TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04104646

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

Adverse event: Overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5 at risk

Adverse event: Poor feeding infant
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Hypotonia neonatal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Infantile vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Post-treatment AE
Frequency: 1 affected / 5 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Post-treatment AE
Frequency: 1 affected / 5 at risk

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

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

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

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk
Study: NCT04105842

Adverse event: Hordeolum
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 37 at risk

Adverse event: Cyst
Serious: no
Organ System: Eye disorders
Notes: Asymptomatic raised spot in left lower lid.
Frequency: 1 affected / 37 at risk

Adverse event: Foreign body trail
Serious: no
Organ System: Eye disorders
Notes: Foreign body trail on cornea (epithelium).
Frequency: 1 affected / 35 at risk
Study: NCT04106817

Adverse event: Chest discomfort/tightness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

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

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 12 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 12 at risk
Study: NCT04107675

Adverse event: moderate acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk
Study: NCT04109222

Adverse event: Parainfluenzae virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk
Study: NCT04109313

Adverse event: Superficial spreading melanoma stage unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 68 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 194 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 194 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 194 at risk

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 194 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 194 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 194 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 194 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 194 at risk

Adverse event: Chronic spontaneous urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 194 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 194 at risk
Study: NCT04110054

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 101 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 101 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 103 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 103 at risk

Adverse event: Hypogeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 100 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Hypogeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 100 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 102 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 102 at risk
Study: NCT04110145

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

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

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

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Developmental delay
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk
Study: NCT04111497

Adverse event: Myopathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: progressive generalized muscle weakness of unclear etiology, most consistent with acute myopathy
Frequency: 1 affected / 15 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: symptoms suggestive of a URI, increased oxygen needs, no infectious agent identified
Frequency: 1 affected / 15 at risk

Adverse event: Mastitis
Serious: yes
Organ System: Infections and infestations
Notes: infected breast wound of unclear etiology
Frequency: 1 affected / 15 at risk

Adverse event: muscle cramping
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 15 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 15 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 15 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk
Study: NCT04111536

Adverse event: General
Serious: no
Organ System: General disorders
Frequency: 10 affected / 28 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 28 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Frequency: 15 affected / 28 at risk
Study: NCT04112069

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 20 at risk
Study: NCT04112303

Adverse event: Patella fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 37 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 37 at risk
Study: NCT04112316

Adverse event: Total
Serious: no
Organ System: Investigations
Frequency: 15 affected / 28 at risk

Adverse event: Total
Serious: no
Organ System: Investigations
Frequency: 9 affected / 28 at risk
Study: NCT04112823

Adverse event: Cerebellar stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 104 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Verbatim Term: Markedly Elevated Blood Sugar
Frequency: 1 affected / 104 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Verbatim Term: Drowsiness
Frequency: 4 affected / 104 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 104 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 104 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Verbatim Terms: Weakness, Lack of Energy
Frequency: 3 affected / 104 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Verbatim Term: Stomach ache
Frequency: 2 affected / 104 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 104 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: Verbatim Term: Drowsiness
Frequency: 9 affected / 105 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 105 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 105 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Verbatim Terms: Weakness, Lack of Energy
Frequency: 2 affected / 105 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Verbatim Term: Stomach ache
Frequency: 1 affected / 105 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk
Study: NCT04114058

Adverse event: Fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 17 at risk
Study: NCT04114357

Adverse event: Dental Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

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

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

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

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

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

Adverse event: Anxiety
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: bilateral halux infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

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

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

Adverse event: rash at sensor insertion site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: low vitamin D
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: sweating during blood draw
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: CGM fell off
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 10 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk
Study: NCT04115059

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

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

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

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

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

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

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

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

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

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

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

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

Adverse event: Body Aches
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 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: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3 at risk

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

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

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3 at risk

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

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk
Study: NCT04115098

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal 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: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk
Study: NCT04115228

