TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04581785

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

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

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

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

Adverse event: Cytokine release syndrome
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 2 at risk

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

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

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

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

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

Adverse event: Thrombotic microangiopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2 at risk

Adverse event: Cytokine release syndrome
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 2 at risk

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

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

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

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

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

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 2 at risk

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

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

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

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

Adverse event: Deafness neurosensory
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 2 at risk

Adverse event: Transaminases increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk
Study: NCT04582149

Adverse event: Transient redness of the skin where device touches the skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk
Study: NCT04582396

Adverse event: Emergency Room visit
Serious: no
Organ System: Gastrointestinal disorders
Notes: Emergency Department visit unrelated to the study, satisfactorily resolved without an inpatient admission. The study team was not required to take any further action.
Frequency: 1 affected / 1 at risk
Study: NCT04583709

Adverse event: Product related adverse event
Serious: no
Organ System: Product Issues
Notes: Redness on skin under electrodes of ECG Belt system
Frequency: 1 affected / 20 at risk
Study: NCT04584346

Adverse event: Lower back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Generalized muscle ache with headache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Indegestion with acid reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Headache s/p hit head
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 7 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Salivary hypersecretion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Fatigue
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Indegestion with acid reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dyskinesia (increased from baseline)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 9 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 15 at risk

Adverse event: Fatigue
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 15 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Flexing and External rotation of toes
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Malaise
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 15 at risk
Study: NCT04586673

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

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 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: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Loss of appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 10 at risk
Study: NCT04588207

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

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

Adverse event: Headaches
Serious: no
Organ System: Nervous system 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: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

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

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

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk
Study: NCT04589663

Adverse event: Device failure
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 24 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Device failure
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 24 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk
Study: NCT04594941

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

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk
Study: NCT04596267

Adverse event: Bright yellow urine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 7 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Left Ankle Pain
Serious: no
Organ System: General disorders
Notes: Due to sprained ankle
Frequency: 1 affected / 7 at risk

Adverse event: Right knee contusion with abrasion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Bright yellow urine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 7 at risk
Study: NCT04598321

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk

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

Adverse event: Endocrine disorders, other
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 1 at risk

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

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

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

Adverse event: Small intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk

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

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

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1 at risk

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

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

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

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

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk

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

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

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

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

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

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

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

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

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1 at risk
Study: NCT04600323

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 16 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 16 at risk

Adverse event: New Lower Extremity Edema
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 16 at risk

Adverse event: Increase in antihypertensive therapy
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 16 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 18 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 18 at risk

Adverse event: Dialysis initiation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 18 at risk

Adverse event: New Lower Extremity Edema
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 18 at risk

Adverse event: Increase in antihypertensive therapy
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 18 at risk

Adverse event: Increase in diuretic therapy
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 18 at risk

Adverse event: High serum bicarbonate level
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 18 at risk
Study: NCT04600752

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 136 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 136 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 136 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 68 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 68 at risk
Study: NCT04601532

Adverse event: Burn to left shoulder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild, unrelated to study procedure or product.
Frequency: 1 affected / 13 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild, unrelated to study procedure or product.
Frequency: 1 affected / 13 at risk

Adverse event: Limb swelling
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Mild, unrelated to study procedure or product.
Frequency: 1 affected / 13 at risk

Adverse event: pain (burning/stinging)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild, unrelated to study procedure or product.
Frequency: 1 affected / 13 at risk

Adverse event: Parathesis, tingling
Serious: no
Organ System: Nervous system disorders
Notes: Mild, unrelated to study procedure or product.
Frequency: 1 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Mild, unrelated to study procedure or product.
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Mild, unrelated to study procedure or product.
Frequency: 1 affected / 13 at risk

Adverse event: Sinusitis
Serious: no
Organ System: General disorders
Notes: Mild, unrelated to study procedure or product.
Frequency: 1 affected / 13 at risk

