TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02459587

Adverse event: Death by suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 157 at risk

Adverse event: Death by overdose
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 157 at risk

Adverse event: Psychiatric Hospitalization: Suicidal Ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 42 affected / 155 at risk

Adverse event: Medical Hospitalization
Serious: no
Organ System: Surgical and medical procedures
Notes: Includes hospitalizations for medical related events only (e.g. surgery, accidents, injuries, illnesses)
Frequency: 8 affected / 157 at risk

Adverse event: Residential Treatment
Serious: no
Organ System: Psychiatric disorders
Notes: Treatment for psychiatric or substance use disorders
Frequency: 44 affected / 157 at risk

Adverse event: Suicide attempt
Serious: no
Organ System: Psychiatric disorders
Frequency: 19 affected / 157 at risk

Adverse event: Psychiatric Hospitalization: Acute Substance Use
Serious: no
Organ System: Psychiatric disorders
Notes: Includes hospitalizations for detoxification, intoxication, overdose, or increased substance use.
Frequency: 9 affected / 157 at risk

Adverse event: Psychiatric Hospitalization: General
Serious: no
Organ System: Psychiatric disorders
Notes: Includes hospitalizations for general mental health reasons, excluding suicidal ideation or substance use
Frequency: 6 affected / 157 at risk

Adverse event: Death by heart attack
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 150 at risk

Adverse event: Death by suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 150 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Psychiatric disorders
Notes: Participant inpatient hospitalization for to a suicide or substance related reason immediately following a study interaction
Frequency: 4 affected / 150 at risk

Adverse event: Psychiatric Hospitalization: Suicidal Ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 40 affected / 150 at risk

Adverse event: Medical Hospitalization
Serious: no
Organ System: Surgical and medical procedures
Notes: Includes hospitalizations for medical related events only (e.g. surgery, accidents, injuries, illnesses)
Frequency: 18 affected / 150 at risk

Adverse event: Residential Treatment
Serious: no
Organ System: Psychiatric disorders
Notes: Treatment for psychiatric or substance use disorders
Frequency: 33 affected / 150 at risk

Adverse event: Suicide attempt
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 150 at risk

Adverse event: Psychiatric Hospitalization: Acute Substance Use
Serious: no
Organ System: Psychiatric disorders
Notes: Includes hospitalizations for detoxification, intoxication, overdose, or increased substance use.
Frequency: 6 affected / 150 at risk

Adverse event: Psychiatric Hospitalization: General
Serious: no
Organ System: Psychiatric disorders
Notes: Includes hospitalizations for general mental health reasons, excluding suicidal ideation or substance use
Frequency: 12 affected / 150 at risk
Study: NCT02459665

Adverse event: Pruritus genital
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 17 at risk

Adverse event: Pain during sex
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 17 at risk

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

Adverse event: Typhoid fever
Serious: yes
Organ System: Infections and infestations
Notes: A participant was hospitalized with typhoid fever during the study; this occurred after the intervention period.
Frequency: 1 affected / 17 at risk

Adverse event: Pruritus genital
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 17 at risk

Adverse event: Pain during sex
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 17 at risk

Adverse event: Malaria during pregnancy
Serious: yes
Organ System: Infections and infestations
Notes: A participant was hospitalized with malaria (while pregnant) during the study; this occurred after the intervention period.
Frequency: 1 affected / 17 at risk

Adverse event: Genital burning sensation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 17 at risk

Adverse event: Pruritus genital
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 17 at risk

Adverse event: Burning when passing urine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 17 at risk

Adverse event: Genital burning sensation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 17 at risk

Adverse event: Pruritus genital
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 17 at risk

Adverse event: Pain during sex
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 17 at risk

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

Adverse event: Sores in the genital and/or anal area
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 17 at risk
Study: NCT02459769

Adverse event: Serious Adverse Event
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 32 at risk
Study: NCT02459795

Adverse event: Metastatic malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 187 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 19 affected / 187 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 20 affected / 187 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 187 at risk

Adverse event: Acute Congestive Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 189 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 189 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 21 affected / 189 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 23 affected / 189 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 189 at risk

Adverse event: Group B Streptococcus Wound Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 93 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 93 at risk
Study: NCT02459899

Adverse event: Deafness neurosensory
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 36 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 36 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 36 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 36 at risk

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 35 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 35 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 35 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 35 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 35 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 35 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 35 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 35 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 35 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk
Study: NCT02459964

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk
Study: NCT02460172

Adverse event: Superficial Skin Peeling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Superficial skin peeling upon device removal
Frequency: 1 affected / 25 at risk
Study: NCT02460263

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 30 at risk

Adverse event: Unrelated to Tablo System
Serious: no
Organ System: Investigations
Notes: Adverse events deemed unrelated to Tablo Hemodialysis System
Frequency: 13 affected / 30 at risk

Adverse event: Blood Loss from Dialyzer & Lines
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 30 at risk

Adverse event: Vascular access site complication
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 30 at risk

Adverse event: Unrelated to Tablo System
Serious: no
Organ System: Investigations
Notes: Adverse events deemed unrelated to Tablo Hemodialysis System
Frequency: 6 affected / 30 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 28 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 28 at risk

Adverse event: Unrelated to Tablo System
Serious: no
Organ System: Investigations
Notes: Adverse events deemed unrelated to Tablo Hemodialysis System
Frequency: 9 affected / 28 at risk

Adverse event: Blood Loss from Dialyzer & Lines
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 28 at risk
Study: NCT02460289

Adverse event: Pain (crown of head)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Joint injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 61 at risk

Adverse event: Middle ear effusion
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 61 at risk
Study: NCT02460497

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Influenza
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk
Study: NCT02460575

Adverse event: Acute lymphocytic leukaemia
Serious: no
Organ System: General disorders
Notes: All non serious AEs
Frequency: 28 affected / 40 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 17 affected / 40 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 40 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 40 at risk

Adverse event: Acute lymphocytic leukaemia
Serious: no
Organ System: General disorders
Notes: All non serious AEs
Frequency: 16 affected / 20 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 20 at risk

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

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 20 at risk
Study: NCT02460666

Adverse event: Asthenia/Lassitude/Increased Fatigability
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 89 at risk

Adverse event: Failing memory
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 89 at risk

Adverse event: Tension/Inner Unrest
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 89 at risk
Study: NCT02460783

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

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

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 20 at risk

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

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

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk
Study: NCT02460991

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 2 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Desquamation of bottom of feet
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

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

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

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 2 at risk

Adverse event: Lung Metastasis
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 2 at risk
Study: NCT02461134

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

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

Adverse event: Haematemesis, Parainfluenza
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk

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

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1 at risk
Study: NCT02461550

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

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
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: Resp, thoracic & mediastinal disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk
Study: NCT02461563

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

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

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

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

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

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 3 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 3 at risk

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

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

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

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

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

Adverse event: Tension headache
Serious: no
Organ System: Nervous system 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: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3 at risk

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

Adverse event: White blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

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

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

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