TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03533660

Adverse event: skin irritation/indentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Number of participants who reported skin irritation/indentation typically noted this was from wearing the device too tightly - strap was adjustable and most reported issues resolved with adjustment/removal
Frequency: 7 affected / 14 at risk

Adverse event: strap being itchy/scratchy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Number of participants who reported device strap was itchy/scratchy
Frequency: 2 affected / 14 at risk

Adverse event: Uncomfortable
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Number of participants who reported wearing the device was uncomfortable (sleeping or otherwise)
Frequency: 4 affected / 14 at risk

Adverse event: Participants uncomfortable with device appearance
Serious: no
Organ System: Product Issues
Notes: Number of participants who commented that the device was unappealing in appearance
Frequency: 1 affected / 14 at risk

Adverse event: skin irritation/indentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Number of participants who reported skin irritation/indentation typically noted this was from wearing the device too tightly - strap was adjustable and most reported issues resolved with adjustment/removal
Frequency: 7 affected / 13 at risk

Adverse event: strap being itchy/scratchy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Number of participants who reported device strap was itchy/scratchy
Frequency: 4 affected / 13 at risk

Adverse event: Uncomfortable
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Number of participants who reported wearing the device was uncomfortable (sleeping or otherwise)
Frequency: 2 affected / 13 at risk

Adverse event: Participants uncomfortable with device appearance
Serious: no
Organ System: Product Issues
Notes: Number of participants who commented that the device was unappealing in appearance
Frequency: 2 affected / 13 at risk
Study: NCT03533829

Adverse event: Presyncope
Serious: no
Organ System: Vascular disorders
Notes: Air conditioning in room not working. The patient felt better after being fanned for five minutes. Symptoms lasted between 1 and 5 minutes.
Frequency: 1 affected / 10 at risk
Study: NCT03535571

Adverse event: Mental breakdown
Serious: yes
Organ System: Psychiatric disorders
Notes: Determined to not be related to the study product
Frequency: 1 affected / 20 at risk

Adverse event: Back, muscle, leg pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Neuropathy, paresthesia, tension headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 20 at risk
Study: NCT03535649

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 105 at risk

Adverse event: Mouth ulceration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Adenoiditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 105 at risk

Adverse event: Cytomegalovirus colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 105 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 105 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Clostridium difficile colitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 105 at risk

Adverse event: Cytomegalovirus syndrome
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 105 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 105 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 105 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 105 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 105 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 105 at risk
Study: NCT03535974

Adverse event: allergic reaction while on placebo
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 29 at risk

Adverse event: allergic reaction while on placebo
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 29 at risk
Study: NCT03536923

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Common Cold
Frequency: 1 affected / 23 at risk

Adverse event: Suspected urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Culture negative irritative voiding
Frequency: 1 affected / 23 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk
Study: NCT03536949

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 157 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 157 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 157 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 157 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 157 at risk

Adverse event: Vital dye staining cornea present
Serious: no
Organ System: Investigations
Frequency: 5 affected / 157 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 157 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 77 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 77 at risk

Adverse event: Vital dye staining cornea present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 77 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 77 at risk
Study: NCT03537092

Adverse event: Bleeding abnormality
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 64 at risk

Adverse event: Pruritus genital
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 64 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 64 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 13 affected / 64 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 64 at risk
Study: NCT03537404

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

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

Adverse event: Blood lactate dehydrogenase decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

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

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 18 at risk
Study: NCT03537729

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Participant was hospitalized for unspecified reason.
Frequency: 4 affected / 55 at risk

Adverse event: Fall with injury
Serious: no
Organ System: General disorders
Notes: A fall with resulting injury, non specified.
Frequency: 2 affected / 55 at risk

Adverse event: Fall without injury
Serious: no
Organ System: General disorders
Notes: A fall was reported but no injury sustained.
Frequency: 2 affected / 55 at risk

Adverse event: Minor Illness
Serious: no
Organ System: General disorders
Notes: Minor illness was reported but not specified.
Frequency: 1 affected / 55 at risk

