TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04536012

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 52 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 52 at risk

Adverse event: Orthopedic
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 52 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 52 at risk

Adverse event: Fitbit-related
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 52 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 8 affected / 52 at risk

Adverse event: Orthopedic
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 51 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Orthopedic
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 51 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 51 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 13 affected / 51 at risk
Study: NCT04537078

Adverse event: nausea and abdominal distention
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 41 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 41 at risk

Adverse event: nausea and abdominal distention
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 42 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 42 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 42 at risk
Study: NCT04537234

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 8 affected / 82 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 8 affected / 82 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 37 affected / 82 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 8 affected / 82 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 9 affected / 82 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 82 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 9 affected / 82 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 83 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 83 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 30 affected / 83 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 83 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 7 affected / 83 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 83 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache events that occurred after 7 days post-vaccination were considered as unsolicited AE.
Frequency: 5 affected / 83 at risk
Study: NCT04537910

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

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

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

Adverse event: Faeces discoloured
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk
Study: NCT04538040

Adverse event: New Onset Diabetes Mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

Adverse event: Renal Cell Carcinoma Removal
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 20 at risk

Adverse event: Episode of Hypoglycemia
Serious: no
Organ System: Metabolism and nutrition 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: Viral Load of 330
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Loose Stool
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Arthritis in Right Hand
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

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

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

Adverse event: Ligament sprain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk
Study: NCT04538950

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

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

Adverse event: Moderate chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Mild atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 6 at risk

Adverse event: Mild Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk
Study: NCT04539249

Adverse event: Mild (asymptomatic) diastolic hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 4 at risk

Adverse event: Severe (symptomatic) hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Mild (asymptomatic) diastolic hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 46 at risk

Adverse event: Mild (asymptomatic) systolic hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 50 at risk

Adverse event: Mild (asymptomatic) diastolic hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 50 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 50 at risk
Study: NCT04539821

Adverse event: Discontinuation of Buprenorphine
Serious: no
Organ System: Gastrointestinal disorders
Notes: expected side effects of Buprenorphine
Frequency: 2 affected / 44 at risk
Study: NCT04539886

Adverse event: Swelling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild swelling at site of lesion treatment that resolved within 7 days
Frequency: 3 affected / 59 at risk
Study: NCT04540367

Adverse event: Other
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: The subject had an arm muscle strain from having an untrained arm. They were treated with ibuprofen, cleared by the PI and were able to complete the study.
Frequency: 1 affected / 16 at risk
Study: NCT04540627

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 25 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 25 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Notes: Considered by the investigator to be probably related to challenge virus inoculation.
Frequency: 1 affected / 25 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 25 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 25 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 25 at risk
Study: NCT04540874

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

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

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

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk
Study: NCT04541004

Adverse event: Pharyngeal paraesthesia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 253 at risk

Adverse event: Pharyngeal swelling
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 253 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 132 affected / 253 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 253 at risk

Adverse event: Ear pruritus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 101 affected / 253 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 253 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 253 at risk

Adverse event: Enlarged uvula
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 253 at risk

Adverse event: Glossodynia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 253 at risk

Adverse event: Lip oedema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 253 at risk

Adverse event: Lip swelling
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 253 at risk

Adverse event: Mouth swelling
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 253 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 253 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 253 at risk

Adverse event: Oedema mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 253 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 253 at risk

Adverse event: Oral pruritus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 169 affected / 253 at risk

Adverse event: Swollen tongue
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 253 at risk

Adverse event: Tongue eruption
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 253 at risk

Adverse event: Tongue ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 253 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 253 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 253 at risk
Study: NCT04541173

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

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

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

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

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

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

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

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

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

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

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

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 3 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk
Study: NCT04541667

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 98 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 98 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 102 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 102 at risk
Study: NCT04542226

Adverse event: Klebsiella sepsis
Serious: yes
Organ System: Infections and infestations
Notes: This SAE was classified by the Investigator as not related to Polyoxidonium treatment. The patient had a history of previous bacterial pneumonias over the past 3 years.
Frequency: 1 affected / 81 at risk

Adverse event: PQ interval prolonged / Electrocardiogram PR prolongation*
Serious: no
Organ System: Investigations
Notes: Patients received a combination of lopinavir+ritonavir, and this AEs was supposed by the Investigator to be caused by the antiviral drugs. After completion of antiviral treatment all symptoms eliminated and didn't require any additional actions.
Frequency: 2 affected / 81 at risk

