) variation >40% after induction of general anesthesia
Serious: no
Organ System: Cardiac disorders
Notes: Patients in whom a variation higher than 40% was registered after induction of general anesthesia were treated with ephedrine and fluid boluses to return MAP to baseline levels.
Frequency: 1 affected / 20 at risk

Adverse event: Mean arterial pressure (MAP) variation >40% after induction of general anesthesia
Serious: no
Organ System: Cardiac disorders
Notes: Patients in whom a variation higher than 40% was registered after induction of general anesthesia were treated with ephedrine and fluid boluses to return MAP to baseline levels.
Frequency: 6 affected / 20 at risk
Study: NCT02714153

Adverse event: SVC Tear
Serious: yes
Organ System: Vascular disorders
Notes: An SVC tear occurred intraoperatively during the course of the study. The procedure was thoroughly reviewed by the data safety monitoring committee and it was concluded deployment of the balloon had no relation to the adverse outcome of the SVC tear.
Frequency: 1 affected / 23 at risk
Study: NCT02714400

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea without vomiting
Frequency: 2 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Nausea without vomiting
Frequency: 1 affected / 20 at risk
Study: NCT02715076

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 50 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 48 at risk