Adverse event: Too fatigued
Serious: no
Organ System: General disorders
Notes: Participant became too fatigued to continue in the study.
Frequency: 1 affected / 55 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Participant was hospitalized for unspecified reason.
Frequency: 7 affected / 62 at risk

Adverse event: Fall with injury
Serious: yes
Organ System: General disorders
Notes: A fall was reported with non-specific injury.
Frequency: 3 affected / 62 at risk

Adverse event: Outpatient Hospitalization
Serious: no
Organ System: General disorders
Notes: Went to emergency department or other outpatient area for unknown reason but was discharged home the same day.
Frequency: 1 affected / 62 at risk

Adverse event: Fall with injury
Serious: no
Organ System: General disorders
Notes: A fall with resulting injury, non specified.
Frequency: 3 affected / 62 at risk

Adverse event: Fall without injury
Serious: no
Organ System: General disorders
Notes: A fall was reported but no injury sustained.
Frequency: 3 affected / 62 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Participant was hospitalized for unspecified reason.
Frequency: 5 affected / 55 at risk

Adverse event: Fall with injury
Serious: yes
Organ System: General disorders
Notes: A fall was reported with non-specific injury.
Frequency: 2 affected / 55 at risk

Adverse event: Outpatient Hospitalization
Serious: no
Organ System: General disorders
Notes: Went to emergency department or other outpatient area for unknown reason but was discharged home the same day.
Frequency: 1 affected / 55 at risk

Adverse event: Fall with injury
Serious: no
Organ System: General disorders
Notes: A fall with resulting injury, non specified.
Frequency: 3 affected / 55 at risk

Adverse event: Fall without injury
Serious: no
Organ System: General disorders
Notes: A fall was reported but no injury sustained.
Frequency: 2 affected / 55 at risk

Adverse event: Minor Illness
Serious: no
Organ System: General disorders
Notes: Minor illness was reported but not specified.
Frequency: 4 affected / 55 at risk

Adverse event: Too fatigued
Serious: no
Organ System: General disorders
Notes: Participant became too fatigued to continue in the study.
Frequency: 1 affected / 55 at risk
Study: NCT03537937

Adverse event: Relative bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 808 at risk
Study: NCT03538158

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 92 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 92 at risk

Adverse event: Fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 92 at risk

Adverse event: Heart surgery
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 89 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 89 at risk

Adverse event: Fall
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 89 at risk

Adverse event: Limb injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 89 at risk

Adverse event: Back injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 89 at risk
Study: NCT03538262

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 226 at risk
Study: NCT03538431

Adverse event: Mild allergic reaction to medication prescribed not related to the study
Serious: no
Organ System: Immune system disorders
Notes: The participant reported having a mild allergic reaction to vitamins B12 and D3 that were prescribed by the primary care physician. This was determined to be unrelated to the study drug.
Frequency: 1 affected / 26 at risk

Adverse event: Concussion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: The subject reported receiving a concussion between enrolling in the study and medication driving simulation visit. The concussion healed prior to the drive. This was determined to be unrelated to the study
Frequency: 1 affected / 26 at risk

Adverse event: Chest Tightness, mild excitement, and nausea
Serious: no
Organ System: Cardiac disorders
Notes: Participant reported suffering from chest tightness, mild excitement, and nausea while taking the new medication. Chest tightness was possibly related, and excitement and nausea were related to the drug. All resolved 24 hours after onset.
Frequency: 1 affected / 26 at risk

Adverse event: Mild nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Participant endorsed nausea as a side effect of buspirone medication. This side effect was mild, expected, and related to the study drug. It resolved 24 hours after onset.
Frequency: 1 affected / 26 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: The subject reported having a head cold during the medication driving simulation visit and was not able to sleep. This event was considered mild and unrelated to the study drug,
Frequency: 1 affected / 26 at risk
Study: NCT03538444