Adverse event: Skin rash, allergic reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild, probably related to study product (silver sulfadiazine). Per PI, subject was withdrawn from the study.
Frequency: 1 affected / 13 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild, unrelated to study procedure or product.
Frequency: 1 affected / 13 at risk

Adverse event: Dermal budding
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild, unrelated to study procedure or product.
Frequency: 1 affected / 13 at risk

Adverse event: Limb swelling
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Mild, unrelated to study procedure or product.
Frequency: 1 affected / 13 at risk

Adverse event: pain (burning/stinging)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild, unrelated to study procedure or product.
Frequency: 2 affected / 13 at risk

Adverse event: Parathesis, tingling
Serious: no
Organ System: Nervous system disorders
Notes: Mild, unrelated to study procedure or product.
Frequency: 1 affected / 13 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild, unrelated to study procedure or product.
Frequency: 1 affected / 13 at risk

Adverse event: Feeling hot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild, unrelated to study procedure or product.
Frequency: 1 affected / 13 at risk
Study: NCT04603391

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk
Study: NCT04604652

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 24 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 24 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 subject experienced an adverse event after study drug discontinuation (follow-up period)
Frequency: 2 affected / 24 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Adverse events occurred after study drug discontinuation (follow-up period)
Frequency: 2 affected / 24 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: 1 subject experienced an adverse event after study drug discontinuation (follow-up period)
Frequency: 2 affected / 24 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 24 at risk

Adverse event: Liver function test increased
Serious: no
Organ System: Investigations
Notes: Adverse events occurred after study drug discontinuation (follow-up period)
Frequency: 4 affected / 24 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: 1 subject experienced an adverse event after study drug discontinuation (follow-up period)
Frequency: 2 affected / 24 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: 1 subject experienced an adverse event after study drug discontinuation (follow-up period)
Frequency: 2 affected / 24 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 24 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 24 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 subject experienced an adverse event after study drug discontinuation (follow-up period)
Frequency: 5 affected / 24 at risk
Study: NCT04606927

Adverse event: Diverse
Serious: yes
Organ System: Cardiac disorders
Frequency: 60 affected / 150 at risk

Adverse event: Diverse
Serious: yes
Organ System: Cardiac disorders
Frequency: 70 affected / 160 at risk
Study: NCT04607044

Adverse event: Infection in foot
Serious: yes
Organ System: Infections and infestations
Notes: Infection in foot
Frequency: 1 affected / 42 at risk

Adverse event: Loosen External Fixator
Serious: yes
Organ System: Product Issues
Notes: Loosen External Fixator
Frequency: 1 affected / 42 at risk

Adverse event: Broken screw with nonunion at the navicular-cuneiform joint
Serious: yes
Organ System: Product Issues
Notes: Broken screw with nonunion at the navicular-cuneiform joint
Frequency: 1 affected / 42 at risk

Adverse event: Redness and swelling lower leg and ankle
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness and swelling lower leg and ankle
Frequency: 1 affected / 42 at risk

Adverse event: Infected IM Nail with nonunion of ankle fusion site
Serious: yes
Organ System: Infections and infestations
Notes: Infected IM Nail with nonunion of ankle fusion site
Frequency: 1 affected / 42 at risk

Adverse event: infected wire on external fixator
Serious: yes
Organ System: Infections and infestations
Notes: infected wire on external fixator
Frequency: 1 affected / 42 at risk

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

Adverse event: Abcess/cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: Abcess/cellulitis
Frequency: 1 affected / 42 at risk

Adverse event: Broken screw with nonunion at the navicular-cuneiform joint
Serious: no
Organ System: Product Issues
Notes: Broken screw with nonunion at the navicular-cuneiform joint
Frequency: 1 affected / 42 at risk

Adverse event: Redness and swelling lower leg and ankle
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness and swelling lower leg and ankle
Frequency: 1 affected / 42 at risk
Study: NCT04608448

Adverse event: Rash/redness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash at site of application
Frequency: 4 affected / 22 at risk

Adverse event: Rash/redness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash at site of application
Frequency: 4 affected / 22 at risk