TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01523756

Adverse event: Skin irritation (peristomal)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 19 at risk

Adverse event: Itchy peristomal skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 19 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Notes: Not related to the testproducts
Frequency: 1 affected / 19 at risk

Adverse event: sclerose attack
Serious: no
Organ System: Nervous system disorders
Notes: Not related to the testproducts
Frequency: 1 affected / 19 at risk

Adverse event: Herpes on the back of the thigh
Serious: no
Organ System: Infections and infestations
Notes: Not related to the testproducts
Frequency: 1 affected / 19 at risk

Adverse event: candidiacis on labia
Serious: no
Organ System: Infections and infestations
Notes: candidadiacis
Frequency: 1 affected / 19 at risk

Adverse event: Skin irritation (peristomal)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 18 at risk

Adverse event: Bleeding peristomal skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Itchy peristomal skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 18 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not related to the testproducts
Frequency: 2 affected / 18 at risk

Adverse event: Gastroenterit
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Gastroenterit
Serious: no
Organ System: Gastrointestinal disorders
Notes: Not related to the testproducts
Frequency: 1 affected / 20 at risk

Adverse event: Urin retension
Serious: no
Organ System: Renal and urinary disorders
Notes: Not related to the testproducts
Frequency: 1 affected / 20 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Notes: Not related to the testproducts
Frequency: 1 affected / 20 at risk

Adverse event: febrilia
Serious: no
Organ System: Infections and infestations
Notes: Not related to the testproducts
Frequency: 1 affected / 20 at risk

Adverse event: pain in bladder/Tenesmi
Serious: no
Organ System: Renal and urinary disorders
Notes: Not related to the testproducts
Frequency: 1 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Notes: Not related to the testproducts
Frequency: 1 affected / 20 at risk

Adverse event: elevated prostataspecific antigen
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Not related to the testproducts
Frequency: 1 affected / 20 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Not related to the testproducts
Frequency: 1 affected / 20 at risk
Study: NCT01523834

Adverse event: Urinary tract pain
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 35 at risk

Adverse event: Acute renal injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: Pancytopenia and Gastroenteritis with dehydratation and acute renal failure.
Frequency: 1 affected / 35 at risk

Adverse event: Parossistic atrial fibrillation and congestive heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 35 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Nodular lesion rigth breast
Frequency: 1 affected / 35 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 35 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 35 at risk

Adverse event: Subileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Nausea, vomit, diarrea, ipoK+, atc prolonged
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 35 at risk

Adverse event: Diplegia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 35 at risk

Adverse event: Aortic aneurysm rupture
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 35 at risk

Adverse event: Disease progression
Serious: no
Organ System: General disorders
Frequency: 8 affected / 35 at risk
Study: NCT01523886

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Postoperative observation
Frequency: 1 affected / 25 at risk

Adverse event: Readmission to hospital
Serious: yes
Organ System: Surgical and medical procedures
Notes: Undiagnosed gallstones in the common bile duct
Frequency: 2 affected / 25 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 25 at risk

Adverse event: Pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 25 at risk

Adverse event: Headache and vertigo
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 25 at risk

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

Adverse event: Hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Postoperative observation
Frequency: 1 affected / 23 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 23 at risk

Adverse event: Headache and vertigo
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 23 at risk

Adverse event: Bleeding from sutur
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 23 at risk
Study: NCT01523964

Adverse event: scab on left ankle abrasion dislodged
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject has prior left ankle abrasion with scab. During 6 minute walk scab was dislodged during a fall.
Frequency: 1 affected / 31 at risk
Study: NCT01524198

Adverse event: Fine tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 448 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 448 at risk

Adverse event: Fine tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 458 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 458 at risk
Study: NCT01524536

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 23 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 23 at risk

Adverse event: Swelling face
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 23 at risk

Adverse event: Fluid retention
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 23 at risk

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

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

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 23 at risk

Adverse event: Polyuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 23 at risk
Study: NCT01524627

Adverse event: Coughing (mild)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Dizziness (mild)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 22 at risk

Adverse event: Headache (mild)
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 22 at risk

Adverse event: Nausea (mild)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: Nausea (moderate)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Sedation/Drowsiness (mild)
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 22 at risk

Adverse event: Vivid Dreams (mild)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 22 at risk

Adverse event: Upper Respiratory Infection (moderate)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Nausea (mild)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 21 at risk

Adverse event: Nausea (moderate)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Sedation/Drowsiness (mild)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Skin Irritation (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 21 at risk
Study: NCT01524770

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 47 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 47 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 47 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 47 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 49 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 49 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 49 at risk
Study: NCT01524796

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 4 affected / 128 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 128 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 128 at risk

Adverse event: Vertigo
Serious: no
Organ System: General disorders
Frequency: 3 affected / 128 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 3 affected / 128 at risk

