TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03589976

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 35 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 35 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Notes: Urinary tract infection, upper respiratory infection, skin infection, sinus infection
Frequency: 21 affected / 35 at risk

Adverse event: Aphthae, gingivitis, and oral herpes-like vesicles
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 35 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 35 at risk

Adverse event: Edema in Lower Limbs
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 35 at risk

Adverse event: Acne, Petechiae, Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 35 at risk

Adverse event: Fall
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 35 at risk

Adverse event: Worsening of Movement Disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 35 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 25 affected / 35 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Notes: Urinary tract infection, upper respiratory infection, skin infection, sinus infection
Frequency: 4 affected / 12 at risk

Adverse event: Aphthae, gingivitis, and oral herpes-like vesicles
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 12 at risk

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

Adverse event: Edema in Lower Limbs
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk

Adverse event: Acne, Petechiae, Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 12 at risk

Adverse event: Fall
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 12 at risk

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

Adverse event: Worsening of Movement Disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 12 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 4 affected / 12 at risk
Study: NCT03590613

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk
Study: NCT03590743

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 2 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk
Study: NCT03590847

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Participants reported headaches during fasting periods.
Frequency: 2 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 10 at risk
Study: NCT03591068

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 11 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

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

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

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

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

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

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk
Study: NCT03591107

Adverse event: Severe or significant emotional or psychological distress
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 19 at risk

Adverse event: Release of PII
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Severe or significant emotional or psychological distress
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 21 at risk
Study: NCT03591354

Adverse event: Hyperglycemia or ketosis events without meeting criteria for Diabetic Ketoacidosis
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 55 at risk

Adverse event: Hyperglycemia or ketosis events without meeting criteria for Diabetic Ketoacidosis
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 55 at risk
Study: NCT03591458

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk
Study: NCT03591874

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 29 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk
Study: NCT03592186

Adverse event: Juvenile justice involvement
Serious: no
Organ System: Investigations
Frequency: 3 affected / 60 at risk

Adverse event: Juvenile justice involvement
Serious: no
Organ System: Investigations
Frequency: 3 affected / 62 at risk
Study: NCT03592277

Adverse event: Death due to sepsis or septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 54 at risk

Adverse event: Readmissions within 30 days
Serious: yes
Organ System: Infections and infestations
Notes: Readmissions within 30 days of index hospitalization
Frequency: 17 affected / 54 at risk

Adverse event: Death due to sepsis or septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 52 at risk

Adverse event: Readmissions within 30 days
Serious: yes
Organ System: Infections and infestations
Notes: Readmissions within 30 days of index hospitalization
Frequency: 15 affected / 52 at risk
Study: NCT03592368

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Notes: Expressed suicidal ideation in direct response to school stressor (with method and intent) but no plan or behavior. Emergency evaluation resulted in discharge to current outpatient care with no increase in level of care.
Frequency: 1 affected / 20 at risk

Adverse event: Suicidal behaviour
Serious: yes
Organ System: Psychiatric disorders
Notes: Hospitalization for aborted suicide attempt following family argument. Occurred after randomization but prior to exposure to intervention.
Frequency: 1 affected / 22 at risk
Study: NCT03592745

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: Subject suffered from the flu (unrelated to study intervention) and consequently missed repeated sessions. Subject was ultimately withdrawn from the study as a consequence.
Frequency: 1 affected / 18 at risk

Adverse event: Wrist fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Subject fractured wrist and was consequently unable to return for follow-up.
Frequency: 1 affected / 18 at risk
Study: NCT03592771

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: The reason or primary concern for hospitalizations was not collected.
Frequency: 15 affected / 104 at risk

Adverse event: Disease progression caused change in treatment
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 104 at risk

Adverse event: Side effects from AET caused change in treatment
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 104 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: The reason or primary concern for hospitalizations was not collected.
Frequency: 9 affected / 98 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: The reason or primary concern for hospitalizations was not collected.
Frequency: 6 affected / 102 at risk

