TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03672916

Adverse event: Study-hip affected: Revisions of implant system
Serious: yes
Organ System: Surgical and medical procedures
Notes: One or more components revised. Reasons for revision: dislocation (N=4), femur fracture (N=1), deep infection (N=1)
Frequency: 6 affected / 185 at risk

Adverse event: Study-hip affected: Luxation/Dislocation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 185 at risk

Adverse event: Study-hip affected: Periprosthetic femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 185 at risk

Adverse event: Musculoskeletal (non-study hip)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes contralateral THA, TKAs, etc
Frequency: 22 affected / 185 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 185 at risk

Adverse event: Oncological
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 185 at risk

Adverse event: Infection (non-study hip)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 185 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 185 at risk

Adverse event: Pulmonary/Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Reported deaths with unknown causes
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 185 at risk

Adverse event: Study-hip affected adverse events
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Squeaking hip (N=4), pain due to a fall (N=1), periprosthetic femur fracture (N=1)
Frequency: 6 affected / 185 at risk

Adverse event: Musculoskeletal (non-study hip)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Includes osteoarthritis other joints, fractures, pain, etc
Frequency: 28 affected / 185 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 185 at risk

Adverse event: Oncological
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 185 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 185 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 185 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 185 at risk

Adverse event: Others
Serious: no
Organ System: General disorders
Notes: Psychiatric disorder (N=2), Respiratory (N=1), Gastrointestinal (N=1), Dermatological (N=1),
Frequency: 5 affected / 185 at risk
Study: NCT03673046

Adverse event: Increased anxiety or depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 40 at risk

Adverse event: Suicidal ideation worsening
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 40 at risk

Adverse event: Allergies, allergic reactions
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Injuries and accidents
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Shoulder/neck injuries, car accident, broken finger
Frequency: 3 affected / 40 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Endometriosis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 40 at risk

Adverse event: Medical procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 40 at risk

Adverse event: Increased anxiety or depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 40 at risk

Adverse event: Suicidal ideation worsening
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 40 at risk

Adverse event: Allergies, allergic reactions
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Injuries and accidents
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Shoulder/neck injuries, car accident, broken finger
Frequency: 1 affected / 40 at risk

Adverse event: Procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 40 at risk

Adverse event: Medical procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 40 at risk

Adverse event: Other
Serious: no
Organ System: Psychiatric disorders
Notes: panic attack, jaw pain, BDD symptom worsening
Frequency: 3 affected / 40 at risk
Study: NCT03673098

Adverse event: Admission to Emergency Department, Unrelated to Study
Serious: yes
Organ System: Psychiatric disorders
Notes: An enrolled participant who had not attended group sessions was admitted to the Emergency Department for depression. The participant was connected to mental health care. The IRB determined that this SAE was unrelated to the study and not reportable.
Frequency: 1 affected / 23 at risk
Study: NCT03673176

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Possibly related to treatment
Frequency: 1 affected / 9 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Possibly related to treatment
Frequency: 1 affected / 9 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Possibly related to treatment
Frequency: 1 affected / 9 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to treatment
Frequency: 1 affected / 9 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated to treatment
Frequency: 1 affected / 9 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated to treatment
Frequency: 1 affected / 9 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to treatment
Frequency: 1 affected / 9 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to treatment
Frequency: 2 affected / 9 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Related to treatment
Frequency: 1 affected / 9 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated to treatment
Frequency: 2 affected / 9 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: Unrelated to treatment
Frequency: 1 affected / 9 at risk
Study: NCT03673943

Adverse event: nausea (grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Notes: All adverse events were either mild or moderate in severity. There were no adverse events that were severe, life-threatening or disabling, or that resulted in death. Adverse events that were mild in severity included nausea, vomiting, headache
Frequency: 1 affected / 63 at risk

Adverse event: headache (grade 1)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: syncope (grade 2)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: melanoderma (grade 1)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: flushing (grade 1)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: vomiting (both grade 1)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 63 at risk
Study: NCT03673956

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

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

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

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

Adverse event: Face Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk
Study: NCT03674541

