TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04042103

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 21 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 21 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 21 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 21 at risk
Study: NCT04042233

Adverse event: Fall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: 17 days post-op patient fell off some steps outside their home. Fall was mechanical in nature. Patient unable to weight bear afterwards. XR showed Vancouver B2 fracture. Patient underwent revision THA. After careful review, deemed unrelated AE.
Frequency: 1 affected / 10 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient went to ED for rectal bleeding.
Frequency: 1 affected / 10 at risk

Adverse event: serosanguinous drainag
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient had small part of distal incision with serosanguinous drainage 8 days post-op. By day 16 day post-op) the incision had stopped draining w/ no overlying erythema etc at any point.
Frequency: 1 affected / 10 at risk
Study: NCT04042311

Adverse event: Thrombosed popliteal aneurysm
Serious: yes
Organ System: Vascular disorders
Notes: The SAE was a thrombosed popliteal aneurysm that occurred in the period between two exercise sessions. The patient was admitted for surgery and underwent a lower limb bypass procedure. Symptoms occurred 2 days after exercise so unlikely related.
Frequency: 1 affected / 70 at risk

Adverse event: Post-exercise dizzines
Serious: no
Organ System: General disorders
Notes: There were 7 occurrences of dizziness that occurred after exercise sessions or CPET
Frequency: 6 affected / 70 at risk

Adverse event: Dull chest ache
Serious: no
Organ System: Cardiac disorders
Notes: an isolated episode of a 'dull chest ache' that occurred in the period between two exercise sessions. Following referral to cardiology a diagnosis of probable angina was made but not confirmed as a diagnostic angiogram was refused.
Frequency: 1 affected / 70 at risk

Adverse event: Back spasm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: The occurrence of a back spasm after an exercise session.
Frequency: 1 affected / 70 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: One occurrence of a headache after exercise
Frequency: 1 affected / 70 at risk

Adverse event: Hypertensive CPET response
Serious: no
Organ System: Cardiac disorders
Notes: One occurrence of a hypertensive CPET response
Frequency: 1 affected / 70 at risk
Study: NCT04042623

Adverse event: Decreased blood pressure
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1 at risk

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

Adverse event: Feeling heavy (heaviness) in the back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1 at risk
Study: NCT04044352

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 76 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 76 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 76 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 76 at risk

Adverse event: Blood pressure diastolic decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 76 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 76 at risk

Adverse event: Blood pressure systolic increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 76 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 76 at risk

Adverse event: Respiratory rate increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 76 at risk
Study: NCT04044664

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 141 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 141 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 52 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 52 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 46 at risk
Study: NCT04044716

Adverse event: Irritation at auricular acupressure site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk
Study: NCT04045132

Adverse event: Hospitalization-Breach of Confidentiality
Serious: yes
Organ System: Psychiatric disorders
Notes: A breach of confidentiality occurred when a participant disclosed that they were hospitalized during the study (unrelated to study activities). Study personnel broke confidentiality and contacted social workers at the participant's child's clinic.
Frequency: 2 affected / 37 at risk

Adverse event: Protocol Deviation- Incorrect Version of Informed Consent
Serious: no
Organ System: Psychiatric disorders
Notes: A minor protocol deviation occurred and an older version of the informed consent was used. This version didn't include the section on arranged transportation. Participants were verbally informed during their visit about the transportation options.
Frequency: 1 affected / 37 at risk

Adverse event: Protocol Deviation- Unstamped Version of Informed Consent
Serious: no
Organ System: Psychiatric disorders
Notes: A minor protocol deviation occurred and a version of the informed consent was used that was not stamped by the IRB. The content of the unstamped ICF was identical to the IRB stamped version, the physical forms were just missing the IRB approval stamp
Frequency: 6 affected / 37 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: A participant disclosed that they were hospitalized during the study (unrelated to study activities). Participants consented to contact between the study team and the participant's child's doctor. The study team followed up and provided resources.
Frequency: 2 affected / 37 at risk

Adverse event: Protocol Deviation- Incorrect Version of Informed Consent
Serious: no
Organ System: Psychiatric disorders
Notes: A minor protocol deviation occurred and an older version of the informed consent was used. This version didn't include the section on arranged transportation. Participants were verbally informed during their visit about the transportation options.
Frequency: 2 affected / 38 at risk

Adverse event: Protocol Deviation- Unstamped Version of Informed Consent
Serious: no
Organ System: Psychiatric disorders
Notes: A minor protocol deviation occurred and a version of the informed consent was used that was not stamped by the IRB. The content of the unstamped ICF was identical to the IRB stamped version, the physical forms were just missing the IRB approval stamp
Frequency: 6 affected / 38 at risk
Study: NCT04045145

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 8 at risk

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

Adverse event: Blepharospasm
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 8 at risk

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

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

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

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

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

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

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk
Study: NCT04046094

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk
Study: NCT04046250

Adverse event: GI Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 11 at risk

Adverse event: GI Disorders
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 11 at risk
Study: NCT04046263

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Notes: 2 participants died, likely due to COVID-19. Was determined not to be study related
Frequency: 2 affected / 17 at risk

Adverse event: GI symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: includes common GI symptoms such as nausea \& vomiting.
Frequency: 9 affected / 17 at risk
Study: NCT04046328

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pulpitis dental
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 13 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pulpitis dental
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 13 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 13 at risk
Study: NCT04046471

Adverse event: Lupus Flare
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 63 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Respiratory fume inhalation disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 63 at risk

Adverse event: Heart Failure Complications
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Bladder obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 63 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 66 at risk
Study: NCT04046848

Adverse event: Anti factor VIII antibody positive
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 4 at risk

Adverse event: Haemoperitoneum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Spontaneous haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Retroperitoneal hematoma
Frequency: 1 affected / 4 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Roseolovirus test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

Adverse event: Anti factor VIII antibody positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 8 at risk

Adverse event: Anti factor VIII antibody positive
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 16 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 16 at risk

Adverse event: Renal colic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 16 at risk
Study: NCT04046952

Adverse event: Any hematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 220 at risk

Adverse event: Bleeding requiring intervention
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: any intervention beyond TR band reinflation
Frequency: 2 affected / 220 at risk

Adverse event: Radial artery occlusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 220 at risk

Adverse event: Any hematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 223 at risk

Adverse event: Radial artery occlusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 223 at risk
Study: NCT04047420

Adverse event: Immunisation reaction
Serious: no
Organ System: General disorders
Notes: reactogenicity symptoms
Frequency: 1 affected / 23 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: right shoulder pain
Frequency: 1 affected / 23 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Notes: extrapyramidal symptoms
Frequency: 1 affected / 23 at risk

Adverse event: Immunisation reaction
Serious: no
Organ System: General disorders
Notes: reactogenicity symptoms
Frequency: 2 affected / 21 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Anal erythema
Serious: no
Organ System: Gastrointestinal disorders
Notes: rectal erythema
Frequency: 1 affected / 21 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Diarrhea
Frequency: 1 affected / 21 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Immunisation reaction
Serious: no
Organ System: General disorders
Notes: reactogenicity symptoms
Frequency: 1 affected / 19 at risk

Adverse event: Anal fissure
Serious: no
Organ System: Gastrointestinal disorders
Notes: Perianal tear
Frequency: 1 affected / 19 at risk

Adverse event: Vulvovaginal discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Minor vaginal discomfort
Frequency: 1 affected / 19 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 19 at risk
Study: NCT04047446

Adverse event: Postoperative neurologic symptoms at 7 days after surgery
Serious: no
Organ System: Nervous system disorders
Notes: Includes the presence of one or multiple: numbness, tingling, weakness, stiffness, or coldness of hand and/or finger tips, wrist, elbow, arm. Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
Frequency: 6 affected / 43 at risk

Adverse event: Postoperative neurologic symptoms at 7 days after surgery
Serious: no
Organ System: Nervous system disorders
Notes: Includes the presence of one or multiple: numbness, tingling, weakness, stiffness, or coldness of hand and/or finger tips, wrist, elbow, arm. Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated
Frequency: 3 affected / 42 at risk
Study: NCT04047602

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 18 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 18 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk
Study: NCT04047797

Adverse event: Respiratory, thoracic, and mediastinal disorders- other, specify (COVID-19 pneumonia)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

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

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

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

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

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

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3 at risk

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

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

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

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

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk
Study: NCT04047979

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Vertigo
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Ureteroscopy with lithotripsy
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 30 at risk

Adverse event: Hypertension emergency
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Reconstructive surgery 3rd, 4th, 5th phalange
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 30 at risk

Adverse event: Cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: West Nile Virus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk
Study: NCT04048122

Adverse event: Falls
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: falls
Frequency: 8 affected / 28 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Renal and urinary disorders
Notes: Experienced recurrent falls and had OH, so went to the ER; admitted to the hospital for 6 days; determined there was an acute kidney injury/infection that was causing the falls and OH
Frequency: 1 affected / 29 at risk

Adverse event: Falls
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: falls
Frequency: 15 affected / 29 at risk