Adverse event: Incision-site issue
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Three (3) subjects experienced redness at the site (cause undetermined) and of these, 2 resolved with treatment, and 1 resolved spontaneously. One (1) had a positive bacterial culture at the site, which resolved with treatment.
Frequency: 4 affected / 10 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Not device or procedure related.
Frequency: 2 affected / 10 at risk

Adverse event: Previously-planned surgery for unrelated issue
Serious: no
Organ System: Surgical and medical procedures
Notes: One (1) subject had surgery for torn tendon and/or ligaments in right shoulder. One (1) had total replacement of right knee.
Frequency: 2 affected / 10 at risk

Adverse event: Unconfirmed report that implant "stopped working"
Serious: no
Organ System: Product Issues
Notes: Subject's impression could not be confirmed. Device check showed normal operation. Subject completed a voiding diary at 13 weeks, which showed responder status.
Frequency: 1 affected / 10 at risk
Study: NCT04115384

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Persistent coughing
Frequency: 1 affected / 3 at risk
Study: NCT04116112

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Sepsis and cardiac failure
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: Carotid artery re-occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Gastrointestinal hemorrhage associated with gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: New contralateral large vessel occlusion stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk
Study: NCT04116489

Adverse event: Tick on skin (not embedded)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Occurred during Activity 1/ Forest Walk
Frequency: 2 affected / 18 at risk

Adverse event: Mild hypoglycemic symptoms during walk
Serious: no
Organ System: Endocrine disorders
Notes: Occurred during Activity 1/ Forest Walk
Frequency: 1 affected / 18 at risk

Adverse event: Transient pain from acorn falling on shoulder
Serious: no
Organ System: General disorders
Notes: Occurred during Activity 1/ Forest Walk
Frequency: 1 affected / 18 at risk

Adverse event: Skin scratch from holding baby squirrel
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Occurred during Activity 2/ Wildlife rehabilitation care
Frequency: 1 affected / 18 at risk
Study: NCT04117178

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: Capgra syndrome
Frequency: 1 affected / 65 at risk

Adverse event: Death
Serious: yes
Organ System: Surgical and medical procedures
Notes: Fall causing hip fracture, resulting in death
Frequency: 1 affected / 65 at risk

Adverse event: Donepezil overdose
Serious: yes
Organ System: General disorders
Notes: Donepezil overdose (20 mg. daily for approx. 2 weeks) due to mistanke on part of the participant/relative.
Frequency: 1 affected / 65 at risk

Adverse event: Hospitalization due to headache
Serious: yes
Organ System: Nervous system disorders
Notes: Tension-type headache
Frequency: 1 affected / 65 at risk

Adverse event: Death due to lung cancer with metastases
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Diagnosed with lung cancer with cerebral metasteses after enrollment in study
Frequency: 1 affected / 65 at risk

Adverse event: Antebrachium facture
Serious: yes
Organ System: Surgical and medical procedures
Notes: Antebrachium facture due to fall (bike accident)
Frequency: 1 affected / 65 at risk

Adverse event: various minor non-related events
Serious: no
Organ System: General disorders
Notes: various minor non-related events not meeting the criteria for SAE.
Frequency: 42 affected / 65 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 67 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 67 at risk

Adverse event: Death
Serious: yes
Organ System: Vascular disorders
Notes: Cardiac failure, anaemia
Frequency: 1 affected / 67 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Notes: COVID-19 respiratory infection
Frequency: 1 affected / 67 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Notes: COVID-19 infection
Frequency: 1 affected / 67 at risk

Adverse event: synkope
Serious: yes
Organ System: Vascular disorders
Notes: Orthstatic Syncope
Frequency: 1 affected / 67 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Hospitalized due to stroke. Later death due to stroke complications.
Frequency: 1 affected / 67 at risk

Adverse event: various minor non-related events
Serious: no
Organ System: General disorders
Notes: various minor non-related events not meeting the criteria for SAE.
Frequency: 46 affected / 67 at risk