TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03786744

Adverse event: Infectious nature
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 3 cases of influenza

1. case laryngitis
2. case tracheobronchitis
Frequency: 5 affected / 10 at risk

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

Adverse event: NON Infectious nature
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Infectious nature
Serious: no
Organ System: Gastrointestinal disorders
Notes: food toxicology
Frequency: 2 affected / 10 at risk

Adverse event: NON Infectious nature
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastritis
Frequency: 1 affected / 10 at risk

Adverse event: NON Infectious nature
Serious: no
Organ System: Nervous system disorders
Notes: head pain, dizziness
Frequency: 2 affected / 10 at risk

Adverse event: Psychiatric symptoms
Serious: no
Organ System: Psychiatric disorders
Notes: aggression irritability anxiety
Frequency: 1 affected / 10 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: seasonal allergy
Frequency: 1 affected / 10 at risk

Adverse event: Infectious nature
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 3 cases of influenza

1. case laryngitis
2. case tracheobronchitis
Frequency: 4 affected / 10 at risk

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

Adverse event: NON Infectious nature
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Infectious nature
Serious: no
Organ System: Gastrointestinal disorders
Notes: food toxicology
Frequency: 1 affected / 10 at risk

Adverse event: NON Infectious nature
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastritis
Frequency: 2 affected / 10 at risk

Adverse event: NON Infectious nature
Serious: no
Organ System: Nervous system disorders
Notes: head pain, dizziness
Frequency: 1 affected / 10 at risk

Adverse event: Psychiatric symptoms
Serious: no
Organ System: Psychiatric disorders
Notes: aggression irritability anxiety
Frequency: 1 affected / 10 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: seasonal allergy
Frequency: 2 affected / 10 at risk
Study: NCT03787095

Adverse event: Thyroiditis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 4 at risk

Adverse event: Blood thyroid stimulating hormone decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Thyroxine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Drug-induced liver injury
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 4 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 4 at risk

Adverse event: Blood bicarbonate decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Blood thyroid stimulating hormone decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Creatinine renal clearance decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 4 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

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

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

Adverse event: Blood phosphorus decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk
Study: NCT03788616

Adverse event: failure of restoration
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 35 at risk

Adverse event: failure of restoration
Serious: no
Organ System: Product Issues
Frequency: 7 affected / 35 at risk
Study: NCT03789175

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

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

Adverse event: Muscle tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1 at risk
Study: NCT03790137

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 19 at risk

Adverse event: Reduced Appetite
Serious: no
Organ System: General disorders
Frequency: 8 affected / 19 at risk

Adverse event: Enuresis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Viral Illness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 19 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 19 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Seasonal Allergies
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Repetitive speech
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: low serum calcium level
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: acne exacerbation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk
Study: NCT03790280

Adverse event: Subdural haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Perioperative unwitnessed fall resulted in left subdural hematoma requiring evacuation.
Frequency: 1 affected / 8 at risk
Study: NCT03790917

Adverse event: Acute myiocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Non-fatal AMI
Frequency: 1 affected / 201 at risk

Adverse event: Unstable angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 201 at risk

Adverse event: CHF decompensation
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization due to CHF decompensation
Frequency: 5 affected / 201 at risk

Adverse event: Sarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 201 at risk

Adverse event: Paroxysm of atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Paroxysm of atrial fibrillation, emergency hospitalization
Frequency: 5 affected / 201 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 201 at risk

Adverse event: Bleeding in the retina
Serious: yes
Organ System: Eye disorders
Notes: Bleeding in the retina, emergency hospitalization
Frequency: 1 affected / 201 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Severe iron deficiency anaemia, emergency hospitalization
Frequency: 1 affected / 201 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: General disorders
Notes: Bleeding of different localization due to NOAC therapy, non-severe
Frequency: 18 affected / 201 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 201 at risk

Adverse event: Urticaria
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 201 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 201 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Notes: amiodarone-induced hypothyroidism
Frequency: 1 affected / 201 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 201 at risk

Adverse event: Gynaecomastia
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Spironolactone-induced gynecomastia
Frequency: 1 affected / 201 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 201 at risk
Study: NCT03791489

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 30 at risk

Adverse event: Postprocedure pain/discomfort
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 30 at risk

Adverse event: Palate numbness
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 30 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk
Study: NCT03792126

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 21 at risk
Study: NCT03792477

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 59 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 12 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Lip disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk
Study: NCT03792737

Adverse event: Papillary thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 162 at risk

Adverse event: Breast adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 162 at risk

Adverse event: Haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 162 at risk

Adverse event: Asthenia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: General disorders and administration site conditions
Frequency: 1 affected / 162 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 162 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 162 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 162 at risk

Adverse event: Papillary thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 161 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 161 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 161 at risk

Adverse event: Skin oedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 161 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 161 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 161 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 25 affected / 161 at risk

Adverse event: Metastatic lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 162 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 162 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 162 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 162 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 162 at risk
Study: NCT03793439

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Notes: Flare of neurosarcoidosis with peripheral neuropathy requiring escalation of glucocorticoids and subsequent withdrawal from the clinical trial. Treated with high dose glucocorticoids and infliximab, resolved.
Frequency: 1 affected / 5 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Upper extremity cellulitis during post-study monitoring period. Occurred while on prednisone 30 mg/day, 9 days after the last study drug dose, 10 days after infliximab 5 mg/kg, resolved.
Frequency: 1 affected / 5 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild rash on scalp and face, resolved without intervention.
Frequency: 1 affected / 5 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Emesis after suspected ingestion of spoiled food, resolved without intervention.
Frequency: 1 affected / 5 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1. ER visit, arthrocentesis with non-inflammatory fluid, no crystals, resolved with conservative management.
2. Motor vehicle accident w/ ER visit for right knee and left shoulder pain. X-rays without fracture. Resolved with physical therapy
Frequency: 2 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 3 days of diarrhea, resolved without intervention.
Frequency: 1 affected / 5 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Exacerbation of seasonal nasal allergies
Frequency: 1 affected / 5 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough up to 3-4x/week, resolved without intervention.
Frequency: 1 affected / 5 at risk

Adverse event: Renal colic
Serious: no
Organ System: Renal and urinary disorders
Notes: ER visit for renal colic, initially thought to be urinary tract infection and given antibiotic however urinalysis and culture negative. Renal stones on CT, required pain medication and hydration, resolved.
Frequency: 1 affected / 5 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: ER visit for bronchitis, no pneumonia in imaging. Treated with oral antibiotics, resolved.
Frequency: 1 affected / 5 at risk
Study: NCT03793608

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 24 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Injection site urticaria
Serious: no
Organ System: General disorders
Frequency: 3 affected / 24 at risk

Adverse event: Medical device pain
Serious: no
Organ System: General disorders
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: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 24 at risk

Adverse event: Pain in extremity
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: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 24 at risk
Study: NCT03793621

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk
Study: NCT03793972

Adverse event: Ruptured Abdominal Aortic Artery
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: see main paper
Frequency: 1 affected / 6294 at risk
Study: NCT03794089

Adverse event: Symptom exacerbation
Serious: no
Organ System: Social circumstances
Notes: Clinically significant increase in anxiety and depression symptom severity from 2nd to 3rd intervention session. This was unrelated to the intervention or study, rather it was directly related to a psychosocial stressor (father unexpectedly died).
Frequency: 1 affected / 17 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: Participant was admitted to the hospital overnight for monitoring of a pre-existing medical condition that was unrelated to the treatment received in the study.
Frequency: 1 affected / 18 at risk
Study: NCT03794323

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 16 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vessel puncture site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

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

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk