TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03297294

Adverse event: Product intolerance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 69 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 69 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 69 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 69 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 69 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 69 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 69 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 69 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 69 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 69 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 69 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 66 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 66 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 66 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 66 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 66 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 66 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 14 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk
Study: NCT03297645

Adverse event: Child hospitalization due to asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 118 at risk

Adverse event: Child emergency department visit due to asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 48 affected / 118 at risk

Adverse event: Child rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash on face due to unwashed pillowcase cover
Frequency: 1 affected / 118 at risk

Adverse event: Child hospitalization due to asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 69 at risk

Adverse event: Child cancer diagnosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 69 at risk

Adverse event: Child emergency department visit due to asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 69 at risk

Adverse event: Child rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash on face due to unwashed pillowcase cover
Frequency: 1 affected / 69 at risk

Adverse event: Child hospitalization due to asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 63 at risk

Adverse event: Child emergency department visit due to asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 63 at risk
Study: NCT03297944

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

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

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk
Study: NCT03298048

Adverse event: Hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: 60 days after Fecal microbiota transplantation (FMT), stool C. difficile toxin was negative but diarrhea continued. 3 months later, subject had colon removed because of ulcerative colitis and was released from the hospital 3 days after colon removal.
Frequency: 1 affected / 4 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk
Study: NCT03298113

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

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

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

Adverse event: Device adhesion issue
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 10 at risk

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

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk
Study: NCT03298412

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1 at risk
Study: NCT03298477

Adverse event: Bleeding/Anemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 98 at risk

Adverse event: Bowel
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 98 at risk

Adverse event: Cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 98 at risk

Adverse event: Malignancies
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 98 at risk

Adverse event: Miscellaneous
Serious: yes
Organ System: General disorders
Frequency: 19 affected / 98 at risk

Adverse event: Nellix Device
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 98 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 98 at risk

Adverse event: Pulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 98 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 98 at risk

Adverse event: Surgical Site Wound
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 98 at risk

Adverse event: Urogenital
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 98 at risk

Adverse event: Vascular
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 98 at risk

Adverse event: Bowel
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 98 at risk

Adverse event: Cardiac
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 98 at risk

Adverse event: Nellix Device
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 98 at risk

Adverse event: Malignancies
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 98 at risk

Adverse event: Miscellaneous
Serious: no
Organ System: General disorders
Frequency: 12 affected / 98 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 98 at risk

Adverse event: Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 98 at risk

Adverse event: Surgical Site Wound
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 98 at risk

Adverse event: Urogenital
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 98 at risk

Adverse event: Vascular
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 98 at risk
Study: NCT03298880

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 75 at risk
Study: NCT03298945

Adverse event: Colorectal cancer diagnosed on colonoscopy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1139 at risk

Adverse event: Hospitalization for mania and psychosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1139 at risk

Adverse event: Hospitalization for lung surgery
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1139 at risk

Adverse event: Hospitalization for respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1139 at risk

Adverse event: Hospitalization for DKA
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1139 at risk

Adverse event: Colorectal cancer diagnosed on colonoscopy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 1100 at risk
Study: NCT03299101

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Patient described slight chest discomfort and tingling to staff, staff noticed that patient was disoriented.
Frequency: 1 affected / 35 at risk

Adverse event: Suspected ischemic stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 35 at risk

Adverse event: Unrelated inpatient hospitalization
Serious: yes
Organ System: General disorders
Notes: Chest pain, shortness of breath, shaking chills after surgery
Frequency: 1 affected / 35 at risk

Adverse event: Detox
Serious: yes
Organ System: General disorders
Notes: Inpatient prior to surgery for detox.
Frequency: 1 affected / 35 at risk

Adverse event: Unrelated inpatient hospitalization
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hospitalization for shortness of breath
Frequency: 1 affected / 35 at risk

Adverse event: Post-operative pain unrealted inpatient hospitalization
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 35 at risk

Adverse event: Second unexpect surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: Patient needed a second, unexpected surgery. Unrelated to this protocol.
Frequency: 1 affected / 35 at risk
Study: NCT03299166

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 122 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 122 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 122 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 122 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 122 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 122 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 122 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 122 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 122 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 122 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 122 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 122 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 122 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 122 at risk
Study: NCT03300206

Adverse event: Anticipated Adverse Events
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Most of the observed anticipated adverse events were related to syncope/fainting/panic attack/excessive bleeding (1 case)/hematoma (1 case). All these events were resolved the same day they started.
Frequency: 9 affected / 316 at risk

Adverse event: Anticipated Adverse Events
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Most of the observed anticipated adverse events were related to syncope/fainting/panic attack/excessive bleeding (1 case)/hematoma (1 case). All these events were resolved the same day they started.
Frequency: 4 affected / 209 at risk
Study: NCT03300427

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Blood potassium increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk
Study: NCT03300544

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pain (lower back)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: ANC low
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3 at risk

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

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

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

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

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk
Study: NCT03300570

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 13 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 14 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Skin and subcut tissue disord - Oth spec
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk
Study: NCT03300648

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Respiratory problems from ventilator
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 17 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 17 at risk
Study: NCT03300674

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 77 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 77 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 77 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 77 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 77 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 77 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 77 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 77 at risk
Study: NCT03300752

Adverse event: presumed myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: The participant experienced a sudden unexplained death at home. The family reported that the participant's clinician attributed it as likely "a heart attack'
Frequency: 1 affected / 40 at risk

Adverse event: emergency department visit
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 40 at risk

Adverse event: emergency department visit
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 40 at risk
Study: NCT03300843

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

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

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

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

Adverse event: Skin induration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1 at risk
Study: NCT03301272

Adverse event: Weakness of Injected Limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 16 at risk

Adverse event: Pain of Injected Limb
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Weakness of Injected Limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 16 at risk