Adverse event: Fever (Intermittent fever included) / Pyrexia
Serious: no
Organ System: General disorders
Notes: Fever was apparently a result of SARS-CoV-2 infection and intoxication.It was classified by Investigators as not associated with Polyoxidonium treatment; some of them noted more rapid fever and intoxication decline in Polyoxidonium treated patients.
Frequency: 3 affected / 81 at risk

Adverse event: Pneumonia bacterial
Serious: no
Organ System: Infections and infestations
Notes: Bacterial pneumonia was diagnosed. The Investigator did not associate the development of pneumonia with PO administration. Bacterial pneumonia is common COVID-19 complication in elderly patients.The investigator consider this event as AE.
Frequency: 1 affected / 81 at risk
Study: NCT04542278

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 14 at risk

Adverse event: mood changes
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 14 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 14 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk

Adverse event: Nerve injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 16 at risk
Study: NCT04542525

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 32 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk
Study: NCT04542694

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: According to investigators, the causal relationship with the study drug was estimated as "unrelated", SAE was associated with the presence of concomitant diseases, i.e. type 2 diabetes mellitus, obesity, and hyperthyroidism.
Frequency: 1 affected / 100 at risk

Adverse event: Multiple organ failure syndrome
Serious: yes
Organ System: General disorders
Notes: According to investigators, the causal relationship with the study drug was estimated as "unrelated", SAE was associated with the presence of concomitant diseases, i.e. type 2 diabetes mellitus, obesity, and hyperthyroidism.
Frequency: 1 affected / 100 at risk

Adverse event: Aortic valve stenosis
Serious: yes
Organ System: Cardiac disorders
Notes: According to investigators, the causal relationship with the study drug was estimated as "doubtful", SAE was associated with the presence of concomitant diseases, i.e. type 2 diabetes mellitus, obesity, and hyperthyroidism.
Frequency: 1 affected / 100 at risk

Adverse event: Increased alanine aminotransferase activity
Serious: no
Organ System: Hepatobiliary disorders
Notes: According to investigators, the causal relationship with the study drug was estimated as "unrelated" in 22.2%
Frequency: 18 affected / 100 at risk

Adverse event: Increased aspartate aminotransferase activity
Serious: no
Organ System: Hepatobiliary disorders
Notes: According to investigators, the causal relationship with the study drug / standard therapy was estimated as "unrelated" in 69.2% /61.5%
Frequency: 13 affected / 100 at risk

Adverse event: Increased alanine aminotransferase activity
Serious: no
Organ System: Hepatobiliary disorders
Notes: According to investigators, the causal relationship with the study drug was estimated as "unrelated" in 22.2%
Frequency: 19 affected / 100 at risk

Adverse event: Increased aspartate aminotransferase activity
Serious: no
Organ System: Hepatobiliary disorders
Notes: According to investigators, the causal relationship with the study drug / standard therapy was estimated as "unrelated" in 69.2% /61.5%
Frequency: 13 affected / 100 at risk
Study: NCT04543136

Adverse event: Unlikely related
Serious: no
Organ System: Renal and urinary disorders
Notes: Symptoms of urinary tract infection (UTI)
Frequency: 1 affected / 16 at risk

Adverse event: Possibly related
Serious: no
Organ System: Renal and urinary disorders
Notes: Symptoms of urinary tract infection (UTI)
Frequency: 1 affected / 16 at risk

Adverse event: Possibly related
Serious: no
Organ System: Renal and urinary disorders
Notes: Urinary tract infection (UTI)
Frequency: 1 affected / 16 at risk
Study: NCT04544358

Adverse event: Headaches
Serious: no
Organ System: General disorders
Notes: Two participants reported headaches after receiving MRIs.
Frequency: 2 affected / 10 at risk
Study: NCT04544566

Adverse event: Non serious adverse event
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Erosion of peristomal skin
Frequency: 1 affected / 12 at risk

Adverse event: Non serious adverse event
Serious: no
Organ System: Infections and infestations
Notes: Parodontitis Spicalis
Frequency: 1 affected / 12 at risk

Adverse event: Non serious adverse event
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Erosion of peristomal skin
Frequency: 1 affected / 12 at risk
Study: NCT04545385

Adverse event: Vaginal prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 31 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 33 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 33 at risk