Adverse event: Post-Exertional Malaise (PEM)
Serious: no
Organ System: Immune system disorders
Notes: Hallmark of ME/CFS. Manifestation of flu-like symptoms following physical or emotional exertion.
Frequency: 13 affected / 23 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Residual pain from catheterization of radial artery
Frequency: 2 affected / 23 at risk

Adverse event: Post-Exertional Malaise (PEM)
Serious: no
Organ System: Immune system disorders
Notes: Hallmark of ME/CFS. Manifestation of flu-like symptoms following physical or emotional exertion.
Frequency: 11 affected / 22 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Residual pain from catheterization of radial artery
Frequency: 4 affected / 22 at risk
Study: NCT03674970

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 15 at risk

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

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

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

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk

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

Adverse event: Hiccups
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 15 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 15 at risk

Adverse event: Other
Serious: no
Organ System: Investigations
Frequency: 3 affected / 15 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 15 at risk

Adverse event: Other
Serious: no
Organ System: Investigations
Frequency: 3 affected / 15 at risk
Study: NCT03675321

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild skin irritation from adhesive
Frequency: 5 affected / 50 at risk

Adverse event: Local discomfort
Serious: no
Organ System: General disorders
Notes: Local discomfort at site of electrode placement
Frequency: 4 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Mild headache, possible related to intervention. Resolved.
Frequency: 1 affected / 50 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: mild, possibly related to intervention
Frequency: 1 affected / 50 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Mild skin irritation from adhesive
Frequency: 11 affected / 46 at risk

Adverse event: Local discomfort
Serious: no
Organ System: General disorders
Notes: Local discomfort at site of electrode placement
Frequency: 4 affected / 46 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Moderate; possibly related to intervention
Frequency: 1 affected / 46 at risk
Study: NCT03675360

Adverse event: Emergency room visit
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Emergency Room Visit
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 75 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 75 at risk

Adverse event: Surgery and hospitalization
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 75 at risk

Adverse event: Surgery
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 75 at risk

Adverse event: Emergency room visit
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Emergency Room Visit
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 75 at risk

Adverse event: Surgery
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Surgery
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk
Study: NCT03675581

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 17 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 17 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 17 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 17 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 17 at risk

Adverse event: Drug-induced liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 17 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 17 at risk
Study: NCT03675685

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 12 affected / 12 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 12 at risk

Adverse event: Injection site oedema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 12 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

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

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Injection site nodule
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Nervous system 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: Drug withdrawal headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

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

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

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 12 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk
Study: NCT03675776

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 15 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 15 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Glucose urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 15 at risk

Adverse event: Drug withdrawal syndrome
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

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

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 17 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 18 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

Adverse event: Feeling abnormal
Serious: no
Organ System: General disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

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

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk
Study: NCT03676465

Adverse event: Hypoglycaemic seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Participant received insulin for dinner but did not eat much. She then went to a store with her sister who reports that the CGM was alarming and participant said her glucose was in the 60s. While waiting to buy a drink, she collapsed with a seizure.
Frequency: 1 affected / 22 at risk
Study: NCT03676634

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: general disorders and administration site conditions
Frequency: 4 affected / 32 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Notes: general disorders and administration site disorders
Frequency: 3 affected / 32 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: general disorders and administration site conditions
Frequency: 1 affected / 32 at risk
Study: NCT03676751

Adverse event: Fever (self-report)
Serious: no
Organ System: General disorders
Notes: 14 days following azithromycin or placebo treatment among children aged 0-59 months
Frequency: 37 affected / 221 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: 14 days following azithromycin or placebo treatment among children
Frequency: 16 affected / 221 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 221 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 221 at risk

Adverse event: Fever (self-report)
Serious: no
Organ System: General disorders
Notes: 14 days following azithromycin or placebo treatment among children aged 0-59 months
Frequency: 42 affected / 209 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Notes: 14 days following azithromycin or placebo treatment
Frequency: 2 affected / 209 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: 14 days following azithromycin or placebo treatment among children
Frequency: 4 affected / 209 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 209 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 209 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 14 days following azithromycin or placebo treatment
Frequency: 1 affected / 209 at risk