Adverse event: Increase in weight
Serious: no
Organ System: General disorders
Frequency: 3 affected / 128 at risk

Adverse event: Palpitations
Serious: no
Organ System: General disorders
Frequency: 1 affected / 128 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 128 at risk

Adverse event: Reduced energy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 128 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 1 affected / 128 at risk

Adverse event: Depression
Serious: no
Organ System: General disorders
Frequency: 1 affected / 128 at risk

Adverse event: Mood
Serious: no
Organ System: General disorders
Frequency: 1 affected / 128 at risk

Adverse event: Head ache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 128 at risk

Adverse event: Constipation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 128 at risk
Study: NCT01524900

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 246 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 246 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 246 at risk
Study: NCT01525173

Adverse event: Oesophageal carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 70 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 70 at risk

Adverse event: Prolonged hospitalization cardiac ischemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 67 at risk

Adverse event: Exacerbation of depression disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 67 at risk
Study: NCT01525225

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 2 at risk
Study: NCT01525238

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

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

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

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

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk
Study: NCT01525329

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Notes: Patient with lupus antioagulant, hospitalized for 2 transient ischemic attacks. Not thought to be related in any way to the skin photodynamic therapy.
Frequency: 1 affected / 4 at risk
Study: NCT01525407

Adverse event: DAH
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Fever/Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 38 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pneumotosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pulmonary Emboli
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Graft versus host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 7 affected / 38 at risk

Adverse event: Relapse
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: IPS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Nausea/Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: EBV-PTLD
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 38 at risk
Study: NCT01525420

Adverse event: No AE term known- see description
Serious: yes
Organ System: Social circumstances
Notes: Unrelated to the study, bipolar participant hospitalized.
Frequency: 1 affected / 59 at risk

Adverse event: No AE term known - see description
Serious: yes
Organ System: Social circumstances
Notes: Unrelated to the study, a participant was robbed and hospitalized.
Frequency: 1 affected / 59 at risk
Study: NCT01525563

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1000 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Adenomyosis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1000 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1000 at risk
Study: NCT01525849

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastoenteritis reported at 118 days post procedure (unrelated).
Frequency: 1 affected / 76 at risk

Adverse event: Atypical Chest Pain
Serious: yes
Organ System: Cardiac disorders
Notes: Participant underwent tests to rule out coronary artery disease. Participant withdrew before study procedure (unrelated).
Frequency: 1 affected / 75 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Methicillin-resistant Staph aureus infection and cellulitis on the nasal tip reported at 276 days post procedure (unrelated).
Frequency: 1 affected / 75 at risk
Study: NCT01525862

Adverse event: Complication of diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Notes: Participant was hospitalized for complications related to diabetes mellitus. The event is not related to the study device or procedure.
Frequency: 1 affected / 21 at risk
Study: NCT01525875

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: diarrhea
Frequency: 10 affected / 22 at risk

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

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

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

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

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Notes: Sinus, Dental, urinary
Frequency: 1 affected / 22 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: diarrhea
Frequency: 9 affected / 22 at risk

Adverse event: Loose Stool
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Flatulance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

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

Adverse event: Increased bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 22 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 22 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 22 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Notes: Sinus, Dental, urinary
Frequency: 5 affected / 22 at risk
Study: NCT01526577

Adverse event: Nausea and so on.
Serious: no
Organ System: Gastrointestinal disorders
Notes: One of the related AE.
Frequency: 43 affected / 82 at risk

Adverse event: Nausea and so on.
Serious: no
Organ System: Gastrointestinal disorders
Notes: One of the related AE.
Frequency: 10 affected / 10 at risk

Adverse event: Nausea and so on.
Serious: no
Organ System: Gastrointestinal disorders
Notes: One of the related AE.
Frequency: 8 affected / 21 at risk
Study: NCT01526629

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 354 at risk

Adverse event: Ventricular arrhytmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 354 at risk

Adverse event: Cardiac decompensation
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 354 at risk

Adverse event: Atrial arrhytmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 354 at risk

Adverse event: Infection or pocket hematoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 354 at risk

Adverse event: Event of aggravation
Serious: yes
Organ System: Cardiac disorders
Notes: dyspnea, heart failure, stroke...
Frequency: 6 affected / 354 at risk

Adverse event: cardiovascular procedures
Serious: yes
Organ System: Cardiac disorders
Notes: stent, ablation, transplantation..;
Frequency: 4 affected / 354 at risk

Adverse event: cardiovascular complication
Serious: yes
Organ System: Cardiac disorders
Notes: aneurysm, pericarditis, stenosis...
Frequency: 5 affected / 354 at risk

Adverse event: Non cardiovascular causes
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 354 at risk

Adverse event: Integrity default of material components
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 354 at risk