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk
Study: NCT03538756

Adverse event: Hospitalizations
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalizations were for atrial flutter and atrial fibrillation; they were unrelated to device use.
Frequency: 2 affected / 69 at risk

Adverse event: Hospitalizations
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hospitalizations were for pneumonia/respiratory problems; they were unrelated to device use.
Frequency: 2 affected / 69 at risk

Adverse event: Hospitalizations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Hospitalizations were for hip fractures; they were unrelated to device use.
Frequency: 2 affected / 69 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Hospitalization was for critical anemia; it was unrelated to device use.
Frequency: 1 affected / 69 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization was for severe hypotension; it was unrelated to device use.
Frequency: 1 affected / 69 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Hospitalization was for low magnesium; it was unrelated to device use.
Frequency: 1 affected / 69 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: Hospitalization was for mental health; it was unrelated to device use.
Frequency: 1 affected / 69 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Hospitalization was for a surgical procedure; it was unrelated to device use.
Frequency: 1 affected / 69 at risk

Adverse event: Falls with Minor Injuries
Serious: no
Organ System: General disorders
Notes: This study collected information on falls, per the World Health Organization (WHO) definition. Minor injuries included scrapes and bruises. Many participants suffered from comorbidities and used medications that may have impacted their balance.
Frequency: 24 affected / 69 at risk

Adverse event: Hip Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 69 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 69 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin irritation includes blisters, cracked skin, rashes, etc. on participants' feet or lower legs.
Frequency: 9 affected / 69 at risk
Study: NCT03538795

Adverse event: Elevated blood pressure
Serious: no
Organ System: Vascular disorders
Notes: Not related to participation.
Frequency: 1 affected / 3 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Notes: Related to study but anticipated. Problems with pain are a feature of stroke.
Frequency: 1 affected / 3 at risk

Adverse event: Depressive symptoms
Serious: no
Organ System: Psychiatric disorders
Notes: Not related to study. Depressive symptoms are a feature of stroke. Did not meet criteria for major depressive disorder. Denied suicidal ideation.
Frequency: 1 affected / 3 at risk

Adverse event: Lethargy
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Not related to study. Side effect of medication prescribed by participant's personal physician.
Frequency: 1 affected / 3 at risk
Study: NCT03538808

Adverse event: Nasal Polyp Removal
Serious: no
Organ System: Surgical and medical procedures
Notes: Participant reported undergoing a surgery to remove a nasal polyp. This is not considered to be related to the study medication (varenicline).
Frequency: 1 affected / 20 at risk

Adverse event: Nocebo Effect/Sexual Dysfunction
Serious: no
Organ System: Renal and urinary disorders
Notes: Pt reported experiencing sexual dysfunction when taking the medication. Once medication was stopped, the symptoms ceased. It should be noted that this pt was assigned to a placebo condition (i.e., no varenicline medication was provided).
Frequency: 1 affected / 20 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Notes: Pt depressed mood (denied any suicidal or homicidal ideations). Instructed to immediately stop medication and seek emergency services. Pt indicated that his symptoms ceased once he stopped the medication and was not in need of further treatment.
Frequency: 1 affected / 20 at risk

Adverse event: Nocebo Effect/Depressed Mood
Serious: no
Organ System: Psychiatric disorders
Notes: Pt reported depressed mood and immediately stopped medication. Symptoms improved once she stopped the medication. It should be noted that this pt was assigned to the placebo condition (i.e., no varenicline was provided).
Frequency: 1 affected / 20 at risk
Study: NCT03538951

Adverse event: Skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 41 at risk

Adverse event: Skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 42 at risk
Study: NCT03539432

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

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk
Study: NCT03539458

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

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Prosthetic cardiac valve regurgitation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Arrhythmia or conduction disturbance
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Worsening Congestive Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Mesenteric Ischemia and Hemorrhagic Shock
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Stroke/TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Respiratory insufficiency/Failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Arrhythmia or Conduction Disturbance
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 11 at risk

Adverse event: Heart Failure treated with IV diuretics
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Laryngeal dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 11 at risk