TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00530920

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 30 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 30 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 25 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 28 at risk

Adverse event: Aspartate aminotransferase increaset
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 28 at risk

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 28 at risk
Study: NCT00530946

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 43 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 41 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 41 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 41 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 41 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 41 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk
Study: NCT00531011

Adverse event: Cardiac death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 101 at risk

Adverse event: Coronary artery dissection
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 101 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 101 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 101 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 101 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Thrombosis in device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Vascular stent stenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 101 at risk

Adverse event: Complication associated with device
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Events under Mechanical complication are plaque shifts. There is no exact code for this event in MedDRA
Frequency: 4 affected / 101 at risk

Adverse event: Procedural complications
Serious: yes
Organ System: General disorders
Notes: Events in this code wer failure of the stent to cross the lesion and failure of the wire to cross the lesion. There are no exact codes for these events in MedDRA.
Frequency: 2 affected / 101 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 91 at risk

Adverse event: Coronary artery dissection
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 91 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 91 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 91 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 91 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 91 at risk

Adverse event: Vascular stent stenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 91 at risk

Adverse event: Complication associated with device
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Events under Mechanical complication are plaque shifts. There is no exact code for this event in MedDRA
Frequency: 2 affected / 91 at risk

Adverse event: Angiocardiogram
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 91 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 91 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 91 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 91 at risk
Study: NCT00531206

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 65 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 65 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 65 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 65 at risk
Study: NCT00531518

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 87 at risk

Adverse event: Negative events
Serious: no
Organ System: Psychiatric disorders
Notes: "Negative events" is the measure that includes hospitalizations, incarcerations, assaults, suicides and suicide attempts. It is the sum of such events within each experimental treatment condition.
Frequency: 19 affected / 87 at risk

Adverse event: Negative events
Serious: no
Organ System: Psychiatric disorders
Notes: "Negative events" is the measure that includes hospitalizations, incarcerations, assaults, suicides and suicide attempts. It is the sum of such events within each experimental treatment condition.
Frequency: 51 affected / 205 at risk
Study: NCT00531843

Adverse event: Drop in hematocrit
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 81 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 81 at risk

Adverse event: Superficial nonoccluding clots
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 81 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 6 at risk
Study: NCT00531882

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: joint pain possibly related to simvastatin
Frequency: 2 affected / 10 at risk
Study: NCT00532480

Adverse event: decreased libido
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 10 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 10 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 10 at risk

Adverse event: crying more often
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Panic attack
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

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

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

Adverse event: Nervousness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Premature ejaculation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 10 at risk
Study: NCT00533117

Adverse event: Hospitalization or ED visitn
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 18 at risk

Adverse event: Hospitalization or ED visitn
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 20 at risk
Study: NCT00533351

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

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

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 7 at risk

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

Adverse event: Leukocyturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2 at risk

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

Adverse event: Pityriasis rosea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Renal pain
Serious: no
Organ System: Renal and urinary disorders
Notes: Event occurred during Period 3 (Observational/No Treatment)
Frequency: 1 affected / 2 at risk
Study: NCT00533442

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 31 affected / 86 at risk

Adverse event: Major Cardiovascular Event
Serious: yes
Organ System: Vascular disorders
Frequency: 15 affected / 86 at risk

Adverse event: New Onset Diabetes Mellitus Type 2 after Transplant (NODAT)
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 86 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 32 affected / 84 at risk

Adverse event: Major Cardiovascular Event
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 84 at risk

Adverse event: New Onset Diabetes Mellitus Type 2 after Transplant (NODAT)
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 84 at risk
Study: NCT00533468

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 28 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 24 at risk
Study: NCT00533507

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 230 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 230 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 230 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 230 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 230 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 230 at risk

Adverse event: Dermatitis atopic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 230 at risk

Adverse event: Dermatitis diaper
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 230 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Gastroenteritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 230 at risk

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 230 at risk

Adverse event: Meningitis aseptic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 230 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 230 at risk

Adverse event: Vesicoureteric reflux
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 230 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 54 affected / 230 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 146 affected / 230 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 144 affected / 230 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 139 affected / 230 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 190 affected / 230 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 153 affected / 230 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 203 affected / 230 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 159 affected / 230 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 55 affected / 230 at risk
Study: NCT00534001

Adverse event: Any Non-Serious Adverse Event
Serious: no
Organ System: General disorders
Notes: Adverse events (not including serious) only tracked for clinical monitoring; all participants noted at least one adverse event during the 8-week period of monitoring.
Frequency: 48 affected / 48 at risk

Adverse event: Any Non-Serious Adverse Event
Serious: no
Organ System: General disorders
Notes: Adverse events (not including serious) only tracked for clinical monitoring; all participants noted at least one adverse event during the 8-week period of monitoring.
Frequency: 47 affected / 47 at risk
Study: NCT00534118

Adverse event: All cause mortality by 3 years after first DLI
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 15 at risk

Adverse event: All cause mortality by 3 years after first DLI
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 12 at risk
Study: NCT00534209

Adverse event: Grade 3 Edema limbs
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1 at risk

Adverse event: Grade 3 Vascular access complication
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1 at risk
Study: NCT00534365

Adverse event: Bladder injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 136 at risk

Adverse event: Transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 136 at risk

Adverse event: Ureteric injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 136 at risk

Adverse event: Bowel injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 136 at risk

Adverse event: Bladder injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 127 at risk

Adverse event: Bowel injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 127 at risk
Study: NCT00534404

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 827 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 827 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Reports of participants' deaths were received third person after the fact. These adverse events were classified by the Institutional Review Board as unrelated to study, unexpected.
Frequency: 2 affected / 828 at risk
Study: NCT00534703

Adverse event: LVAD Alarm
Serious: yes
Organ System: Product Issues
Notes: LVAD Alarm and power increase with hospital admission
Frequency: 1 affected / 4 at risk

Adverse event: Worsening heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: Heart transplantation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 4 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Vessel puncture, site haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Iron deficiency - Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

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

Adverse event: Site Bleeding
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

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

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Device alarm issue
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 4 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 4 at risk

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

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1 at risk
Study: NCT00534937

Adverse event: Cellulitis / Infection of lower extremity
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 42 at risk

Adverse event: Cellulitis / Infection of lower extremity
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 42 at risk

Adverse event: Cellulitis / Infection of lower extremity
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 47 at risk
Study: NCT00535392

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 33 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 33 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 33 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 33 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 33 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 33 at risk