Adverse event: Side effects from AET caused change in treatment
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 102 at risk
Study: NCT03593200

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Administration site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Injection site discolouration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 4 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 4 at risk

Adverse event: Scrotal irritation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 4 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk
Study: NCT03593473

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 54 at risk
Study: NCT03593538

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 26 at risk

Adverse event: Increased Sweating
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Minor Head Injury
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

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

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

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 21 at risk

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

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 22 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 22 at risk

Adverse event: Increased Sweating
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Mouth Sores
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 22 at risk
Study: NCT03593629

Adverse event: Hospitalization, caesarian
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Caesarian section; unrelated to study medication
Frequency: 1 affected / 166 at risk

Adverse event: Hospitalization, Intrauterine fetal death
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Hospitalization and induced delivery due to Intrauterine fetal death ; unrelated to study medication
Frequency: 1 affected / 166 at risk

Adverse event: Hospitalization, normal delivery
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Normal delivery; unrelated to study medication
Frequency: 1 affected / 166 at risk

Adverse event: Hospitalization, hysterectomy
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Hysterectomy, dysfunctional uterine bleeding; unrelated to study medication
Frequency: 1 affected / 163 at risk

Adverse event: Hospitalization, ectopic pregnancy
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Ectopic pregnancy; unrelated to study medication
Frequency: 1 affected / 163 at risk
Study: NCT03593681

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 130 at risk

Adverse event: Intra-abdominal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 130 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 130 at risk

Adverse event: Uterine perforation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 130 at risk

Adverse event: Fallopian tube perforation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 130 at risk
Study: NCT03593772

Adverse event: Suicide Ideation
Serious: no
Organ System: Social circumstances
Notes: Participants reported suicide ideation as part of Patient Reported Outcomes. All Suicide Ideation was escalated to the Veteran's Mental Health provider as per protocol and VA policies.
Frequency: 7 affected / 196 at risk

Adverse event: Suicide Ideation
Serious: no
Organ System: Social circumstances
Notes: Participants reported suicide ideation as part of Patient Reported Outcomes. All Suicide Ideation was escalated to the Veteran's Mental Health provider as per protocol and VA policies.
Frequency: 7 affected / 168 at risk
Study: NCT03594045

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

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

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

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Nail discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

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

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

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

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk
Study: NCT03594123

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 163 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 163 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 163 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 163 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 163 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 163 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 163 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 96 at risk
Study: NCT03594175

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 253 at risk

Adverse event: Clostridium difficile infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 253 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 253 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 253 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 253 at risk

Adverse event: Device breakage
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 253 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 253 at risk

Adverse event: Polyneuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 168 at risk
Study: NCT03594266

Adverse event: Persistent post-surgical site pain
Serious: no
Organ System: Surgical and medical procedures
Notes: Commercial Trial Period Related
Frequency: 1 affected / 59 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Notes: Commercial Trial Period Related
Frequency: 1 affected / 59 at risk

Adverse event: Reaction from wound dressing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: SCS Trial Lead Implant Procedure-Related
Frequency: 1 affected / 38 at risk

Adverse event: Reaction from wound dressing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Commercial Trial Period Related
Frequency: 1 affected / 38 at risk

Adverse event: Neurostimulator device entered "safe mode"
Serious: no
Organ System: Product Issues
Notes: Unknown Relationship to the Investigational Device
Frequency: 1 affected / 38 at risk

Adverse event: Irritation from wound dressing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: SCS Trial Lead Implant Procedure-Related
Frequency: 1 affected / 39 at risk

Adverse event: Lead dislodgement
Serious: no
Organ System: Surgical and medical procedures
Notes: SCS Trial Lead Implant Procedure-Related
Frequency: 1 affected / 39 at risk

Adverse event: Reaction from wound dressing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Commercial Trial Period Related
Frequency: 1 affected / 39 at risk
Study: NCT03595384

Adverse event: Mild injuries
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hamstring strain, calf strain, or Achilles' tendinitis
Frequency: 5 affected / 41 at risk